FDA WARNING_LETTER - Golden Pride, Inc. - August 14, 2013

On October 17, 2014, 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 website review in July 2014. The firms distribute dietary supplements under the Flexezy and Physician’s Signature brands.

The FDA determined that products like Pulsate Plus, Lipid Results, OC-Max, Cardio Results Omega III, Flexezy FLX, Flexezy-GC, Honey Bee Propolis, and Glyco Results are promoted on www.vitaminsdirectonline.us with therapeutic claims, classifying them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of claims include "virtually eliminated their rosacea," "lowered their blood sugar levels," "reduce the risk of heart disease," and "aid in the treatment of arthritis." These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval, violating sections 505(a) and 301(d) of the Act.

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 they address conditions not amenable to self-diagnosis, thus lacking adequate