FDA WARNING_LETTER - CDRL Nutritional, Inc. - November 25, 2019

The FDA issued a Warning Letter to Curapure and Healthy Hemp Strategies after reviewing their websites in September and October 2019, identifying multiple violations related to cannabidiol (CBD) products. Several products, including "CBD Oil Drop Tincture," "CBD Softgels," "CBD Pain Relief Cream," "CBD Carnival Gummies," "CBD-Infused Sheet Mask," and "CBD Softgels for Kids," were deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act. These products are not recognized as safe and effective for their intended uses, which include treating various diseases, and lack FDA approval. The agency specifically highlighted concerns about the "CBD Softgels for Kids, 10 mg" product due to risks in vulnerable populations. Furthermore, these drug products are misbranded under section 502(f)(1) of the FD&C Act, as their labeling lacks adequate directions for use for conditions not amenable to self-diagnosis. CBD products marketed as dietary supplements, such as "CBD Softgels, 25 mg," "CBD Oil Drop Tincture," and "CBD Carnival Gummies, 600 mg," do not meet the dietary supplement definition under section 201(ff) because CBD is an active ingredient in an authorized drug investigation. The "CBD Carnival Gummies, 600 mg," promoted as a conventional food, violates section 301(ll) for adding a drug under investigation to food. Additionally, CBD is an unapproved food additive under section 201(s) and 409(a), rendering the food adulterated under section 402(a)(2)(C)(i) as it is not generally recognized as safe (GRAS), with potential toxicity concerns. The company must promptly correct these violations and notify the FDA within fifteen working days with detailed corrective actions. Failure to comply may lead to legal action, including seizure and injunction.