Vitamins Direct (USA), Inc. – FDA Warning Letter, Aug 14, 2013

The FDA issued a Warning Letter to Vitamins Direct (USA), Inc. and Golden Pride, Inc. following an inspection from August 9-14, 2013, and a subsequent review of their website, www.vitaminsdirectonline.us, in July 2014. The letter identifies multiple violations related to the distribution and promotion of dietary supplements under the Flexezy and Physician’s Signature brands. The primary issue is that several products, including Pulsate Plus, Lipid Results, OC-Max, Cardio Results Omega III, Flexezy FLX, Flexezy-GC, Honey Bee Propolis, and Glyco Results, are promoted with therapeutic claims on the website, causing them to be unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act). These products are not generally recognized as safe and effective for their claimed uses and lack required FDA approval (Section 505(a) and 301(d)). Furthermore, Lipid Results, Cardio Results Omega III, Honey Bee Propolis, and Glyco Results are deemed misbranded under section 502(f)(1) of the Act because their labeling lacks adequate directions for use, as they address conditions not amenable to self-diagnosis. The OC-Max product is also cited as a misbranded dietary supplement under section 403(r)(1)(B) due to an unauthorized health claim ("May reduce the risk of heart disease") that fails to meet the specific requirements of 21 CFR 101.83. Introducing misbranded drugs or dietary supplements into interstate commerce violates section 301(a) of the Act. The FDA requires prompt corrective action, including investigating the causes of these violations and preventing their recurrence. Failure to comply may result in legal action, such as seizure or injunction. A written response detailing corrective actions is required.