FDA WARNING_LETTER - Tennessee Scientific, Inc./Scientific Formulations LLC - September 30, 2010

The FDA issued a Warning Letter to Tennessee Scientific, Inc./Scientific Formulations LLC after reviewing their websites, www.theformulation.com and www.scientificformulations.com, in September 2010. The agency determined that products such as NAC Supplement, Antioxidant Supplement, Anti-Angiogenesis Supplement, and Immune Enhancement Supplement are promoted with therapeutic claims that cause them to be unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. Specifically, these products are marketed for conditions like cancer prevention and treatment, establishing them as drugs under 21 U.S.C. § 321(g)(1)(B). As they are not generally recognized as safe and effective, they are considered "new drugs" (21 U.S.C. § 321(P)) requiring prior FDA approval (21 U.S.C. § 355(a)). Furthermore, their labeling lacks adequate directions for use, leading to misbranding under 21 U.S.C. § 352(t)(1), and their introduction into interstate commerce violates 21 U.S.C. § 331(a). The letter also cited violations of the FTC Act (15 U.S.C. § 41 et seq.) for advertising disease prevention/treatment claims without competent scientific evidence. The firm must take prompt action to correct these violations and notify FDA and FTC within fifteen working days, detailing corrective steps. Failure to comply may result in regulatory actions like seizure, injunction, or monetary penalties.