Ganeden warning letter revisited
This article was originally published in The Tan Sheet
Executive Summary
FDA reposted a warning letter on its Web site for Ganeden Biotech. FDA removed the 1letter in March while it was in discussions with Ganeden (2"The Tan Sheet" March 5, 2007, In Brief). An FDA spokesperson says no changes were made to the letter. The letter states some of the firm's Digestive Advantage products are misbranded foods and unapproved news drugs. The products were labeled as medical foods, which FDA says is incorrect...You may also be interested in...
Ganeden Biotech warning letter
The FDA warning letter sent to medical foods marketer Ganeden Biotech and reported in the Feb. 26 issue of "The Tan Sheet" has been removed from the agency's Web site. An FDA spokesperson told "The Tan Sheet" the letter was issued by the agency's Cincinnati office, but FDA is now in discussions with the firm over whether to withdraw the letter. The spokesperson noted that, as far as FDA is concerned, a letter was issued, and the decision to withdraw the letter was FDA's (1"The Tan Sheet" Feb. 26, 2007, In Brief)...
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