FDA WARNING_LETTER - Institute for Healthy Aging

On June 2, 2008, the FDA issued a Warning Letter to Dr. Mark A. Rosenburg of The Institute for Healthy Aging, citing violations related to products promoted on www.alternativecancersolution.com. The FDA determined that "Green Tea Extract," "Melatonin," "Myco-Immune Complex," "Selenium," "Shark Liver Oil," "Squalamine," and "Vitamin K2" are promoted with therapeutic claims for the cure, mitigation, treatment, or prevention of disease. These claims, found on the website, through scientific publication citations (21 CFR 101.93(g)(2)(iv)(C)), the website's URL, and metatags, cause the products to be unapproved drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. As these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) and are illegally marketed without prior FDA approval as required by section 505(a). Additionally, the products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use. The FDA mandates prompt corrective action within fifteen working days, requiring a written response detailing steps taken to rectify violations and prevent recurrence. Failure to comply may result in enforcement actions, including product seizure and injunctions.