FDA Takes Supplement Marketers to Task

WASHINGTONFDA posted five recent warning letters related to product claims made for dietary supplements on various websites. While the companies were unrelated, the letters, posted Feb. 8, 2011, shared common themes including concerns about health claims positioning products as unapproved new drugs as well as misbranded drugs. The warnings, listed in reverse chronological order, included:

Tennessee Scientific Inc./Scientific Formulations warning letter, sent Feb. 1, stated FDA determined therapeutic claims made on the companys websites for NAC Supplement, Antioxidant Supplement, Anti-Angiogenesis Supplement and Immune Enhancement Supplement position the products as unapproved new drugs; further, the letter cites FTC regulations related to substantiation of health claims, particularly as related to the use of product names, website names and metatags. FDA provided specific examples of anti-cancer and other disease treatment claims for the products and specific ingredients used therein.

The warning letter to Natural Option USA, sent in late December 2010, focused on OsteOrganicCAL, a sea algae calcium product with vitamin D. FDA mentioned not only the Internet marketing of a case study, but also the use by Natural Option of personal testimonials related to increases in bone density, reduction in fractures and reversing osteopenia and osteoporosis."

Nutri Herb, a Florida-based marketer, had claims for several Custom Advantage" products called into question as positioning the products as drugs, not supplements. For example, Custom Advantage CoQ10 was promoted online for Cancer Prevention" and slowing progression of Alzheimers disease. FDAs December 2010 letter noted the claims make the products both unapproved new drugs and misbranded drugs.

A letter sent in mid-October 2010 to Green Earth Health Food Market, a retail store in New York, and to Living Naturally, the Sarasota, Fla.-based provider of website content and other e-services for retailers, cited concerns with therapeutic claims made for four productstwo botanical products from Natures Way, a garlic formula from Kyolic and an acidophilus supplement from Nutrition Now.

FDAs warning letter to Kanec USA, sent in early October 2010, preceded a recall conducted by the company in January 2011. The agency informed the company that its testing found the STUD Capsules for Men and XOX For Men contained prescription drugs for erectile dysfunction, positioning the products as unapproved new drugs. The product labeling also was called out by FDA as making the two products drugs, not dietary supplements. Further, FDA listed several violations of GMP (good manufacturing practice) standards, including a lack of testing procedures, lack of batch records, and no quality control unit for oversight of components.