FDA WARNING_LETTER - KetoKerri LLC - January 31, 2020

On March 31, 2020, the FDA issued a Warning Letter to Ms. Rivera regarding products sold on www.ketokerri.com, www.facebook.com/iamketokerri/, and an Amazon storefront. The FDA determined that products including “Dr. Fitt Robynzyme,” “Level Up Clean MCT C8 Oil,” “KK Black Seed Oil,” and others are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The FDA cited numerous disease treatment and prevention claims on the website, social media, Amazon storefront, and product literature, establishing the products' intended use as drugs. Examples include claims related to inflammation, autism, Lyme disease, and cancer. These products are not generally recognized as safe and effective for their intended uses, making them "new drugs" requiring prior FDA approval, which they lack, violating sections 301(d) and 505(a) of the Act.

Furthermore, several products, including “Dr. Fitt Robynzyme” and “KK Black Seed Oil,” are intended for conditions not amenable to self-diagnosis or treatment, thus lacking adequate directions for layperson use. This renders them misbranded under section 502(f)(1) of the Act, and their introduction into interstate commerce violates section 301(a). The letter requires a written response within fifteen working days detailing corrective actions and prevention measures. Failure to comply may