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FDA Warns 15 Companies Selling CBD Products

Safety concerns include liver injury and interactions with other drugs

The FDA has issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.

 “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,’” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “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.”

Safety concerns related to CBD products include potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.

CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, foods such as chocolate bars and teas, and topical lotions and creams.

The warning letters raise other legal and public health concerns:

  • Some of the products are marketed for infants and children—a vulnerable population that may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute or excrete a substance such as CBD.
  • 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. CBD is an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient.
  • Some of the products are marketed as dietary supplements. However, CBD products do not meet the definition of a dietary supplement under the FD&C Act.
  • One product outlined in a warning letter to Apex Hemp Oil LLC is intended for food-producing animals. The agency remains concerned about the safety of human food products from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.

The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.

Source: FDA, November 25, 2019

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