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The FDA Strikes Again: Fight Back!

© Karyn Siegel-Maier

In the interest of safety and appropriate labeling, the Dietary Supplement Health and Education Act (DSHEA) was signed by President Clinton on October 25, 1994. Its purpose was to establish guidelines for literature supporting nutritional and health claims and labeling practices. The DSHEA recognized that consumers wanted to learn more about dietary supplements and botanical medicines as a method of maintaining wellness and that such consumers had a right to their access. But now, the FDA wants to rock the boat again.

Prior to enactment of the DSHEA, the Federal Drug Administration (FDA) considered dietary supplements as strictly vitamins, including minerals and proteins. Congress, acting on the DSHEA, expanded this definition to include many herbs, fish oils, enzymes, glandulars and combinations thereof. In fact, the literary definition of a "dietry supplement" according to the DSHEA is as follows:

1. "A product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract or combinations of these ingredients.

2. is intended for ingestion in pill, capsule, tablet, or liquid form.

3. is not represented for use as a conventional food or as the sole item of a meal or diet.

4. is labeled as a "dietary supplement."

5. includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision)."

Sorry to drag you through all that, but it's important to know where dietary supplements, particularly herbal products, stand in the market before the FDA attempts to regulate your choices. You read that right. The FDA is going to try to curb your access to dietary supplements and information about using them to prevent illness.

The proposed regulation even attempts to alter the definition of disease to further promote its purpose. If this legislation is passed, common "natural" states, such as aging, menopause and pregnancy will be classified as diseases. (Not that allopathic physcians haven't been treating them as such.) Furthermore, consumers will no longer be able to purchase an herbal product over the counter with the intention of reducing cholesterol, or abate nausea, for instance, because the FDA will move to classify that supplement as a drug.

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