Cannabidiol (CBD) competed with Vitamin C as a top ingredient in new cosmetic products this past year, with promises of having anti-inflammatory effects and other healing properties. Amid the hype, at the end of 2018, the Agriculture Improvement Act of 2018, P.L. 115-334 (the “2018 Farm Bill”) was signed into law, changing the marketing of hemp and derivatives of cannabis and further removing hemp from the Controlled Substances Act thereby making it no longer an illegal substance under federal law. See Section 297A. The 2018 Farm Bill amended the definition of “hemp” to specifically include “all derivatives, extracts, cannabinoids,” which has been construed as an attempt to include hemp-based CBD under the definition of industrial hemp. The 2018 Farm Bill allows, subject to certain restrictions, hemp cultivation, along with the sale, transport (including via interstate commerce), and possession of hemp-derived products.
Despite the major move in hemp legalization, the Food and Drug Administration (“FDA”) still reigns over CBD. When the 2018 Farm Bill passed, the FDA issued a press release acknowledging the “growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD).” The FDA communicated its commitment to “advance new steps to better define public health obligations in this area” and “continue to closely scrutinize products that could pose risks to consumers.” Critically, the press release warned that it is unlawful to introduce into interstate commerce food, including dietary supplements, containing CBD absent FDA approval, regardless of whether the substance is hemp-derived (because CBD is an active ingredient in FDA-approved drugs). The FDA further advised that there are pathways available to seek approval from the FDA to market such products, such as Epidiolex (the first drug containing CBD to be approved by the FDA for the treatment of epilepsy), and that the FDA is also considering its authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement.
Therein lies some confusion as to the effect of the passing of the 2018 Farm Bill and the FDA’s interpretation of its authority—hemp and hemp-derived products have been officially removed from the Controlled Substances Act (i.e. no longer treated as a drug) but the FDA maintains that regardless of their source, CBD products, including those derived from hemp, and, at least those used in food and dietary supplements, are still subject to pre-market approval by the FDA. The 2018 Farm Bill was intended to aid farmers so that they can grow hemp for industrial applications and apply for grants and insurance to do so. Although related, legislators have not expressly authorized the extraction of CBD from hemp plants for human consumption as a food additive, dietary supplement, or medication. The FDA has determined though that hulled hemp seeds, hemp seed protein powder and hemp seed oil are safe for use without FDA approval and thus added to the Generally Recognized as Safe (GRAS) list. Hemp-derived CBD was not among the hemp derivatives added to GRAS and the FDA confirmed that these new GRAS conclusions “do not affect the FDA’s position on the addition of CBD and THC to food”, which is prohibited under section 301(II) of the Federal Food, Drug, and Cosmetic Act.
Notably, the FDA press release was devoid of any mention of CBD in cosmetic products or where included in a product unintended for medical use or oral consumption. The December 2018 press release is still informative in highlighting the FDA’s attention to CBD and under the 2018 Farm Bill, the new regulatory scheme for industrial hemp. With new legislation and recent guidance from the FDA, we can expect even more clarity from the FDA on CBD products through further interpretation and application of the law via additional postings and enforcement measures, including warning letters. As stated in the press release, “[t]he FDA has sent warning letters in the past [the last of which were in 2017] to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer.” CBD therefore still remains a controversial ingredient, but generally, we can expect greater production of hemp-based products.
For more on cosmetics and personal care products regulation and litigation, see our Management Alert.