Spring Update from Capitol Hill – SAFE Banking, the MORE Act, and Appropriations
Photo By CannabisCamera.com
by Michelle Rutter Friberg, NCIA’s Deputy Director of Government Relations
It’s hard to believe that somehow it’s March again, but all the while, the NCIA team in D.C. has been hard at work lobbying and advocating on behalf of you and your business. Things are really beginning to warm up and spring into action, so keep reading below for a quick update on where things are at with SAFE Banking, comprehensive reform, appropriations, and more!
SAFE Banking
Bill reintroductions in both chambers have been off to a slow start. Between a new session, most people still working remotely, a delayed organizing resolution in the Senate, and a somewhat contentious COVID relief package that’s finallypassed, members of Congress and their staff have been incrediblybusy. But, now that that’s all behind us, I’d suggest preparing for many cannabis bills to be introduced soon.
Specifically, you can expect the reintroduction of the SAFE Banking Act to happen in both the House of Representatives and the Senate within the next couple of weeks. When the bill was introduced in the House during the 116th Congress, it had over 100 cosponsors. In the Senate, it was introduced with more than 20 — that’s more than a fifth of the entire chamber! The bill later went on to be passed by the entire House of Representatives in September 2019 by a vote of 321-103.
You’ll remember that the SAFE Banking Act addresses urgent public safety concerns by allowing tightly regulated marijuana businesses the ability to access the banking system and make our communities safer. The bill also provides protections from money laundering laws for any proceeds derived from these state-legal marijuana businesses. The bill also includes the Financial Institution Customer Protection Act and protections for hemp and hemp-derived CBD-related businesses, which sometimes still struggle in accessing financial services despite the legalization of hemp in the 2018 Farm Bill.
Don’t expect any big changes, however — the bill this Congress includes minor technical changes to the safe harbor language, strengthened hemp provisions, and other technical updates.
Comprehensive Reform
While SAFE Banking’s timeline is clear, the same can’t completely be said for more comprehensive reform. When I say comprehensive reform, I’m talking specifically about bills that would remove marijuana from the Controlled Substances Act like the MORE Act and the upcoming Schumer-Booker-Wyden bill.
In the House, we are continuing to work with various committees and members to determine the best path forward for the MORE Act and what changes should be made. I wouldn’t be surprised if that bill gets reintroduced sometime this spring, but the process is truly still in flux, so I also wouldn’t be surprised if it was postponed awhile. This will be determined by the lead sponsors’ offices and also by the congressional calendar and how various bills/issues move through the legislative process.
In the Senate, we’re excited to be working with Leader Schumer (D-NY) and Sens. Booker (D-NJ) and Wyden (D-OR) on their new cannabis bill. That bill will draw heavily on provisions from the MORE Act, but will also include expanded language on taxation and smart regulations. Now that the COVID relief bill has passed into law, I think we can expect to see their bill be introduced sometime in the near future.
You’ll also remember that NCIA was one of two industry trade associations invited to the initial meeting with those Senators to discuss this new bill. We’re looking forward to their discussion draft and offering our thoughts.
Appropriations
It’s spring, which means it’s appropriations season here in D.C.! These bills are legislation that “appropriates,” or sets aside, federal funds to be divided between specific federal government departments, agencies, and programs. For a refresh on the history of appropriations, click here, or, if you’re interested in how these provisions relate to cannabis, click here.
While the appropriations amendment that protects medical cannabis businesses, patients, and programs has been in law since 2014, we’ve had difficulty expanding those provisions and passing new cannabis-related amendments due to the formerly-Republican controlled Senate. However, now that Democrats control both houses of Congress, we’re excited to go back to the drawing board and get creative with the appropriations process to help provide some certainty and relief to the cannabis industry.
We’ll be looking at amendments pertaining to adult-use cannabis programs, banking, veterans access, allowing Washington, D.C. to finally implement a functioning 21+ cannabis program — and that’s just scratching the surface!
All of this is to say: things are really springing into action in D.C.! Prepare for many cannabis bills to begin getting reintroduced, and remember that the appropriations process takes months, so stay tuned via our blog, newsletter, NCIA Connect, and the new NCIA Mobile App to remain in the loop and get involved!
Valentine’s Day is coming. To some, it will be a wonderful day filled with candy and gifts and expressions of devotion. To others, it feels like an obligation designed to enrich greeting card companies, jewelry stores, and florists.
Whichever side of the fence you fall on, the fact is, this is one of the most important periods for retailers. According to the National Retail Federation, Valentine’s Day spending in 2020 totaled about $27.4 billion.
And with all this spending, brands really matter.
For instance, who wouldn’t want to get a silver or white gold necklace from Tiffany? Truthfully, it’s not that different from other necklaces on the market that are just a fraction of the price, but those don’t come with the Tiffany name and that iconic powder blue rigid box packaging.
The Unboxing Makes It Special
Beautiful packaging provides the foundation for companies to build a luxury brand and command higher prices in the marketplace. It’s how Harry and David can charge $40 for the box of 9 pears I received for the holidays.
I know their fruit is top of the line quality, but I just checked and I can get pears for about a buck each at my local Whole Foods. That’s more than just a bit of a difference!
What makes the price palatable and the product premium is the packaging.
Steve Jobs knew this and insisted that Apple products were always creatively packaged. “Packaging can be theater,” he said. “It can create a story.”
A beautiful package leaves a lasting impression. When a consumer has a hard time throwing away the box a gift came in, it’s a sign your brand is on the right track. How many of you kept the box your iPhone came in? I know I did and probably still have it.
Whether it is the precise fit of Apple’s packaging that makes you wonder how all those items fit so perfectly inside, or the fresh-off-the-farm feeling you get when opening a gift from Harry and David, luxury brands rely on premium packaging to help convey the idea that they are truly special and worth the higher price.
Cannabis Love
While Valentine’s Day isn’t as big a holiday in the cannabis world as 420, it does generate an impressive boost in sales.
Point-of-sale data from the cannabis software firm Flowhub and analytics company Headset found that Valentine’s Day spending increased among recreational consumers with sales jumping 20-32 percent over a typical day. Infused “mocktails” had the largest jump with sales rising 596 percent above normal.
Bath products and salts increased by 186 percent. Massage oil and lubricant sales rose by 88 percent.
Infused chocolates increased 33% and infused gummies rose 43%.
And the single most important factor in purchasing decisions, whether in the mainstream or the cannabis sector, is branding.
An article in Civilized said that cannabis products can be made exceptional and more valuable by communicating their distinctive properties through the branding process.
“Branding in the cannabis industry is what makes an agricultural product and the business that refines the plant more distinctive,” the article stated. “Branding creates an emotional connection, and when done effectively, branding can prevent products or services from failing.”
And with limited options to build a cannabis brand through traditional media, the packaging becomes even more vital to the product’s success.
The importance of packaging cannot be overstated. It is one of the strongest factors that influence a purchasing decision. It provides the first impression of the product to the consumer and it is the last thing they see before making their selection.
Not only can good quality packaging grab a consumer’s attention, but it can also communicate a brand’s messaging and convey key competitive differences. Conversely, some otherwise excellent products fail due to inferior packaging.
Therefore, it is vital that packaging is carefully designed so that it builds the brand, stimulates sales, conveys key messaging, and generates consumer loyalty.
So, this Valentine’s Day, whether you celebrate with cannabis or candy or not at all, remember that brands matter. People want gifts from the brands they know, trust, and aspire to own.
Personally, I am hoping to luxuriate in a tub filled with infused bath salts while opening a special little blue box (Jon, are you listening?).
Happy Valentine’s Day!
Kary Radestock, CEO, launched Hippo Premium Packaging in March 2016 offering an array of services to the cannabis market, including: Marketing Strategy, Brand Development, Social Media, Public Relations, Graphic and Web Design, and of course, Printing and Packaging. Radestock brings over 20 years of award-winning print and packaging expertise, and leads a team of the nation’s top brand builders, marketers and print production experts. Hippo works with businesses looking for a brand refresh or an entire brand development, and specializes in helping canna-business get their products to market in the most beautiful and affordable way possible. Radestock’s Creative Collective of talent and experts, allows her to offer world-class solutions to support the unique needs of the Cannabis Industry.
Member Blog: Hemp Production, Testing, and the FDA
The new U.S. Domestic Hemp Program will approve cultivation plans issued by states and Indian Tribes and can approve plans submitted by producers that live in a state or Tribe where plans are not already submitted and where hemp production is not forbidden. According to the USDA website, 28 states and Puerto Rico and U.S. Virgin Islands have had their hemp plans approved by the USDA, 11 states have plans under review, 5 states have obtained a license from USDA, 5 are electing to continue under the 2014 Hemp Pilot Program, Colorado is resubmitting their plan, Alaska is drafting their plan, and Idaho is awaiting state legislation. What is surprising is that some of the biggest hemp growing states, such as Montana (44,910 acres), Colorado (20,330 acres) and Kentucky (18,910 acres) do not yet have their plans approved by the USDA. Montana is choosing to operate under the 2014 Hemp Pilot Program, Colorado is resubmitting their plan to USDA and Kentucky’s plan is still under review.
While there has been a rush to plant hemp by farmers eager to cultivate a high-priced crop with enormous demand, there has not been the same rush to set up extraction facilities. This is a critical step for the manufacture of cannabidiol (CBD) raw material. Hemp must be dried properly before extraction or it will rot so cultivating a plant that is susceptible to rot without an assigned material manufacturer (extractor) is risky. The impact of the differences between hemp and typical crop cultivation for farmers and the lack of extraction companies has been disastrous for some farmers. Hemp must be monitored for THC levels as the crop grows because any hemp harvested with an amount of THC over 0.3% must be destroyed. This is completely different from soy or cotton cultivation. And when the cost of clones to plant in a large field is included, the potential loss increases dramatically.
Then there are the Food and Drug Administration (FDA) hemp/CBD product issues. While there has been positive movement towards the legal sale of hemp products on the USDA cultivation side, the FDA has authority over foods and dietary supplements, and the FDA’s position is that the addition of hemp/CBD to a food or dietary supplement is “violative.” There is speculation that dietary supplement FDA rules are imminent but until the FDA makes those rules public, sales of finished product is still illegal.
In a Consumer Update statement revised on November 25, 2019 the FDA clearly stated that “it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.” Numerous warning letters have been issued by FDA to CBD manufacturers for disease claims about their products. Whether sold as dietary supplements, conventional foods, cosmetics, animal food, so of the violative disease claims include pain relief, anti-inflammatory, diabetes, acne, anxiety, depression, and cancer. For example, one Warning Letter issued by FDA on November 22, 2019, cites 45 diseases. FDA has stated that CBD in products sold as dietary supplements does not meet the definition of a dietary ingredient in the Federal Food, Drug, and Cosmetic Act (321(ff)(B)(i)(ii)). This provision clarifies that a dietary ingredient cannot be a substance that has been approved as an active ingredient in a drug. FDA has approved CBD as an active pharmaceutical ingredient in the drug Epidiolex. Although the FDA is only taking enforcement action on companies making products that contain disease claims, once the disease claim is made the FDA will cite other regulatory enforcement issues. Companies not making disease claims have not been targeted for enforcement yet. Several states, including New York and Oregon, are following the FDA’s lead by banning some products containing CBD, mostly infused food.
In addition to these challenges, there have been a series of class-action lawsuits filed against hemp/CBD manufacturers. These are based on the fact that the FDA has stated hemp and CBD is illegal in food and dietary supplements. The lawsuits claim the plaintiffs suffered economic loss because the products were not dietary supplements according to the FDA. The 11th Circuit Court of Appeals is allowing the consumer injury requirement necessary to sustain a complaint to be satisfied by the allegation that an FDA product is “illegal.” This ruling may open the floodgates for more class-action lawsuits.
All testing of hemp must be performed by a laboratory with a Drug Enforcement Agency (DEA) license. This is because hemp that does not meet the less than 0.3% tetrahydrocannabinol (THC) does not fall under the industrial hemp definition and is still under the jurisdiction of the DEA. A list of U.S.-based licensed laboratories is available on the DEA website and also on the USDA website. Pesticide screening is one of the tests dictated for hemp in the US Domestic Hemp Program. Ten pesticides have been approved for use on hemp by the Environmental Protection Agency (EPA). The latter is a notable step since the EPA could not do this before the removal of hemp from The Controlled Substances Act. Nine of the allowed pesticides are biopesticides and one is a conventional pesticide.
Then there is the matter of CBD as either a full-spectrum oil vs. an isolate. Unlike marijuana flower which is a very popular product, hemp flower is very rarely sold at the retail level. Full-spectrum oil is extracted from the plant, and depending on the solvent used, produces an oil with the same, or close to the same, naturally occurring chemicals from the plant. The oil, therefore, includes all the cannabinoids present along with any terpenes, lipids, or other compounds present in the plant. Full-spectrum oil is a botanical extract and is a dark thick oil. Isolate is produced by separating the constituents of the full spectrum oil by molecular weights or boiling points to have very pure chemicals in the 95%+ purity range. CBD isolate is a white crystalline substance and bears the greatest resemblance to synthetic raw material and at its purest form cannot be distinguished as coming from a plant in the dirt or a synthesized chemical. Full-spectrum oil bears the greatest resemblance to a botanical dietary supplement. It remains to be seen what the FDA will allow in the future.
I believe in this industry and I am rooting for the pioneers who have taken all the risk thus far, but am concerned about the lack of understanding over FDA’s authority particularly as this industry aims to transition to a regulated future. Most don’t understand FDA’s purview or don’t think it applies to them or their products. When that day comes, bringing the hemp industry into compliance with federal regulations will be challenging.
Hemp pioneers deserve to benefit from their labor and the risk they have taken. For those hemp product companies that do not think compliance is worth the effort or cost, there are many FDA compliant human food, animal food, dietary supplement, pharmaceutical, or cosmetic companies that are waiting to take your business…
Charlotte Peyton supports EAS Consulting Group hemp, CBD and hemp clients as well as that of dietary supplement and pharmaceuticals. As an independent consultant she assists with projects ranging from startup through manufacturing and support. Her expertise includes quality, regulatory and management, method development and method validation for FDA regulated drug, dietary supplement, and bioanalytical samples. She has extensive experience in writing validation protocols, reports and SOPs and assists with implementation of stability programs and report writing for finished products.
EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD. www.easconsultinggroup.com
Member Blog: Creating a Diverse, Inclusive, and Sustainable Cannabis Industry
This year, a national outcry against police violence and the impact of COVID-19 on Black and brown communities initiated a reckoning with the legacies of oppression and injustice in the U.S. Along with recognizing our institutionalized and internalized racism, we have started to come to terms with our economic inequality now that the income gap is worse than it has been in 50 years and three families alone control more wealth than 50% of Americans.
As with the rest of the country, the cannabis industry is lived differently based on the intersectionalities of race, class, gender, orientation, (dis)ability, and veteran status. For example, already wealthy, white, male individuals have amassed fortunes in cannabis with roughly 74% of U.S. cannabis businesses owned by men and 81% by whites, according to a 2017 Marijuana Business Daily survey.
After most states designated cannabis “essential” during COVID-19, private individuals, family funds, and pension funds plowed $2.6 billion into corporate cannabis, and multi-state operators posted record sales in the hundreds of millions. Earlier in September, the second cannabis exchange-traded fund (ETF) was announced which involves an investment portfolio of multi-state operators, REITs, and CBD companies. In contrast, Black and brown communities face mass incarceration for that same plant whereby African Americans are four times more likely nationally to be arrested for cannabis offenses than whites, while in states such as Kentucky and Montana, almost 10 times more likely, cited by a 2020 ACLU report.
These economic barriers to entry entrench the lack of representation in cannabis. For most entrepreneurs, the main obstacle to starting a cannabis business is the lack of access to traditional banking. It takes at least $300,000 to open a cannabis retail store, and up to millions of dollars for other cannabis enterprises, according to the 2019 Marijuana Business Factbook. Without traditional banking, most professionals finance their businesses through family wealth or personal contacts – 84% of U.S. cannabis companies are self-funded by founders, and 22% capture additional funding through a Family and Friends Round, cited by that same report. In this system, minority entrepreneurs are at a disadvantage. U.S. median household net worth ranges from $171,000 for white families to $17,600 for African Americans, $20,700 for Latinx, and $64,800 for “Other,” based on a 2016 Federal Reserve Board survey.
In addition to funding challenges, cannabis entrepreneurs must navigate onerous state and local regulations to obtain and maintain licensing. Some states have launched Social Equity Programs to help communities historically targeted by the criminalization of cannabis to now participate in the profits of legalization. However, even Illinois’s Social Equity Program, which is considered the gold standard, awarded only 21 out of its total 75 retail social equity licenses, leaving unclaimed 54 licenses that could have transformed the applicants’ economic circumstances. The 21 finalists were taken from a total pool of 1,667 applicants, which equates to only 1.3%. Low success rates stifle market entry and ensure that corporate, multi-state operators continue to saturate the cannabis space.
Beyond media proclamations, we must actualize an inclusive cannabis industry that reflects and celebrates the rich diversity of our community and provides equal opportunities to all professionals throughout the growth cycles of the market. We must operationalize sustainable businesses that produce unionized jobs and foster generational wealth. To do so, we must not only promote our own professional aspirations, but we must champion our friends’ and colleagues’ pathways into and up the cannabis industry.
While federal legalization remains the ultimate goal, local policies that would articulate a diverse, inclusive, sustainable cannabis industry must include explicitly legalized access to banking and finance, an overhaul of law enforcement and the criminal justice system, and social equity programs that encourage market activity. Until then, we must collectivize our professional resources and knowledge to build a true business community that empowers each of us to achieve our cannabis ambitions.
Rebecca Lee Katz is an attorney at an international law firm and President of Pakaloh LLC, the free business resource for an inclusive cannabis, CBD, and hemp industry. Pakaloh offers three types of membership which are all free, and members may select as many as they choose. Membership is available to 1) “Individuals”, including new and established entrepreneurs and professionals, 2) “Providers of Products”, or plant-touching businesses, and 3) “Providers of Services”, including ancillary services.
A WOC-owned company, Pakaloh provides its members with a comprehensive suite of services, starting with free information and discounts at financial institutions like banks, lenders, and payment processors that work in cannabis. Pakaloh also features free Business Tutorials that cover a range of cannabis topics from accounting to agriculture. These are informative, introductory online videos submitted by members that allow them to reach an audience of potential clients who may need to hire their services. Additionally, members may post and search for job opportunities.
Partner companies also offer discounts for members to use on individual and bulk orders. Members network on the site by accessing directories and sending messages directly to each other. Lastly, Pakaloh curates information on professional and activist organizations and events. Pakaloh is pledged to every community, and comes from pakalolo, an embrace of generations of the founder’s family in Hawai’i. Pakaloh holds true that no matter your roots, each of us aspires toward something greater than ourselves, be it our family, our nation, our cannabis movement.
Member Blog: GMPs – A Way Ahead for Hemp and CBD Firms
The hemp industry is the marijuana industry’s half-sister. Both are variations of the plant cannabis sativa and both were made illegal in 1937 with the passing of The Marijuana Tax Act. Flash forward to the Agriculture Improvement Act of 2018 (known as the 2018 Farm Bill) that was signed into law by Congress on December 20, 2018. One year later, The USDA issued interim regulations that entitled Establishment of a Domestic Hemp Production Program for the cultivation of hemp on October 31, 2019. Both were huge steps forward for public access to hemp and hemp products. FDA legalized the growing of hemp in states with a state-mandated hemp program and removed hemp and its derivatives from Drug Enforcement Administration (DEA) Schedule I status and the U.S. Domestic Hemp Program aims to approve cultivation plans issued by states and Indian Tribes.
Even so, then FDA Commissioner Scott Gottlieb issued a statement hours after the signing of the Farm Bill reiterating that “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”
Still today, two years later and counting, FDA only permits CBD products submitted as an Investigational New Drug (IND) Application as a pharmaceutical and there remains only one such accepted CBD product, Epidiolex, manufactured by G.W. Pharma. All other CBD products are illegal for interstate shipment.
In-state production and sales may be a different story, provided that state has a mandated hemp program. In those cases, provided state law is followed, production and sales are legal and protected, but the minute products cross state lines, they become the jurisdiction of the federal government and, more specifically, the FDA. At least 47 states have enacted legislation to establish hemp production programs or allow for hemp cultivation research.
Section 10113 of The 2018 Farm Bill states that (c) Nothing in this subtitle shall affect or modify:
(1) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) section 351 of the Public Health Service Act (42 U.S.C. 262); or
(3) the authority of the Commissioner of Food and Drugs and the Secretary of Health and Human Services- ‘‘(A) under- ‘‘(i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or ‘‘(ii) section 351 of the Public Health Service Act (42 U.S.C. 262); or ‘‘(B) to promulgate Federal regulations and guidelines that relate to the production of hemp under the Act described in subparagraph (A)(i) or the section described in subparagraph (A)(ii).”
The mission of the FDA is “to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” As such, FDA categorizes every product for sale in the U.S. which is either ingested or applied to a human or animals into categories. That means hemp-derived CBD products will have to lawfully fit into one of those categories, however, while there has been positive movement towards the legal sale of hemp products on the USDA cultivation side, the FDA has authority over foods and dietary supplements, and the FDA’s position is that the addition of hemp/CBD to a food or dietary supplement is “violative.” In a Consumer Update statement revised on November 25, 2019, the FDA clearly stated that “it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
That being said, FDA has indicated it would be open to review of safety data for submission of a cannabinoid as Generally Recognized as Safe (GRAS) for Food or as a New Dietary Ingredient (NDI) in a supplement as the lack of any federal regulation runs the potential of putting people at risk. That has sent the industry scurrying to design and initiate studies in the hopes of demonstrating levels of safety that meet FDA’s satisfaction.
In the meantime, those currently operating in states where hemp manufacturing is legal, must ensure Good Manufacturing Practices (GMPs) are adhered to closely. Should the FDA ever allow hemp products with CBD to be sold in the future, a manufacturer’s ability to demonstrate understanding and compliance with GMPs will be critical. Each FDA regulated industry has its own set of GMPs for the development and implementation of quality systems.
21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food
21 CFR 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals
21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA Draft Guidance for Industry, Cosmetic Good Manufacturing Practice, June 2013
As the industry waits in the hopes that FDA will come on board with those states that have already legalized CBD’s use in products, it important to take the necessary steps to develop GMP protocols and quality systems as part of documented Standard Operating Procedures and record-keeping that those procedures are being followed, products are being tested and those tests are being validated.
Ensure as you begin to develop or strengthen your GMP programs that you do so with a full understanding of the requirements set forth in 21 CFR 111. Whether these programs are designed in-house or with the assistance of an outside consulting firm, ensure your GMPs are specific to your manufacturing procedures as opposed to a stock one-size-fits-all program. A reputable consulting firm with demonstrable expertise in FDA regulations and in helping to develop these GMPs is a good place to start, one that listens to your questions and concerns before providing you their stock answer. A good consulting firm can walk you through your unique processes.
Ensure your quality systems are robust and documented, including your demonstrations that your cGMPs are being followed.
Charlotte Peyton supports EAS Consulting Group CBD and hemp clients as well as that of dietary supplements and pharmaceuticals. As an independent consultant, she assists with projects ranging from startup through manufacturing and support. Her expertise includes quality, regulatory and management, method development, and method validation for FDA regulated drug, dietary supplement, and bioanalytical samples. She has extensive experience in writing validation protocols, reports, and SOPs and assists with implementation of stability programs and report writing for finished products.
EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.
A Different Kind Of Season: Gearing Up For Appropriations
by Morgan Fox, NCIA’s Director of Media Relations
It’s that time again on Capitol Hill: appropriations season, when Congress determines how to spend – or not spend – your tax dollars for the next year. As you can imagine, this year will be unlike any in recent memory as a cash-strapped nation struggles with how to weather the economic storm caused by the pandemic while finding the funds to support important government functions and programs. Appropriations are also a time when our champions in the legislature are once again introducing sensible cannabis policy reforms through an avenue that historically has been effective. Many of these reforms would actually save taxpayers money!
What’s in:
For the second year in a row, language that prevents the Department of Justice from using resources to target state-legal medical cannabis programs was included in the original language of the commerce, justice and science funding bill. If approved or continued, this would be the sixth year that Congress has told federal law enforcement to leave medical cannabis patients and providers alone.
Language that would prevent the Department of Treasury from using resources to penalize banks and other financial institutions for working with legal cannabis businesses was included in the financial services and general government funding bill. While not as comprehensive as the SAFE Banking Act, which was approved by the House last year and included in its most recent coronavirus relief bill, this provision would give financial services providers more assurances needed to encourage working with the cannabis industry and would help improve public health and safety.
A measure that would protect public colleges and universities from being denied federal funds due to conducting research on cannabis was included in the bill funding agencies related to education, labor, health, and human services. Many institutions have cited the potential loss of funding as a major discouragement to research. This also makes it easier for universities to study cannabis products available in regulated state markets. An additional provision to this bill also prevents federally funded schools from engaging in any advocacy in support of making any Schedule I substances legal.
Additional funding would be made available through the agriculture and FDA appropriations legislation for research, regulation, and consumer protection related to hemp, CBD, and other cannabis components.
Language that asks the Office of Personnel Management to reconsider allowing federal employees to legally consume cannabis in accordance with applicable state laws without fear of retribution was added to the financial services and general government funding bill. While this is non-binding, it would hopefully encourage the federal government to review its employment practices and not punish law-abiding employees who choose to use cannabis outside of work.
What’s not:
A provision that has prevented the District of Columbia from regulating cannabis after voters there approved a ballot initiative making adult use legal in 2014 was left out of the new spending package. So long as it is not added again in either the House or Senate, the nation’s capital will finally be able to fully carry out the intent of the voters more than half a decade after residents decided this issue. Currently, adult possession and limited home cultivation are permitted in the District, but non-medical sales are not.
What could be added:
While the spending bill that funds the Department of Veterans Affairs did not originally contain any cannabis-related provisions, supporters are leaving open the possibility that language which would allow doctors in the VA system to recommend medical cannabis to their patients in accordance with state laws to be included before the process is complete.
Reps. Earl Blumenauer (D-OR) and Tom McClintock (R-CA), joined by Delegate Eleanor Holmes Norton (D-DC), are considering the introduction of a rider which would prevent the Department of Justice from interfering in any state cannabis program, extending the previously-approved protections for medical cannabis programs to regulated adult-use systems that exist in 10 states and counting. This legislation was approved in last year’s House spending bills but was not included in the final legislation.
It is difficult to tell what will happen with the various appropriations bills this session. There is still time for members of the House to amend funding legislation. While the House is moving forward with these bills, the Senate has yet to introduce any of their own. However, the upper chamber is in the process of considering a new coronavirus relief package. NCIA has been working with that chamber to have cannabis banking reform language included in that bill as it was in the last relief bill approved by the House, but it is by no means certain at this point. It is also possible that Congress won’t reach an agreement on the new spending bills and will simply decide to continue with the prior year’s budget outlays, which would at least continue medical cannabis protections for another year.
Stay tuned for more updates and be sure to join us next Wednesday, July 29, for an exclusive members-only fireside chat with NCIA’s dedicated government relations team!
When the COVID-19 pandemic started to ramp up in the U.S. last March and stay at home orders were being put in place, medical cannabis patients took notice.
I saw it firsthand with my wife who stocked up for three months, not knowing what she was in for and wanted to make sure she had her treatments, just in case dispensaries were closed down. She was not alone, it has been well documented that this stocking upsurge took place and sales increased dramatically over a few months.
But many of these businesses did not close during the shutdown and it was a big milestone that several state governments declared medical dispensaries essential. This was a big statement to make for an emerging new industry that has been saddled with controversy over the years.
Prior to COVID-19, the industry was already going through a reset in late 2019. The large players overextended themselves globally with huge capital investments in facilities and then oversupply hit the market, prices started to decline and the anticipated demand to pull CBD products did not materialize. Add COVID-19, and you have the perfect storm to amplify the reset button.
Consolidation is in the works — restructuring of management teams, companies closing doors because they were not strong enough to start with other factors too. This pushed these businesses over the edge.
As we have been slowly reopening the country, the cannabis industry has the potential to emerge stronger than ever. There might be fewer players, but the ones that have survived will be set for the next push of maturity of the marketplace.
States that do not currently have adult-use programs will most likely look at cannabis as a way to drive new tax revenue into the state to help offset the heavy losses during these several months of lockdown.
When these states do pull the trigger on adult-use, regulation and compliance will be a key issue. The current companies who have been using all the latest tracking platforms, ERP systems, and implementing cGMP standards will be in very good shape to meet the requirements and deliver authentic products that are high quality and safe to consume.
Consumers will want to know the origin of the materials being used to manufacture these products and demand transparency from the brands. New innovative technologies using unique molecular-based tags to apply to the flower, oils, isolates and edible products will help take the industry to a new level of scientific proof of authenticity offering forensic transparency across global supply chains.
Even in the face of a pandemic, cannabis is here to stay! Over 60% of the population is in favor of it for both medical and adult use. The science that has taken place over the last 20 years globally has articulated how the human body can take advantage of the cannabis plant in many ways. And for folks who want to use it as a recreational alternative, they should have the right to do so, of course with responsibility.
There is clear global demand, it still needs to be sorted out and that will happen over the course of the next couple of years as this emerging industry matures into a profitable market segment in the world’s economy.
It is an exciting time for cannabis and as we begin to focus on reopening business across the nation, we are eager to take advantage and to be a part of the opportunities that are ahead.
John Shearman, Vice President of Marketing and Cannabis Business Lead at Applied DNA Sciences, has over 30 years of deep enterprise and advertising agency experience across all marketing, sales and IT disciplines. John’s experience allows him to advise on structuring sound strategies that address business goals and objectives. His extensive technology background stems from working with several leading technology companies throughout his career. John spearheads Applied DNA Sciences Cannabis vertical leading the vision, strategy, and product development for this emerging market. John also oversees the marketing for the entire company driving the marketing strategy for its other core verticals.
Meet The Team: Michelle Rutter Friberg – Deputy Director of Government Relations
by Michelle Rutter Friberg, NCIA’s Deputy Director of Government Relations
I grew up in rural King George County, Virginia, where I lived until I went to college. Let me just say: if you had asked me in high school where I saw my career going, I would not have guessed the cannabis industry! But, it turns out life had other plans for me.
When I began my time at James Madison University (go Dukes!), my major was undeclared. As time went on, I decided to study Political Science with a minor in History. I learned about our government, political theory, lobbying, and focused primarily on domestic politics. Working on all those papers and assignments for class during my undergraduate studies was where my knowledge of cannabis policy began.
When I was told one day that I could choose any topic to do a research project in one of my PoliSci classes, I somehow came across cannabis. It seemed too easy to write about — you’re telling me this drug is Schedule I but has never killed anyone? But from then on, every time I got to choose a topic, it was cannabis, so I began learning more and more. By the time I graduated, I had a decent understanding of the history behind prohibition, but my mind had turned to the same question everyone I knew was having: what was I going to do now that I had graduated? At the time, the Great Recession had unemployment close to 10%, so I did what many college-aged kids do: spent a month traveling around western Europe! Side note, my favorite city that I visited on that trip was Amsterdam, but not just because of the accessibility to cannabis!
When I came home, it was time to find a job. Eventually, I was lucky enough to be offered a job at a government affairs company in Alexandria, Virginia, where I researched state and local regulations for various clients. After a little more than a year, one of my coworkers mentioned in passing that a gentleman from the cannabis industry was coming in the next day to talk about our services. Before I could stop myself, I asked if I could sit in on the meeting. Lucky for me, they said yes, and that’s where the story of my career in cannabis began.
The gentleman who came in was (and still is!) NCIA’s Director of Government Relations, Mike Correia. While the company I worked for pitched him on their services, all I could focus on was Mike who elaborated on the incredible work NCIA was doing, about how he was a one-man government relations team and working from home. All I heard was: this guy is going to need to hire someone, and I knew it had to be me! After talking to my boss and getting his blessing to reach out to Mike, we set up a time to grab a drink and talk more about the industry. Lucky for me, Mike and I were like old friends catching up, and though NCIA didn’t have the budget at the time to hire another government relations staffer, he said he would keep me in mind. About six months later, NCIA was ready to expand the D.C. team and I applied for the job of government relations coordinator. Words can’t explain to you how happy I was when I received the offer to join NCIA’s team in October 2014.
A lot has happened since I was hired almost six years ago. Nine more states have elected to implement adult-use cannabis programs, and many others have opted to allow for medical marijuana or CBD. The way I was received on Capitol Hill with chuckles about “munchies” or “weed” are long gone, as NCIA and the cannabis industry are now received like any other business sector in D.C. We passed appropriations amendments in both chambers, planned many lobby days for our members, and passed the SAFE Banking Act out of the House of Representatives, just to name a few accomplishments. I went from government relations coordinator, to government relations manager, and worked hard to recently become NCIA’s deputy director of government relations. Not only that, but our government relations team has grown, and what was once just Mike, then Mike and I, has now become Mike, Michelle, and Maddy. The “3Ms” as we are often called are my best friends.
I remember thinking when I started with NCIA: what am I supposed to do now that I’ve gotten my dream job? Now, all these years later, I can tell you: I’m just getting started.
Meet The Team: Madeline Grant – NCIA’s Government Relations Manager
by Madeline Grant, NCIA’s Government Relations Manager
It’s funny how things just happen… one day, like any normal day, I was working the lunch shift at a restaurant called Carolina Ale House in Columbia, South Carolina. At first, I was worried about how much I would make in tips that day, as anyone with experience in the service industry can relate to, but then I started chatting with one of my tables… small talk, really. I told them how I was a sophomore at the University of South Carolina studying journalism and mass communications with a focus in public relations and a minor in women and gender studies. One man asked, “Well what do you want to do after college?” A question I thought about often but never had an answer to. He handed me his business card and asked if I was interested in politics. A few days later, I reached out, interviewed with the firm partners, and successfully scored the internship.
As I entered the political realm, I knew close to nothing but had a desire to learn as much as possible. Growing up, I was never really introduced into the world of politics as my parents didn’t say much about it – it was a whole new world to me! I attended caucus meetings, sat in the Senate and listened, followed legislation pertaining to their clients, researched, etc. My boss walked in one day and said he had an interesting project for me: to research and find everything I can about medical cannabis. I discovered so many fascinating miracle stories such as the effectiveness of medical cannabis for children with epilepsy. Seeing the great benefits and possibility, I kept thinking: why is this classified a Schedule 1 substance?
Fast forward to the classic “college graduate in search of a job” situation. I moved back home to Frederick, Maryland and started as an intern on Capitol Hill. After two months of interning, I landed a job on Capitol Hill and fell passionately in love with health issues (every staffer that went the legislative route had their assigned issues to become experts on). I began to learn more about cannabis and the detrimental effects of its Schedule 1 status.
Cannabis being classified as a Schedule 1 substance deems it to have a high potential for abuse, no currently accepted medical treatment use, and lack of accepted safety for use under medical supervision. Because of this classification, we can’t fully explore the medicinal benefit that it can in fact offer.
As I started taking more meetings with cannabis advocates, lobbyists, and patients, there was one significant group that stuck with me: a group of mothers and children with debilitating chronic diseases. The mothers were there to advocate on behalf of their children who significantly benefited from CBD oil. They told me a story about a family that uprooted their entire lives for their epileptic child because CBD was the only medicine that was working to reduce the seizures. On that day, I realized how important cannabis is for patients and how it truly can make an unlivable life livable. And that was JUST CBD. Can you imagine what we could gain from the whole plant? If we had the ability to research every single component of the plant, we could begin to know the full, true potential of medical cannabis.
The Schedule 1 status of marijuana hinders research and that needs to change, but thankfully, I can help.
As the Government Relations Manager at NCIA, I passionately lobby for those patients and businesses. I’ve been at NCIA for nearly three years and slowly but surely I’ve seen a significant change in the stigma associated with cannabis on Capitol Hill. It is my job to educate members of Congress, Hill staffers, and the public on all issues the cannabis community faces. This can include anything from cannabis business getting access to banking to educating members on the injustice the war on drugs had on Americans. My job is to educate and tell your stories which I do with great honor. I’m proud to represent you and what you do in the cannabis community.
As we are at home, I would love to meet with you virtually!
As I am unable to be on Capitol Hill right now, I want to use my time to compile your stories to forward to Hill offices, so please reach out if you are able and willing to tell your story. Stay safe and healthy.
Committee Blog: Cannabis Banking – Regulatory Outlook and Effective Compliance
During a recent webinar, we polled the audience on their current positions on offering financial services – traditional financial services – to direct marijuana-related businesses (MRBs). The results, as you might imagine, were mixed but we identified one common theme: The vast majority have taken action to address cannabis banking issues. This has been the theme we’ve been championing for years. The dichotomy between state and federal cannabis laws has placed our financial institutions in a precarious position: Bank the cannabis industry, be first to the market in doing so, create a non-traditional revenue stream and help to solve public safety and other logistical issues by solving the all-cash conundrum OR continue to watch from the periphery as others take the leap?
We see the number of financial institutions – banks and credit unions – that offer financial services to cannabis businesses expanding, but not to the level suggested by FinCEN SAR data. There remains a critical need for financial services within the cannabis industry.
Why the hesitancy in tackling this issue?
The current regulatory environment is a critical factor. As it stands, our industry is relying primarily upon the FinCEN guidelines to offer financial services to cannabis-related businesses. These guidelines, coupled with a surge of proposed legislation and a regulatory perspective on risk-based risk-taking, have allowed financial institutions across the country to effectively provide financial services to cannabis-related businesses. There is a key term we’ve been using: cannabis-related businesses. Within this term, we encompass direct and indirect marijuana-related businesses, hemp, and CBD entities. The majority of those polled feel more comfortable with hemp and CBD entities primarily due to the passage of the 2018 Farm Bill. Getting into the intricacies of how the Farm Bill and the USDA’s resulting interim final rule have added a layer of complexity to banking hemp and CBD businesses is more than we can cover in this blog post. Let’s focus instead on those providing financial services to direct MRBs, those that are state-legal, licensed cultivators, extractors, and dispensaries.
It IS possible to actively bank direct MRBs, to offer stable banking services that bring the cash off the street and provide a means for these businesses to operate more effectively and efficiently, and surely in a less costly manner than an all-cash business. The regulators are not criticizing financial institutions for providing financial services to MRBs; they review these services as they would any higher-risk, complex activity. When an institution takes on too much too fast or does not have sufficient controls to know whether it actually has a higher risk or complex business concentration within its customer base, the regulators will be critical… as they should be.
So, what are they looking for?
This goes back to the theme we mentioned: Financial institutions actively addressing cannabis banking issues.
Every financial institution, whether it intends to bank direct or indirect MRBs, hemp or CBD should have a Cannabis Banking Program that assesses the inherent risks of doing so, speaks to the controls necessary to effectively manage those risks, and determine whether they are well-positioned, or have a risk-appetite for, providing financial services to the cannabis industry. Conversely, if a financial institution that has no appetite for, or does not reflect sufficient regulatory health to bank cannabis, it must establish effective controls to ensure that position can be maintained.
But, this post is about empowerment. It is about speaking to the regulatory environment in which we find ourselves. It is about providing the perspective that banking marijuana, hemp and CBD CAN be done effectively, safely and soundly. Yes, there is a significant level of infrastructure needed to do so. Yes, it does come with the need for ongoing, strong risk management and control enforcement. Yes, it can be a bit scary. By establishing a Cannabis Banking Program, comprised of a comprehensive risk assessment that drives an equally comprehensive policy, a financial institution can provide financial services across the spectrum of marijuana, hemp and CBD, and undergo regulatory scrutiny with confidence. Moreover, such a program has become a regulatory expectation to support a financial institution’s cannabis position. This is also not a program where a financial institution will set it and forget it. The risk assessment and policy must remain dynamic as legislation evolves, as regulatory perspective changes, and as a financial institution’s position or outlook may shift.
This is an industry that has already proven prolific. This is a time that will be ingrained within our nation’s history. Let’s be remembered as those who championed the issues, established the country’s infrastructure, and set the standard for those who follow.
As a former Federal bank regulator and seasoned consultant, Angela’s knowledge of regulatory compliance, risk management and investment advisory services has established her reputation as a leading resource within the financial consulting industry, spanning consumer protection and anti-money laundering statutes, fraud and cannabis banking issues.
Angela is the Managing Partner and Co-Founder of Sterling Compliance, LLC, a consumer compliance consulting firm based out of Pittsburgh, Pennsylvania. Sterling specializes in consumer protection and anti-money laundering compliance within the community banking industry and enjoys a significant online presence with a client base spanning the coasts.
In December 2019, Angela joined Integrated Compliance Solutions, LLC (ICS) upon the ICS acquisition of Sterling Compliance as an independent operating subsidiary. Angela oversees the firm’s Compliance Strategies division, of which cannabis banking is a significant component. ICS is a financial technology, banking compliance and innovative payments solution provider helping financial institutions with complex solutions. In joining the ICS team, Angela has continued the firm’s mission of bringing its complete SEED-TO-BANK™ solution to financial institutions and cannabis-related businesses throughout the United States, and has expanded the firm’s industry engagement as a well-respected authority on the regulatory and compliance issues surrounding cannabis banking.
Member Blog: Hemp and Marijuana Genetics – A Closer Look At The Differences
There are many ways to classify cannabis variants, but the most popular distinction is between hemp and marijuana. Although most of us take these classifications for granted, perhaps you’ve wondered if they are really legit? Put another way: are there real genetic and anatomical differences between marijuana and hemp? And, if so, what are they?
The hemp/marijuana classification is still a major debate within the cannabis community. Although up-to-date research suggests there are genetic differences, critics contend these distinctions have much more to do with legality than botany.
To better understand the complexity of the hemp v. marijuana classification, let’s quickly go through a primer on the cannabis genus. Afterward, we’ll take a closer look at the differences often associated with hemp v. marijuana and why these terms have gained such prominence.
The Basics Of Cannabis Distinctions
The first thing we should clear up is that the word “cannabis” is reserved for the plant genus. This means that both hemp and marijuana technically fall under the cannabis label. For many years, botanists have categorized the cannabis genus into the following three groups:
Cannabis sativa
Cannabis indica
Cannabis ruderalis
Of these three, sativa and indica are probably the most familiar to you. Usually, cannabis connoisseurs draw the sativa v. indica distinction to help differentiate the physiological effects of each strain. Sativa-heavy strains are said to be more energizing while indicas are supposedly more sedating.
It’s important to remember, however, that sativas and indicas were first split up due to their flowering patterns and features. Here are just a few of the key distinctions often ascribed to these two cannabis variants:
Indicas
Short
Fat leaves
Fast-growing
Enjoys mild climate
Sativas
Tall
Thin leaves
Slow-growing
Enjoys a humid climate
Ruderalis is a shrub-like variety of cannabis that evolved in harsh northern environments. Due to its history in regions with little light or warmth, ruderalis strains evolved unique genetics that allows them to flower automatically rather than relying on specific amounts of light.
Cultivators nowadays cross-breed ruderalis strains with indicas, sativas, or hybrids to create what are known as “autoflowering seeds.” These auto varieties are convenient due to their predictable flowering period, but they tend to have fewer cannabinoids than standard sativas or indicas. Most often new cannabis cultivators use auto seeds to gain valuable growing experience.
Hemp v. Marijuana: The Legal Distinction
So, why do we need a hemp v. marijuana distinction on top of all these cannabis varieties? A short answer is that drawing the line between hemp and marijuana helps a lot in the legal department.
You see, hemp is legally defined as a substance containing less than 0.3 percent of the high-inducing compound tetrahydrocannabinol (THC). Marijuana, on the other hand, could have 0.3 percent THC content or above.
Obviously, this makes it a lot easier for legal authorities to categorize what is and what is not legal. As of today, the U.S. legalized hemp at a federal level, but marijuana laws vary by state.
Beyond THC: The Different Uses Of Hemp V. Marijuana
This all doesn’t mean that the hemp v. marijuana distinction was arbitrarily drawn up to help legislators. OK, the 0.3 percent benchmark was pretty arbitrary, however, it’s true that hemp naturally produces less THC than marijuana strains. But there’s more to this story than just THC.
Now that the CBD market has skyrocketed, it’s often hard for us to imagine non-edible uses of hemp. However, for most of human history, hemp has been cultivated strictly for industrial purposes. Indeed, people have used the hemp plant’s fibrous stalks to make clothing and rope for thousands of years. Amazingly, hemp is now showing great potential in a variety of fields including papers, plastics, cosmetics, and even fuel.
Marijuana, on the other hand, has always been associated with recreational and medical use. Growers who cultivated marijuana were always interested in maximizing certain terpene and cannabinoid profiles for their chosen strain.
So, the distinction between industrial hemp and marijuana is still valid and useful as the cannabis industry expands. Growing hemp for industrial purposes is far more interested in quantity rather than quality. Marijuana cultivation, on the other hand, requires a greater degree of care and attention to detail.
Industrial hemp cultivators could often get away with planting their male and female seeds in rather tough environments. Professional marijuana cultivators, on the other hand, need to focus a lot of attention on making their environment hospitable for female seeds.
Of course, there are now many high-CBD hemp cultivators out there using similar marijuana grow methods. With that in mind, it’s still quite useful for cultivators to distinguish between industrial hemp and marijuana to better plan their growth cycle.
Does Hemp Look Different Than Marijuana?
Now we know how hemp and marijuana differ in THC content, growth features, and traditional uses… but do they look different?
To the untrained eye, mature hemp and marijuana might appear to be the same. Indeed, there are many cases of police accidentally arresting truck drivers for “marijuana possession” when they were actually transporting hemp. There are, however, a few key anatomical differences to look out for.
For instance, hemp plants are generally taller than most varieties of marijuana. Remember that many cultivators are interested in hemp’s fibrous stalks, which is why they’ve bred them to grow as tall as possible.
In addition to their height, hemp plants also tend to have thinner fan leaves compared with most strains of marijuana. These hemp leaves also tend to be concentrated at the top of the hemp flower with few leaves further down the stem. Marijuana plants, on the other hand, tend to have more leaves evenly spread throughout their branches.
Looking Into The Genes: Novel Research On Hemp v. Marijuana
After reading the above description, you might understandably conclude that hemp strains might lean more towards the sativa side. After all, sativas are typically associated with tall height and thin leaves.
While this makes logical sense, recent genetic research is changing how we think about the sativa v. indica theory. A team of Canadian researchers recently published a study examining the genetic makeup of over 80 marijuana and about 40 hemp strains. Shockingly, they found that hemp plants have a closer genetic tie to indicas rather than sativas. Most marijuana strains, however, showed a mix of sativa and indica influences.
The scientists concluded that there was enough of a genetic difference between hemp and marijuana strains to warrant the classification. Of course, more research will be necessary to understand these complex hereditary differences.
So, Is The Hemp v. Marijuana Distinction Valid?
While there will likely still be a debate about the hemp v. marijuana distinction, this classification system is popular for good reason. Also, there appears to be a scientific basis for grouping hemp and marijuana into separate genetic categories.
Distinguishing between hemp and marijuana can help consumers make a more informed decision when purchasing hemp flowers, hemp trim, oils, or other products. Plus, with the growing interest in hemp’s industrial uses, it’s important for farmers to separate out strains for industry and those for human consumption.
While it might not be a perfect classification system, “hemp v. marijuana” is still around because it continues to help cultivators and consumers make informed choices.
George Mouratidis is a cannabis writer and freelance contributor to Industrial Hemp Farms, Cannabis Tech, and Highlife Media.
IHF LLC is a Colorado-based, fully licensed & certified hemp farming and wholesale company. IHF wholesales CBD hemp biomass and many different cultivars of clones and seeds. The Company also wholesales CBD distillate, T-Free, Decarboxylated Crude, Isolate and other cannabinoids produced at our extraction facility. One of our primary goals is to make mutually beneficial deals, connections and contacts in the hemp industry.
Member Blog: There’s No Place Like CBD For The Holidays
While April 20th, or “420” is the “high” holiday of cannabis, did you know there are a variety of lesser-known CBD-related holidays throughout the year that can be great grist for the promotional mill? To achieve notoriety and engagement, CBD purveyors may want to include lesser-known celebrations into their annual marketing calendar.
For example, there’s National CBD Month in January, National Hemp Day February 4, National Hemp Month in July, Oils and Concentrates Day July 10 (sometimes referred to as 710 because OIL upside down resembles the number), National CBD Day August 8 and National Pet CBD Month in October.
And let’s not forget Jack Herer’s (The Hemperor’s) birthday celebrated June 18. According to Wikipedia, the devoted cannabis rights activist and author promoted cannabis and hemp for decades. His book, “The Emperor Wears No Clothes” has been in print for three-plus decades. Herer was “frequently cited in efforts to decriminalize and legalize cannabis… Herer also founded and served as the director of the organization Help End Marijuana Prohibition (HEMP).”
CBD purveyors wanting to get even more innovative can use their branding — including labels — to tie to lesser-known holiday promotions. Here are some ways to use labels as powerful promotional tools in conjunction with “holiday” celebrations:
Extend their reach for a whole year via extended content labels (ECLs). For CBD purveyors committing to promotions tied to a calendar of holidays, ECLs can be a fun and impactful way to present information, offers and calls to action.
Create a major promotion around one celebration (e.g., January’s National CBD Month), and use ECLs to explain/inform. This could be a contest with details, one or more discount offers, or even a history of the CBD “movement.”
Print specific labels for each holiday. For example, create fun and informative labels around “The Hemperor’s” birthday month in June. A series of labels could detail various hemp-related accomplishments by Herer, even possibly going so far as to be small pieces of art depicting him and his life’s work.
Use them to link to digital media. There’s always a case to be made for labels containing QR codes, URLs and other links to more information. This can be especially appropriate for surveys, reviews and other interactive platforms where consumer feedback is desired. Any of these efforts can be themed around holiday celebrations (e.g., an upcoming anniversary of hemp or CBD adoption/legalization). In the CBD world particularly, companies need to understand how their consumers view them, assess the quality of products and express any concerns that may emerge.
Present labels as a quality control and consumer safety tool. At a time when buyers worry about the safety and authenticity of the products they consume, labels can help come to the rescue. And what better holiday than one which celebrates both the healthy effects of products and a concerted effort to protect those consuming them?
For example, new label technologies enable consumers to verify the authenticity of their products through a smartphone app that scans a small digital ID on the label. These track-and-trace digital IDs offer a powerful deterrent to counterfeiting, protecting consumers from harmful or ineffective fake products. In turn, CBD product manufacturers can demonstrate to customers that they are working actively to ensure their safety. That creates favorable word-of-mouth, goodwill and loyalty among buyers who will criticize or even pursue regulatory and legal remedies if they feel there’s a problem.
Gary Paulin is Director of Sales and Client Services for Lightning Labels, a Denver-based label printer that has been offering state-of-the-art affordable, full-color custom labels and custom stickers of all shapes and sizes to cannabis purveyors for more than a decade. They offer many options for materials and laminates and special effects to achieve digital short-run requirements (50 minimum) on up to 15 million labels, plus Lightning fast delivery. For more information and to place orders online, visit LightningLabels.com. For the latest in packaging news and labeling promotional offers, find Lightning Labels on, Facebook, Instagram, Twitter (@LightningLabels), Pinterest, and LinkedIn.
Member Blog: 6 Key Questions To Ask When Evaluating Water-Soluble Technology For Cannabis Products
Consumers and manufacturers of products that have been infused with THC or CBD are probably very familiar with two key issues that plague the product class: slow onset time and uneven dosing of the active ingredient. In a bid to provide a solution, many groups are marketing “water-soluble technology,” or “nanotechnology.” The vast majority of the groups claiming water-soluble (more properly referred to as “water-compatible”) technology are offering up a nanoemulsion.
Nanoemulsion technology is a very promising and accessible solution. It has the ability to allow for both (1) rapid onset and (2) uniform distribution of the active ingredient in infused products such as beverages, gummies, and water-based topicals. Unfortunately for most businesses and consumers, there are many factors that can destabilize a nanoemulsion and eliminate the benefits of the technology. Making things even more difficult is the fact that consumers and businesses are usually not equipped to properly evaluate their options, due to the technology being so new in its commercial use.
In order to evaluate your options, whether you’re a consumer or a business looking to enhance your products, you need to have a high-level understanding of nanoemulsions and how they are made. Put very simply, you create a nanoemulsion when oil is combined with functional ingredients and then blasted with energy or combined with a catalyst which, in both cases, causes the oil particles to split into smaller pieces. When made small enough, the particles disperse uniformly in water and won’t separate out into larger globs of oil. Other added benefits of the small size are a dramatic drop in the onset time for THC – from around 45 minutes to under 10 minutes – and increased absorption of the active ingredient.
Knowing this, there are a number of questions that you should always ask of your technology provider. Each of these questions helps you dig into how well-designed a formulation is and ultimately whether the technology you use will truly enhance your products. Every provider of nanoemulsion technology should be able to speak to:
Particle Size of the Nanoemulsion – You should be looking for an average size under 100 nanometers, preferably under 50 nanometers (as measured by the “dynamic light scattering test”).
Particle Size Test Method – The “by volume” test is far more optimistic, and less useful, than the “dynamic light scattering test.” Look for a solution that is less than 50 nanometers, measured using the dynamic light scattering test.
Temperature Stability – Nanoemulsions tend to destabilize (lose their nanoemulsion properties) over time when exposed to heat. This can be a major issue if the product is shipped or stored in warm/hot environments or if consumers use the product on a hot day.
pH Stability – Low pH environments, such as citric beverages, can cause instability and can also contribute to rapid degradation of the active ingredient (e.g. THC or CBD). Poor formulations can cause as much as 50% of the active ingredient to degrade over a period of one month – not ideal if the product is stored or sits on the store shelf for a while prior to being consumed.
Stability with Artificial Sweeteners – Many end products that are being infused use artificial sweeteners, which can cause the nanoemulsion to become cloudy and lose its rapid onset and enhanced absorption properties.
Active Ingredient Degradation – pH is just one of a number of factors that can contribute to rapid degradation of the active ingredient.
Creating a nanoemulsion that addresses these challenges is not an easy task, but each one of the parameters is important if it’s going to provide the performance benefits claimed by the technology provider. Regardless of whether you choose to engage in your own R&D or use a third-party solution, these questions will help you understand how well a particular water-soluble technology will work for you. Consumers will gravitate toward products that maintain the benefits of this water-soluble technology, and manufacturers will consequently need to do the same.
Andrew Wong – President of Axiomm Technologies
Having spent nearly five years at the nationally-recognized corporate law firm of Stikeman Elliott LLP, Andrew is experienced in securities, M&A and private equity matters. He has acted for both public and private companies, as well as private equity and investment funds with assets under management of $500 million to $1 billion. Andrew moved from Stikeman Elliott to Shea Nerland LLP in 2016, where he founded the cannabis practice group and provided clients with regulatory, structuring, finance and corporate governance counsel.
Andrew co-founded Axiomm Technologies in late 2017. Axiomm is a technology company whose team of technical experts combines academic and industrial expertise in the development and commercialization of novel manufacturing and consumption methods. All technologies and products are designed with the health and wellness consumer in mind, and each increases the efficiency and speed with which the body absorbs vitamins, nutraceuticals and cannabinoids.
Member Blog: Hemp And CBD Consumer Insights – Who, Why, And How
Hemp CBD became the fastest growing CPG product in 2019, following its legalization in the Farm Bill of December 2018. Consumers show great interest in its use for wellness, health & beauty applications and for pets. Its many distribution channels require integrating convenience store and shipment data not required for most dispensary products.
In U.S. Convenience Stores, total sales of CBD have increased 168% in the first half of 2019 while average weekly dollar sales increased by 235%.
The higher revenue growth accompanied CBD content per package increasing from 100mg on January 5, 2019 steadily to over 350mg on July 20, 2019, after having peaked briefly in June 2019 near 450mg per unit. See graph below.
Mg CBD per SKU at Retail
Medical Conditions Treated with Cannabis
Pain relief is the major reason cited as a medical condition for cannabis use, followed by nausea, PTSD, muscle spasms, IBD and opioid addiction as seen in the following table:
Source: Consumer Research Around Cannabis
Cannabis and Opioid Use Disorder
Of particular note is the growing number of consumers using Cannabis to treat Opioid Use Disorder (OUD). As of August 2019, seven states have approved medical cannabis for treating OUD: PA, NY, NJ, NM, MO, IL & CO. Twenty-one studies (2009-19) show the effect of cannabis on helping opioid users to reduce or eliminate the use of opioids to treat pain. NFL professional athletes have withdrawn from using opioids after they retire, with the aid of CBD and/or adult cannabis.
Consumer Purchase Drivers of OTC Hemp CBD
The top consumer drivers of OTC Hemp CBD are pain relief, reducing anxiety and helping sleep, as shown in the following graph.
Cannabis Product Composition and Patient Outcomes
Over the past several years, advances in technology have greatly enhanced the prospects for cannabis growers, processors, and dispensaries to provide medical cannabis products to patients that efficaciously treat the medical conditions and alleviate the incapacitating symptoms that they suffer.
Pre-clinical scientific research is determining the physiological effects of individual cannabinoids and terpenes on specific medical conditions and symptoms. Mobile apps are enabling the systematic querying of patients about the efficacy of specific cannabis strains and products in alleviating symptoms and conditions.
Collectively, these advances and other medical research are creating volumes of evidence to which human and artificial intelligence will be applied to develop insights for use by patients and medical researchers, growers, and processors in formulating products creating newer therapeutic options. Patients are already making informed decisions that improve individualized treatment of medical conditions progressively over time due to CBD being an approved over-the-counter consumer product.
Advanced Consumer and Patient Targeting to Improve Marketing and Medical Outcomes
Consumer attitudes, perceptions, and usage in local markets create richer, more actionable insights from customer segments, creating advanced quality scores and indices for scoring first-party internal data.
Cannabis consumer data is used for strategic and tactical product development, applications including:
Market Architecture: differentiating dimensions of product form and brand choice
Key Reasons for Use and Purchase
Affinity with Media, Channel, and other Product Categories
Multiple correspondence analysis of hundreds of consumer survey category questions is used to understand dimensional distinctions and differences between clusters. These key spatial dimensions for segmentation illuminate key differentiators, for use in innovation/new products, brand strategy, marketing execution, and digital media tactics.
Create Target Profiles
Merging cannabis consumer data with general consumer data such as Financial, Healthcare, Restaurants, Grocery/Drug Stores, and Media usage & exposure for each respondent facilitates creation of new consumer segments.
Using zip code identified respondent level data, the above Target Profile clusters can be integrated with other market and first–party data to prioritize personalization, enhance brand positioning, inform messaging, new customer marketing & acquisition efforts, and multi-touch attribution databases.
Mr. Stephen J. Gongaware is Sr. Vice President of Business Development at MSA (Management Science Associates, Inc.), a privately held diverse information technology development and service firm that for over 50 years has provided innovative solutions within its three core competencies of analysis, technology and data management. He has played a major role in developing and managing several MSA businesses in addition to his focus since 2014 on the medical value of cannabis for prospective patients, beginning with CBD and 20 other nonpsychedelic cannabinoids then measured by leading edge test labs. Other businesses he’s created and managed at MSA in the last 20 years includes services to develop/market pharma “rare disease” solutions, and MSA Casino Gaming solutions improving operation of slot floors, player satisfaction and also lead smart phone and sports book innovative projects with 6 of the Top 10 global casino operators and with several major gaming equipment manufacturers.
Prior to joining MSA, Mr. Gongaware was CEO of NetworkNext, an innovative national advertising firm; R&D Director at Cellomics, Inc. where he was awarded US Patent #US6365367; and an Electrical Engineer at Westinghouse Electric Corp. He received his BSEE degree from University of Pittsburgh in 1992 and his MBA from its Katz School of Business in 1995.
MSA is an Analytics firm with Big Data integration capability incorporated in 1963 to focus on improving government and management decisions. MSA has 800+ professionals with expertise in data science & AI, software development, test marketing, data management and management consulting and many of its innovations have become industry-standard solutions. MSA has served over 70 Fortune 500 Customers/Clients in the CPG, Media, Metals, Life Sciences & Pharma, and Casino Gaming & Sports Betting industries. It has been engaged in cannabis research since 2013 with the goal of providing the cannabis industry similar services to what has been now provided to the CPG, Steel, Tobacco, Casino Gaming, and Pharma industries for more than 50 years.
Post-Recess Predictions: Looking Into The Crystal Ball
by Andrew Kline, NCIA’s Director of Public Policy
Kids are back in school. The weather is starting to cool off. Congress’s August recess has come to a close. And it’s time to get back to the business of marijuana reform.
As 2019 starts to wind down and we gear up for 2020, it’s a great time to reflect on what we’ve accomplished, what challenges lie ahead, and what we think we can accomplish in the coming months.
Will we see Congressional action on myriad marijuana bills pending before Congress? Will we see new marijuana-related bills being introduced? Will Senate Republicans allow a floor vote on any marijuana-related legislation? Will House Democrats reach a consensus on marijuana-related priorities? Will the Presidential candidates reach consensus on the right approach for marijuana? The answer to all of these questions is… maybe. And the reason is not just that Republicans have been historically opposed to marijuana-related legislation. It’s because there is no consensus on the right approach. No consensus on a policy issue in Congress? Shocking, huh?
We’re starting to see this divide in Congress, with Democrats sponsoring legislation that de-schedules marijuana and Republicans supporting more incremental approaches like SAFE Banking and the STATES Act. Who will win the battle of the ages? It’s anyone’s guess. And while NCIA supports incremental approaches, they are plainly suboptimal. Below, I lay out two scenarios that are simultaneously at play. But first, let’s take a step back.
There’s no industry with a more impressive growth rate – and more potential than cannabis. Period. Whether you’re talking THC, CBD, CBN, or CBG, it’s all the rage. Recently, analysts called for $200 billion in yearly sales within a decade. And Congress should care about this issue because of the economics alone. But – and this is a big but, in order for the industry to reach those economic goals, or anything close to it, one thing must happen: The United States has to legalize all forms of cannabis at the federal level. And by federal legalization, I mean de-scheduling. And for those of you less familiar with Washington speak, “de-scheduling” means:
Removing cannabis from the authority of the DEA
Removing cannabis from a list of illegal drugs that have no medicinal benefits like heroin, LSD, and meth
Legalizing cannabis at the federal level so that there is no conflict with state laws
Legalizing cannabis at the federal level so that banks no longer a risk of federal money laundering charges by doing business with the industry
Legalizing cannabis at the federal level so that the federal tax code permits businesses to take small business deductions
And providing FDA and the Department of Treasury with regulatory authority like they do with alcohol, tobacco, prescriptions drugs, dietary supplements, and foods
There is no other long-term viable option for the cannabis community.
My role at the National Cannabis Industry Association (NCIA) is to lead public policy development for the industry. We’re working hard – on and off Capitol Hill – on comprehensive reforms that begin with de-scheduling. And if you’re committed to the growth of the industry, then you should join us.The Policy Council that I lead needs cannabis professionals to help us develop policies that support the best possible climate for entrepreneurs. If you care about being able to materialize the financial opportunity here, then you should care about creating the public policy climate that will allow the industry to really flourish.
Make no mistake about it: We’ve come an incredibly long way in the U.S. since the mid-90s when no state had legalized medical or adult-use marijuana, and support for legalization stood at roughly 25%. Today, two-thirds of respondents to Gallup’s annual poll favor legalizing recreational marijuana, with about 90% in support of medicinal cannabis. 33 states have approved medical cannabis in some capacity. Of these 33 states, a third (11) also allow adult-use consumption.
So, where is the federal government on this? Here are two possible scenarios.
Scenario One is that Congress passes some sort of incremental legislation in the near term.
There is a lot of cannabis-related activity going on in Washington D.C. these days. And there is good reason to believe that Congress will pass some form of cannabis legislation in the 116th Congress. But, if that happens, it’s likely to be an incremental approach – like SAFE Banking or the STATES Act – which provide protection for state-legal cannabis businesses from federal encroachment.
There was a hearing in the Senate Banking Committee on SAFE banking last month. Yes, you heard that right. There was a full committee hearing, chaired by a conservative Republican from Idaho. And Republican Senator Corey Gardner from Colorado testified in support of SAFE banking legislation. Senator Gardner is also a champion of the STATES Act, another incremental approach. This is an amazing feat, but does it mean that republican leadership has seen the light on cannabis? Maybe.
Or, maybe they just know the Presidential election will be decided by slim margins and the republicans can’t cede the marijuana issue to the democrats. Banking would be an easy win. And they wouldn’t have to support full federal legalization to support banking.
We also know that the House is poised to pass something soon. They have 206 co-sponsors for SAFE Banking. An impressive number. Word on the street is that that bill could move as quickly as this month in the House.
And think about this. Dozens of Attorneys General recently sued big pharma for knowingly selling opioids that are highly addictive and actually killing thousands of people annually. At the same time, three dozen Attorneys General sent a letter to Congress, asking that they pass the SAFE Banking Act for cannabis. Quite amazing.
Where there’s smoke, there’s fire, right? With all of this legislative activity, a bill must be coming to the floor, right? Maybe.
Mitch McConnell is not a cannabis fan, and he controls the legislative calendar in the Senate. But, hemp is a huge industry in Kentucky and NCIA has worked to have protections for hemp and CBD added to the SAFE Banking Act, so Mitch McConnell may now care more than he did just a month ago.
So, I do think that it’s likely that we will see some kind of legislative compromise on incrementalreform soon. And all signs appear to point to SAFE banking.
But, it’s unlikely that any such compromise will include de-scheduling.
And unless cannabis is made federally legal through de-scheduling, banks still risk federal money laundering charges by doing business with the industry, the federal tax code would still prohibit cannabis businesses from taking small business deductions, and possession of cannabis would still be federally illegal, setting people up for continued arrests for federal crimes that are state-legal in 33 states across the country. The economic impact of anything short of de-scheduling will continue to cripple any real small business growth.
So, while I actually think that we may see some legislative action in the coming weeks, it will likely not be the “end all be all” that some of us have been working toward. And it might not be enough to pacify investors or key constituencies.
But, it’s also possible that even small marijuana reform might not happen anytime soon.
So, here is scenario two: We don’t see any real movement in the coming weeks, notwithstanding some positive signs, for a handful of reasons:
Republicans generally aren’t fans of cannabis. Republicans have historically had a more negative view of cannabis than Democrats or Independents. In Gallup’s October 2018 poll, 75% of Democrats and 71% of Independents favored broad-based legalization, which compares to “just” 53% of Republicans – the party that controls the White House and Senate. And Senate Majority Leader Mitch McConnell, no friend to the industry, controls all of the cards in the Senate.
CBD regulations are stuck in a bureaucratic morass at FDA. Lawmakers are also taking their cues from the U.S. Food and Drug Administration (FDA), which has been contemplating how to regulate CBD for months. THC regulation will be harder. Much harder. And once Congress de-schedules, the FDA and Department of Treasury need to be ready to regulate. That is not tomorrow. Or next week. Or next month.
The U.S. Treasury is raking it in. Because cannabis businesses can’t take normal business deductions because of arcane tax rules, companies are paying an effective tax rate of more than 80%. So, the IRS is collecting massive taxes from businesses that are federally illegal. Once cannabis becomes federally legal, businesses can take normal deductions and pay less than half of the current tax rate. This would cost the U.S. treasury billions.
So, it’s possible that Congress does nothing in the short term.
No matter what, NCIA will continue to fight, on and off the Hill, for comprehensive reforms. And while we would be happy in the short term with some incremental relief, only de-scheduling solves myriad problems facing this burgeoning industry. It’s time for Congress to act. And there is no time like the present to get the ball rolling. NCIA will soon be releasing a white paper on how we believe that marijuana should be regulated at the federal level. And that plan starts with de-scheduling. We hope that Congressional leaders will take note.
Member Blog: The Differences Between Strain Specific Terpenes, Terpene Enhanced Flavors, and E-Juice Flavoring
As the nation’s largest wholesale terpene provider, we spend a lot of time getting to know the needs and wants of our customers. One of the biggest questions our new clients have refers to the flavor profiles of our terpenes. More specifically, people are wondering why our strain-specific terpenes (like Banana Sherbet, Cherry Pie, and Cookies & Cream) don’t taste like the real sugary sweet confections that go by the same name.
There is a slight misconception when it comes to terpenes. Many people expect terpenes to work like e-juice in a vaporizer to make whatever you’re smoking taste like something else. While it isn’t uncommon for vape juice to taste like Skittles, cinnamon rolls, mojitos, and orange juice, terpenes don’t. There are no additional additives like sugar or artificial flavors in the terpenes that’ll make a hash pen or oil taste just like fruit, candy, and cake. It’s best to only use what nature gives us!
Here’s the difference between isolated terpenes and wholesale versus e-juice for vaporizers, as well as a quick rundown on flavor enhanced terpenes to help you or your customer make a more educated purchase:
What are terpenes?
Terpenes are organic compounds found in all plants that are responsible for giving the plant – from blueberry bushes to pine trees – its distinct smell. The unique smell helps plants existing in the wild to attract pollinators and ward off predators. Terpenes are the primary source of the resin and trichome production in cannabis, and they are created in the same glands that produce CBD and THC. That being said, marijuana can create its own combinations of terpenes. No two plants smell exactly the same.
Terpenes are also responsible for several medical benefits and adult uses. When they’re combined with some of the different cannabinoids found in cannabis, they can create what is known as the entourage effect. The entourage effect is what gives strains of cannabis a variety of different effects since the flavor profiles can come about from an almost infinite number of terpene combinations.
In layman’s terms, terpenes are so useful because they can be blended seamlessly with each other. This gives enthusiasts more control over what they taste and feel when they vape. Cannabis contains over 100 different terpenes that offer unique effects.
Liquid terpene products and extracts typically contain a combination of terpenes found in cannabis. Some products will have more of an indica profile (like Blackberry Kush) while others will have more of a Sativa (Clementine) or Hybrid (Banana Kush) profile. This helps to encourage the specific physical effects you’ve come to expect from cannabis.
What is e-juice?
The e-juice, vape juice, and e-liquids can be used in vapes and electronic cigarettes to create actual vapor. Most of the time, e-juice contains nicotine though many flavored e-juices don’t contain any. E-juices come in a ton of different flavors that cater to just about everyone, from people with intense tobacco cravings to people with a sweet tooth. E-juice is made with propylene glycol or vegetable glycerin, flavoring (often with terpenes, but usually artificial) and water. Vape juices that are made with propylene glycol are more likely to irritate your throat while you smoke it. On the other hand, e-juices made with vegetable glycerin are more likely to add a thick layer of sweetness to the vapor.
This is where a lot of the misconception kicks in. Since some vape juices made with vegetable glycerin are sugary sweet and taste like candy, many people assume that terpenes by themselves are responsible for the flavoring. By adding terpenes to e-juice, you can achieve a variety of different and new flavors. However, the terpenes won’t add anything artificial.
Natural terpenes vs. artificial flavors
E-juice, hash oil and CBD isolate can all benefit from adding terpenes and flavonoids to the mix. While marijuana has one of the most extensive ranges of flavor profiles in the plant kingdom, it will never naturally taste like cake, blue raspberry, or piña colada. Those are artificial flavors that have no natural terpene representation in the plant kingdom. Essentially, that just means that if you want blue raspberry vape cartridges, you’ll need to get artificial flavoring and avoid terpenes. Terpenes won’t be able to come close in taste and umami to that artificial flavor that doesn’t exist anywhere naturally.
Natural terpenes are becoming increasingly popular to add to cartridges, oils, and vaporizers. These are natural flavors that mimic the natural terpene profiles of cannabis strains. Natural terpenes are an excellent option if you’re trying to give your products an extra burst of flavor. For example, a processor wants to make the perfect Blue Dream cartridge, though the cannabis used for the extraction didn’t taste as vibrantly blueberry as the processor hoped. To achieve that ideal Blue Dream flavor profile, they could add a close match of terpenes found in the Blue Dream strain profile. The terpenes can add the sweet, summer-berry flavor the cannabis extract may be missing to the mix. That will allow the processor to create a tastier product with no side effects.
Overall, you should choose terpenes if you want to mimic natural flavors found in cannabis. You should select artificial flavors if you want something to taste like something unnatural or extra sweet.
What are flavor-enhanced terpenes?
Flavor-enhanced terpenes are the best of both worlds. While e-juice is more often artificially flavored, it often tastes better than terpenes alone. Flavor enhanced terpenes are terpenes extracted from cannabis with extra flavoring added in. Flavor enhanced terpenes offer the natural health benefits of natural terpenes but with the added benefit of tasting delicious. Our line of flavor enhanced terpenes includes fruit flavors like Ripe Strawberry and Berries and Cream as well as non-fruit flavors like breakfast cereals and pastries.
Do strain-specific terpene flavors really taste like the strain they’re based on?
Flavor is subjective and depends on things like classic tastes, aromatic chemicals, and the taster’s mood and physiology. Strain-specific terpenes are scientifically formulated to mimic the real strain’s natural terpene ratios.
To create strain specific terpene extracts, we primarily identify the terpene ratios commonly found in the strains and reverse engineer the process while removing the cannabinoids from the mix. It’s best to start by testing real cannabis at a certified lab. Then recreate that flower’s terpene profile in the lab and test the formula against real cannabis flowers. If the terpene profile doesn’t make the cut, it doesn’t get sold.
Our strain-specific terpenes are designed to match the terpene profiles of the flowers we extract these essential oils from. Just because they’re named Birthday Cake and Biscottidoesn’t mean they’ll taste like the real thing. However, they do taste like the real cannabis strain since their terpene profiles match.
Terpenes Vs. E-Juice: TL;DR
If you’re just here for a quick answer, here’s the difference between natural terpenes and vape juice.
All plants naturally produce terpenes.
E-juice or vape juice is often artificially flavored
Artificial flavors are not terpenes. They don’t exist anywhere naturally and are created synthetically.
Strain-specific terpenes are reverse engineered to mimic natural terpene profiles of cannabis strains
Strain-specific terpenes contain no artificial flavorings
Strain-specific terpenes will taste like the cannabis strain, not the food or fruit it’s named after. For example, Chocolate Cookies tastes like hash, spice, and coffee, just like the cannabis strain. It doesn’t taste sugary sweet and chocolatey.
If you want the best of both worlds, try flavor enhanced terpenes to get the benefit of terpenes and the flavor of e-juice.
Everyone has different taste and smell preferences, but now you should be able to find the best fit when looking for that perfect terpene blend.
Nicole Flanigan is one of the newest additions to the Peak Supply Co family. Her knowledge base on terpenes and cannabinoids has helped throughout the educational process. Nicole is a Colorado-based content marketing professional who has dedicated her life to cannabis awareness, advocation, and education. When she’s not writing or developing something groundbreaking for her clients, she enjoys growing cannabis organically and hiking all over Colorado with her two huskies. Peak Supply Co provides the first true all in one solution providing terpenes, vape cartridges, package design and production, helping clients progress from starting creative to finished product.
FDA Rulemaking on Hemp/CBD – Hurry Up And Wait?
by Andrew Kline, NCIA’s Director of Public Policy
In April of 2019, the National Cannabis Industry Association (NCIA) formed a coalition of more than 100 CBD/Hemp entrepreneurs, scientists, medical doctors, and FDA lawyers to inform and influence FDA rulemaking on cannabis and cannabis-derived compounds. Over the past two months, coalition members worked tirelessly to draft public comments. Our goal was to answer all of the questions posed by FDA (including scientific questions), to be helpful to FDA by informing their rule-making process, and to influence the direction of their rule-making.
NCIA Files Public Comment And Testimony
On May 30, 2019, we filed 60 pages of formal comments which can be found here. I’m really grateful for the coalition’s collaborative work and quite proud of our final product. I’m also extremely grateful to the authors, including Alena Rodriguez of RM3 Labs, Dr. Paul Murchowski of Dr. Pauls, Khurshid Khoja of Greenbridge Corporate Counsel, Vanessa Marquez and Chris Elawar of CBD Care Garden, Jonathan Havens from Saul Ewing, Andrew Livingston from VS Strategies, and many others who devoted time to produce a great submission.
On May 31, I testified before the FDA and listened intently as dozens of others spoke. My takeaways were that most of the industry echoed our sentiment – that CBD is generally safe, but that safety issues do arise with adulterated products and with irresponsible manufacturing and marketing practices. I spoke about the need for consensus-driven industry standards, to include marketing and labeling practices, and for mandated lab testing. These practices will go a long way toward making certain that the industry is safe for consumers.
Concerns And Misinformation
I am genuinely concerned that there is currently great confusion in the market. People seem to think that CBD is federally legal as a result of passage of the Farm Bill of 2019. But, that is only partially true. While CBD was de-scheduled, the FDA still retains the authority to regulate the industry as a result of their prior approval of a prescription drug for epilepsy, Epidiolex. In the absence of clear regulatory guidance, people are making health claims that violate federal law. And banks and payment processors are shutting off accounts for CBD businesses because they are having difficulty assessing whether a particular business is operating lawfully.
We hope that FDA will act with deliberate speed in drafting regulations for the industry. If FDA takes its time in crafting regulations, there is danger that many CBD companies will shudder because of a lack of banking and payment processing. And we will inevitably lose market share to Canada and other international players. As always, NCIA stands ready to help.
Learning objectives for the panel include, (1) what the FDA was interested in learning about and why, (2) understanding how our industry coalition responded to the FDA’s scientific questions, (3) predictions for how the FDA will regulate CBD/Hemp and what it might mean for cannabis regulation in the future. Panelists will include members of the coalition who drafted our public comments to FDA.
In the coming weeks, NCIA will be releasing some new policy papers via NCIA’s Policy Council – the think tank for the state-legal cannabis industry. As always, if you’re interested in joining the Policy Council or have any thoughts about how we can propel this industry, please reach out me at andrew@thecannabisindustry.org.
Member Blog: How To Build A Successful Hemp CBD Company
The legalization of industrial hemp in December, 2018, has opened the door to a host of new products and processes that have the potential to enhance health and technological innovation while being environmentally sustainable and most importantly, highly profitable.
Entrepreneurs who want to stake their claim in the hemp space face some of the same challenges as others starting a new business, but other challenges are unique. Like anyone starting a business, you must understand your market. Right now hemp’s “low hanging fruit,” cannabidiol (CBD), is gaining popularity. Established brands such as Bluebird Botanicals, Endoca, and CV Sciences – which recorded $48.2 million in revenue for 2018, an increase of 133 percent over the previous year – are taking off.
Growth like this explains why predictions for overall expansion in the CBD market are meteoric, with cannabis industry analysts The Brightfield Group predicting it could hit $22 billion by 2022. But in order to get on that ride you will need to understand CBD consumers, prepare to meet their needs, and plan to expand their awareness of ways your product or service can help them. You will also need capital.
Stand out to investors
Once you have a good idea of the market and demand, you will be ready to start thinking about funding your company. It used to be that a passionate founder with a good pitch deck could attract investors after one meeting, but times have changed. Investors want cold, hard data to back up your claims, and they will want better analysis than your gut feeling, and a larger sample size than your friends and family.
Your pitch needs to not only support your market analysis with data, but differentiate your brand from others competing for the same investor dollars. The business model and differentiation need to encompass:
Revenue source
Where will you sell your product? Options include wholesale, white label, and retail through either online, brick-and-mortar store or a third-party vendor, or a combination of those.
Product category
Will you market your product as a cosmetic, pet supplement, nutraceutical, specialty beverage, functional food or something else? You will need specific information about the market for that product category and what roles CBD can occupy in them.
Product quality
What extraction methods are you using? Is your product purity third-party verified?
Are you using the highest grade of CBD isolate or distillate in your product line?
Product sourcing
Where does your hemp and raw materials come from?
How hands-on are you with your suppliers?
How stringently do you track your product from farm to consumer?
Vertical integration is increasingly seen as the optimal approach to CBD supply chain management. Producers such as Shi Farms in Colorado specialize in vertical integration.
Cannabinoid science:
Are your product and marketing firmly grounded in the best available science supporting the uses of CBD and other cannabinoids?
Product story
Do you have a compelling narrative that explains your personal investment in making the product available to consumers?
Does your marketing comply with FDA standards?
Some things you should not DIY
The issue of FDA compliance deserves special attention and professional support for CBD businesses. It is one of a few areas where hiring a consultant can make the difference between success and failure.
Your outward-facing communications will have to walk a line between including all the required elements without making any claims that violate FDA regulations. Cosmetic and nutraceutical labeling must list all ingredients, while nutraceuticals also need to provide a dietary supplement facts panel. Structure and function claims can be particularly tricky. CBD is not classified as a drug and therefore verbs such as treat, diagnose, prevent and cure are absolutely off limits. The language has to convey that some consumers use CBD in certain ways without employing medical terms or guaranteeing any particular outcomes. You can do your own research on compliance but it is always wiser to hire a consultant who specializes in this area.
As you get past the initial planning and push to get your business started, you will find there’s no substitute for long-term planning. Collecting ongoing data on the purity and potency of your product, the costs of raw materials and effectiveness of your marketing will enable you to make mid-course corrections in your projections so that your business and revenue grow.
Long-term planning based on robust data will ultimately make a huge difference for your business. I predict a failure rate of about 70 percent for CBD companies over the next five years. Whether they are underfunded, lack an effective management structure or are out of compliance with FDA standards, many new businesses won’t be able to compete with major players like Kraft, P&G and Unilever as they enter and begin to dominate in the CBD space. But some of those starting a CBD business now will not only learn how to stay afloat, they will prosper to the point that those major players will come knocking at their doors with generous offers to buy. Build in a pathway for your desired exit strategy and have all of your operating agreements and documents at the ready. If this looks like a possibility, or you want it to become one, you will need top notch, cannabis-savvy representation like McAllister-Garfield in your corner.
Learning and networking
If you want to make a deeper dive into starting or building a CBD or hemp concern, The Hemp Biz Conference is here for you. During symposia around the country you can learn about industry trends in an interactive forum, and get access to experts in discussion and workshop sessions designed for everyone from beginners to established professionals. Scheduled tracks – agriculture, processing, manufacturing, extraction, textiles, biofuels and plastics – allow you to focus your time where it matters most to you and your business. The Hemp Biz symposia attract the hottest hemp companies, investors and entrepreneurs in the industry so you will leave with connections that will help you grow for years to come.
Christie Lunsford, CEO, leads The Hemp Biz Conference’s charge into creating a sustainable hemp industry by bringing together the best experts, entrepreneurs, farmers and scientists in the cannabis space in the Hemp Symposium Series.
Before launching The Hemp Biz Conference in 2018, Christie founded Endocannabinioidology, a consulting firm providing cannabis science, FDA compliance support, technology and education management to businesses and individuals in the cannabis and hemp communities, where she successfully wrote or advised on winning cannabis license applications in several states. She has also overseen operations for a producer of horticultural LED technology, helped formulate and launch the first retail channel of CBD nutraceutical products derived from industrial hemp in the U.S, and was named Cannabis Woman of the Year at the 2015 Cannabis Business Awards. In addition to producing The Hemp Biz Conference’s Hemp Symposium Series she is a regular contributor on the business of hemp for Green Entrepreneur.
NCIA Submits Public Comment To FDA On Hemp and CBD Products
Today, NCIA responded and submitted public comments to the U.S. Food and Drug Administration’s (FDA) request for comments on Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.
Given the substantial interest in this topic and the need for regulations and standardization throughout the industry, NCIA and this coalition are providing specific insight into all facets the FDA would like to examine, including health and safety risks, manufacturing and product quality, and marketing, labeling, and sales.
Hemp-derived CBD is in high demand by consumers, and the industry is eagerly awaiting the FDA’s regulatory framework for these products. Our industry coalition firmly believes that by working in partnership with the FDA to inform rulemaking, we can develop an appropriate regulatory framework to ensure the safety and efficacy of these important products.
CBD (cannabidiol) is everywhere right now. Front page articles proclaim its virtues and ubiquity. New retailers announce their intentions to sell CBD products almost every day. But a lot of the media coverage of CBD is inaccurate or misleading. Below are five common misconceptions about the legal status of CBD.
CBD is legal in all 50 states
Unscrupulous promoters like to claim that the 2018 farm bill has fully legalized hemp as well as any and all derivatives of hemp. That’s not true. The 2018 farm bill exempted hemp and its derivatives from the definition of marijuana under the federal Controlled Substances Act (CSA), but it does not require states to do the same. Furthermore, under the 2018 farm bill, states are permitted to prohibit hemp production and several states continue to do so. While some states explicitly authorize and regulate the production and sale of CBD, or otherwise provide legal protection for authorized individuals to engage in commercial hemp activities, other states maintain outdated drug laws that do not distinguish between marijuana, hemp and/or hemp-derived CBD, resulting in hemp being classified as a controlled substance under state law. In these states, sale of CBD, notwithstanding origin, is either restricted to state medical or adult-use marijuana program licensees or remains unlawful under state criminal laws. Additionally, a number of states prohibit the sale of certain consumable CBD products, such as CBD-infused foods or dietary supplements. So, before you start selling CBD or invest into a CBD company, do your research on the states where you will be producing and selling product; you could be violating state criminal laws.
The FDA doesn’t regulate CBD products
Although the 2018 farm bill removed hemp and the cannabinoids derived from hemp from the purview of the CSA, the 2018 farm bill expressly preserves the U.S. Food and Drug Administration’s (FDA) authority to regulate food, dietary supplements, cosmetics, and drugs, including those that contain hemp ingredients. The FDA’s position is that THC and/or CBD cannot lawfully be added to food or marketed as dietary supplements. To date the FDA has sent warning letters to several CBD companies expressing this position and requesting corrective action. Therefore, although the FDA is accepting public comment and is holding a hearing to evaluate alternative approaches for regulating CBD products, the agency currently has jurisdiction over food, supplements, cosmetics and drugs containing CBD and continues to disseminate warning letters to CBD manufacturers for violating federal laws and regulations.
CBD is non-psychoactive
CBD is often marketed as the non-psychoactive cousin of THC. This is misleading. Research has indicated CBD has antipsychotic, anxiolytic (anxiety-reducing), and antidepressant effects – clearly demonstrating that it is a mood-altering substance (i.e., psychoactive or affecting the mind or behavior). It would be more accurate to say that CBD lacks the intoxicating effects of THC. From a legal perspective this matters because making deceptive claims in advertising is illegal and can result in serious consequences. Section 5(a) of the Federal Trade Commission Act prohibits “unfair or deceptive acts or practices in or affecting commerce.” We have seen the FTC jointly send warning letters with the FDA to a number of CBD companies and ongoing litigation surrounding the marketing of CBD products demonstrates there is meaningful risk that false or misleading label claims can create a cause of action for fraudulent inducement.
CBD has no side effects
There is increasing evidence that CBD has side effects and may interact with other medications, such as the anticoagulant warfarin, especially at high doses. The FDA has identified several safety concerns associated with the consumption of certain CBD drug products, including potential for liver injury, somnolence, lethargy hypersensitivity, decreased appetite, diarrhea and sleep disorders. FDA further noted that the potentially serious risk of liver injury can be managed through medical supervision, but questioned how effectively this particular risk can be managed in the absence of medical supervision and FDA-approved labeling. While more research is necessary to better understand the impacts of long-term CBD use at various levels, blanket claims that CBD has no side effects may provide false and misleading information to consumers.
CBD can be freely included in pet products
Although CBD products are widely marketed for pets, there are currently no hemp (or CBD) ingredients that have received express FDA approval for use in animal products. The FDA cooperates with the Association of American Feed Control Officials (AAFCO) for the implementation of uniform policies regarding the regulation of animal feed products, and although the FDA does not recognize animal supplements as its own regulatory category (it either classifies such products as food or drugs), the FDA’s policy has generally been to exercise enforcement discretion, allowing animal supplements where stakeholder groups such as the National Animal Supplement Council (NASC) permit them. At present, neither AAFCO nor NASC permits the use of CBD in animal products. While NASC’s position on the use of hemp ingredients in “dosage-form products” as of January 30, 2019, is that hemp is allowed in dosage form products (i.e. supplements) provided it doesn’t contain CBD concentrates, isolates, or synthetics, and the THC content is 0.3% or less, AAFCO has not approved any hemp ingredients for use in animal feed. As with human products, risk of enforcement and regulatory scrutiny is increased where products make any disease claims, where products are marketed as containing “CBD,” and where products are advertised widely in interstate channels. In addition, a product may be considered misbranded if its labeling is false or misleading in any way or fails to include required information.
Due to the highly nuanced nature of cannabis regulation, the infancy of the domestic legal industry, and the constantly changing regulatory landscape at both the state and federal level, businesses must be sure to stay informed, educated, and vigilant.
2 – Grayson, L., Vines, B., Nichol, K., Szaflarski, J. P., & UAB CBD Program (2017). An interaction between warfarin and cannabidiol, a case report. Epilepsy & behavior case reports, 9, 10–11. doi:10.1016/j.ebcr.2017.10.001
3 – Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments 84 Fed. Reg. 90, 12969 (April 3, 2019) (to be codified at 21 C.F.R. pt.15).
4 – Id.
5 – Hemp and CBD in Pet Supplements Weaves Same Tangled Web as in Products for Humans (Jan. 31, 2019), NUTRA ingredients-usa.com
Charlie Alovisetti, Vicente Sederberg LLC
Charles Alovisetti is a partner and chair of the corporate practice group at Vicente Sederberg LLP based in Denver. He assists licensed and ancillary cannabis businesses with corporate legal matters, and he has experience working with clients on a broad range of transactions.
Courtney Barnes and Corey Cox are associate attorneys in Vicente Sederberg LLP’s Denver office. They both aremembers of the firm’s hemp and cannabinoid practice group, where they focus on policy, regulatory compliance, and risk management in the hemp space.
Juicing is an increasingly popular health trend. Many people, from nutritionists to athletes, are consuming pressed vegetable juices to get the nutrients contained in leafy greens like spinach and kale. But what about cannabis?
Health Benefits of the Cannabis Plant
The leaves of the cannabis plant are rich in antioxidants, polyphenols and antibiotics, along with cancer-reducing and anti-inflammatory compounds. In fact, the U.S. federal government found in pre-patent research that CBD, which is a cannabinoid found in raw cannabis, is a stronger antioxidant than vitamins C or E.
Along with its nutritional value, raw cannabis can provide therapeutic effects and promotes basic cell function – activating receptors in your brain, releasing antioxidants, and removing damaged cells from the body.
Studies have also shown that consuming raw cannabis has the potential to treat lupus, arthritis and neurodegenerative diseases, help stimulate appetite and decrease nausea, prevent the spread of malignant prostate cancer cells, and prevent cell damage that can lead to serious illness and poor health.
Consuming Raw Cannabis
Consuming raw cannabis does not cause the “high” feeling that one gets when smoking cannabis or consuming it via edibles. This is beneficial for those who do not enjoy the psychoactive feeling often associated with marijuana.
By consuming the plant raw, one can receive all the nutritional and health benefits of the plant without feeling stoned. In fact, it’s been reported that you lose 99% of the health benefits of the cannabis plant when you smoke or cook it.
Juicing marijuana is the easiest and most convenient and way to consume the nutrients found in raw cannabis. Juicing the leaves of raw marijuana extracts essential minerals, vitamins and antioxidants, including:
Iron
Zinc
Calcium
Potassium
Selenium
Carotenoids
In terms of dosage, one suggestion is to consume 30g of fresh cannabis leaves per day.
Tips for Juicing Raw Cannabis
Add in 2- to 4-inch buds and 15 large fan leaves into a juicer. You can use the juice in smoothies with other vegetable and fruit juices, or freeze the juice to make ice cubes. Freeze leftover leaves to preserve their nutrients for future juicing.
Additional Tips for Juicing Cannabis:
Don’t use dry cannabis or nuggets that have already been cured for smoking.
Look for small, sticky crystals on the flowers and make sure that buds are amber colored.
Combine 1-part cannabis juice to 10-parts carrot juice to help reduce cannabis bitterness.
Additional Raw Cannabis Information
When incorporating raw cannabis into your diet, there are side effects to consider, including allergic reactions, possible ingestion of insecticides and pesticides, and compromised immune system from possible pathogenic exposure.
Consuming raw cannabis isn’t the best solution for fast symptom relief. Typically, it takes about three days to notice benefits. For some, the benefits may not be noticed for four to eight weeks as the nutrients build in your system.
To learn more about the benefits of cannabis, or to find a medical marijuana-recommending physician near you, visit MarijuanaDoctors.com.
Jason Draizin is the Founder and CEO of the Medical Cannabis Network and MarijuanaDoctors.com. Founded in 2010, MarijuanaDoctors.com is a secure portal for qualifying patients looking to connect and schedule an appointment with medical marijuana-certified physicians. The site has assisted in the certification of more than 300,000 patients in the U.S., and has established a network of more than 700 physicians nationwide.
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