Posted February 6, 2013

Ingredient Supplier Warned For Meal Replacement Product Misbranding and Adulteration

On October 4, 2012, the FDA issued a warning letter to dietary supplement ingredient supplier Raw Deal, Inc., after a facility inspection found the company’s Men’s Meal Replacement Blend and Women’s Meal Replacement Blend powdered mixes to be misbranded because they are labeled as both dietary supplements and meal replacement products. Under federal regulations, dietary supplements cannot be represented as a meal replacement product.

Men’s Meal Replacement Blend was also found to be misbranded because the product label failed to declare the potential allergens whey and soy.

Additionally, both products were found to be adulterated because they were prepared, packed, or held under conditions that do not meet current good manufacturing practice for dietary supplements. For example, Raw Deal Inc. did not maintain proper batch records, did not perform identity testing on at least one ingredient, and did not calibrate instruments or controls used in the manufacturing or testing of these products.

Men’s Meal Replacement Blend and Women’s Meal Replacement Blend are sold to another company for re-packaging, labeling and retail sale, although this second company was not identified in the FDA’s letter.

See’s Reviews of Nutrition and Meal Replacement Bars, Protein Powders and Drinks and Greens and Whole Foods Powders for tests of related products.

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