FDA WARNING_LETTER - Nutrition, Inc. - January 21, 2020

The FDA inspected Only Natural Inc. / Bio Nutrition Inc. in January 2020, followed by a review of product labels and websites, revealing serious violations of the Federal Food, Drug, and Cosmetic Act. Several products, including Only Natural Alpha Lipoic Acid Plus, Bio Nutrition Urilow, and Oww-Gout, were identified as unapproved new drugs and misbranded drugs. Their claims for disease treatment, cure, mitigation, or prevention classify them as drugs under section 201(g)(1)(B) of the Act. Lacking GRAS/E status, they are "new drugs" under Section 201(p) requiring FDA approval. Some were also misbranded under section 502(f)(1) for inadequate directions, as they address conditions needing professional supervision. Numerous other products, such as Joint Wellness and Cholesterol Wellness, were cited as misbranded dietary supplements under Section 403 of the Act due to various labeling deficiencies. These include failure to repeat all required label information in foreign languages (21 CFR 101.15(c)), improper nutrition information presentation (21 CFR 101.36), failure to identify botanical plant parts (21 CFR 101.4(h)(1)), missing servings per container (21 CFR 101.36(b)(1)(ii)), undeclared common ingredient names (21 CFR 101.36, 21 CFR 101.4), and non-compliant nutrient content claims (e.g., "super fruit antioxidants") under 21 CFR 101.54(g). The use of "additional ingredients" was also non-compliant (21 CFR 101.4(g)). The firm must promptly correct these violations and respond to the FDA within fifteen working days, detailing corrective and preventative actions. Non-compliance may lead to legal action, including seizure or injunction.