Ephedra Ban Overturned

On April 13, 2005 the 2004 Final Rule issued by the FDA banning Ephedra was overturned by a Federal Judge. The Plaintiffs, Nutraceutical Corporation aka Solary, Inc., challenged the FDA’s Final Rule which called Ephedra, in any amount, too much of a health risk.

The Final Rule, which was published in February, 2004, claimed that the use of Ephedrine-alkaloid dietary supplements (known as EDS) caused “unreasonable risk or illness or injury.”

One of the primary concerns that currently exists with EDS relates to what is considered and classified as a “safe” amount. Because EDS accelerate metabolism, increase fat burning and promote weight loss—the very reason many people seek out EDS products in the first place--efforts have been made banning the product altogether, and now, only in certain strengths. The FDA claimed that an EDS was adulterated in it contained 8 mg or more of ephedrine alkaloids per serving.

Clearly, any supplement, prescription, or over-the-counter medicine could easily induce the same health risks that an overdose of Ephedra could. For that matter, there are many approved diet pills on the market today that have a much greater stimulating effect than the EDS products currently allowed. This was the Plaintiff’s winning point.

The FDA’s main claim was that the benefits of EDS have no proven positive effect, so that in light of even the slightest risk, EDS should not be made available to the public. The Plaintiff pointed out that under DSHEA, there is no provision that supports the FDA’s contention. In fact, dietary supplements aren’t classified on the same basis as drugs are. There is no requirement or obligation of the manufacture (or retailer) to prove the effectiveness of the product’s claim.

Current manufactures understand the importance of drug regulation. However, that does not lesson the blow that a natural herbal supplement is treated as more dangerous than innumerable synthetic supplements currently on the market. These synthetic supplements, even when taken in approved amounts, pose just as much if not more danger then their counterparts. Incidentally, many over-the-counter cold medicines---that have not been scrutinized—contain ingredient that may have been derived from Ephedra.

The FDA’s Final Ruling that EDS in any amount present an unreasonable risk was not properly or logically supported and therefore, the Court was just in ruling in the Plaintiff’s favor. There is still an appeal pending….check back for the outcome.