On November 21, 2022, the FDA’s Center for Food Safety and Applied Nutrition issued warning letters to five manufacturers of food and beverages containing cannabidiol (CBD).

These letters mark the latest in a continued trend of FDA enforcement against CBD in recent years that dicentra has covered. The letters outline 2 major compliance violations:

1. FDA stated that there is insufficient evidence to demonstrate that CBD could be generally recognized as safe (GRAS) for its intended use. With no GRAS pathway available, CBD can only be approved as a food additive, requiring premarket approval. Currently, there is no food additive regulation that authorizes the use of CBD.
2. That CBD was sold as an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. This “drug preclusion” clause was invoked because the drug product Epidiolex containing CBD as its active ingredient, was first approved as an Investigational New Drug (IND) for the treatment of Dravet Syndrome.

You can access the warning letters here.

If you are a manufacturer of a full-spectrum hemp extract for use in foods or dietary ingredients, and you are concerned that your product may be adulterated, contact us today.

dicentra can help you obtain GRAS status, ensure that your dietary supplement and food labelling is compliant with all applicable FDA rules, regulations, and guidance documents, and can assist your business through the process of clinical trial design and trial execution.