Thursday
Nov062008
Thu, November 6, 2008 | Lisa Barger The Herbal Exemption
“There’s been a lot of talk around about the ‘herbal exemption’. What does that mean?”
The so-called “herbal exemption” refers to a loophole in the U.S. Food & Drug Administration’s regulations regarding the sale of herbs and herbal supplements. It comes from something called the Dietary Supplement Health and Education Act.
In 1994, then-President Bill Clinton signed into law an act that was supposed to make it easier for people to find, purchase and use herbs, herbal supplement and other nutritional products. Essentially, it gave manufacturers a way to sell those products without having to go to the time and expense of having them approved as drugs.
It also does something else significant. It puts the burden of proof on the FDA. If a product is suspected to be illegal or mis-labeled, it’s up to the FDA to prove it. It’s NOT the responsibility of the manufacturer to prove the product is legitimate.
Basically, when a company takes an “herbal exemption”, all this means is that they’ve decided to sell a product without making any real medical claims. The label might say, for example, “Contains garlic” or “Supports health”. But it would never say, “Cures cancer” because that would be medical claim.
References:
U.S. Food and Drug Administration. (1994). Dietary Supplement Health and Education Act of 1994.
The so-called “herbal exemption” refers to a loophole in the U.S. Food & Drug Administration’s regulations regarding the sale of herbs and herbal supplements. It comes from something called the Dietary Supplement Health and Education Act.
It also does something else significant. It puts the burden of proof on the FDA. If a product is suspected to be illegal or mis-labeled, it’s up to the FDA to prove it. It’s NOT the responsibility of the manufacturer to prove the product is legitimate.
Basically, when a company takes an “herbal exemption”, all this means is that they’ve decided to sell a product without making any real medical claims. The label might say, for example, “Contains garlic” or “Supports health”. But it would never say, “Cures cancer” because that would be medical claim.
References:
U.S. Food and Drug Administration. (1994). Dietary Supplement Health and Education Act of 1994.
This is "retired" article left in place for archival purposes. It may not reflect current thinking or research on the topic.
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