Elevated
Herbal health risks
Published January 9, 2004

Acting on mounting evidence of serious side effects, including sudden death, the FDA banned the herbal supplement Ephedra at the end of December. The New York Times reported that there are other supplements currently being investigated by the FDA, raising the specter of more bans. Amusingly, the manufacturers of Ephedra supplements can and probably will sue the FDA to have the ban lifted. Does anyone else think that it's time to change the way we regulate this industry?

I should actually correct the previous sentence. There is essentially no regulation of the dietary supplement industry. This is probably a surprise to most people. When you go into a drug store--which is were most of these supplements are sold--and buy something, you expect that a certain amount of testing and verification has gone into the product you are about to consume. We Americans are, perhaps, somewhat naieve in this regard: we expect everything we buy to do what it says it does and to be as safe as it should be. Sadly, this is obviously not the case.

The FDA can only regulate dietary supplements that have been shown to cause harm to those consuming them. Every other aspect of the production, testing, and marketing of such supplements is the sole responsibility of the manufacturers. The law does, of course, require that the manufacturer test its product and verify that it is safe to use, properly labeled and otherwise fit for consumption, but there is little verification of claims made by manufacturers. Because of this, the FDA recommends careful research before using dietary supplements, especially if you have a preexisting health condition, like high blood pressure.

The only time the FDA steps in is in the case of so-called "new dietary ingredients," essentially supplements that have ingredients in them that were not sold in the US before the 1994 Dietary Supplement Health and Education Act. Again, however, it is not up to the FDA to determine if a particular ingredient was sold before 1994; the manufacturer must present documentation to prove its case. In every other case, the company making a dietary or herbal supplement need not present the evidence on which it is basing its claims of safety and effectiveness.

It is obvious that this hands-off system has produced abuses; just as plainly, in the case of supplements like Ephedra, it is not in the best interests of supplement manufacturers to bother with rigorous or detailed investigations of possible side effects and unwanted consequences stemming from their products. The majority of manufacturers will be honest and will probably do a decent job, though there is no way to know for sure, but it is surprising to me that we are so willing to lay our trust in a company that is, in the final analysis, trying to make money by selling a product.

We do not lay that sort of trust in pharmaceutical manufacturers, nor in their drugs. In fact, new drugs are subjected to a rigorous testing and review process by the FDA before they can be sold anywhere; even then, many are considered controlled substances, only available with a doctor's express approval. The reasoning behind that restriction is the same as that behind the FDA recommendation that consumers check with their doctors before using any dietary supplement. The law, however, does not take this similarity between drugs and supplements as seriously as it should.

The FDA currently has neither the mandate nor the resources to regulate the dietary supplement industry. Consumers are being misled, and there is no real guarantee of product safety or effectiveness. Neither of these facts are common knowledge to consumers, and the result is illness and death, as in the case of Ephedra, and fraud and theft in the case of supplements advertising benefits that are unsubstantiated by any real scientific data. This should change; a more rigorous standard should be put into place, not necessarily as stringent as the current system for pharmaceuticals, but one in which we can all place our confidence, knowing that we are protected from the abuses that might otherwise occur.

I can't say whether the fallout from the Ephedra case will lead to greater regulation of the industry as a whole, or if the current "wait until something goes wrong" attitude will prevail. That attitude leads to illness and death as well as to low prices. We just need to decide which we prefer, just like in the regulation of beef cattle and mad cow disease. How much death and devastating loss are we willing to accept for the sake of convenience? Until we find an answer to that question, I'd urge everyone to do some careful fact checking before using any dietary supplements.

For more information, check out the FDA's web site.