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The FDA issued warning letters to several companies marketing their CBD products in ways that violate the Federal Food, Drug, and Cosmetic Act.
Officials with the FDA have issued warning letters to 15 companies for illegally marketing and selling products containing cannabidiol (CBD), according to an agency press release.
Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use or of their safety profile. As the CBD industry grows, the FDA is working to clarify their regulatory approach to overseeing these products.
Despite medical claims of CBD’s benefits in certain conditions and diseases, such as epilepsy, anxiety, and pain management, questions remain surrounding the safety considerations raised by widespread use. CBD is typically marketed in a variety of product types, such as oil drops, capsules, syrups, food products, topical lotions, and creams.
According to the warning letters issued today, the particular companies in question have been using product webpages, online stores, and social media to market CBD products in interstate commerce ways that violate the Federal Food, Drug, and Cosmetic (FD&C) Act. This includes marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals, as well as marketing CBD products as dietary supplements and adding CBD to human and animal foods.
The companies receiving warning letters are:
Several products outlined in the warning letters also raised other concerns. Violations include marketing unapproved products for infants and children, adding CBD to human and animal foods, and selling CBD products as dietary supplements.
According to the FDA, the agency cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human and food.
“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’,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a statement.
The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations.
Aside from 1 prescription drug product to treat rare, severe forms of epilepsy, no other CBD products have been reviewed and approved by the FDA. The prevalence of CBD reaching consumers serves as an opportunity for pharmacists to educate patients on available products.
As such, the agency indicates it will continue to monitor the marketplace and take action as needed against companies that violate the law.
FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details. Accessed November 26, 2019.