FDA Updates Guidance for CBD Products and a New Round of Warning Letters and Announcement of Date of Public Hearing

On April 2, 2019, the U.S. Food and Drug Administration issued a sweeping press release from outgoing Commissioner Scott Gottlieb covering new steps to advance the agency’s continued evaluation of potential regulatory pathways for CBD products. The five-page statement outlined what the FDA has in store for the industry over the next several months.

Among other things, the FDA has scheduled a public hearing for May 31 to allow stakeholders to share experiences and challenges with CBD products, including opinions on public safety concerns.

Additionally, the FDA issued three warning letters to companies marketing CBD products using “egregious and unfounded claims aimed at vulnerable populations.”

In the press release, Gottlie reinforced the FDA’s position that it is unlawful to introduce food with added CBD or THC into interstate commerce, or to market CBD and THC dietary supplements.

While the availability of CBD products has dramatically increased over the past several years, many unanswered questions and potential health risks remain, according to the FDA. Chief among these are the potential for liver injury and cumulative exposure to CBD if accessed by consumers across a range of products.

Several large retailers recently announced they will begin selling CBD-infused products. Shortly after the press release, Commissioner Cottlieb addressed his concern, tweeting..”I was also concerned to hear recently that several national pharmacy chains and other major retailers have begun to sell or will soon begin to selling CBD products in several states. We’ll be contacting them to remind them of FDA obligations and our commitment to protect consumers against product that can put them at risk.”