Member Blog: Where Is Delta-8 THC Legal and Where Is It Banned? CBD Oracle’s Map Has the Answers
Delta-8 THC is probably the most controversial cannabinoid on the planet right now. With the 2018 Farm Bill being widely considered to have removed the THC isomer from the federal list of controlled substances, hemp and CBD companies quickly found a use for their excess CBD isolate. But if you’re considering selling delta-8 THC,federal law is only a part of the picture, and at state level, you have a patchwork of different laws and regulatory schemes to contend with.
This is why CBD Oracle, working alongsideNeil Willner co-chair of the Cannabis Group at Royer Cooper Cohen Braunfeld, has produced astate-by-state map of delta-8 THC’s legality based on extensive reviews of state law. If you want to know what’s going on with delta-8 THC in a specific state, this is one of the best resources around to get the answer you’re looking for.
Delta-8 THC Is Legal in 22 States and 1 District With Limited Regulation
Despite the controversy surrounding delta-8 THC, it remains legal in 22 states and 1 district, with only limited regulation. This covers the following states:
Alabama*
Arizona
Arkansas
Florida*
Georgia (?)
Illinois
Indiana (?)
Kentucky*
Maine
Maryland* (?)
Missouri
Nebraska
New Jersey
New Mexico
North Carolina
Ohio
Oklahoma
Pennsylvania (?)
South Carolina (?)
Texas (?)
Washington D.C.
Wisconsin
Wyoming*
Here, a * beside the state’s name means they’ve instituted age restrictions, preventing anybody aged 21 or under from buying delta-8 THC. States marked with (?) are currently involved in legal action about the status of delta-8 THC.
In the majority of these cases, state law basically follows the blueprint laid down by the 2018 Farm Bill with few or no additional rules. In fact, only a handful of states (Alabama, Florida, Kentucky, Maryland and Wyoming) have even passed laws preventing youth from buying delta-8 THC.
Legal actions are ongoing in several states, with the situation being slightly different in each. For instance, in Maryland, thehemp industry won a temporary injunction against the state, preventing the state from enforcing the provisions of House Bill (HB) 556 which relate to hemp until the action is resolved. The bill originally made it so that delta-8 THC products (and most CBD) could only be sold in licensed marijuana dispensaries, but this was deemed by the court to create a monopoly.
Delta-8 THC Is Banned in 17 States and Severely Restricted in 7 More
For every state where delta-8 THC is de facto legal, there is another state which has either banned or severely restricted the cannabinoid. In total, CBD Oracle’s analysis shows that delta-8 THC is banned in 17 states and severely restricted in 7 more. The states with bans are:
Alaska
Colorado
Delaware
Hawaii
Idaho
Massachusetts
Mississippi
Montana
Nevada (technically could be approved for marijuana industry)
New York (isomerization banned, could theoretically be sold in adult use)
North Dakota
Oregon
Rhode Island
Utah (possible in medical industry)
Vermont
Washington
West Virginia
And there are severe restrictions – limiting all THCs to be under 0.3% for hemp products, unless otherwise noted – in the following seven states:
Iowa
Kansas
Louisiana (all THCs must be under 8 mg per serving and 1% by dry weight)
Michigan (all THCs under 0.3% and only marijuana-derived delta-8 allowed)
Minnesota (all THCs under 0.3% and less than 5 mg per serving)
New Hampshire
Virginia (2 mg serving limit or >25:1 CBD:THC ratio)
Exactly how delta-8 THC is banned or restricted varies by state. For instance, while Coloradobans the “isomerization” process used to make delta-8 from CBD, Idahobasically bansanything that contains THC at all, even if it’s just CBD with trace, federally-acceptable levels of delta-9 THC. For the restricted states, most require that all THCs total to under 0.3% by dry weight, which is technically possible for a delta-8 THC product to meet, but essentially none do.
The analysis also revealed that – just like with marijuana – making delta-8 THC illegal doesn’t automatically remove it from a community. In Hawaii and Mississippi, for instance, despite state law banning delta-8 THC, it is still openly sold.
Only Three States Have Substantial Regulations on Delta-8 THC
In California, Connecticut and Tennessee, delta-8 THC is legal but has substantial regulations in place. In California and Connecticut, delta-8 THC is treated as marijuana and is sold as part of the adult use industry. This automatically institutes a wide range of requirements on the cannabinoid, including rules on testing and labeling to ensure safety and transparency for consumers.
Tennessee is the unique case here, where delta-8 THC is regulated as a “hemp-derived cannabinoid” and is legal to sell to adults aged 21 and over.Senate Bill (SB) 378 includes requirements for testing for contaminants, informative labeling and marketing which does not target youths, as well as a 25 mg serving size limit.
The Patchwork of Laws and the Future of Delta-8 THC
The key take-away for sellers of delta-8 THC is that current state regulations are a patchwork, making it very difficult to navigate for even the most responsible of companies. The product you can sell in Arizona without issues is probably not legal in Kansas, and would require batch testing and more to be sold in Tennessee.
This uncertainty may be resolved by the upcoming 2023 Farm Bill, but even this isn’t a sure thing. While the 2018 Farm Bill opened the door to a whole host of products and simply assumed (incorrectly) that the FDA would step up to regulate finished products, the new version might offer the clarity that was lacking. However, it’s just as likely that the bill will redefine “hemp” in a way that excludes delta-8 THC by default.
Pretty much the only thing you can depend on is that you’ll need to keep a close eye on state laws in the coming year. CBD Oracle’s map will be continuously revised to reflect the current legal reality and help responsible hemp companies remain compliant. ______________________________________________________________________________________
Lee Johnson is the senior editor at CBD Oracle, and has been covering science, vaping and cannabis for over a decade. He focuses on research-driven deep dives into topics ranging from medical uses for CBD to industry and user statistics, as well as general guides and explainers for consumers.
CBD Oracle is a cannabis consumer research company working to improve the safety and transparency of cannabis and hemp products, which publishes in-depth scientific, legal and consumer analyses on cannabis and cannabinoids.
Committee Insights: Cannabis Vaping – Avoid Being an Easy Target
NCIA’s #IndustryEssentials webinar series is our premier digital educational series featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most. The NCIA Committee Insights series showcases content produced in partnership with one of our 14 member-led committees.
Join us for Episode 2 of the vape-related #IndustryEssentials webinar series, presented by NCIA’s Cannabis Manufacturing Committee. In this highly informative session, we’ll delve deep into the world of cannabis manufacturing risk management, focusing on essential tips and strategies to help manufacturers avoid and effectively manage risks associated with the production of cannabinoid-containing products.
The 2019 EVALI outbreak stirred up the cannabis vape industry making some businesses an easy target in the court of public opinion. However, vaping continues to be a popular form of consumption among GenZ users, creating a demand for companies to design safer products and expand their due diligence testing during the product development phase. NCIA’s second vaping webinar of 2023 will sit down with industry experts to discuss what their companies are doing to avoid being an easy target, prevent another EVALI-like crisis, and how to navigate an industry in the absence of regulations.
Learning Objectives:
• Risk assessment and due diligence protocols to determine consumer exposure limits.
• Best practices and manufacturing standards during product development
• Youth prevention strategies
• Insights gained from emissions testing of vape products
Don’t miss this opportunity to stay ahead in the ever-evolving cannabis industry. Register now and join us for an engaging discussion on cannabis manufacturing risk management.
HHS Recommends Rescheduling: Now What? | 9.14.23 | Fireside Chats with NCIA’s Government Relations Team
NCIA’s #IndustryEssentials webinar series is our premier digital educational platform featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most. The Fireside Chat series of NCIA’s #IndustryEssentials webinars are an opportunity for industry professionals to hear from our government relations team and guests about the latest developments in federal policy LIVE.
For more than fifty years, the federal government has maintained that cannabis is a Schedule I drug, meaning that it has a high potential for abuse and no accepted medical value.
That recently changed when the Department of Health and Human Services (HHS) recommended to the Drug Enforcement Administration (DEA) that cannabis be placed in Schedule III, meaning that it has moderate to low abuse potential, a currently accepted medical use, and a low potential for psychological dependence.
There’s no doubt this move was an historic one– but what does it mean? What’s next? How will it impact your business? Join NCIA’s Aaron Smith and Michelle Rutter Friberg as they unpack all these questions surrounding cannabis rescheduling impact and more!
Committee Insights | 7.26.23 | Concepts for Regulatory Consideration – Shifting the Conversation from “Cannabis vs. Hemp” to “The Cannabinoids”
NCIA’s #IndustryEssentials webinar series is our premier digital educational platform featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most.
In this edition of our NCIA Committee Insights series, originally aired on July 26, we were joined by leading cannabinoid product manufacturers and Cannabis Regulators Association (representing cannabis and hemp regulators across more than 40 states and U.S. territories) to examine different approaches to regulating consumer products containing cannabinoids across the US and discuss the potential for harmonized regulations in the future.
Regulating the cannabinoids is difficult enough, but throw in the challenges associated with cannabinoids derived from marijuana or hemp and the challenges can get even more complicated. Not to mention the debate between intoxicating and non-intoxicating cannabinoids and how to address the risks to public health and safety from these different types of cannabinoids. Then you have the proverbial “cherry on top” with how to address cannabinoids, both naturally occurring and novel, being produced by genetically modified organisms and scientists in the lab. There has got to be a logical way to solve this problem.
One potential solution is shifting the conversation away from cannabis vs. hemp and toward the constituents of concern, the cannabinoids. By regulating the cannabinoids, we can focus the debate on what matters, how to regulate cannabinoid ingredients in a way that is proportional to the level of risk to public health and safety. This ensures we have both a functional and vibrant cannabinoid products market and the means to protect consumers.
Learning Objectives:
• Learn about the similarities and differences between marijuana and hemp regulations for consumer products containing cannabinoids
• Find out what a consumer product containing cannabinoids is and how this concept can be used to promote more common sense regulations
• Listen to new perspectives on the challenges facing the cannabinoid-containing consumer products space and how to more efficiently regulate this marketplace
Curious about the complex world of cannabinoid regulation? Sit back and settle in for an insightful webinar where we delve into the challenges (and solutions!) surrounding cannabinoids derived from marijuana and hemp.
Safeguarding Consumers in the Cannabinoid Product Landscape (Part III):
Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing (Part IV): https://bit.ly/3rEUeKP
Committee Insights: NCIA Mythbusters – Is Cannabis Safer Than Alcohol?
NCIA’s #IndustryEssentials webinar series is our premier digital educational series featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most. The NCIA Committee Insights series showcases content produced in partnership with one of our 15 member-led committees.
It is estimated that more than 140,000 people die from alcohol-related causes annually, making alcohol the fourth-leading preventable cause of death in the United States. How does cannabis compare? Find out in this special edition of Mythbusters brought to you by members of NCIA’s Scientific Advisory Committee and State Regulatory Committee. As more and more states move towards adult use, business owners must learn about safe access best practices and ways to reduce harm when it comes to their consumers.
Learning Objectives
• Learn what a contraindication is
• Learn which physiological and mental health conditions should avoid THC and CBD
• Familiarize yourself with State Regulations to Avoid Harm and Increase Safe Access
• Policy Recommendations to Avoid Harm
Panelists
Paloma Lehfeldt, M.D.
Senior Director of Clinical Science and Partnerships
Vireo Health
David Vaillencourt
CEO and Founder
The GMP Collective
Cynthia Shelby-Lane
MD/CEO
ShelbyLaneMD PC
Paul Muchowski, Ph.D.
CEO & CSO
Defined Research
Cassin Coleman
Founder
Cassin Consulting
Service Solutions: Taking Your Profits Higher – Navigating the Maze of Cannabis Marketing
NCIA’s Service Solutions series is our sponsored content webinar program which allows business owners the opportunity to learn more about premier products, services and industry solutions directly from our network of established suppliers, providers and thought leaders.
In this edition originally aired on Wednesday, July 20, 2022 we were joined by Fox Rothschild LLP whose national cannabis team discussed discussed how agencies and companies can comply when marketing products.
A successful business relies on marketing and advertising to grow and bring in new customers. But what happens when those promotional efforts are heavily regulated or even restricted? These are questions and hurdles cannabis businesses face, but there are ways to navigate this maze.
04:04 – How is marketing & advertising cannabis different than other industries?
07:45 – How is marketing & advertising for cannabis different from state to state?
13:40 – Are these state restrictions for cannabis OK under the First Amendment and do similar state constitutional free speech protections exist or apply here?
15:25 – Virginia State Board of Pharmacy & Thompson Case
16:26 – Central Hudson Case & The Four-Part Test for Commercial Speech
19:57 – Equal Protection Challenges on the Horizon
26:00 – California Cannabis Consumption Event Permitting Process
31:39 – How is marketing & advertising for hemp-based CBD products different than other industries?
37:28 – What is a curative healthcare claim and how can cannabis (or CBD-based) companies develop creative methods to comply while still distinguishing themselves?
41:40 – What trends and challenges do you see on how cannabis products are being advertised and sold?
by Michelle Rutter Friberg, Deputy Director of Government Relations
With the start of 2022 also comes the final year of the 117th Congress. Last year was marked with some small victories, although meaningful cannabis reform has yet to be enacted on the federal level this session. While it’s a midterm election year, I have no doubt that we’ll see some significant movement over the coming months. Keep reading to see my answers to some of your FAQ’s for the new Congress:
What’s going on with the SAFE Banking Act?
You’ll remember that during the 116th Congress, the SAFE Banking Act became the first cannabis-related bill to be passed by a chamber of Congress. It also became the first piece of cannabis legislation to pass the 117th Congress in April of 2021 by a vote of 321-101. Since last spring, the bill has languished in the Senate due to disagreement over enacting comprehensive versus incremental reform.
This year, expect pressure on the passage of SAFE to increase. While efforts to enact comprehensive reform continues, the votes are simply not there as of now. If you’re interested in learning more about this conundrum, take a look at this piece that the Brookings Institute recently posted.
NCIA is continuing to build support for the SAFE Banking Act in the Senate, but some big news was announced this week that will certainly impact the legislation in the future: longtime champion and lead sponsor, Rep. Ed Perlmutter (D-CO), just announced that he will not be running for re-election next session.
What’s next for comprehensive cannabis reform? Is legalization on the horizon?
There are numerous bills that have received much attention in terms of descheduling cannabis – among them the MORE Act (H.R. 3617), the States Reform Act (H.R. 5977), and the discussion draft (not formally introduced) of the Cannabis Administration and Opportunity Act (CAOA).
Back in the 116th Congress, the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act became the first piece of comprehensive legislation to pass the House of Representatives by a vote of 228-164. More recently, the MORE Act passed out of the House Judiciary Committee in September 2021 by a vote of 26-15. While this is certainly news to be celebrated, the bill has been referred to another eight committees of jurisdiction and faces a more conservative chamber overall than last session for full passage.
The States Reform Act is a newer piece of legislation that was introduced in the House by freshman Congresswoman Nancy Mace (R-SC). The bill deschedules cannabis, regulates it through ATF/TTB for cannabis products and FDA for medical use, and institutes a 3% federal excise tax on products to fund law enforcement, small business, and veterans mental health initiatives. Many have lauded the pro-business elements of the bill, however, additional provisions must be added to address equity and restorative justice. It’s unlikely that the bill will move this Congress for partisan reasons – particularly during an election year.
As for the Senate-led CAOA – there are too many unknown elements to make any real predictions! Senate Majority Leader Schumer (D-NY), Finance Committee Chairman Wyden (D-OR), and Sen. Cory Booker (D-NJ) outlined their plans for the CAOA in February 2021, unveiled the text in July 2021, with comments due by September 1 (make sure you check out NCIA’s response!). Due to the sheer magnitude of input received, the never-ending pandemic, and other legislative priorities, official language still has not yet been introduced. NCIA continues to work with the sponsoring offices on the CAOA and anticipates introduction in the spring.
What’s going to happen at the committee level?
If you’re following cannabis policy at the federal level, definitely keep your eyes on what’s happening in various congressional committees. Given that there were few cannabis-related hearings and markups in 2021, I’m hopeful that there will be more this year. I’ll specifically be keeping my eye on both chambers’ appropriations, financial services, tax, and judiciary committees.
Midterm elections will be here before we know it, but NCIA is continuing to keep the pressure on our elected officials to reform our outdated cannabis laws. Want to learn more about what’s possible? Make sure your company is an active member of NCIA and register for our next webinar, check out our podcast, and hop on over to NCIA Connect to chat with us and learn more about what we’re working on in D.C.!
Committee Blog: Don’t Wipe Out – Riding the Wave of Cannabis Standardization
Staying ahead of the quick rollout of state, national, and international cannabis regulations is a huge and complex challenge. The patchwork of more than three dozen (and counting) different state regulatory regimes remains disconnected as cannabis remains federally illegal as a Schedule I drug. The framework of regulations and standards that guides allied sectors such as Foods, Dietary Supplements, Pharmaceuticals, or Tobacco is just beginning to take shape. Where do you look for guidance? How do you choose how to invest, how to design your operation, and how to produce?
There are a number of considerations and industry-relevant organizations to become familiar with when looking to conduct business in the cannabis space. In doing so, businesses can operate more successfully and mitigate risk. Risk should not be underestimated – many cultivation and manufacturing facilities will fall seriously short of the expectations of agencies such as the Federal Food and Drug Administration (FDA), Occupational Safety and Health Administration(OSHA), the Environmental Protection Agency (EPA), if risk, both business and consumer health and safety, is not considered upfront. Market pressures will build quickly as brand-savvy companies with significant capital and operational expertise enter the field. One way to avoid wiping out – is looking to national and international standards, guidelines and regulations already in place. For a comprehensive list of relevant standards regulatory bodies, refer to our recent blog post here.
As standards continue to be developed by industry experts for adoption by regulators, businesses can be empowered to run their operations with more predictability and reliability knowing that they demonstrate compliance with approved industry guidelines. Laboratories will have access to valid test methods and reference materials. Equipment specifications will require globally accepted certification marks or labels (such as CE or UL) which ensures safety and longevity of operations.
What is the cost of not adhering to established standards?
A simple batch loss can easily exceed tens of thousands of dollars of lost product, let alone the damage to your brand, labor costs surrounding rework, and relationships with your clients. Crop and batch losses due to subpar equipment sourcing, processes that are not validated, and worse – risk of fines or losing your license are all symptoms of a business lacking standardization.
Credible standards – they are data-driven, go through a rigorous and transparentprocess. In most cases, these standards were developed with input and guidance from federal and international regulatory agencies.
Here is the snapshot today. Read it fast, because it may be out of date next month:
The NCIA has several relevant committees sharing best practices and developing guidance for our industry.
ASTM International, one of the oldest and most recognized Standards Development Organizations (SDO) formed Committee D37 on Cannabis in 2017, and has already approved over 25 standards that provide guidance on key areas such as:
AOAC International, another 100+ year old SDO has a Cannabis Analytical Science Program (CASP) where cannabis standards and methods have also been developed – principally in the area of product standard method performance requirements (SMPRs) and methods of analysis such as:
You don’t have to put your business at risk of wiping out! The resources that NCIA Committees continue to create have your best interest in mind. Stay tuned to ensure you have the latest resources and guidance!
Hurry Up And Wait: Descheduling, DEA Licenses, And Other Reform Legislation to Watch
By Morgan Fox, NCIA’s Director of Media Relations
The cannabis world is still eagerly awaiting the introduction of Senate Majority Leader Chuck Schumer’s comprehensive descheduling legislation, but that doesn’t mean things haven’t been moving on the policy front in recent weeks!
First up, the DEA announced that it was finally moving forward with approving applications to cultivate cannabis for research purposes, which would effectively end the federal government’s stranglehold on research production. The agency spent years fending off lawsuits from applicants, who correctly asserted that not only was the monopoly limiting research, but the cannabis being grown at the single licensed facility at the University of Mississippi was basically unusable for research purposes anyway. This announcement comes several years after the DEA publicly stated that it would begin the licensing process. Better late than never.
Next, Sen. Ron Wyden, who is also working closely with Majority Leader Schumer on descheduling along with Sen. Cory Booker, introduced S. 1698 last week. While text of this bill is currently not publicly available, the name suggests that this legislation would direct the FDA to allow hemp-derived CBD, made legal under the 2018 Farm Bill, to be used as a dietary supplement or in food. Some perceive this bill as necessary to get some regulatory clarity from the FDA, which has been dragging its feet and missed several deadlines for CBD regulations. Many in the industry blame this lack of regulation for larger retailers staying out of the CBD market, which has led to massive supply gluts of the substance and has been hypothesized to be a leading cause for the recent boom in Delta 8 THC production.
And earlier this month, Rep. David Joyce, an Ohio Republican who co-chairs the Congressional Cannabis Caucus, introduced a narrowly tailored bill to remove cannabis from the schedule of controlled substances. The bill assigns regulatory responsibilities to the FDA and the Alcohol and Tobacco Tax and Trade Bureau and gives them a one-year deadline to come up with a regulatory structure similar to alcohol. It also contains provisions similar to the protections that exist in the House-approved SAFE Banking Act, calls for studies on how cannabis impacts pain and driving, and improves access for veterans. Notably, this bill does not contain any social equity or restorative justice language.
While the chances of such legislation passing in the Democrat-controlled House are slim, it could serve as a doorway to get fence-sitting Republicans into the debate. It could also be a tool to identify those members of the GOP who are steadfastly opposed to any legalization bill and out of touch with their constituents, many of whom would directly benefit from cannabis policy reforms and who are increasingly in support of ending federal prohibition.
We’re also getting word that the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act is getting reintroduced in the House this week (and may have already been at the time of this publication). This legislation made history last December when it became the first descheduling bill to receive a floor vote – and pass – in either chamber of Congress. We are hopeful that there will be some revisions from the previous bill, including the removal of a provision that would allow federal licensors to deny applications for cannabis business licenses based on prior state or federal felony convictions, and the inclusion of a more sensible and robust regulatory framework.
We are less than halfway through the calendar year, and it is shaping up to be a momentous one for cannabis advocacy! Stay tuned for more updates from Capitol Hill.
P.S. On the state side, Alabama became the latest state to approve an effective medical cannabis law. Yes, Alabama. That brings the count of medical states to 36, after unfortunately losing Mississippi to a shameful court decision. So far in 2021, four states have approved adult-use or medical cannabis legislation, and more are expected to do so in the coming weeks and months.
USPS and Vaping Devices: What You Need To Know
by Madeline Grant, NCIA’s Government Relations Manager
The most recent omnibus that passed into law in December 2020 included a small provision related to vaping devices that could potentially have big implications.
The bill included language related to the Preventing Online Sales of E-Cigarettes to Children Act (the Act). The intent of the Act was to prevent underage smoking by applying the same safeguards already in place for cigarettes and smokeless tobacco products to the online sales of e-cigarettes — a mission we all wholeheartedly support. The Act also amends the Jenkins Act, which generally prohibits mailing of cigarettes to consumers through the United States Postal Service (USPS), to include Electronic Nicotine Delivery Systems (ENDS) and to subject them to the same mailability restrictions.
The Act defined ENDS as any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device. The provisions also extend to any component, liquid, part, or accessory of an ENDS, regardless of whether sold separately from the device. Unfortunately, this definition is overly broad, and despite the name, an item can be interpreted to qualify as an ENDS without regard to whether it contains or is intended to be used to deliver nicotine — this means devices used for the vaporization of cannabis or hemp, essential oils, and other aromatics, or even water vaporizers used for babies.
What does this actually do?
Prohibits the mailing of non-nicotine devices to consumers through the USPS
Triggers burdensome and illogical compliance requirements for mailing through common carriers (i.e. requires the labeling of packages as containing nicotine, payment of state tobacco taxes, reporting of consumer data, and more, even if non-tobacco products)
Eliminates USPS exception for B2B mailings for non-nicotine devices, as the form requires tobacco product license information which non-nicotine businesses do not hold
As a result of this Act and subsequent confusion, many common carriers have changed their policies to ban shipments of any vaporization devices and components, nicotine or otherwise
How can you help?
Although the time to submit public comments has passed, you can still make a call to your congressional representative and senators to express your concerns. To find your elected officials you can visit congress.gov, type in your zip code, and this will bring you to your representative photo and information. From there call the Washington, D.C. office, state your name and address, to confirm you are a constituent and discuss the talking points below. Every constituent call can make a difference as staffers log all comments and concerns for the office.
When relaying your concerns, note that this broad interpretation of ENDS was not the intent of the legislation. It creates conflicts with existing regulations (e.g. FDA deeming rules, USPS mailability of hemp products, and state tax guidelines, etc.) and delivers significant unintended consequences.
Ultimately, it means consumers and patients may not be able to receive the state-legal, non-tobacco products they want and could significantly increase costs — all at a time when USPS is already struggling to bring stability to the agency.
Along with a fantastic informal coalition that formed to address this issue, NCIA has submitted comments that ask USPS to clarify that their interpretation of ENDS to not include these additional product categories that were not the intent of the original statute. As a united front, we will continue to educate congressional offices. We will continue to monitor any movement of this legislation and keep our members informed. Please reach out to your elected officials. Of course, if you have any questions please feel free to reach out to Madeline@TheCannabisIndustry.org.
Webinar Recording: Good Manufacturing Practices in the Age of COVID-19
Tune in to this webinar recording from Wednesday, April 15, 2020. As the realizations of the Coronavirus sink in, one thing is certain – cannabis companies need to be leveraging good manufacturing practices, otherwise known as GMPs. GMPs are the practices required in order to conform to the guidelines recommended by the Food and Drug Administration (FDA). The FDA is the public health agency in the United States that controls the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. While many companies in cannabis are already following these guidelines, some are not.
This panel explores the GMPs themselves, how companies can become compliant, how GMPs can be amplified to make certain that we are preventing the spread of COVID-19, and whether there are extra precautions that should be taken to keep cannabis consumers safe.
Panelists:
Andrew Kline, Director of Public Policy National Cannabis Industry Association
Haley Brandsgard, Senior Quality and Compliance Manager Mary’s Brands
Alena Rodriguez, Managing Director Rm3 Labs
Trevor Morones, Founder Control Point
Jen Komerda, Quality Assurance Manager Wana Brands
Member Blog: Pathogens And Public Health – The Dire Need To Detect Microbes
As a new industry, cannabis has the opportunity to do business the right way. From day one. Many industries have come before ours, making missteps as well as setting best practices. In fact, we have the Harvard Business Review articles to prove it.
That’s why it frustrates me to no end to see industry players short-cut the right path forward. One of those areas is testing. In every consumer product area, testing is vital to ensuring consumer health and safety, but it is even more dire for products that are consumed or inhaled.
The Dire Need to Detect Microbes
Microbial contaminant testing is a critical step in the supply chain for all food and agricultural products, but it becomes ever more important to ensure cannabis products are verified as free of hazardous contaminants as cannabis-derived products become accepted treatments for various medical conditions.
Currently, the regulatory framework for evaluating the safety of cannabis products differs from state to state, with an abundance of clinical cases to back up the reason for testing, and the availability of technology to meet the safety standards to protect immuno-compromised patients and consumers. Conventional methods such as Petri-dish culturing and qPCR methods are not nearly as accurate or sensitive as commercially available, next-generation technology such as DNA microarray testing. Yet, the continued use of these outdated methods opens up the possibility that dangerous and deadly contaminants can enter the supply chain, and get consumed by millions of consumers.
In a recent study released to regulators and labs across the country, it was presented that plate culturing and qPCR testing was unable to detect the presence of a deadly fungal species, Aspergillus, that is presently common in both recreational and medical marijuana. A different technology, the DNA-Microarray tests not only detected Aspergillus, it also identified the exact species of the fungus, a nuance that requires longer testing times and additional testing steps when using petri dishes or qPCR methods.
Technologies such as sequencing and DNA microarrays can test for dozens of different deadly pathogens multiple times simultaneously from the same sample, whereas plate and qPCR methods test for a single or limited number of microbes. What this means is definitive confirmation when using the Microarray technology. This is where the technology is different and better, and also saves on costs, streamlines the entire testing process and reduces any opportunity for operator error.
In addition to being more accurate, DNA microarray testing is also faster. Plate methods require microbials to be cultured before being tested, which takes a minimum of 24 hours and often closer to a week for slower-growing organisms, such as many fungi including Aspergillus. In contrast, DNA Microarray testing yields results in six hours, and reduces harm to lab technicians by not subjecting them to large amounts of live cultures.
The point here is when technology is available that protects consumers and patients to an even greater level, is faster and more economical to process, and better in terms of performance, then why should the cannabis industry walk down the same path other industries have traversed, and one which they have tripped over multiple times? Why not learn from the lessons of these other industries and set a path that ensures greater safety and quality to the product?
History Not Worth Repeating
We’ve seen what happens when industries and governments turn a blind eye to deadly matters. In the pharmaceutical industry, the FDA came under scrutiny after a study found that excess dosages of the Merck drug Vioxx tripled a patient’s risk of cardiac arrest. In front of a Senate Finance Committee, the FDA was asked why danger signals of Vioxx went ignored. Questioning specifically focused on its relationship with the drugmaker, its expedited review process and the timeliness in conducting and stopping clinical trials when potentially adverse information was found that put the public at risk.
And yet, a similarly concerning matter remains ongoing with asbestos makers. The U.S. began regulating asbestos in the 1970s but has yet to ban the mineral, despite it being the number one cause of work-related deaths in the world. In fact, evidence suggests there is no safe level of asbestos exposure.
Similarly, science shows that there are no safe levels of Aspergillus. All it takes is one spore to kill. Sub-par and outdated testing methods not only risk the health of immunocompromised patients, it also puts consumers exposed over a period of time into the line of fire – as well as the credibility of the industry as a whole. Regulators need to demand cannabis is 100 percent contaminant-free by using testing methods that deliver absolutely proven and reliable results.
A number of stakeholders in the industry and beyond have reason to take up the call. In the recent e-vape crisis over 2,000 people have been hospitalized and 50 people have died due to lung infections. The pathogenic strains of the Aspergillus family would exacerbate this crisis further, and so gives the industry reason to ‘tighten’ the regulatory framework even more so not only with trusted testing methods, but ones that definitively protect public health. Even today in certain states that have not mandated testing of Aspergillus, but only mandating testing of Yeast & Mold, those states are allowing their consumers and patients to inhale Aspergillus ultimately fueling a national pandemic in lung infections. Just reference a peer-reviewed scientific paper by Kagan MD et al in the Journal of Allergy Clinical Immunology published in 1983, where the authors concluded that “[t]he use of MJ thus assumes the risks of both fungal exposure and infection, as well as the possible induction of a variety of immune and infectious lung disorders. Given the extraordinary number of individuals estimated to be MJ smokers, the occurrence of these illnesses may well become more commonplace”.
Sometimes the way things have always been done just isn’t good enough anymore. Technology has changed the way we take pictures, listen to music and even hail a ride. Can you do those things the old way? Sure, but they won’t have as much definition or clarity. It won’t be as convenient or cheap. When there is truly a better way, why wouldn’t you change?
And that’s what we ask when it comes to protecting the supply chain, a place where quality and accuracy cannot be compromised. When it comes to which testing method is the best, there is a clear choice – a choice that literally comes down to life and death. In order to safeguard both consumers and the legitimacy of the industry, cannabis stakeholders should demand labs use rigorous testing methods that pinpoint pathogens and protect public health.
Photos by Michael Chansley Photography, www.michaelchansley.com
Mr. Patel leads the strategic vision, financial health and global growth of PathogenDx, a Scottsdale, AZ based company which provides disruptive DNA-based pathogen testing technology and solutions for the cannabis, botanical, food and agricultural industries.
Previously, Mr. Patel spent over 25 years working with large public, small private and entrepreneurial companies in numerous fields from the life sciences, to biotechnology, to government services and the automotive industry. Milan served as COO/CFO of GMSbiotech. He also was CFO of 2020 Company, LLC, a leading premier professional services firm that delivered business and technology solutions to the government, in the areas of health, education and science.
Mr. Patel also worked at Intel Corporation in Sales & Marketing, Finance and Manufacturing. He has extensive experience in corporate finance, mergers and acquisitions, business strategy and planning, infrastructure and organizational development, and controls, compliance and audit and has led several company exits.
Milan earned his BS in Electrical and Electronics Engineering from the University of Detroit Mercy; a MS in Biomedical/Medical Engineering, University of Michigan; and a MBA in Finance and Marketing, University of Detroit Mercy.
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.
Top Ten Reasons NCIA Supports De-Scheduling Cannabis
Today, the House Judiciary Committee (Subcommittee on Crime, Terrorism and Homeland Security) is holding a hearing on marijuana policy reform proposals and related social equity provisions. While NCIA supports the STATES Act and other incremental approaches to reform, we strongly prefer a longer-term approach that includes de-scheduling cannabis and the inclusion of robust social equity provisions. Let’s get this right the first time around.
Below are the top ten reasons to support de-scheduling:
1. De-scheduling is good public policy because cannabis should not be classified alongside dangerous drugs like heroin and methamphetamines, and cannabis has proven medicinal properties and is safer for adults than alcohol and many over-the-counter medicines.
2. De-scheduling automatically solves the banking problems plaguing the cannabis industry and automatically cures issues related to the unfair tax provisions imposed by 280E.
3. De-scheduling removes many of the roadblocks in the way of creating an industry that prioritizes and promotes social equity and inclusion.
4. De-Scheduling would allow for cannabis to be transported across state lines in accordance with interstate trade compacts, opening opportunities for licensed growers to get their product into more markets and to stabilize supply and demand issues currently facing some state markets.
5. De-scheduling takes regulatory authority away from the DEA and creates opportunities for the federal government to regulate marijuana through FDA and Treasury with regimes that are more appropriate, given the relative harm of cannabis compared to other adult products.
6. De-scheduling immediately makes federal research and grants possible.
7. De-scheduling immediately changes current immigration policy that prohibits people with “bad moral character” from applying for citizenship because of their work in the cannabis industry.
8. De-scheduling allows for the provision of bankruptcy protection for cannabis-related businesses.
9. De-scheduling would allow veterans access to plant-based medicine and retention of VA benefits if they choose to use medicinal marijuana.
10. De-scheduling still allows for state autonomy while simultaneously providing for federal continuity.
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.
Member Blog: Federal Authorities’ Current Position On Cannabis In 2019
Marijuana is anything but boring. And the politics of cannabis gets more and more interesting by the minute. On the tails of the 2018 Farm Bill signed into law, as we predicted, hemp-derived CBD leads as the most controversial subject in the pot trade. Politicians and lawmakers are divided. Federal government agencies, like state agencies, have separate and distinct enforcement and regulatory authority which lends itself to polar opposite view points.
U.S. Attorney General Nominee William Barr Takes A Favorable 360º Turn
In less than a month since the Act was signed into law, we have the nominated Attorney General William Barr taking a 360 from former U.S. Attorney General Jeff Sessions. In Senate confirmation hearings just recently, newly appointed Attorney General William Barr stated that he would “not go after” marijuana businesses operating in states where cannabis is legal. Barr reasoned that companies relied on the Obama-era Cole Memo (which Jeff Sessions rescinded) that kept federal authorities at bay from criminal prosecutions under Federal law. We are all aware Federal law prohibits the possession and sale of marijuana. A new bill was introduced into Congress last Friday that would revive the relaxed Cole Memo enforcement guidelines.
USFDA Commissioner Scott Gottlieb Announces CBD Product Sales Illegal
In stark contrast, USFDA Commissioner Scott Gottlieb issued a press release statement and didn’t mince words. Gottlieb expressly stated that introducing CBD/THC food products into interstate commerce is illegal “regardless of whether the substances are hemp-derived” – as we predicted and discussed in previous blogs. Despite the FDA’s foreseeable regulatory posture, we continue to believe there remains the open question:
“Can you produce and sell CBD food products – marijuana or hemp-derived – so long as you do not tout its medicinal benefits? A question that has yet to be specifically addressed by lawmakers. Ironically, the states’ legalization of marijuana all began with medical marijuana because of its medicinal benefits as an alternative treatment.”
Commissioner Gottlieb’s FDA Statement does not answer this question.
Stay Tuned – We’re Staying On Top Of Cannabis Politics For You
An experienced corporate litigator having worked in both the private and government sectors, Attorney Robyn Ranke has taken a modern business approach to the cannabis industry and in working with cannabis business startups. Throughout her legal career, Robyn has represented a diverse base of business clientele in a variety of industries involving both complex and novel legal matters. Her diverse experience as a business litigator provides a valuable legal platform from which she is uniquely postured to address the regulatory hurdles, costly pitfalls, unique business transactions, and business litigation risks that confront California cannabis business owners today and into the future as state regulations continue to evolve.
Senate Subcommittee Just Says Yes… To A Hearing
by Michelle Rutter, Government Relations Coordinator
Earlier this month, the Senate Judiciary Subcommittee on Crime and Terrorism held a hearing entitled ”Researching the Potential Medical Benefits and Risks of Marijuana,” which was presided over by Sens. Graham (R-SC), Whitehouse (D-RI), Klobuchar (D-MN), Grassley (R-IA), and Blumenthal (D-CT). Witnesses included Sen. Kirsten Gillibrand (D-NY) and Sen. Kirsten Gillibrand (D-NY), federal officials from NIDA (National Institute on Drug Abuse), NIH (National Institute of Health), and the FDA (Food and Drug Administration), and members of the medical and legal community. For more information on the hearing and the witnesses, click here.
The first panel included Sens. Gillibrand (D-NY) and Booker (D-NJ), who both testified on the benefits medical cannabis can provide and noted that they are both original co-sponsors of the Compassionate Access, Research Expansion, and Respect States Act (S. 683), better known as the CARERS Act. Some of the key points that the Senators mentioned during the hearing included removing cannabis from its designation as a Schedule I drug, dismantling NIDA’s monopoly on cannabis used for research, and the urgent need to ease restrictions to allow for more research.
The next panel was comprised of two government agency officials: the Director of the Division of Extramural Research at the National Institute on Drug Abuse at the National Institutes of Health, and a doctor who is Deputy Center Director for Regulatory Programs at the FDA. Both panelists repeatedly stressed the importance of continued research into the therapeutic and medicinal benefits of cannabis, as well as the development of cannabis-based drugs. The FDA official also highlighted that the DEA is currently reviewing a recommendation on cannabis’s designation as a Schedule I drug, and the decision is pending.
The third panel included two doctors and a lawyer representing the DEA. The first doctor noted that THC and CBD do have therapeutic value but stressed the need for more research to determine if/how to mitigate any negative side effects of medical cannabis use. The second doctor on the panel is a well-known cannabis opponent, whose testimony sounded more like “reefer-madness” than a Senate hearing on cannabis in 2016. The lawyer present gave a moderately short statement, but did state that the DEA regulations around Schedule I drugs already provide a great deal of flexibility for research and can and are waived to allow legitimate studies and that the reclassification of cannabis to Schedule II would have little impact on the barriers to research – a statement that most in the cannabis community would strongly disagree with.
During questioning, Sen. Graham (R-SC) asked if the witnesses believed that cannabis should be re-scheduled as a Schedule II drug. Both the FDA official and the NIDA/NIH official weighed in, and with the same conclusion: more research is needed in order to make that determination. Chairman Graham also asked how to best facilitate medical cannabis research, which was answered by the DEA’s lawyer, who responded that the “flexibility” in the regulatory system could allow for it.
What does it mean?
Past Congressional hearings regarding cannabis have typically focused on the harms, not the benefits, of marijuana. As such, it’s a positive sign that the Chairman of the Senate Judiciary Subcommittee on Crime and Terrorism, Lindsey Graham (R-SC), held a hearing on the potential therapeutic benefits of medical cannabis. The main takeaway from the hearing was the desire from all parties – Senators, government officials, and medical professionals alike – for more research on cannabis, its compounds, and its effects.
Regardless, this hearing shows the progress that the industry has made in Congress and the momentum building nationwide behind the cannabis movement.
Guest Post: Regulating Marijuana – What Direction for FDA?
The Food and Drug Administration (FDA) has learned the hard way, over decades, that there is a moving ‘thin blue line’ for it to take legal action. On one side, the last thing FDA wants is to see thousands of seriously ill people demonstrating at the gates, as happened during the AIDS crisis when FDA stood between horrendously ill and dying patients and potentially life-saving drugs. FDA has become a much more savvy political organization since then and knows that any action it takes is always subject to second guessing by the courts, by Congress, and by political pundits on all sides. On the other side, FDA must act when there is clear evidence of people being harmed by products that fall within its jurisdiction.
There is no question that marijuana, whether in smokable, edible, or any other form, creates drug-like effects in people and animals. This medical fact is acknowledged by everyone and everyone admits that FDA could have jurisdiction to act, if it chooses to act. So why hasn’t FDA acted, and can we read the tea-leaves to foresee when it will act, and how it will act?
The key issue for FDA is always safety to people and especially ‘at risk’ patients such as children, people who might mistakenly take cannabis, or people who are medically compromised. Since no one can smoke cannabis by mistake, and FDA physicians can assure themselves that smoking cannabis has remarkably few toxicity issues, the only remaining safety concern is ingestion. Since it is possible to keep ingesting cannabis-containing food materials until a person reaches levels of medical concern, the question moves to: let’s take a look at the data.
Steve Goldner, Regulatory Affairs Associates
While there may be some overdosed patients who have not been reported into the hospital reporting networks, we do have a couple of years with consumers and consumables in Colorado and Washington State. While there have been some reports of regrettable overdoses that created harm, in general, epidemiologists are surprised by the remarkable absence of medical problems. Frankly, we were expecting significant reports of mortality and morbidity, and the reports are nowhere near the level of concern that FDA sees in field reports when action is necessary to save lives. Certainly there have been isolated problems, but far less than were expected and the trend seems to be towards better labeling, better quality control, and better information at point-of-sale.
So if past action was not necessary by FDA, and current action doesn’t appear necessary, what about future action? Does it look like the marijuana movement is working towards higher standards, more scientific analysis, and greater transparency with medical and scientific collaboration? Or is this movement trying to hide problems and deny that critical self-examination issues need to be addressed?
Clearly the industry is making itself safer on a weekly basis through self-regulation and multiple state regulations. Can we do better? Absolutely! So what are the primary opportunities to make huge leaps forward toward better service and better products for our patients and customers?
We suggest these are the top 5 for you to consider. See if you can answer YES to each of these:
Do I use a test lab regularly, with suitable sampling, and have they performed ‘FDA validation’ for their analysis procedures so I know they are giving true values?
Is the cannabis product produced regularly in the same way so that the product is predictable and do I follow Good Agricultural Practices (GAP)?
Am I always honest about having safe and clean product for my customers?
Do I know all the state rules and regulations and am I and my workers following them in all parts of my operations?
Have I protected myself and my workers from adverse working conditions?
If you can say YES to all 5, then give yourself a hand, and keep looking ahead, so you can stay ahead.
Steve Goldner was Supervisor Forensic Toxicologist at Office of the Chief Medical Examiner, New York City while working on the team that developed the first commercial laboratory chromatography tests for drugs, which helped launch the drug screening industry in the 1970s. He then formulated the drug methadone with his mentor John Broich from Brookhaven Labs., got FDA approval and managed the drug company for several years. After earning his law degree at Quinnipiac University Law School and practicing law in Connecticut, he specialized in gaining FDA approval for new medical technologies, foods, drugs and medical devices. His consulting firm, Regulatory Affairs Associates, became members of NCIA in June 2015, and has helped get over 240 products approved by FDA which launched many new companies. He also has served as FDA Expert Consultant to the National Institutes of Health and advises testing labs, food and drug companies on FDA, State and International compliance.
This site uses cookies. By using this site or closing this notice, you agree to the use of cookies and our privacy policy.
By Morgan Fox, NCIA’s Director of Media Relations
The most recent omnibus that passed into law in December 2020 included a small provision related to vaping devices that could potentially have big implications.
