These actions come as the agency continues to explore potential paths for various types of CBD products to be lawfully marketed, including ongoing work to obtain and evaluate information to address outstanding questions related to safety while maintaining public health standards. An update will be released in the coming weeks on the agency’s progress to approach on these products.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.
“In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” she continued. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety—including reports of products containing contaminants, such as pesticides and heavy metals—and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
Unanswered questions remain in regards to the gaps in data about CBD toxicity, some of the available data raises concerns about potential harm. The revised update outlines specific safety concerns, and questions remain about cumulative use and impacts on vulnerable populations.
CBD is marketed in a variety of product types such as oils, drops, capsules, syrups, food products, teas, topical lotions, and creams. The warning letters to the particular companies states that they are marketing these products in ways that violate the FD&C Act, including marketing products to treat diseases or for other therapeutic uses for humans and/or animals, other violations include marketing products as dietary supplements and adding CBD to food that have not been approved by the FDA.
The FDA has previously issued warning letters to other companies that were illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat, or cure serious diseases or otherwise violated regulations; and some products were in further violation because CBD was added to food, and some were marketed as dietary supplements despite products containing CBD not yet meeting the definition of a dietary supplement.
The FD&C Act requires any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product other than food that is intended to affect the structure or function of the body of humans/animals is a drug to be subject to the FDA approval process; currently the FDA still has not approved any CBD products other than one prescription human drug to treat a severe and rare form of epilepsy.
Unlike those products approved by the FDA there has been no FDA evaluation of whether unapproved products are effective or safe for their intended use, what the dose should be, if they interact with other drugs, or whether there may be side effects; and additionally the manufacturing processes of unapproved CBD products have also yet to be subject to FDA review as part of the approval process.
The 15 companies in this round of warning letters are requested to respond to the FDA within 15 working days stating how the company will correct the violations, failure to correct any violation promptly may result in legal action, including product seizure and/or injunction.
