FDA Warns Companies Illegally Selling CBD Products

The agency is requesting responses from the companies addressing the issues described in warning letters.

November 23, 2022

WASHINGTON—The Food and Drug Administration (FDA) has sent warning letters to five companies for illegally selling products containing cannabidiol (CBD). The companies are 11-11-11 Brands, Naturally Infused LLC, Newhere Inc. dba CBDFX, Infusionz LLC and CBD American Shaman LLC.

“These companies are selling CBD-containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,” writes the FDA in a statement.

The FDA says there are safety concerns surrounding the use of CBD consumption, especially long-term use, citing studies that show possible harm to the male reproductive system, liver harm and interactions with some medications.

“The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm,” wrote the FDA. “People should be aware of the potential risks associated with the use of CBD products.”

The FDA’s warning letters outline additional violations of the FD&C Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing reasoning and supporting information as to why the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

In 2018, Congress passed the Farm Bill, which removed industrial hemp (and, by proxy, hemp-derived CBD) from its previous classification as a Schedule I controlled substance under the Controlled Substances Act (CSA), making it legal for interested parties to produce, distribute and dispense it.

However, the 2018 Farm Bill made no changes to the FDA’s authority to regulate the sales of food products, dietary supplements and certain body care products containing hemp-derived CBD under the FD&C Act—a significant hurdle for manufacturers interested in distributing and retailers interested in selling such products. The Farm Bill also did not change FDA’s regulatory oversight of health claims made in the marketing of products.

NACS has provided a resource for members to help navigate the gray areas around the sale of CBD and CBD-related products.