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Posted December 13, 2013

Maker of Menopause Blend and Other Supplement Ingredients Warned by FDA of Violations

On November 21, 2013, the FDA issued a warning letter to Raw Deal, Inc. following a facility inspection which found the company's products, including Pre-Mix, Herb Blend, and Menopause Blend to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

The company, which supplies raw material ingredients to dietary supplement manufacturers, was found to have added significant amounts of maltodextrin and white rice powder to its Pre-mix, Allergy 1:1 Herb Blend, and Menopause Blend, but did not list these ingredients on its labels for customers.

For example, one Pre-Mix Blend, which was labeled as containing only ascorbic acid, alpha lipoic acid, and citrus bioflavonoids, was found to contain 95.6% maltodextrin and white rice powder, by weight. The Menopause Blend, which was labeled as containing black cohosh powder, don quai powder, sage powder, borage GLA, evening primrose powder, soy isoflavone powder, and vitex berry extract, was found to contain just 54% of these listed ingredients by weight - and 46% maltodextrin.

(See's Reviews of Alpha-Lipoic Acid Supplements, Menopause Supplements (including soy isoflavones and Black cohosh supplements) and Evening Primrose Supplements for tests of related products.)

In addition, Raw Deal substituted several ingredients in its blends: dong quai powder for Angelica dahurica root, orange peel for immature tangerine peel, and Epimedium PE 10% for Ledebouriella root.

Supplement manufacturers who may have purchased these blends from Raw Deal, and finished products that might contain these blends, were not identified.

To read the FDA's warning, use the link below.