FDA warning letter

An FDA warning letter is a formal notice informing a company that the agency considers it to have violated federal law, most often through unapproved drug claims.

Letters are public, cite the specific statements or practices at issue, and request a written response within a set period describing corrective action. They are not themselves penalties, but ignoring one can lead to seizure, injunction or other enforcement. In the CBD sector, most letters have concerned marketing that presented products as able to address named diseases, frequently on websites and social media rather than on the label.

For a reader, the letters serve as a published guide to the language regulators consider unacceptable, and searching a company's name in the FDA database is a quick check. A letter about claims does not mean a product is unsafe or mislabeled, and the absence of one does not mean a company's claims are compliant. Some letters have also cited products marketed for animals and products found to contain different cannabinoid amounts than labeled.