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Medical food warning letter

This article was originally published in The Tan Sheet

Executive Summary

Several products marketed by Ganeden Biotech are the subject of a recent FDA warning letter because they are labeled as medical foods but do not meet the definition under federal regulations required for products carrying such a distinction, the agency says. "Your products are not medical foods because the diseases and conditions described in the product labels do not have distinct nutritional requirements established by medical evaluation and because the products do not have any unique impact on the dietary management of those diseases and conditions beyond that which could be achieved by modification of the normal diet alone," the letter says. In addition, several of the products' names and claims make them misbranded, FDA says. For example, Arthritis Advantage claims to be "clinically proven to reduce pain and increase mobility," while Digestive Advantage is "for those who suffer from chronic constipation"...

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