FDA works on regulatory pathways for CBD products

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. However, the FDA has not approved any CBD products other than one prescription human drug product (Epidiolex) to treat rare, severe forms of epilepsy. In addition, the agency has determined that CBD products cannot be marketed as dietary supplements.

Warning Letter due to unapproved Health Claims

The U.S. FDA and the Federal Trade Commission (FTC) recently posted a joint warning letter due to the illegal selling of unapproved products containing CBD with unsubstantiated claims. Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence (e.g. data derived from well-controlled human clinical studies). Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

Regulatory pathways for cannabis and cannabis-derived ingredients

Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process. The (approved) drug products have to be produced (and controlled) in compliance with the guidelines on Good Manufacturing Practice ((c)GMP). Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.

The agency states that "there is significant public interest in cannabis and cannabis-derived compounds". Therefore, the FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients (like CBD) to "fill in the knowledge gaps about the science, safety and quality of many of these products".