Buyer beware: Makers of dietary supplements should have to prove safety

This is an archived article that was published on in 2006, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

Here's why the current method for regulating dietary supplements doesn't make sense:

Orrin Hatch's federal law requires the Food and Drug Administration to regulate dietary supplements as food, not drugs. As food, they are exempted from pre-market safety testing. If the FDA wishes to ban a dietary supplement, it must prove that the product is not safe.

Drug manufacturers, by contrast, must prove that their products are safe, or at least that they generally do more good than harm if the patient follows package directions. Pharmaceutical companies meet this safety standard by conducting testing that must satisfy panels of experts at the FDA before a drug is approved for sale. The burden of proof is on the drug manufacturers

Ephedrine-alkaloid dietary supplements, sometimes called ephedra, put the FDA in a tough spot. These chemical stimulants, found naturally in plants, raise heart rate and blood pressure, and have been sold as products to help people lose weight and to improve athletic performance.

Because ephedra is a dietary supplement, there was no rule that it pass safety testing prior to sale. Ephedrine-alkaloids have been used in folk medicine for centuries.

But when the FDA got reports linking the supplements to harmful side effects, including strokes and heart attacks, it didn't have much data about how the chemical worked in particular doses. The supplement manufacturers insisted it was only dangerous if used in conjunction with other chemicals, such as caffeine.

The FDA banned sales of ephedra in 2004, arguing that even small doses could not be proven safe. A supplement manufacturer sued to overturn that ban. In 133,000 pages of testimony, the FDA could cite only a single study on low dosages, and that was a mathematical projection from a related substance.

The federal government sponsors some scientific research of dietary supplements, but it is minimal compared to pharmaceutical research. The dietary supplements industry has no incentive to do the research, since it is neither required nor proprietary.

In the case of ephedra, that led to an information vacuum. And that's no way to protect public health. If companies are going to sell this kind of stuff, they should have to prove it's safe.