It is a bitter irony that the suffering of Faith Rumph and 1,500 other victims of l-tryptophan did not led not to better safety and quality control. Instead, the disaster led to lower standards and a largely voluntary system. Here how it happened:

The spectrum of what we put into our mouths can be divided in two by the FDA's own name: food and drug administration. We take food for nutrition and its pleasures. Drugs are to cure illness, relieve symptoms and prevent disease. For the multitude of foods, the regulatory hand of the federal government is light, except for additives and contaminants. Drugs, because of their much greater capacity for both good and harm, are tightly regulated. They are tested among hundreds or even thousands of people who are systematically observed. The scientific record establishing the medical profile of a new drug is tens of thousands of pages long and represents six or seven years of research. No drug may be offered for sale across state lines without FDA approval

But what about vitamin pills? A food or a drug? They contain essential chemicals and minerals found in foods, and a balanced diet provides the officially recommended amounts. But a dire shortage causes diseases like scurvy and pellagra or birth defects. That sounds like disease prevention, the job of drugs; and vitamins are sold as pills, just like many drugs. For decades the answer was not clear; as a result, an uneasy hostility existed between the FDA and the vitamin industry which feared it's products might be regulated as drugs. Vitamins were popular with the public and had supporters in Congress, and the FDA's efforts to tighten controls were repeatedly blocked. But it was a small category of products with potential benefits and seemingly modest risks.

Then came the l-tryptophan craze. It was an amino acid-one of the 23 basic building blocks of all living things. It was already present in foods, which are constructed of these same building materials. It was so widely promoted that tens of thousands consumers bought it-and even Faith Rumph doctor recommended it. It was "natural" and for trouble sleeping, seemed safer than moving up to heavy-duty prescription drugs in the tranquilizer family. Even if it was just a placebo-which many observers believed-what harm was done?

As Faith Rumple can attest, a lot of harm was done--with 1,500 people doomed to a lifetime of misery and disability. L-tryptophan hadn't been carefully studied like new drugs. As handy building blocks, they could be readily transformed into a wide variety of other compounds. There was no government scrutiny of quality control-such as for drugs-to insure that the pure amino acid actually got into the bottle. In the case of the l-tryptophan liked to the EMS cases, more than 50 separate contaminants were identified, with 6 major suspects. The l-tryptophan tragedy had unmasked an important safety problem.

In response, two scientific task forces pondered what needed to be done to prevent another catastrophe. A panel of biochemical scientists examined what was known about the safety of amino acids-such as l-tryptophan, l-carnitine, asparagine and aspartic acid. It concluded that not enough was known to assure the safety of amino acids, when sold in concentrated form rather than in foods. At the same time then Commissioner David Kessler appointed a separate FDA panel to review the whole spectrum of products-- vitamins and minerals, botanicals and herbals, and amino acids. This panel also recommended tighter regulation of the entire area, but provided no blueprint for how strict and how burdensome to industry these new regulations might be. The wheels of government bureaucracy turn slowly. The EMS epidemic was discovered in 1989; the FDA report did not appear until five years later, in June of 1993.

While the FDA report barely registered among the public, it put the dietary supplement manufacturers on the warpath. An industry that had earlier blocked FDA efforts to control vitamins now pushed for an all-out legislative victory. Here was the battle cry:

"Write to Congress today or kiss your supplements goodbye!" This was the message of red-white-and-blue brochures from the Nutritional Health Alliance, a group created by supplements companies.

The alliance's most outlandish claim was this: "In preparation for increased enforcement activities, the FDA has hired 100 criminal investigators led by a 20-year veteran of the U.S. Secret Service. These new G-men will be unleashed on the supplement industry."

"It was an industry group," recalled Dickinson, the official for a different industry organization. "They had a small number of companies. Those companies included companies like GNC that had 3,000 stores in which petitions could be put. It included companies that were in the mail order business that could put things in orders that went out by mail." Dickinson's own group, the Council for Responsible Nutrition, also joined the legislative campaign.

An election-year Congress was deluged with mail from alarmed voters. In politics as in war, truth can be the first casualty-and certainly was in this case. The manufacturers generated so much constituent mail that even veteran targets of letter-writing campaigns were both impressed and frightened. In the waning months of a Democratic majority in 1994, Congress passed a law sharply limiting FDA powers over dietary supplements.

"It was a law built on a lie!" said Abbey Meyers, president of the National Organization for Rare Diseases. "Those lobbyists designed very effective campaign, not just with Congress, but by convincing the public that the FDA is the enemy."

This was how the l-tryptophan catastrophe that disabled Faith Rumple resulted in Congress cutting a large hole in the umbrella of protection that consumers enjoy for a wide array of other products with the capacity to harm. Now, five years after deregulation, how well does the system work? Is strict regulation and independent safety review really necessary?