FDA WARNING_LETTER - Saw Palmetto Harvesting Co.

The FDA issued a Warning Letter to Saw Palmetto Harvesting Co. after reviewing their websites, www.sawpalmetto.com and www.redroosterpills.com, in October 2010. The agency determined that the products "Saw Palmetto" and "Red Rooster Pills" are illegally marketed as unapproved new drugs and misbranded. Therapeutic claims on the websites, such as treating Benign Prostatic Hyperplasia (BPH) and erectile dysfunction, cause the products to be drugs under 21 U.S.C. § 321(g)(1)(B). Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under 21 U.S.C. § 321(p)(1) and cannot be legally marketed without prior FDA approval as per 21 U.S.C. § 355(a). Furthermore, the products are misbranded under 21 U.S.C. § 352(f)(1) because their labeling lacks adequate directions for use, as the conditions they claim to treat are not amenable to self-diagnosis. Introducing these misbranded drugs into interstate commerce violates 21 U.S.C. § 331(a). The FDA requires the firm to take prompt action to correct these violations and prevent recurrence, responding within fifteen working days with documentation of corrective steps. Failure to comply may lead to enforcement actions, including product seizure and injunctions.