FDA WARNING_LETTER - Healthwest Minerals, Inc. dba Mt. Capra Products - June 26, 2012

Between May 15 and June 26, 2012, the FDA inspected Mt. Capra's facility in Chehalis, Washington, revealing violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). This caused products like Coconut Dream Deep 2 30, Banana Smoothie Deep 2 30, Strawberry Splash! Deep 2 30, Double Bonded Protein, and CapraGreens to be adulterated under 21 U.S.C. § 342(g)(1).

A significant issue was the potential misbranding of Coconut Dream Deep 2 30, Banana Smoothie Deep 2 30, and Strawberry Splash! Deep 2 30. These products, labeled with "Nutrition Facts" panels and marketed as "Our Most Delicious Drink Yet!", appeared to be represented as conventional foods, which is inconsistent with dietary supplement classification (21 U.S.C. § 321(ff)(2)). While website corrections to "Supplement Facts" panels were noted, they require verification.

Specific CGMP violations included: * Failure to establish product specifications for identity, purity, strength, composition, and contamination limits for finished batches (21 CFR 111.70(e)), specifically for Coconut Dream Deep 2 30, Banana Smoothie Deep 2 30, Strawberry Splash