UNPA / FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Yesterday afternoon, FDA issued an unprecedented 15 warning letters to companies selling CBD products, including a number over what it says are drug claims—as we have seen previously. But of much greater interest: in the warning letters, the agency has also explicitly made clear its position that CBD is a drug and that products in the marketplace for human or animal use are not lawful, specifically foods claiming GRAS status, and dietary supplements.
We have enclosed below a stakeholder meeting letter we received this morning that includes links to yesterday’s announcement and an updated Consumer Update that outlines additional CBD health concerns by the agency. We encourage all of you with an interest in this category to carefully review the revised Consumer Update.
Additionally, enclosed as an attachment is the email announcing the warning letters that FDA sent to congressional offices yesterday with its positions and concerns.
Regarding GRAS status for foods:
“Some of the products are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food.”
Regarding CBD in dietary supplements:
“Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.”
As per FDA policy, the companies have 15 days to provide information about what steps they have taken to address the problems identified in the letters.
What appears clear:
---------- Forwarded message ---------
From: FDA Stakeholder Engagement Team <FDAStakeholderEngagementTeam@fda.hhs.gov>
Date: Mon, Nov 25, 2019 at 5:49 PM
Subject: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
To: FDA Stakeholder Engagement Team <FDAStakeholderEngagementTeam@fda.hhs.gov>
The FDA announced that it has issued warning letters to a number of companies for illegally selling products containing cannabidiol (CBD). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. As described in the warning letters, the companies are using product webpages, online stores and social media, to market CBD products with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. Additionally, some of the products are being illegally sold as dietary supplements and illegally added CBD to human and animal foods.
Given the interest in products containing cannabis or cannabis-derived compounds, and CBD in particular, the FDA has and continues to take an agency-wide, integrated, and collaborative approach to addressing the regulation of products made from CBD that fall under its jurisdiction. Over the past few months, the FDA held a public hearing in May, and opened a docket for written comments, to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds. The agency encourages health care professionals and consumers to continue to report adverse reactions associated with these or similar products to the agency’s MedWatch program. The new warning letters and updated Consumer Update come as FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed, including ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products while maintaining FDA’s rigorous public health standards.
Stakeholder Engagement Staff
Office of External Affairs
U.S. Food and Drug Administration