Dynamic Nutritional Associates – FDA Warning Letter

The FDA issued a Warning Letter to DNA Labs Inc. after reviewing their website, online product catalog, labeling, and marketing for several homeopathic products, including D-17 Tumorell and D-62 Rubilin. The review found that these products are misbranded under sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act (the Act). Due to their intended uses, such as treating tumors, epilepsy, diabetes, and measles, the products are classified as drugs under section 201(g)(1)(B) and (C) and as prescription drugs under section 503(b)(1) of the Act. Consequently, they are misbranded under section 503(b)(4) because their labels fail to bear the required "Rx only" symbol. The marketing of these misbranded products further violates sections 301(a) and (k) of the Act. Although labeled as homeopathic, these products do not meet the conditions for marketing under the FDA's Compliance Policy Guide (CPG 7132.15) for over-the-counter homeopathic drugs, as they are not intended for self-limiting conditions amenable to self-diagnosis. DNA Labs Inc. must take prompt action to correct these violations and notify the FDA in writing within fifteen working days, detailing corrective steps, recurrence prevention, and actions for distributed products. Failure to comply may result in legal action, including seizure and injunction, and could impact future federal contracts.