FDA WARNING_LETTER - Pure Energy Products, Inc. - October 19, 2012

The FDA issued a Warning Letter to Pure Energy Products, Inc. following an October 2012 inspection and August 2013 labeling review, identifying significant product adulteration and misbranding. The product obestrim is adulterated under 21 U.S.C. § 342(a)(2)(C)(i) due to 1,3-dimethylamylamine (DMAA), an unsafe food additive not recognized as a dietary ingredient. This also violates 21 U.S.C. § 331(ll) as DMAA was an approved drug before being marketed in food. Products Vivetra, Intensa, Cialafil, Zirex, and Phentrazine 37.5 are promoted with therapeutic claims, making them unapproved new drugs under 21 U.S.C. § 321(p) and § 355(a). Vivetra, Cialafil, and Zirex are also misbranded under 21 U.S.C. § 352(f)(1) due to inadequate directions for use. The inspection revealed numerous Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111) for dietary supplements, including obestrim, COLON-ES, T-Slim 2000, ViaGOLD, Acai Berry Blast, and RK SLIM, causing adulteration under 21 U.S.C. § 342(g)(1). Deficiencies included failures in quality control, labeling specifications, testing, record-keeping, and complaint handling. As a distributor, the firm holds ultimate responsibility for CGMP compliance. Additionally, several dietary supplements are misbranded under 21 U.S.C. § 343 due to various labeling non-compliances, such as undeclared ingredients, improper nutrition panel presentation, missing botanical plant part identification, and misrepresenting "Ginseng." Pure Energy Products must promptly correct all violations and respond in writing within fifteen working days, detailing corrective actions and preventive measures. Failure to comply may result in legal action and reinspection fees.