NYSW Beverage Brands – FDA Warning Letter, Jun 25, 2014

On June 4-25, 2014, an FDA inspection of NYSW Beverage Brands, Inc. revealed violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing products like "VBlast Acai Berry" to be adulterated. Additionally, "VBlast Tropical Punch," "VBlast Gator Pit Energy Formula," and "VBlast Pomegranate + Cherry" were misbranded under 21 CFR Part 101.

The FDA noted that the products, despite bearing "Supplement Facts" panels, are represented as conventional foods (e.g., "water," "punch" in identity statements, 500 mL single servings, similar packaging to beverages), which would misbrand them if labeled as dietary supplements.

Specific CGMP violations included: 1. Failure to establish finished product specifications for identity, purity, strength, and composition (21 CFR 111.70(e)). 2. Failure to establish component specifications for identity, purity, strength, and composition (21 CFR 111.70(b)(1), 111.70(b)(2)). 3. Failure to establish and follow written procedures for quality control operations and ensure quality control personnel responsibilities (21 CFR 111.103, 111.105). 4. Failure to prepare and follow written