Exclusive Supplements, Inc. – FDA Warning Letter, Mar 21, 2013

The FDA issued a Warning Letter to Exclusive Supplements Inc. following an inspection from March 7-21, 2013, and a website review in January 2014. The company, which distributes and packages BioRhythm Advanced brand products, was found in serious violation of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Unapproved New Drugs:** BioRhythm Olio and ReGenerate products are promoted with therapeutic claims (e.g., "supports reduction of 'bad' cholesterol," "decrease bone fracture healing time"), classifying them as unapproved new drugs under section 201(g)(1)(B) and 201(p)(1) of the Act. BioRhythm Olio is also misbranded under section 502(f)(1) due to inadequate directions for layperson use. 2. **New Dietary Ingredient:** BioRhythm Androbolix contains 4-etioallocholen-3,6,17-trione, a new dietary ingredient requiring notification under section 413(a)(2) and 21 CFR 190.6, which was not submitted, rendering the product adulterated under sections 402(f)(1)(B) and 413(a). 3. **Dietary Supplement CGMP Violations (21 CFR Part 111):**