Posted March 22, 2013

Maker of Nutrition Shakes Warned For Manufacturing Violations

On February 28, 2013, the FDA issued a warning letter to Healthwest Minerals, Inc., dba Mt. Capra Products, Mt. Capra Whole Foods, and Mt. Capra Cheese, following a facility inspection which found the company’s products, including Coconut Dream Deep 30, Banana Smoothie Deep 30, Strawberry Splash! Deep 30, Double Bonded Protein, and CapraGreens products to be adulterated because they were were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish product specifications for the identity, purity, strength and composition of the finished batch for each dietary supplement, failure to include required information in master manufacturing records and batch production records, and failure to hold reserve samples of each lot of packaged and labeled dietary supplements for distribution.

The FDA also stated that Coconut Dream Deep 30, Banana Smoothie Deep 30, Strawberry Splash! Deep 30, Double Bonded Protein, and CapraGreens products were characterized as both dietary supplements and conventional foods, which is not allowed under federal regulations. For example, the products were promoted as dietary supplements but labeled with a Nutrition Facts panel used for conventional foods, rather the Supplement Facts panel required for dietary supplements.

The agency noted that new product labels on the company website now provide a Supplement Facts panel, and that the correction will be confirmed during the next inspection.

See ConsumerLab.com’s Reviews of Nutrition Nutrition Powders and Drinks and Greens and Whole Foods Powders for tests of related products.

For more information about the FDA’s warning letter, use the link below.