Posts Tagged ‘ dietary supplements ’

“This Statement has not been Evaluated by the FDA”

February 5th, 2010. By Kristine B

Echinacea...pretty, and unregulated And until something changes, it ain’t gonna be.

This week, a study was released suggesting that the combination of herbal remedies and heart medications can be dangerous for patients. According to the study, patients who use popular herbal remedies—including ginko biloba, St. John’s wort and Echinacea—along with heart medications are at an increased risk of serious heart rhythm problems, higher blood pressure and bleeding. Serious stuff.

If you’ve ever wondered how the herbal supplement industry is regulated, read on as Pleading Ignorance dives into the regulation of dietary supplements.

What is a Dietary Supplement?

Good question. The phrase “dietary supplement” gets tossed around a lot. It’s a vitamin. It’s a weight loss miracle. It’s a muscle-builder. Or pleading ignorance copy This Statement has not been Evaluated by the FDA the secret to an improved sex life. “Dietary Supplement” means a lot of things. But the FDA, in accordance with the Dietary Supplement Health and Education Act (DSHEA) of 1994, defines “dietary supplement” as a product taken by the mouth that contains dietary ingredients that are intended to supplement the diet. Sounds like a definition that basically says a lot of nothing–except that the supplement needs to be taken orally. Ok, so what’s a dietary ingredient? According to the FDA site, a dietary ingredient is a:

vitamin
mineral
herb or other botanical
amino acid
dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands)
concentrate, metabolite, constituent or extract

Makes sense, but that date—1994—is important…

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Tags: dietary supplements, FDA, herbal supplements
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