The United States Food, Drug, and Cosmetic Act (“FD&C Act”) is a set of regulations that, among other things, vests authority in the U.S. Food and Drug Administration (“FDA” or “Agency”) to oversee the safety of food, drugs, medical devices, and cosmetics. This includes food additives, such as Cannabidiol (“CBD”), a chemical in the cannabis sativa plant, also known as cannabis or hemp. According to the FDA, prior to the approval of a food additive, “there must be a reasonable certainty that an ingredient’s intended use won’t cause harm.” The FDA has indicated that, at this point in time, it does not have enough information to evaluate the safety of CBD for consumption as a food or beverage ingredient. The Agency is committed to ensuring that companies selling food or beverage products adhere to applicable laws and regulations. In addition to the safety of the product itself, the FDA has warned that businesses must be sure to also comply with applicable CBD marketing regulations.
The FDA’s Warning Letters and the Impact on CBD Marketing
The FDA recently issued warning letters to five companies that were illegally selling products containing CBD. According to the FDA press release, these companies were “selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.” The statement raised further concerns about products that may appeal to minors, such as cookies, gummies, and hard candy. The warning letters identify additional violations of the FD&C Act, including illegally selling unapproved CBD products that claim to cure, mitigate, treat, or prevent certain diseases. As we have reported, marketed products that are found to violate the FD&C Act will be evaluated by the FDA to decide whether to initiate enforcement action.
What is Acceptable CBD Marketing?
Although CBD was removed from the Controlled Substances Act (“CSA”) with the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”), to date, confusion remains as to what constitutes acceptable CBD marketing. Readers of our blog know that the Farm Bill preserved the FDA’s authority to regulate CBD products under the FD&C Act and Section 351 of the Public Health Services Act (the PHS Act”). Please note that the FDA may consult with other federal agencies and/or state law enforcement in making decisions about whether and how to enforce FD&C Act violations; this includes the marketing of illegal CBD products. In fact, the Federal Trade Commission (“FTC”) and FDA have worked together in investigating CBD marketing practices in the past.
Clearly, the law surrounding the sale and marketing of CBD products remains unsettled. Companies seeking to advertise their products should consult with a knowledgeable advertising attorney before launching any CBD marketing campaign. Failing to do so could result in an FTC and/or FDA investigation.