FDA WARNING_LETTER - Raw Deal, Inc - May 06, 2013

On April 9 through May 6, 2013, the FDA inspected Raw Deal, Inc.'s dietary ingredient manufacturing facility in Flanders, NJ. The inspection and subsequent review of records revealed that several products, including (b)(4) Pre-mix, (b)(4) Pre-mix, Allergy 1:1 Herb Blend, and Menopause Blend, were adulterated under Section 402(b)(2) of the Food, Drug and Cosmetic Act.

The primary violation was the substitution of ingredients, wholly or in part, with Maltodextrin and/or White Rice Powder, which were not included in customer formulation specifications or listed on ingredient lists provided to customers. For example, in one instance of (b)(4) Pre-mix, 95.6% of the batch by weight was substituted with Maltodextrin and White Rice Powder. In another (b)(4) Pre-mix batch, approximately 23% was substituted with Maltodextrin. For Allergy 1:1 Herb Blend, 28% of the blend by weight was Maltodextrin, and other ingredient substitutions occurred (e.g., Dong Quai Powder for Angelica Dahurica Root). In Menopause Blend, 46% of the ingredients by weight were substituted with Maltodextrin.

Raw Deal, Inc.'s written responses dated May 16, 21, 31, and September