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In Brief: Bio-Oxy warning letter

This article was originally published in The Tan Sheet

Executive Summary

Bio-Oxy warning letter: Saratoga, Calif.-based Bio-Life International receives April 2 warning letter from FDA's San Francisco district office citing "objectionable" drug claims made by the product, such as "effective against all viruses tested," "inactivating Herpes viruses," and "inhibitory to Saccharomyces species." FDA also notes that Bio-Oxy is misbranded as well as adulterated because it is recommended for use on pets, for which it is not approved, and for use in sterilizing hospital equipment and instruments, causing it to be a misbranded device. The company's "Professional Price List" additionally includes "objectionable claims" for some of its other products including Bee Pollen and Pycnogenol, the letter asserts...

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