A second major perspective on the safety of dietary supplements is not to look at specific products, but instead examine the system intended to safeguard the public. After all, having electricity in our homes is dangerous; we rely on a system that includes electrical codes, city inspections during construction, independent laboratory tests of home appliances, and other consumer safeguards.

Just the numbers alone make it clear elementary safeguards one could reasonably expect in a third world country are not in place. About 1,000 different manufacturers provide approximately 20,000 different products consumed by more than 100 million people, who spend $13 billion annually.

To regulate this entire industry the FDA has a core staff of eight people. Three staff members investigate and follow up on reported adverse reactions. Five others work on compliance, review product claims, and evaluate the safety of new products. Add the people with related tasks-such as answering letters and responding to Congressional inquiries, the entire staff rises to approximately 20. The tally would grow slightly larger by including people who work elsewhere in the FDA but might occasionally deal with an issue involving dietary supplements. A working staff of eight might reasonably assure that the restaurants meet health standards in a mid-sized city, not monitor adequately an important category of drugs in the largest industrialized country in the world.

In some cases, the most basic steps have not been taken. For example, Congress declared that all ingredients and supplements available in 1994 were safe, unless proven otherwise. However, the law did provide for FDA notification and a safety review for any "new" dietary ingredients. But how is a manufacturer to know whether a dietary supplement is "new" and requires FDA notification? The FDA has never published a list of legally exempt products that do not require a safety review.

Is this a mere bureaucratic fine point? Consider the saga of a dangerous dietary supplement called GBL. By itself GBL may not be a great problem, but once inside the body it is rapidly converted to GHB, a dangerous and regulated drug. It can suppress breathing and heartbeat, induce a sleeplike state and is thought to enhance the production of growth and sex hormones. It is sometimes called "the date rape" drug.

A Tennessee supplements company somehow deduced that GBL was a new dietary ingredient and submitted for FDA review the safety studies it believed appropriate.

Small staff or not, an alert and knowledgeable FDA reviewer made the connection, and manufacturer was told it was not safe to market the drug. The date was April, 1998. At first glance, the system seems to be working.

That didn't end the dangers of GBL. Four months and three more deaths later, the FDA was issuing another warning about a close chemical cousin of GBL, which in the body is also converted to the dangerous drug GHB. In warning consumers about the new product the FDA said it believed that manufacturers had made a small chemical change in the product and continued to sell it. Safeguard You Won't Get For another insight into the lack of rudimentary safeguards, consider these safety proposals that the FDA rejected in implementing the 1994 law on dietary supplements:

--Before marketing a new ingredient, every manufacturer ought to be required to search the medical literature for reports of toxicity and adverse reactions and submit the results, one commentator suggested. Not acceptable, said the FDA. It is up to the manufacturer to decide what safety studies are needed.

--Since some new dietary supplements can literally be cooked up by amateurs in someone's garage, the FDA ought to require every manufacturer to check with an expert with experience and formal training in the field--as is required for food ingredients. Not in the law, said the FDA.

-- The FDA should provide "guidance as to the quality and quantity of information necessary" to establish safety. Not required, the FDA responded.

The resulting safety requirements for a new dietary ingredient were certainly brief: One paragraph of 112 words. Since the law was enacted, the FDA has reviewed 46 of roughly 20,000 products on the market. In the last two years it has also inspected 114 establishments-but could only check for problems such as cleanliness. In addition, it reviewed 184 product samples and sent five warning letters.