Former U.S. Food and Drug Administration Commissioner Scott Gottlieb recent stated that, “the CBD craze is getting out of hand…” Federal law currently permits for the distribution of hemp-derived CBD products that contain 0.3% THC or less to be sold, with certain exceptions.
The FDA has indicated that it will be increasing regulations, as well as making recommendation to Congress. In fact, earlier this year, the FDA issued warning letters to companies marketing and selling CBD products, all of whom were allegedly making improper disease-related prevention claims. Most recently, the FDA alleged that a marketer made unsubstantiated claims regarding the “diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.”
At present, Sens. Dianne Feinstein and Susan Collins reintroduced the “Personal Care Products Safety Act” (S. 726) which would require the FDA to evaluate a minimum of five ingredients found in personal care products per year to determine their safety and appropriate use. The review process set forth in the bill would provide companies with clear guidance about whether ingredients should continue to be used and whether consumer warnings are needed.
State Attorneys General Activity
Uncertainty remains about federal enforcement related to the hemp and cannabis industry, including how FTC lawyers may regulate advertising. To date, federal enforcement has been rather passive.
In addition to FDA regulations and activity relating to FDA, it is anticipated that FTC lawyers and state attorneys general will soon be ramping-up enforcement of CBD products and related marketing.
At the state level, Governor Andrew Cuomo of New York recently signed into law a bill decriminalizing marijuana. Hawaii has also done recently done so.
State AGs, have not and will actively police unsubstantiated representations, including alleged health benefits of hemp and cannabis products. More than 30 state attorneys general recently submitted a letter to the FDA about associated risks when it comes to mislabeling help and cannabis products, as well as other dietary supplements.
It is almost certain that state AGs will pursue CBD companies that make false, misleading or deceptive representations, including via the issuance of aggressive civil investigative demands (CIDs).
Contact experienced FTC lawyers if you have questions about complying with applicable advertising regulations, or if you are the subject of an FTC CID investigation or enforcement action.
Richard B. Newman is a digital advertising and compliance lawyer at Hinch Newman LLP.
Attorney Advertising. Informational purposes only. Not legal advice.