FDA: New Cannabis Enforcement, Research Actions Announced

Outgoing U.S. Food and Drug Administration (FDA) chief Scott Gottlieb today announced new steps towards clarifying and constructing a legal framework around cannabis and cannabis-derived products.

In a letter posted on the FDA’s website, Gottlieb outlined a series of actions set to begin as early as next month, including the formation of an exploratory group examining CBD supplements and foods, and a public hearing for “stakeholders to share their experiences and challenges with these products.”

The public hearing, set for May 31, is aimed at helping the FDA gather feedback on existing regulatory strategy and potential changes that could improve predictability and efficiency. Written public comment will also be solicited.

None of the steps outlined in Gottlieb’s letter, however, changes the FDA’s current position prohibiting food with either CBD or THC from being introduced into interstate commerce or to be marketed as dietary supplements. The commissioner noted the actions were “consistent with the approach and commitments described” in a statement released following the passage of the 2018 Farm Bill in December.

“As part of the public hearing and related public comment period, the agency is interested in whether there are particular safety concerns that we should be aware of as we consider the FDA’s regulatory oversight and monitoring of these products,” Gottlieb wrote. “For example, we’re seeking comments, data and information on a variety of topics including: what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients; and other questions outlined in the hearing announcement.”

Gottlieb wrote that the FDA is also seeking “incentives for, and the feasibility of, drug development with CBD and other cannabis-derived compounds would be affected if the commercial availability of products with these compounds, such as foods and dietary supplements, were to become significantly more widespread.” While the market is poised to expand, he also expressed his desire to avoid dissuading companies from pursuing research that could support FDA approval of new drugs and medical treatments.

“It’s important that we continue to assess whether there could be medical ramifications if patients choose to take CBD to treat certain diseases at levels higher or lower than studied in well-controlled clinical studies,” he wrote.

The high-level internal working group will be charged with considering “what options might be appropriate” for the agency based on current law, according to Gottlieb’s letter. The working group will be co-chaired by FDA principal commissioner Amy Abernethy, M.D., Ph.D. and principal associate commissioner for policy Lowell Schiller, and will begin sharing information with the public as early as this summer.

Finally, Gottlieb redoubled the FDA’s commitment to holding companies accountable for making unsubstantiated claims on cannabis and cannabis-derived products. The agency announced today it has issued warning letters to three companies for making claims on over a dozen products and on the Internet. According to Gottlieb, the companies — Advanced Spine and Pain LLC, Nutra Pure LLC and PotNetwork Holdings Inc. — used online platforms to make a number of unfounded claims related to their products’ ability to “limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases.”

“I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” the commissioner wrote. “The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today.”