FDA—An Axe to Grind?

Many critics charge that the Food & Drug Administration (FDA) has acted irrationally when it comes to regulating alternative health and diet products. Here are three oft-cited examples of alleged FDA misdeeds:

• About two decades ago, the FDA published a list of "Unsafe Herbs." Listed along with such clearly toxic plants as poison hemlock were herbs now in common use and recognized as safe: bloodroot, an ingredient in mouthwash and toothpaste; horse chestnut, a European treatment for varicose veins; and St. John's Wort, the best-selling prescription drug in Germany for depression.
• In 1988, the FDA seized two barrels of black current oil on the grounds that the oil was to be sold in gelatin capsules, and, thus, by some twisted logic, was an unapproved food additive. The case went to U.S. District Court, but was summarily dismissed by the judge, who called the FDA's reasoning an "Alice-in-Wonderland approach" that would allow the FDA to subvert the intent of the law.
• The herb stevia has been used as a non-caloric sweetener in Asia for many years, and its safety is unquestioned. Nevertheless, the FDA blocked the importation of stevia on the grounds that it was an unapproved food additive.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) came about in response to an FDA plan to put excessive restrictions on the availability of herbs and other dietary products. DSHEA limits the FDA's power by forcing the agency to prove that products are not safe first before removing them from the market. Since the FDA had previously banned many products for no good reason, the new law caused the FDA ban to be lifted on stevia, evening primrose and other previously banned items.

Although therapeutic health claims are not allowed, the DSHEA allows descriptions of the function of a particular herb or nutrient within the body, as long a disclaimer is included that the claim is not FDA-approved. However, marketers making reasonable function claims have recently begun receiving letters from the FDA stating that their claims are really drug claims, which are not permitted. Also, the agency has begun to consider as drug claims any references to the relief of conditions already treated by pharmaceutical drugs. For example, the FDA temporarily impounded a red yeast used traditionally in China for hundreds of years. According to the agency, it "appears to be an unapproved new drug" due to the manufacturer's claim that it reduces serum cholesterol levels. The yeast also contains the same active ingredient as the prescription drug lovastatin.

Some critics charge that, if the FDA were acting in a reasonable and consistent manner, it would allow Chinese red yeast to be sold, just as it does garlic pills, for which cholesterol-lowering claims also are made.   Based on information in: Herbal Gram #41