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FDA CAM guidance

This article was originally published in The Tan Sheet

Executive Summary

FDA recently released a draft guidance on complementary and alternative medicine because of "an increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug and Cosmetic Act or Public Health Service Act," the agency says. The guidance, entitled "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," describes the differences between various types of CAM and explains whether the product should be regulated as a drug, device, food, supplement or cosmetic. For example, juices made from vegetables and fruits would be considered foods, while botanicals in tablet form would be classified as dietary supplements. An herbal product intended to treat arthritis would be classified as a new drug and subject to pre-market approval "unless it is generally recognized by scientists as safe and effective for use under the conditions prescribed." In reaction to the guidance, American Herbal Products Association President Michael McGuffin said it was interesting that FDA "acknowledged that all CAM products are regulated" in the document. However, he asked, "For an agency strapped for resources, how did this become a priority?"...

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