“This Statement has not been Evaluated by the FDA”

February 5th, 2010. By Kristine B

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 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…

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Under DSHEA, the manufacturers of dietary supplements are responsible for their safety. They are also responsible for ensuring that any claims made about the supplement are, indeed, true and can be substantiated. You’ll notice, however, that this doesn’t say that the FDA is responsible. And that’s because the FDA is not responsible for regulating or approving dietary supplements.

The only exception to this—and this is where 1994 comes into play—is that any dietary ingredient that had not been marketed BEFORE October 15, 1994 is considered “new”. A new dietary ingredient needs to have a pre-market review of safety data submitted to the FDA with the evidence the manufacturer has based its safety or effectiveness claims on.

Beyond the manfacturer providing pre-market safety data though, the manufacturer is not required to register themselves, or the dietary supplement they intend to produce or sell, with the FDA prior to putting the supplement on the market.

So, where’s the list of dietary ingredients that existed before 1994? According to the FDA, “There is no authoritative list of dietary ingredients that were marketed before October 15, 1994.” Well now, that makes things a little tricky, no? Yes—for the manufacturers who are left with the burden of determining whether a dietary ingredient is new or not—and for all the documentation to support that designation.

If all the safety information on a dietary supplement comes from the manufaturer and there’s not really any regulation of that information, then how does someone know if they’re being safe when they’re…

Mixing Dietary Supplements with Prescription Drugs?

Another good question. And, unfortunately, one that doesn’t have a great answer. It comes down to a mix of “buyer beware” and “talk to your doctor”. Because dietary supplements aren’t regulated by the FDA in the same way as prescription drugs, the information available about them can be sketchy at best. As the FDA site states, “It is up to each firm to set its own policy on disclosure of such information.” Hmm.

Tags: dietary supplements, FDA, herbal supplements, Pleading Ignorance

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