Gail Javitt, Jack Wenik, Lauren Farruggia, Megan Robertson, and Brian Hedgeman, attorneys in the Health Care & Life Sciences practice, co-authored an article in Law360, titled “CBD Scrutiny May Signal Broader FDA Enforcement Trend.” (Read the full version – subscription required.)
Following is an excerpt:
On April 2, 2019, the U.S. Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb announcing the agency’s latest enforcement actions taken against companies allegedly engaging in unlawful marketing of cannabidiol, or CBD products. Coming just days before Gottlieb’s departure from the agency, this news otherwise is unsurprising given recent CBD legislative and enforcement initiatives at the federal and state level.
The FDA first forecast its intention to step up enforcement against CBD products in a December 2018 press release issued on the heels of the passage of the Agriculture Improvement Act of 2018, or the Farm Bill. The Farm Bill removed hemp, and CBD compounds derived from hemp, from the Controlled Substances Act definition of marijuana, and legalized the cultivation of hemp for certain purposes.
Although manufacturers of consumer-focused CBD products were enthusiastic about this development, the FDA was quick to remind the industry in its December 2018 press release that it remains unlawful under the federal Food, Drug, and Cosmetic Act to market conventional foods or dietary supplements containing CBD.
The FDA noted that Congress “explicitly preserved the [A]gency’s current authority to regulate” CBD products, citing two sections of the FD&C Act, 21 U.S.C. §§ 331(ll) and 321(ff)(3)(B), to justify its position. These provisions prohibit the sale of any food or dietary supplement, respectively, which contains an ingredient that was the subject of clinical investigations or approved as a drug by the FDA before the ingredient was marketed as part of the food or dietary supplement.
Consistent with the FDA’s position, in early 2019, some state and local governments initiated seizures of CBD products (such as cookies, drinks and other foods) from store shelves. These events set the stage for the FDA to issue warning letters to specific CBD product manufacturers, while still leaving open the larger question about whether the FDA will modify its overall policy toward such products.
Related reading:
Health Law Advisor, “FDA Commissioner Gottlieb Says Agency Will Not Tolerate Deceptive Marketing of CBD Products; Issues Warning Letters,” by Gail Javitt, Lauren Farruggia, and Megan Robertson.
