The enactment of the 2018 Agricultural Improvement Act (the 2018 Farm Bill) and the legalization of hemp and hemp derivatives, including hemp-derived cannabidiol (CBD), has led to a massive CBD craze. Nevertheless, the FDA’s position against the sale and marketing of CBD-infused foods and dietary supplements has resulted in an insurgence of products infused with…
The enactment of the 2018 Agricultural Improvement Act (the 2018 Farm Bill) and the legalization of hemp and hemp derivatives, including hemp-derived cannabidiol (CBD), has led to a massive CBD craze. Nevertheless, the FDA’s position against the sale and marketing of CBD-infused foods and dietary supplements has resulted in an insurgence of products infused with lesser-known cannabinoids.
In light of this recent shift in the industry, this piece explores how these “novel” cannabinoids might be regulated as foods or dietary supplements under federal law, using the current CBD regulatory framework as a starting point.
Before diving into the regulatory framework of these lesser-known cannabinoids, it is important to understand what cannabinoids are.
Cannabinoids are chemical compounds found in the cannabis plant. The most notable cannabinoids are tetrahydrocannabinol (THC), which is the most psychoactive compound in cannabis, and CBD, THC’s nonpsychoactive cousin. Yet, there are over 100 compounds in the cannabis plant that affect the human body in their own unique way. Two cannabinoids have begun getting a lot of attention are cannabigerol (CBG) and cannabinol (CBN).
CBG is the “mother” of all cannabinoids; it helps synthesize other cannabinoids, primarily THC and CBD. Though scientific research remains sparse, CBG has been found to act on specific physiological systems and problems, such as treating glaucoma, decreasing inflammation, and offering antibacterial properties.
While CBG is the precursor of cannabinoids, CBN is the product of a degradation of other cannabinoids. Specifically, CBN comes from the oxidation and decomposition of THC. As for CBG, current research on the effects of CBN is limited; yet, CBN is showing promise as a potent antibacterial agent, an appetite stimulant and as a possible sedative.
CBG and CBN, like CBD, fall under the federal definition of hemp, which means these cannabinoids can be lawfully cultivated so long as they contain no more than 0.3% THC on a dry-weight basis. Because CBG is formed prior to THC in the hemp plant, many in the industry believe cultivating CBG strains will help them circumvent the stringent preharvest “total THC” testing requirement imposed under the USDA’s Interim Rules. CBN strains, however, may not afford the same advantage, given most growers’ inability to cultivate CBN-rich strains. Nevertheless, technologies that convert CBD and THC into CBN are beginning to emerge. This technological change will create a new set of legal issues. For instance, some commentators believe that THC-derived CBN may be treated as an illegal substance under the Federal Analogue Act (FAA). The FAA provides that any substance “substantially similar” to a Schedule 1 controlled substance should also be treated as a Schedule 1 substance. However, this theory is purely speculative and remains to be tested in a court of law.
Similarly to CBD-infused foods and dietary supplements, CBG and CBN products fall under the jurisdiction of the FDA. This is because the 2018 Farm Bill expressly preserves the agency’s authority to regulate products containing cannabis or cannabis-derived compounds under the Food, Drug and Cosmetic Act (the FDCA) and Section 351 of the Public Health Service Act.
CBG and CBN, unlike CBD, have not been approved or investigated by the FDA as new drug ingredients, which means the Drug Exclusion Rule should not apply to these two lesser-known cannabinoids. Indeed, the Drug Exclusion Rule provides that any substance that has been approved or investigated by the FDA as a new drug cannot also be sold and marketed as a food or dietary supplement, unless the substance was sold and marketed as such before investigation. In the absence of the Drug Exclusion Rule, the question of whether CBG and CBN may be sold and marketed as a food or a dietary supplement depends on whether these cannabinoids are safe for human consumption.
Under the FDCA, any ingredient found in a food sold and marketed in interstate commerce is subject to FDA premarket approval, unless the substance is generally recognized as safe (GRAS). A substance is considered GRAS if it is proven to be safe among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use.
Although the FDA has determined three hemp seed ingredients, namely hulled hemp seed, hemp seed protein powder, and hemp seed oil, to be GRAS, the agency has yet to make the same determination for CBD and other cannabinoids. This means that until the FDA explores the safety of these cannabinoids, any CBG- or CBN-infused food sold and marketed in interstate commerce will violate the FDCA.
Pursuant to Section 413 of the FDCA (21. U.S.C. 450b), any dietary supplement that contains a new ingredient — an ingredient not found in a dietary supplement sold and marketed before October 15, 1994 –- must notify the FDA about that ingredient prior to marketing, and provide the agency with information that is the basis on which the manufacturer or distributor has concluded that their product will reasonably be expected to be safe under the conditions recommended or suggested in the labeling. If the manufacturer or distributor receives a no-objection letter from the FDA, or no response at all, they may lawfully market their dietary supplement after the 75-day notification period is over, so long as their scientific evidence of safety is reliable.
Lastly, as for any CBD products, manufacturers and distributors of CBG and CBN-infused foods and dietary supplements should steer clear of any medical claims about the therapeutic values of their products. Doing so would suggest that the products’ intended use is that of a drug, and thus, would violate the FDCA and warrant FDA enforcement actions.
To conclude, given the limited amount of studies on the effects of CBG and CBN, the sale and marketing of these products remains risky under the FDCA. Nevertheless, as reliable scientific research continues to grow, it will give these two lesser-known cannabinoids a viable legal runway in the food and dietary supplement market.
Nathalie Bougenies practices in the Portland office of Harris Bricken and was named a “2019 Rising Star” by Super Lawyers Magazine, an honor bestowed on only 2.5% of eligible Oregon attorneys. Nathalie’s practice focuses on the regulatory framework of hemp-derived CBD (“hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and regulations surrounding hemp and hemp CBD products. She also advises domestic and international clients on the sale, distribution, marketing, labeling, importation and exportation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s Marketplace. Nathalie is also a regular contributor to her firm’s Canna Law Blog.
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