Bindmax Protein, LLC – FDA Warning Letter, Dec 6, 2011

On December 2 and 6, 2011, the FDA inspected BindMax Protein, LLC's facility in New Berlin, Wisconsin, and found significant deviations from food labeling regulations (21 CFR Part 101), causing their BindMax SS, BindMax Pork Flavor, and MPH20 products to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Undeclared Major Food Allergen:** BindMax MPH20 is misbranded because its label fails to declare milk, a major food allergen, despite containing sweet dairy whey and partially hydrolyzed caseinate. 2. **Inaccurate or Missing Ingredient Declarations:** BindMax SS, BindMax Pork Flavor, and MPH20 products fail to list all required ingredients or declare them by their common or usual names. Examples include the omission of silicon dioxide, mislabeling "pork flavor" instead of "pork stock," and incorrectly listing "hydrolyzed soy protein" instead of soy protein concentrate, and "hydrolyzed whey and casein" instead of sweet dairy whey and partially hydrolyzed sodium caseinate. 3. **Inaccurate Place of Business:** BindMax SS and BindMax MPH20 labels fail to accurately declare the street address of the manufacturer, packer, or distributor, listing only a P.O. Box.

The FDA also noted that BindMax SS and MPH20 products