FDA Questions Whether Raw Deal's Products are Dietary Supplements

FLANDERS, N.J.In a warning letter advising Raw Deal, Inc. that it detected a number of regulatory violations, FDA questioned whether the manufacturer of powdered mix products is actually producing a dietary supplement.

FDA informed Raw Deal President and Owner Barry I. Steinlight that his products were "adulterated" under federal law because they haven't been held, packed or prepared under conditions that meet Current Good Manufacturing Practices (CGMPs) for dietary supplements.

"However, this letter should not be interpreted to mean that FDA agrees with the characterization of the products as dietary supplements," Diana Amador-Taro, FDA's District Director of the New Jersey District, wrote in the Oct. 4, 2012 letter. "In fact, the labels that you provided to our investigators for these products also describe the products as meal replacement products."

Amador-Taro explained Raw Deal cannot label the products as both dietary supplements and meal replacement products "because a product intended to replace a meal is not a dietary supplement."

Raw Deal of Flanders, N.J. advised FDA inspectors another firm packages the products as dietary supplements and produces the labels, according to the letter.

In the letter, FDA cited a number of CGMP violations. Raw Deal responded to the agency's findings. FDA stated some responses were inadequate and it intended to assess the corrections during a follow-up inspection.

In an email Thursday, Steinlight told INSIDER that FDA has "all of our documents showing all of the minor corrections that were made months ago."

"These issues have been already addressed with the FDA," he stated in a separate email.