FDA WARNING_LETTER - Hyde Park Holistic Center

The FDA and FTC jointly issued a Warning Letter to Dr. Dahlman following a November 12, 2009, review of www.drdahlman.com. The FDA determined that the website markets "Immune Support Formula" for diagnosing, mitigating, preventing, treating, or curing the H1N1 Flu Virus. This product is unapproved, uncleared, and unauthorized by the FDA for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352. Concurrently, the FTC found that advertising claims regarding H1N1 prevention, treatment, or cure lacked substantiation from well-controlled human clinical studies, which is unlawful under the FTC Act, 15 U.S.C. § 41 et seq. The firm was also cited for making or exaggerating health claims without rigorous scientific evidence. Dr. Dahlman is required to immediately cease marketing these unapproved H1N1-related products. The firm must email both FDA and FTC within 48 hours detailing corrective actions taken. Failure to comply could result in FDA enforcement actions like seizure, injunction, or criminal prosecution, and FTC legal action including consumer refunds. The firm will also be added to FDA's public list of non-compliant entities, and unapproved products offered for import will be detained.