FDA WARNING_LETTER - HCG Platinum, LLC - November 28, 2011

On November 28, 2011, the FDA and FTC issued a Warning Letter to HCG Platinum, LLC, and Rightway Nutrition, LLC, specifically addressing CEO Kevin Wright. The letter stated that the products "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" are unapproved new drugs and misbranded, violating sections 301, 505, and 503 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331, 355, 353]. The FTC also cited violations of the FTC Act, 15 U.S.C. § 41 et seq., for unsubstantiated advertising claims.

The products' labeling and website (www.hcgplatinum.com) made claims such as "Lose up to 1 pound a day," "rapid weight loss," "Fat burning," "Muscle Growth," "Blood Flow," "Appetite Control," "Higher Energy," and "improve blood sugar levels," which classify them as drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. They are also considered "new drugs" under section 201(p) [21 U.S.C. § 32