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In Brief: PhenCal warning letter

This article was originally published in The Tan Sheet

Executive Summary

PhenCal warning letter: Labeling for PhenCal and PhenCal 106 implies the supplements are intended, like the Rx drug phentermine, as "treatments for obesity," FDA tells Weider Nutrition Jan. 6. Product brochures also claim the products treat imbalances of neurotransmitters in the brain, FDA states, noting, "These statements are disease claims and not structure/function claims." Weider says it already has revised labeling in a "minor" way as requested by FDA. Relabeled PhenCal has been available in Walgreen stores since February, and the company plans to make the new packaging available to other distributors. The new label omits references to prescription products and drops the "106" in the product name ("The Tan Sheet" Jan. 5, p. 4)...
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