FDA seeks comments on regulating “CAM products”

A few weeks ago, I commented on the increased action by the US FDA against unapproved drugs that have been used for decades but were never subjected to today’s formal framework of preclinical and clinical safety and efficacy trials (most recent action here).

Over the last couple of months, FDA has been creating a bit of anxiety amongst herbal medicine stakeholders over their document entitled, “Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” (PDF here, html here). The term, CAM product, refers to any of the modalities used by complementary and alternative medicine practitioners, not just restricted to herbal and dietary supplements but extending to “energy medicine” products (magnets, lasers, “detectors,” etc.) which would qualify as medical devices under the Federal Food, Drug, and Cosmetic Act . Read More….

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