Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds
On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it would hold a public meeting on May 31, 2019, to seek scientific data and information from stakeholders about products containing cannabis or cannabis-derived compounds.[i] As set forth in the notice of public meeting (Notice), FDA has opened a docket and will accept comments on the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis and cannabis-derived compounds until July 2, 2019. Submitting comments is a way for interested parties to inform FDA about cannabis-related issues and help shape the way the agency regulates products containing cannabis or cannabis-derived compounds.
In many ways, statements made by FDA in the Notice can be understood as an assertion by the agency of jurisdiction over all cannabis-related products. After referring to Congress’ passage in December of the Agriculture Improvement Act of 2018, Pub. L. 115-334 (the 2018 Farm Bill), which made cannabis with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3% (i.e., “hemp”) no longer a controlled substance, FDA touts in the Notice the fact that “Congress recognized FDA’s important public health role with respect to the products it regulates.”[ii] Because the 2018 Farm Bill “did not change FDA’s authorities,” FDA asserts, “cannabis and cannabis-derived products are subject to the same authorities and requirements as FDA-regulated products containing any other substance, regardless of whether the products fall within the definition of ‘hemp’ under the 2018 Farm Bill.”[iii] The Notice then provides a lengthy primer on FDA’s broad legal authorities over human drugs, human foods/dietary supplements, animal food and drugs, cosmetics, tobacco products, and medical devices.[iv]
Throughout the Notice, this broad assertion of FDA regulatory authority is stated in terms of the Agency’s concerns about safety. For example, FDA acknowledges that “the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years,” but then says that “questions remain regarding the safety considerations raised by the widespread use of these products.”[v] Importantly, FDA states that questions about safety “could impact the approaches we consider taking in regulating the development and marketing of products.”[vi] In FDA’s view, these concerns about safety are not theoretical; the Notice states that the agency already “has taken action against companies illegally selling cannabis and cannabis-derived products that put the health and safety of consumers at risk.”[vii] Indeed, just last week, FDA and the U.S. Federal Trade Commission (FTC) jointly issued a flurry of Warning Letters to companies that were making what FDA Commissioner Scott Gottlieb said in a statement[viii] were “unfounded, egregious” claims about their cannabidiol (CBD) products (e.g., claims that their CBD products slowed the growth of cancer cells and the progression of Alzheimer’s disease).[ix]
To emphasize the safety concerns associated with use of cannabis-derived products (and underscore its regulatory authority and expertise), FDA outlines in the Notice the safety concerns and adverse events associated with CBD, one of the many cannabinoids found in cannabis that is believed to have therapeutic benefits. According to FDA, safety concerns and adverse events associated with CBD that were identified during the agency’s review of the marketing application for the drug product Epidiolex® (cannabidiol) oral solution, which was approved by FDA for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older, include concerns about the potential for liver injury, somnolence and lethargy, hypersensitivity, decreased appetite, diarrhea, and sleep disorders.[x]
Of course, notwithstanding FDA’s broad assertion of authority to regulate products containing cannabis and cannabis-derived compounds, the agency’s authority is not unlimited. Instead, it is circumscribed by the authority granted to it by Congress in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other legislation. As such, whether a product containing cannabis or a cannabis-derived compound (e.g., a CBD-infused product) is subject to FDA regulation will depend on whether the product falls within one of the product categories regulated by the agency under the FD&C Act. If a product containing cannabis or a cannabis-derived compound is subject to FDA regulation (because, for example, the product is a drug or a dietary supplement), then the FDA “approval pathway” for the product, to the extent approval is required, will be the paramount consideration for a firm seeking to bring the product to market.
Even if a product is subject to FDA regulation, the agency’s resources are not unlimited. Citing “enforcement priorities and our limited resources,” Commissioner Gottlieb acknowledged in recent congressional testimony that FDA has not taken enforcement action against hundreds of CBD-containing products that are currently on the market. “We’re using enforcement discretion right now,” he said. “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over-the-line’ claims.”[xi] Speaking to federal legislators at a congressional budget hearing, Dr. Gottlieb said that FDA is concerned about the unapproved CBD-containing products that are being marketed, but understands Congress’ passage of the 2018 Farm Bill to be a signal: “We heard Congress loud and clear here. We know you want a pathway.”[xii]
Clearly, FDA is open to developing marketing pathways for certain products containing cannabis-derived compounds, like CBD. Whether and how and when the agency does so will depend, in part, on the scientific data and information it obtains from stakeholders and the public in connection with the upcoming public meeting on May 31, 2019, and in comments submitted to the associated docket, which are due on July 2, 2019.
[i] FDA, Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments, 84 Fed. Reg. 12,969 (Apr. 3, 2019) [hereinafter “FDA Notice”].
[ii] Id. at 12,970.
[iv] See id. at 12,972-74.
[v] Id. at 12,970.
[viii] See FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products (Apr. 2, 2019).
[ix] See Warning Letter to Advanced Spine and Pain, LLC d/b/a Relievus (Mar. 28, 2019) (claiming, among other things, that CBD product “decreased human glioma cell growth and invasion”); Warning Letter to Nutra Pure LLC (Mar. 28, 2019) (claiming, among other things, that CBD product slowed the progression of Alzheimer’s disease); Warning Letter to PotNetwork Holdings, Inc. (Mar. 28, 2019) (claiming, among other things, that CBD product treated symptoms of “adult and neonatal ischemia, brain trauma, Alzheimer’s disease, Parkinson’s disease, Huntington’s chorea, and amyotrophic lateral sclerosis (Lou Gehrig’s disease)”).
[x] See FDA Notice, 84 Fed. Reg. at 12,970-71.
[xi] Josh Long, “Gottlieb: FDA targeting CBD marketers of ‘over-the-line claims,’” Natural Products Insider (Mar. 28, 2019) (reporting on the hearing on “Review of the FY2020 Budget Request for the FDA” before the U.S. Senate Committee on Appropriations’ Subcommittee on Department of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies).