FDA WARNING_LETTER - High Performance Formulas, L.L.C. (dba HPF, L.L.C.) - April 24, 2012

The FDA issued a Warning Letter to High Performance Formulas, L.L.C. (HPF, L.L.C.) following a March 2012 review of their website, www.hpfonline.com. The agency determined that several products, including "Statin Support 24/7 CoQ10 100mg Soft Gels," "Green T 4,000," "Flex Formula Caplets," "Lyco-O-Mato Clinical Trio Softgels," and "Cholestene," are promoted with therapeutic claims that cause them to be unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act. Claims observed included managing cholesterol, fighting cancer, easing osteoarthritis, and reducing prostate cancer risk. Since these products are not generally recognized as safe and effective, they require prior FDA approval under section 505(a). Furthermore, "Statin Support 24/7 CoQ10 100mg Soft Gels," "Green T 4,000," "Lyco-O-Mato Clinical Trio Softgels," and "Cholestene" are misbranded under section 502(f)(1) because they lack adequate directions for lay use, as their intended conditions are not amenable to self-diagnosis. Introducing these misbranded drugs into interstate commerce violates section 301(a). HPF, L.L.C. must promptly correct these violations, review all labeling, and notify the FDA within fifteen working days of the specific steps taken to prevent future recurrence, or face potential enforcement actions like product seizure or injunctions.