Canada is two years into its “High” on Food, but the FDA still doesn’t want to partake. Can FSMA save the US Cannabis Market?
Will the FDA regulate cannabis in food using rules developed for food or for dietary supplements? What can we learn from Canada's approach?
Kris DeAngelo is an attorney, and teaches several courses with MSU's Institute for Food Laws and Regulations. Scott Haskell teaches the online course “Global Animal Health, Food Safety, and International Trade” each fall semester, and "The Law of the Preventive Controls for Human Food Rule" each spring semester.
Getting a “food high” is easily obtainable in Canada these days. Unlike the US, Canada has already tackled the cannabis elephant in the room to the point of naming him and laying down the house rules. The FDA is still denying that there is even an elephant. It’s time to wake up FDA. Dumbo is already flying high.
In 2018, Canada was the second country in the world (after Uruguay) to legalize marijuana for recreational use with its Cannabis Act (Cannabis Act (S.C. 2018, c. 16). The Cannabis Act is also known as ‘the Act’ or simply CA. This followed with cannabis edibles being approved in 2019. These federal rules are designed to keep cannabis away from those under the age of 18, provide for a legal, as opposed to an illegal, marketplace, and decrease criminal activity by creating rules and regulations concerning sales.
Provinces and territories may also impose their own regulations concerning cannabis products for food; they are regulated as food additives with strict rules as to types of foods they may or may not be used in or with. For example, cannabis may not be an ingredient in a food with more than 30 mg caffeine, may not contain added vitamins or minerals, may not be added to meats or alcohol.
Further, rules regarding amounts including the fact that a package is only permitted to contain 10mg THC are in place so that unwary consumers do not unintentionally consume too much in one sitting. Health Canada recommends ingesting no more than 2.5mg at one time for inexperienced users. In addition, any products must be approved by Health Canada, carry the standardized cannabis symbol and they require a mandatory health warning.
Today edible foods cannabis containing are approved and are beginning to show up in grocery stores and restaurants in Canada. In a new study from the Dalhousie University Agri-Food Analytics Lab (AAL), Canadians are getting used to the idea of legal edible cannabis. “Support for legalization is up — from 49 per cent in 2019 to nearly 80 per cent today — and disapproval has more than halved (30 per cent in 2019 to 14 per cent in 2021).” “According to the survey of 1,047 Canadians in May 2021, 25 per cent of cannabis consumers prefer edibles, which is down from 36 per cent in 2019. And while 65 per cent of Canadians don’t have a problem with restaurants adding cannabis-infused items to their menus, only 24 per cent would consider ordering one.”
What is the US federal government’s stand on this issue? At the federal level in the United States, marijuana is a controlled substance under the Controlled Substances Act of 1970 (21 U.S. Code § 812 - Schedules of controlled substances). So, Cannabis is still currently “listed” as a Schedule I drug, one with a high propensity for abuse.
In December 2020, a Bill (US HR3617 MORE Act Marijuana Opportunity Reinvestment and Expungement Act of 2021) to remove cannabis from the Controlled Substances Act was passed by the U.S. House but was not voted on by the Senate. In short, cannabis in any shape or form, is illegal under federal law. No ifs, and or butts about it. It cannot be consumed or used in any food period. ILLEGAL!
It is currently uncertain if the Food and Drug Administration (FDA) will utilize primarily the rules associated with food or for dietary supplements. Cannabis first and foremost needs to be deregulated to allow the legal use and the development of food regulations to ensure product safety. Once deregulated, the FDA can then develop a regulatory framework for edible cannabis products utilizing the Food Safety Modernization Act (FSMA). Either way, FSMA regulatory guidance is necessary.
But, you say, the recreational use of cannabis is legalized in 18 states, the District of Columbia, Guam, and the Northern Mariana Islands. Additionally, 13 states and the U.S. Virgin Islands have decriminalized its use. Moreover, 36 states and 4 territories allow medical use for cannabis products. States that have passed legalization are looking at cannabis as a ‘cash cow.’ So, what about these states where cannabis is legal, how do they regulate edible cannabis products?
But even ignoring the large federal problem, state laws, governing recreational marijuana edibles have multiple levels of issues. Right now, many consumers often find cannabis labeling on differing products quite confusing. Alaska, Oregon, Colorado, and Washington currently require edible cannabis product labels to disclose a variety of product information. Each state also requires the listing of risk factors associated with cannabis consumption. Other states lack specific regulations for labeling products. But even without labeling inconsistencies there are a significant level of food safety regulatory gaps in these products.
State laws, governing recreational marijuana edibles have not by and large assumed the food safety importance of these products. Additionally, inherent difficulties in enforcing laws around the growing, certifying, processing, manufacturing, packaging, labelling, and marketing of edibles are evident.
Where is FSMA? How are these states informing consumers and keeping the public safe?
Go back to the above federal discussion – cannabis products are illegal! Further, in 2005 in Gonzales v. Raich the U.S. Supreme Court decided that even in cases where marijuana was grown and consumed in a single state, where the federal government is not supposed to claim jurisdiction because there is no applicable commerce clause, the federal government can regulate because otherwise enforcement of the Controlled Substances Act would have giant holes. So, states that have passed marijuana or cannabis legalization legislation are fooling themselves that the federal government cannot control.
Under the Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., the definitions of food and drug are normally not mutually exclusive; an article that happens to be a food but is intended for use in the treatment of disease fits squarely within the drug definition in 21 U.S.C.S. § 321(g)(1)(B) and may be regulated as such. In 1982 in Nutrilab, Inc. v. Schweiker plaintiffs were manufacturing and marketing a product known as "starch blockers" which "block" the human body's digestion of starch as an aid in controlling weight. On July 1, 1982, the Food and Drug Administration ("FDA") classified starch blockers as "drugs" and requested that all such products be removed from the market until FDA approval was received. The next day plaintiffs filed two separate complaints in the district court seeking declaratory judgments that these products are foods under 21 U.S.C. § 321(f) and not drugs under 21 U.S.C. § 321(g). The question is: drug or not a drug?
Quality control is a primary looming issue for cannabis, but FSMA is a place for FDA to start once cannabis is no longer a schedule 1 controlled substance. As FSMA stipulates, current Good Manufacturing Practices (cGMPs), HARPC/HACCP (Hazard Analysis Critical Control Points) requirements with hazard identification, and controls need reworking and rethinking. Cannabidiol (CBD) and Tetrahydrocannabinol (THC) content specifications need adjustment and regulation, and new regulations are needed with continued improvements in testing procedures and transparency. Each step requires regulations and industry acceptance of these standards and development to ensure quality control.
Most importantly a FSMA regulatory framework is necessary. With FSMA the requirements of risked based preventive controls are essential for product safety. HACCP and cGMPs should be included both in the growing/harvesting and processing of the end-product. CBD and THC edible products should either be considered as a crop under the FSMA Produce Safety Rule during plant growth, cultivation and harvest or it should be considered as a food product when incorporated into an edible final product. This would require the FSMA Preventive Controls for Human Food Rule to be followed by the industry. Utilizing these principles will guarantee transparency and traceability of products evaluating critical control points for toxins and the possibility for monitoring biological, physical, and chemical contaminants.
Further, not all CBD/THC is created equal and differing levels of potencies are common between products. Creating differing potency classifications should be indicated. These potency levels will require validation standards. Little is known concerning toxicity levels of products and toxicities have occurred recently. Age of use restrictions may be necessary especially if the products remain Scheduled. Human cannabis products can also be toxic to family pets.
Cannabis first and foremost needs to be deregulated to allow legal use and the development of food regulations to ensure product safety. Once deregulated, the FDA can then develop a regulatory framework for edible cannabis products utilizing FSMA.
How will the US FDA regulatory framework stack up to the impressive work Canada has passed? How long can the government continue to not address this issue? Open your eyes FDA and smell the cannabis infused coffee. You have a framework with FSMA, let’s use it.
Final Regulations: Edible Cannabis, Cannabis Extracts, Cannabis Topicals https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/resources/regulations-edible-cannabis-extracts-topicals.html
Guide on composition requirements for cannabis products https://www.canada.ca/en/services/health/publications/drugs-health-products/composition-requirements-cannabis-products/guide.html
FDA (2020) What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
FOCUS: Foundation of Cannabis Unified Standards https://www.focusstandards.org/
Department of Justice Drug Enforcement Administration (2020) Drug Fact Sheet Marijuana/Cannabis https://www.dea.gov/sites/default/files/2020-06/Marijuana-Cannabis-2020_0.pdf
FSMA Final Rule on Produce Safety https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety
FDA (2019) Dietary Supplements https://www.fda.gov/food/dietary-supplements
FDA 101: Dietary Supplements https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cannabis-and-cannabis-derived-compounds-quality-considerations-clinical-research-guidance-industry
What the Produce Safety Rule Means for Consumers https://www.fda.gov/food/food-safety-modernization-act-fsma/what-produce-safety-rule-means-consumers
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) (2021) https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
5 students taken to hospital after ingesting THC edibles at magnet school in New Haven. https://www.ctpublic.org/2022-01-14/5-students-taken-to-hospital-after-eating-edible-with-thc
Marijuana toxicity in pets https://www.petpoisonhelpline.com/pet-safety-tips/marijuana-toxicity-pets/
'Copycat' cannabis edibles resembling candy causing serious harm to kids, Health Canada warns https://www.ctvnews.ca/health/copycat-cannabis-edibles-resembling-candy-causing-serious-harm-to-kids-health-canada-warns-1.5717135#:~:text=In%20Canada%2C%20legal%20edible%20cannabis,it%20is%20illegal%20and%20unregulated.
Charlebois, S., Music, J., Sterling, B., & Somogyi, S. (2020). Edibles and Canadian consumers’ willingness to consider recreational cannabis in food or beverage products: A second assessment. Trends in Food Science & Technology. 98, 25-29 https://cdn.dal.ca/content/dam/dalhousie/pdf/management/News/News%20%26%20Events/Edibles%20and%20Canadian%20Consumers%20English_.pdf
Pusiak, R. J., Cox, C., & Harris, C. S. (2021). Growing pains: An overview of cannabis quality control and quality assurance in Canada. The International journal on drug policy, 93, 103111. https://doi.org/10.1016/j.drugpo.2021.103111