FDA has repeatedly declared that cannabidiol (“CBD”) cannot be lawfully used in food or dietary supplements because FDA approved CBD as an active ingredient in an epilepsy drug before the first marketing of CBD as a dietary supplement or food. This has not stopped the growth of the CBD industry, however. The 2018 Farm Bill removed “hemp” from control under the federal Controlled Substances Act, which gave a boost to the hemp industry, and a patchwork of state rules has resulted in a proliferation of a wide array of CBD products. Several states have passed legislation allowing the use of CBD in foods and supplements, but many other states have declared such uses illegal. Although FDA maintains its position that the use of CBD in food and dietary supplements is illegal, FDA enforcement has been relatively minimal.
In testimony to before the Senate Committee on Agriculture, FDA asserted that it is exploring regulatory pathways available to hemp products containing CBD, but the Agency predicted that completing a potential rulemaking may take 3 – 5 or more years. In a letter to FDA, a bipartisan group of members of Congress expressed its concern about this time line, suggesting that FDA announce a policy of enforcement discretion and consider the path of an interim final rule to establish a clear regulatory framework for CBD as a dietary supplement and food additive.
Meanwhile, industry has explored ways to get more clarity on CBD in dietary supplements and foods. Early in October, four of the major trade associations, AHPA, CRN, CHPA and UNPA, seemingly frustrated by the state of affairs, sent a letter urging Congress to pass legislation that would make CBD derived from hemp a legal dietary ingredient for use in dietary supplements.
On November 14, 2019, CHPA (one of the signatories of the letter to Congress sent a month earlier) submitted a citizen petition requesting swift action from FDA regarding CBD. Specifically, CHPA asks four things:
- Establishment of a regulatory pathway to legally market dietary supplements containing CBD derived from hemp by promulgating regulations under the FDC Act, stating that hemp-derived CBD is lawful. Rather than going through the time-consuming process of notice and comment rulemaking, CHPA requests that FDA, under section 553(b) of the Administrative Procedure Act, proceed by issuing an interim final rule. Alternatively, if FDA were to decide to go through notice and comment rule making, CHPA asks that, in the interim, FDA issue guidance on enforcement discretion for companies that act consistent with the proposed rule.
- For CBD drugs, continue to enforce the requirements and protections under the new drug application process.
- Increase enforcement actions against “unscrupulous manufacturers” of CBD-containing products that market their product with illegal drug claims or otherwise fail to comply with the FDC Act.
- Monitor safety issues, if any, concerning CBD-containing products.
FDA has expressed concern about lack of information on the safety of CBD products and is hesitant to issue a rule stating that CBD may legally be used in supplements without predetermining the safety of CBD for such use. Rather than putting this burden on FDA, CHPA proposes that FDA’s regulation specify that manufacturers of CBD-containing products must submit new dietary ingredient (NDI) notifications for CBD; CHPA asserts that “NDI notifications would provide FDA with much-needed data on CBD since they must include evidence establishing a reasonable expectation of safety when used under the conditions recommended or suggested in the product’s labeling.”
On November 25, 2019, FDA announced that it had issued another 15 Warning Letters to companies marketing CBD containing supplements or foods. As before, the Warning Letters targeted companies that market CBD containing foods or dietary supplements with disease claims. FDA also revised its consumer update outlining specific potential risks associated with CBD consumption.
We will continue to monitor CBD developments.