Happy New Year!
2019 was quite the year in many regards. One such area was the significant growth of the CBD marketplace. In response, in the last quarter of the year, the Food & Drug Administration (“FDA”) got busy issuing warning letters and posting consumer notices regarding the safety and use of cannabidiol (“CBD”).
For example, on November 25, 2019, FDA posted fifteen new warning letters to companies marketing products containing CBD in ways the FDA asserts violate the Federal Food, Drug and Cosmetics Act (“FDCA”). Certainly this isn’t the first time the FDA has issued warning letters involving CBD products, but the fact that the agency released so many warning letters concerning one issue on a single day suggests an intent to communicate a message to the relevant industries that it is taking the issue very seriously.
On the same day the FDA issued the 15 letters, the agency further emphasized its message with the release of a revised Consumer Update, titled “What You Need to Know (And what We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.” The Update reminds consumers and interested parties that the FDA has approved only one CBD product, a prescription drug to treat rare forms of epilepsy, and that consequently any other “drug” claim for the substance is unapproved. The FDA further noted that research suggests potential risks from CBD use, including potential liver injury, adverse drug interactions, and somnolence, and that additional research was underway, and that going forward the agency would be evaluating the “regulatory framework” for CBD and other cannabis-derived products.
Marketers of cosmetics and topical skincare products containing CBD should pay attention to these developments. The majority of the products addressed in the FDA warning letters were supplements, consumables and pet products. However, several of the products were cosmetics, including lotions, facial moisturizers, soaps, and balms. In addition, the Consumer Update indicated the FDA was concerned about the unknown cumulative effect on consumers who both consumed CBD containing foods and used CBD-infused skin creams.
It is reasonable to anticipate that going forward the FDA will be scrutinizing products marketed as containing CBD. Marketers should be aware of the possibility of receiving warnings that label statements regarding such products assert unapproved drug claims, even for non-specific promotional statements that may have been overlooked in products without CBD. For instance, the recent FDA warning letters specifically included as examples of offending “drug” claims: “CBD Oil infused balm is a powerful topical cream designed for sore muscles, or areas where pain is felt,” “CBD can help with many skin conditions,” and “CBD lotion is the answer for sore muscle aches.”
Given the FDA’s stand in the warning letters, there is no getting around that there is some level of risk of receiving a warning letter for marketing any product as containing CBD and effective for any condition. Regardless of willingness to tolerate some level of that risk, it makes sense for companies to have labels carefully reviewed to minimize language linking CBD to particular outcomes.
Besides product labels, the FDA warning letters additionally make clear that companies offering products with CBD should also carefully audit the text on their website and their social media postings. In particular, the warning letters cite several statements about the effectiveness of CBD found not on labels but on websites and social media as evidence that CBD containing products were intended for use as drugs without FDA approval, and were consequently in violation of the FDCA.
ADDITIONAL TAKE AWAY… Based on the FDA’s statements regarding the concern for the potential concerns around systemic toxicity in individuals that both consume and use topical CBD products or pregnant women, we suggest evaluating the warning statements companies provide on their labels. Diesch Law Group is experienced in performing such label and website reviews to help minimize the risk of liability from marketing claims and are glad to assist in assessing CBD claims and warnings– in addition to other potentially objectionable claims.