Alert June 05, 2019

Key Takeaways From FDA’s May 31 Hearing On CBD

On May 31, 2019, the United States Food and Drug Administration (FDA) held a hearing to receive public comments regarding potential regulation of cannabidiol (CBD) following passage of the 2018 Farm Bill. In addition to receiving public comments, acting FDA Commissioner, Norman “Ned” Sharpless, MD, issued opening remarks on behalf of the FDA. Here are our key takeaways from the hearing:      

FDA Commissioner Reaffirms FDA’s Current Positions on CBD. 

In his opening remarks, Dr. Sharpless reiterated the FDA’s current prohibition on hemp-derived CBD in food products and dietary supplements: “…some compounds found in cannabis – specifically, CBD and THC – have been studied and even approved as drugs. It’s important to note that the Federal Food, Drug & Cosmetic Act prohibits adding drugs to human or animal food in interstate commerce… Similarly, the law excludes these products from the statutory definition of a dietary supplement…What that means is that, under current law, CBD and THC cannot lawfully be added to a food or marketed as a dietary supplement.”[1] Dr. Sharpless referenced “cosmetics” in his opening remarks, but did not affirmatively state whether the FDA prohibits the introduction of CBD in cosmetic products: “There are real risks associated with [CBD and THC] and critical questions remain about the safety of their widespread use in foods and dietary supplements, as well as other consumer products – including cosmetics, which are subject to a separate regulatory framework.” Id

FDA Is Actively Seeking Answers to Open Questions Regarding CBD. 

Dr. Sharpless acknowledged a “potential pathway for CBD products” but expressed reservation at this time due to lack of existing research on CBD: “Prior to the 2018 Farm Bill, population-based research mostly included cannabis-focused observations in aggregate, rather than specific to CBD….[and w]hen hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety.” Id. Dr. Sharpless noted that the FDA has implemented a working group to assist in answering key outstanding questions regarding CBD products: “For example, how much CBD is safe to consume in a day? What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes some CBD oil? How much is too much? How will it interact with other drugs the person might be taking? What if she’s pregnant? What if children access CBD products like gummy edibles? What happens when someone chronically uses CBD for prolonged periods?” Id.

Most Public Comments Favored CBD Products and FDA Regulation. 

Following Dr. Sharpless’s opening remarks, the FDA heard oral statements from a number of significant CBD industry participants and stakeholders, including representatives from the Florida, Virginia, and North Carolina Departments of Agriculture, companies across various industries (e.g., biotech, pharmaceuticals, agriculture, manufacturing, consumer products, etc.), public health and medical associations, universities, advocacy groups, trade associations, legal professionals, and interested individuals, among others. Many speakers advocated for a federally sanctioned pathway for the legality of CBD products and/or urged the FDA to issue regulations so that a more uniform understanding (by industry participants and consumers) of how CBD products are regulated could be achieved. Many speakers also emphasized the need for regulations ensuring uniform labeling and quality standards for CBD products. A minority of speakers called for a prohibition on CBD and cannabis products generally. 

Next Steps. 

Dr. Sharpless did not provide a timetable for the FDA’s issuance of any proposed rules or regulations pertaining to CBD,[2] but he made clear that the public will “be hearing more from [the FDA’s internal working group on CBD issues] in the months to come.” Although the FDA did not offer any specific proposals for policy change or rule-making during the hearing, Dr. Sharpless and other FDA personnel repeatedly requested data, research, and studies. They made clear that anecdotal claims are not going to sway the FDA. Before it endorses the health benefits and safety of CBD and CBD products that many speakers touted, the FDA is going to want to see hard evidence. The hearing was not the last-word for public comments. The FDA is accepting additional public comments and data submissions in writing through its website under the tab for “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments.” All additional comments and submissions will be accepted through July 2, 2019. [3] 

[1] See https://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-sharpless-fda-public-hearing-scientific-data-and-information-about-products-containing.

[2] Additional information regarding the FDA’s rulemaking process can be found on the FDA website:  https://www.fda.gov/regulatory-information/fda-rules-and-regulations.   

[3] See FDA-2019-N-1482, available at https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&dct=PS&D=FDA-2019-N-1482.

Goodwin summer associates Scott Carson, Taylor Harrison and Brennan Meier contributed to this alert.