With CBD (cannabidiol) becoming mainstream and with federal cannabis legalization on the horizon, many are asking how the U.S. Food and Drug Administration will regulate cannabis-based products going forward.
The 2018 Farm Bill, signed into law in December 2018, exempts hemp and hemp-derived products, including hemp-derived CBD, from the Controlled Substances Act (CSA). FDA Commissioner Scott Gottlieb then issued a public statement clarifying that Congress had explicitly preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Food, Drug and Cosmetics Act (FDCA), regardless of whether they are derived from cannabis or hemp.
With respect to a possible easing of restrictions on CBD and other cannainoids, the FDA’s public statement unfortunately only contains a vague assurance that the FDA would “make the pathways for the lawful marketing of these products more efficient.” What this means is unclear.
The FDA’s statement was prompted by widespread confusion in the public during the lead-up to passage of the Farm Bill as to the extent of the “legality” of hemp-derived CBD, with many commentators and even some legal experts conflating legality under the CSA with legality under the FDCA and state food and drug laws.
A product containing cannabis or a cannabinoid may potentially be considered a drug, food, food additive, dietary supplement or cosmetic, depending on how the product is marketed and sold.
How aggressively these products are policed by the FDA and state agencies depends on the nature of the product and how it is defined under the FDCA and state law. The FDA has nevertheless concluded that CBD and THC are impermissible adulterants in food and dietary supplements.
What Comes Next
Although the FDA’s statement references that the agency has authority to “issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement,” it makes clear that it will only do so if all other requirements in the FDCA are met, including those required for food additives or new dietary ingredients. These are not insignificant hurdles. The process can take years and is often exorbitantly expensive. In the meantime, the FDA remains under pressure due to intense public interest in these products.
This uncertainty has prompted multiple letters from Congress to FDA Commissioner Gottlieb. Oregon’s two Senators have requested that Commission Gottlieb update “outdated regulations” that prohibit food products containing CBD from being sold across state lines. On February 15, 2019, a bipartisan group of members of Congress also sent a letter to Commissioner Gottlieb “calling on FDA to swiftly provide guidance on lawful pathways for food products with CBD.”
The letter references significant confusion surrounding CBD and points out that “numerous states are pursuing legislative efforts that would allow for the intrastate commerce of food products with CBD, potentially leading to a patchwork of state regulations.” The members of Congress request that the FDA answer several questions, including when FDA will provide further guidance and hold a public hearing on the topic, and whether FDA has advised states that have taken enforcement actions,
These requests to liberalize the FDA’s position on CBD comes at a time when the FDA is preparing to take a more aggressive stance on regulating the dietary supplement industry. The FDA’s response should come soon but will likely reiterate the FDA’s consistent position that CBD and other cannabinoids must follow the scientific process like any other chemical component which will take many months at the minimum.
Enforcement by FDA and State Agencies
Between 2015 and July 2018, FDA sent several warning letters to companies that sell CBD-infused oils and food products in interstate commerce with associated health claims but took no other visible enforcement action against those companies. After passage of the Farm Bill in December 2018, however, there have been numerous reports of stepped-up enforcement action in several states by the FDA and state authorities.
In February 2019, the FDA issued 12 new warning letters and five online advisories to companies that make health claims associated with CBD products. There are also reports of snap inspections and CBD product embargos ordered by authorities in California, New York and several other states. It has been reported that FDA personnel have participated in some of these inspections, with the state personnel as the apparent lead agency.
Several states and cities, including California, Ohio, Maine, North Carolina, and New York City, have banned CBD-infused food products under state and local laws. As cannabis-based products continue to enter interstate commerce, one should expect to see an increasingly robust response from both the FDA and state authorities.
The FDA has taken no action against cannabis edibles sold in states that have legalized adult use or medical marijuana. This is likely because those products are not sold in interstate commerce and because those sales violate the CSA, such that they are already considered illegal under federal law.
Ian Stewart is a partner in the Los Angeles office of Wilson Elser Moskowitz Edelman & Dicker LLP and is co-founder and chair of the Wilson Elser Cannabis Law practice. Ian uses his 20 years of legal experience to help clients navigate the legalities around cannabis, CBD and hemp, and works with licensed cannabis operators, financial institutions, and insurance companies to comply with their obligations under the law.
Genese Dopson, a partner at Wilson Elser Moskowitz Edelman & Dicker LLP, focuses her practice on the defense of pharmaceutical and medical device manufacturers, and more broadly, the defense of companies against personal injury claims, insurance bad faith, and employment and discrimination claims.