FDA WARNING_LETTER - Revital U International, LLC - May 07, 2019

The FDA issued a Warning Letter to Mr. Richard McWilliams and Ms. Amy McWilliams of Revital U International, LLC, following an inspection from April 29 to May 7, 2019, at their Plano, TX facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their Smart Caps dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Lack of Product Specifications:** Failure to establish product specifications for identity, purity, strength, composition, and contamination limits for finished dietary supplement products, specifically Smart Caps, as required by 21 CFR 111.70(e) and 111.75(c). The company's responses dated May 29 and August 29, 2019, were deemed inadequate, lacking complete specifications or supporting documentation. 2. **Unsafe New Dietary Ingredient:** The Smart Caps product declares Octodrine (DMHA) as a dietary ingredient. The FDA states there is no information demonstrating DMHA was lawfully marketed as a dietary ingredient before October 15, 1994, or that it has been present in the food supply as an unchemically altered food. Therefore, DMHA is considered a "new