April 19, 2011
LENGBY, Minn.Saw Palmetto Harvesting Co., based in Lengby, Minn., with processing facilities in Frostproof, Fla., received an FDA warning letter related to product claims made for its saw palmetto dietary supplements. FDAs Florida District Office, based in Maitland, issued the warning letter in late March after an October 2010 review of two company websites (SawPalmetto.com and RedRoosterPills.com) found products were promoted with therapeutic claims that would position the companys Saw Palmetto and Red Rooster Pill products as unapproved new drugs, not dietary supplements.
FDA cited concerns with Saw Palmetto promoted as a treatment for benign prostatic hyperplasia, and Red Rooster Pills positioned as a leading Herbal Viagra Alternative" and remedy for erectile dysfunction. The agency stated the products are not recognized as safe and effective for those uses, making them new drugs; as they have not been approved by FDA, they may not be legally marketed. Further, the product labeling also bears adequate directions for use, making them misbranded drugs.
The agency requested the company take prompt action to correct the cited violations, and to review all of its websites, promotional materials and labeling. It noted: While reviewing your website, we noticed that it contained links to multiple other websites on which you promote other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your websites were too numerous to list in this letter."
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