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Biofreeze with Ilex

This article was originally published in The Tan Sheet

Executive Summary

April 21 FDA warning letter to Export, Penn.-based Performance Health concludes the topical pain relief product is an unapproved new drug. Labeling for Biofreeze lists menthol 3.5% and camphor .2% as active ingredients. While the herbal extract Ilex Paraguariensis is listed as an inactive ingredient, it is "featured prominently in the labeling and is intended to furnish pharmacological activity and to have a direct effect on the body of man," FDA states. Consequently the herbal extract "is an active ingredient per title 21 Code of Federal Regulations." Biofreeze is labeled for post rotator cuff operations, to treat pulled hamstrings, tendonitis and bursitis and to decrease edema and myospasm. "We do not know of any substantial scientific evidence that demonstrates that your product is generally recognized as safe and effective for its intended uses," the agency says
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