NCIA Director of Communications Bethany Moore checks in with what’s going on across the country with the National Cannabis Industry Association’s membership, board, allies, and staff. Join us every other Thursday on Facebook and LinkedIN for NCIA Today Live.
By Morgan Fox, NCIA’s Director of Media Relations
The process of approving the federal budget is moving full steam ahead, with the House Rules Committee considering several amendments related to cannabis to a series of funding bills this week. Amendments that pass this committee move on to a full vote on the House floor.
In terms of overall cannabis policy reform, the most prominent amendment is one that would prevent the Department of Justice from using funds to interfere with state adult-use and medical cannabis programs or target people and businesses that are in compliance with state cannabis laws. This amendment was offered by bipartisan congressional cannabis champions Reps. Earl Blumenauer (D-OR), Tom McClintock (R-CA), Eleanor Holmes Norton (D-DC) and Barbara Lee (D-CA). The amendment was ruled in order Wednesday and will proceed to a vote, possibly as soon as this week.
Even though the DOJ has generally been respecting state cannabis laws in recent years, passage of this amendment in the final federal budget would add the force of law to that policy for the next fiscal year, providing peace of mind for tens of thousands of regulated cannabis businesses and millions of consumers across the country. This would also add significant momentum to congressional efforts to remove cannabis from the schedule of controlled substances and regulate it at the federal level in separate stand-alone legislation.
Provisions to prevent the DOJ solely from targeting state-legal medical cannabis programs and providers have been approved by Congress every year since 2014. With public support for medical cannabis at roughly 90%, these protections have become mostly a non-issue in Congress and have been included in the original base language of the relevant House appropriations bills since 2019.
The amendment extending those protections to state adult-use programs was approved by the House in the budget votes in 2019 and 2020. Unfortunately, it did not receive the same support in the Senate and was not included in the final funding packages approved by the previous Congress.
An amendment that would remove the renewal of medical cannabis program protections from this legislation, flying in the face of long-supported policy and unnecessarily taking up lawmakers’ time, was also introduced by Rep. Doug LaMalfa (R-CA) and ruled in order.
Rep. LaMalfa, a staunch prohibitionist, has also introduced several amendments to appropriations bills to increase DEA funding for eradication efforts. He made headlines recently when his office released videos of him joining law enforcement in bulldozing outdoor cultivation sites in Siskiyou County, California while grandstanding for the camera and ripping off quotes from the film Apocalypse Now. These sites were located in primarily Hmong communities, a Southeast Asian ethnic diaspora that alleges that the county has prevented its members from obtaining cannabis licenses and prevented water shipments to their communities with serious harm to the quality of life there. LaMalfa’s behavior in these videos is particularly offensive given that many Hmong fled their homes to settle in the United States during and following the Vietnam War after facing persecution for supporting America in that conflict.
Unfortunately, some positive cannabis amendments were ruled out of order by the committee this week and will not be voted upon in this legislation. Delegate Norton offered a pair of provisions that would have prevented the Dept. of Housing and Urban Development from using funds to punish residents of federally assisted housing for state-legal cannabis use in adult-use and medical states, respectively. These reforms are incredibly important, as people living in federal housing can be and are frequently evicted from their homes if they or anyone in their household exercises their legal rights or uses the medicine that works best for them. This leaves many people with no place to legally use cannabis, leading to increased public consumption in low-income communities and continued racial disparities in arrests and citations.
On the positive side, an amendment from Rep. Kurt Schrader (D-OR) to highlight the need for the Food and Drug Administration to establish regulations for CBD products was also ruled in order and approved.
Last week, another bad amendment, introduced by Rep. Debbie Lesko (R-AZ), to remove language from the original legislation that would allow federal funding for universities that are conducting cannabis research was ruled in order but voted down in the House.
The House appropriations bills have a broad range of other cannabis provisions related to topics like banking reform, research, law enforcement funding and grant programs, federal employment guidelines, and allowing the District of Columbia to finally regulate cannabis after it was legalized by voters in 2014. We’ll get into these in more detail in the coming weeks as we get closer to a full vote in the House. Stay tuned!
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.
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
by Morgan Fox, NCIA’s Director of Media Relations
This week, Congress will hit the ground running by holding the first cannabis policy reform hearing of 2020 only weeks into the new session. The hearing, entitled “Cannabis Policies for the New Decade,” will be held by the House Energy Subcommittee on Health on Wednesday.
This hearing is expected to explore the barriers to cannabis research, the health impacts of current federal cannabis policies and the implications of reform, as well as several pieces of cannabis-related legislation including the Marijuana Opportunity, Expungement, and Reinvestment (MORE) Act, the Marijuana Freedom and Opportunity Act, the Medical Cannabis Research Act of 2019, the Medical Marijuana Research Act of 2019, the Legitimate Use of Medicinal Marijuana Act, and the Veterans Medical Marijuana Safe Harbor Act.
This hearing is an excellent sign that Congress is willing to continue the groundbreaking progress it made last year.
Unfortunately, all the witnesses for the hearing are representatives of government agencies that have not been overly receptive to ending cannabis prohibition, namely the Drug Enforcement Administration, the Food and Drug Administration, and the National Institute on Drug Abuse. But while we do not expect these witnesses to be cheerleaders for meaningful cannabis policy reform, there will no doubt be many tough questions asked by lawmakers who understand the importance of changing our nation’s outdated and harmful federal laws.
The hearing also presents an opportunity to help inform members of the subcommittee and others in Congress about the facts on this issue, as well as to show them that the cannabis industry is united in its common goal of removing cannabis from the schedule of controlled substances in a way that helps address the harms caused by prohibition, and let them know we are committed to working with them to address any concerns. A coalition of cannabis industry groups will be submitting a joint letter to the subcommittee, which will be available later this week, outlining these areas of agreement. NCIA will also be submitting written testimony for the congressional record.
You can watch the hearing here and we will be following up afterward with more information as well as responses, so stay tuned!
by Morgan Fox, NCIA Director of Media Relations
In recent weeks, the reports of mysterious respiratory illnesses tied largely to unregulated cannabis vaping products, as well as some other products including nicotine vapes, have turned from a trickle into a steady flow. The most recent count is at over 1000 cases, including more than a dozen deaths. One of the most troubling aspects of this outbreak is that it is still unknown what exactly is causing these illnesses. Early research seems to be pointing to additives or thickening agents as the most likely culprit, but other causes are being explored such as the presence of pesticides and fungicides that create dangerous byproducts, faulty delivery devices, problematic consumption patterns, and pre-existing medical conditions.
One thread seems to tie all these cases together: almost all of them involved untested products that were produced and purchased on the illicit market.
At its roots, however, is the same thing that has caused most of the other problems associated with cannabis: prohibition.
Outdated federal policies are responsible for the existence of the underground market for this popular substance in the first place. Their dominance over this medically beneficial plant for nearly a century continues to block research, discourages states from regulating cannabis and making it legal for adults, prevents the federal government from establishing uniform safety standards or providing guidance to states that are implementing sensible policies, and make it harder for legal businesses to displace illicit operators around the country. This is in addition to the suffering and harm caused by the criminal enforcement of these policies, which disproportionately impacts low-income communities and people of color.
Unfortunately, some governmental agencies are glossing over these facts. Last month, Massachusetts instituted a four-month ban on all vaping products, and on Friday the Food and Drug Administration issued a warning urging people to stop consuming any vape products containing THC, despite THC itself and legal products generally not being implicated in these cases. Other states and localities are considering total bans as well.
The cannabis industry is deeply troubled by this outbreak, but we are also concerned that reactionary responses to it at the state and federal levels could make the problem even worse. Preventing the sale altogether of regulated and quality-controlled cannabis products could easily drive more consumers to purchase potentially dangerous products from the illicit market. The lack of competition from legal, licensed producers and retailers could also embolden irresponsible underground operators to drastically increase production in order to meet demand, as well as cut corners even further and make their products even more unsafe. Such reactions are a common response to tragedies like this, but they often cause more harm than good in the long run.
Rather, states should be reviewing their regulations regarding testing and labeling and should be in close contact with federal and state medical authorities so that they can incorporate the latest information into their regulatory response. Producers should also be reexamining their methods and avoiding the use of any additives that have so far been linked to these cases.
At the federal level, the best way to help fix this issue, as well as prevent further outbreaks from happening at all, is to end prohibition.
On October 3rd, NCIA delivered a letter to every member of Congress signed by more nearly 800 business leaders, advocates, and policy experts, which urges them to immediately work to remove cannabis from the Controlled Substances Act and work to regulate the substance at the federal level. This letter references a paper produced by NCIA’s Policy Council released on October 1 that suggests a regulatory framework for various cannabis products through existing federal agencies, most notably the FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB).
That pretty much says it all. It is up to members of the legal cannabis industry to continue to prioritize consumer safety and do everything in their power to make sure they are going above and beyond state regulatory requirements in this area. But it is ultimately up to Congress to end prohibition, regulate cannabis intelligently, and help us replace the illicit market to the greatest extent possible. With your support, we can continue to work with lawmakers every day to help make this a reality.
by NCIA’s Infused Products Committee;
contributors Todd Winter, Ashley Hansen, Danielle Maybach, Lee Hilbert, Trevor Morones, and Greg Scher
Where is cannabis in the journey of dosing edibles?
Edibles are growing as a market share only behind concentrates. It is essential to have accuracy across the industry to protect human health and stabilize the consumer market. Potency, homogeneity, absorption rate, interpretation of dose (by State, County, International), percentage error/variance, labeling, and source of raw materials are just some of the items always questioned.
While we are discussing this issue, there will be no right answer for everybody. What is the dose? What is a serving? A check of an operator’s shelves will show chocolate bars with 800 mg of THC and a similar sized bar with 80 mg of THC. If you walked off the street and bought the 800 mg bar with only experiencing the 80 mg bar; you are in for a trip, and not a good one.
BDS Analytics’ GreenEdge Retail Tracking Platform as presented by Tamar Maritz in February had shown that when California consumers purchased cannabinoid products in 2018, they often want to know the CBD and THC content.
Label requirements vary state by state on the THC side and are often inaccurate both in the reporting of potency and the way they are displayed on CBD products. Extracts used as raw ingredients in product formulation come in various forms, it is important for the manufacturers to know the percent of actual CBD or THC when making purchase decisions. CBD extracts can be in the form of isolates with low bioavailability, or full spectrum which means the cannabinoid retains more of the plant’s original components.
Additionally, there are infused products, where the flower is extracted by an infusion into an oil, retaining even more of the original cannabinoid profile. All these extracts have specific formulation and labeling nuances that need standardization. The medical community wants even more specific terpene profile information as individual levels of Limonene, Myrcene, and other terpenes gain recognition for properties that have some additional benefit.
Do the terpenes solely earn the credit for their benefits or is it in combination with the other chemical compositions?
There are many ways to add cannabinoids into edibles; for example, when developing cannabis-infused products, are the manufactures using the “sprinkle” method to add the raw material/additive by literally sprinkling isolate? Are they using a pipette for exact measurement from a reputable supplier that is approved for food contact having been third-party audited, or a turkey baster from grandma’s kitchen utensil drawer which has seen some years? Methods abound!
Perhaps the most accurate method to create a homogenous product is to incorporate the raw material during the mixing step; before cooking, gassing (CO2), or pasteurization. Not everybody that starts an edible factory comes from the food or pharmaceutical industry. A standard serving size or dosage, whichever you prefer, could make life easier for all stakeholders with a few exceptions. As yield models mature for extraction, markets will adjust, and prices can stabilize based on real data.
In Iowa, they have just legalized for medical use, but the flower is not legal. It is 100% treated as a drug. Any product needs to have no more than 3% THC to be permitted. We can’t forget our colleagues dealing with burdensome regulation. I doubt they can measure with turkey baster there, and if we saw a manufacturer in Iowa, we would probably see a pipette. Consensus on a dose can help elected officials know more and lift heavy restrictions.
Caffeine, like cannabis, is a naturally occurring alkaloid in 60+ plants. Cannabis produces THC and CBD, which are cannabinoids. The next step for the industry in supporting cannabinoid dosing of THC and CBD or any other cannabinoid is to increase general public recognition, routine toxicology studies, and develop appropriate data and work methods to obtain public recognition or certification for food safety, public safety, and documentation.
In the United States caffeine, when in soda, is limited to 65 mg per 12 liquid ounces of beverage. In pill form, the FDA allows 200 mg of caffeine. While this is about THC/CBD, the parallels are plain. While the Cannabis industry addresses dosing challenges are many. Stakeholders composed of consumers, operators, manufacturers, laboratories, distributors, and regulators would like to see the order in the industry.
The Federal Government does not yet consider cannabis as a food additive that is “Generally Recognized as Safe (GRAS).” Caffeine, a GRAS substance under current regulation, attained status under industry practices over 60 years ago. Within our industry, GRAS is not a deeply-rooted measurement for quality or safety standards. Cannabis has no history of being hazardous when infused in products and defining a serving, or a dose should not impact the operations of notable brands that provide excellent food safety and quality.
Each consumer (patient or recreational user) has their personal approach to cannabis dosing based upon their due diligence. Manufacturers are producing THC and CBD products that range from “micro-dose” to “mega-dose” because they understand that no one standard dose is the right for every individual.
Consumers look at labels to determine which product to buy. Manufacturers rely on testing to confirm THC and CBD content. CBD and micro-dose product categories are trending; unfortunately, many laboratories are not equipped to test CBD products accurately and consistently. THC Micro-dose products have similar problems. Not all laboratories have equipment that can report trace amounts accurately. Homogeneity, labeling, and raw ingredient sourcing are opportunities for manufacturers to set themselves apart to the retail operators in a wide-open market. Let us collectively work together towards clarifying the issue and work with all the stakeholders to define for the public some language that can be understood by all, encourage federalization, and develop a standard of excellence.
NCIA’s Infused Products Committee (IPC) focuses on edible and topical products, reviewing existing business practices and state regulations. Regulation of these products is the IPC’s initial key focus, but the committee’s purpose is to ensure the infused product sector is helping shape its destiny, rather than being driven by differing jurisdictional regulations. The IPC is also working with the Policy Council and Council on Responsible Cannabis Regulation (CRCR) to develop standardized regulations for legislators and regulators to adopt as their states legalize the industry.
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.
by Shawn Hauser, Vicente Sederberg
As we learn more about the cannabis plant and its potential uses and benefits, Cannabidiol, or “CBD,” continues to emerge as one of the most beneficial, and non-intoxicating, parts of the plant. Although there is significant research on the safety and efficacy of CBD, and some forms of CBD derived from hemp are arguably not regulated under the federal Controlled Substances Act (CSA), the Drug Enforcement Administration still considers CBD a marijuana derivative and Schedule I drug that is being illegally marketed in violation of the CSA and the Federal Food, Drug, and Cosmetic Act (FDCA).
In addition to food and drugs, nutrients and other supplements are regulated by the Food and Drug Administration (FDA) under the FDCA. The purpose of the FDCA is to forbid “the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics.” Disregarding the legality of CBD product sales under the CSA, any company contemplating the sale of such products should consider whether the products can be lawfully sold under the FDCA. Any product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease is classified by the FDA as a drug, regardless of the product’s form or how it is marketed or labeled. Drug approval requires an extensive process involving collecting and submitting for review clinical and non-clinical data about the proposed use of the drug. While FDA has not yet attempted to regulate marijuana products sold in licensed marijuana establishments, the proliferation of states legalizing CBD for medical purposes and legalizing the cultivation and sale of hemp products has complicated the legal landscape. As CBD products move out of marijuana establishments and into retail and internet stores, they are catching the FDA’s eye.
In February 2015, the FDA sent letters to companies marketing CBD products stating that the companies were violating the FDCA by making therapeutic claims about the products, which are not approved as “drugs” under the FDCA. The FDA also recently confirmed that CBD cannot be marketed as a dietary supplement, stating that “Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”
In marketing products, the FDA classifies products based on intended use. Any website selling the product or providing references to sites where the product is sold will likely be examined for content by the FDA in determining the product’s intended use. Evidence of intended use includes claims on labels and literature, the citation of publications related to the product, and claims made on any forum where a consumer may see the product. Products may be considered “drugs” if claims are made related to the product’s use for the cure, mitigation, treatment, or prevention of diseases. Evidence of such claims may include therapeutic claims, claims that the product possesses certain medical properties, or the commercial use of scientific publications to promote the product’s sale. Even simple references to scientific studies or general research, such as “cannabinoids are emerging as an effective treatment for infections,” may be considered evidence that the product is a drug.
To further complicate matters, CBD has been granted orphan drug status by the FDA for treatment of Dravet’s Syndrome and Lennox-Gastaut Syndrome. However, the FDA has acknowledged the mixed signals sent by the present controlled substance classification of cannabis, and of CBD specifically, and has publicly supported research regarding CBD’s potential medical uses in testimony before the House Subcommittee on Government Operations.
Prior to marketing CBD products, companies should consult with an attorney who specializes in FDA compliance. This due diligence can not only ensure compliance and prevent action by the FDA, but may also promote the business’s reputation as one that is professional, thorough, and trustworthy. The FDA is less likely to target medical marijuana companies that a) avoid engaging in interstate commerce and only sell products within states that have legalized medical marijuana, and b) do not make claims about the proven efficacy of CBD products. As cannabis and CBD products proliferate, recent FDA activity indicates that the FDA is monitoring retailers and manufacturers of these products and will continue to do so going forward.
Nothing herein is intended to create an attorney client relationship. This article is for educational purposes only and shall not be considered legal advice. Please consult the appropriate legal professional prior to relying on anything mentioned herein.
Shawn Hauser, Esq., is the senior associate at Vicente Sederberg, Sustaining Members of NCIA. Shawn has been working in marijuana and law in policy for almost 7 years, starting with internships in marijuana law while she was studying at the University of Denver Sturm College of Law, where she chaired the school’s chapter of NORML. Prior to joining Vicente Sederberg LLC, Shawn worked at a small law firm specializing in marijuana law, criminal defense and family law. Shawn is the director of the “Local Implementation Project” for the non-profit Sensible Colorado Action, where she works with local governments across the state to pass marijuana laws that foster responsible businesses. Shawn also serves on the board of National Hemp Association, a Denver-based organization dedicated to the re-birth of industrial hemp in America. Shawn came to Denver in 2008 from Austin, Texas, where she fostered her love for live music, while studying psychology at the University of Texas at Austin.
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