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Premier Direct/Healthier You

This article was originally published in The Tan Sheet

Executive Summary

Boca Raton, Fla. company relabeling its products as dietary supplements and submitting structure/function claims notifications to FDA in response to March 11 warning letter. The letter designates as unapproved new drug claims statements in catalogs for 10 of the company's products, including AHF Anti-homocysteine Formula, said to offer "Total freedom from heart attack, stroke or vascular disease," CoQ10-Forte, said to be "used regularly to treat most major heart conditions," and Clear Lungs, described as a Chinese herbal remedy for "the temporary relief of bronchial congestion due to emphysema, bronchitis, pneumonia, flu"
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