8 April 2019
FDA Hearing on CBD Regulation Scheduled for 31 May
The Food and Drug Administration will hold a hearing on 31 May on the regulation of cannabidiol (CBD), a non-psychoactive cannabis product. FDA Commissioner Scott Gottlieb indicated that the 2018 Farm Bill removed hemp from the list of controlled substances, defined as cannabis derivatives with extremely low concentrations (no more than 0.3 percent on a dry weight basis) of the psychoactive compound THC. Products containing hulled hemp seed, hemp seed protein powder and hemp seed oil can be used in foods if they do not contain CBD or THC.
These ingredients can be added to beverages (including juices, smoothies, protein drinks and plant-based dairy alternatives), soups, dips, spreads, sauces, dressings, plant-based meat alternatives, desserts, baked goods, cereals, snacks and nutrition bars, so long as the ingredients are properly listed on the package label. On the other hand, cannabis products containing higher amounts of THC are still classified as controlled substances subject to enforcement by the Drug Enforcement Administration, even as certain states have legalised whole cannabis and THC products for either medical or recreational use.
The FDA is focusing on CBD products because they are proliferating in the U.S. marketplace, including in human drugs, dietary supplements, cosmetics, and animal foods and drugs (which are all under the regulatory purview of the FDA). The public hearing, along with a public comment period and a new FDA working group, will consider regulatory and possible legislative actions needed to ensure public safety related to CBD.
The FDA has a webpage with answers to frequently-asked questions on cannabis products. It notes that the agency has approved a few prescription medications containing THC or CBD for treatment of certain conditions, such as seizures and anorexia. However, the FDA considers the marketing of any product containing CBD outside of the drug approval process to be illegal and remains concerned about the proliferation of unapproved products asserting to contain CBD that are marketed for therapeutic or medical uses. The agency indicates that these products are often sold on-line and are therefore available throughout the United States.
The FDA adds that there are “unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products.” In an effort to address these questions, parties may submit input on such topics as the levels of cannabis and cannabis-derived compounds that may cause safety concerns as well as how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds.
It is also worth mentioning that the FDA took a significant enforcement action on 3 April by sending official warning letters to three companies that made unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, on-line stores and social media websites. According to the FDA, the companies used these on-line platforms to make unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder and other serious diseases without sufficient evidence and the legally required FDA approval.