Hours after President Trump signed the 2018 Farm Bill into law, the FDA released a lengthy statement from its commissioner, Scott Gottlieb, M.D., updating its position on CBD products intended for human consumption.
Flexing its muscle, the FDA points out that the Farm Bill “explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act.” The FDA voices its concern over the number of drug claims being made about CBD products that are not approved by the FDA, cautioning the industry that all cannabis-derived products claiming to have a medical benefit must go through the FDA approval process for human use before being marketed. Similarly, the FDA reminds the industry that under the FD&C Act, it is unlawful to “introduce food containing added CBD or TCH into interstate commerce, or to market CBD or THC product as dietary supplements, regardless of whether the substances are hemp-derived.”
Despite reaffirming its current stance against CBD products intended for human consumption, the FDA nevertheless signals a potential easing of restrictions on CBD, stating that it “will continue to take steps to make pathways for the lawful marketing of these products more efficient.” Recognizing the significant public interest and the potential opportunities that cannabis-derived compounds could offer, the FDA states that it is “committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.” To this end, the FDA will hold a public meeting in the “near future” for industry members to share their experiences and challenges with CBD-based products.
This new statement by the FDA signals a recognition by the agency of the public’s intense interest in CBD-infused products. The CBD market continues to grow despite the FDA’s prohibition. Until approved by the FDA, however, using CBD as an ingredient in foods and supplements results in risks that include regulatory enforcement and exposure to liability in civil lawsuits.
Ian is a partner in the Los Angeles office of Wilson Elser. He is co-founder and chair of the Wilson Elser Cannabis Law practice and uses his 20 years of legal experience to help clients navigate the legalities around cannabis and hemp. Ian works with licensed cannabis operators to comply with their obligations under the law and to develop risk management best practices. He also regularly consults with insurance companies to assist with cannabis-related underwriting practices and the development of new policy forms.
He is currently Chair of the National Cannabis Industry Association’s Finance and Insurance Committee, as well as Vice-Chair of the California Cannabis Industry Association’s Insurance Committee. Ian received his B.A. from Washington University in St. Louis, and his JD from St. Louis University. He has been with Wilson Elser for the past 18 years.
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