Amino Acids Supplements: Are the Feds Going to Regulate Amino Acids?

It's now official. On June 18, 1993, the Food and Drug Administration published its proposal to regulate amino acids as drugs, and the question most people are asking is, Why does the FDA want to do this? Although there are those who have strong opinions about the FDA being controlled by the pharmaceutical industry and having a clear bias against dietary supplements, there are two more obvious reasons for the government's action.

The first deals with safety an issue that was raised a few years ago by the association of the amino acid L-tryptophan with a new disorder known as eosinophilia-myalgia syndrome, or EMS, which has affected 1,511 people and killed 38. The second has to do with the way amino acids are marketed.

By definition, a drug is a substance that is used in the treatment, mitigation and/or prevention of a disease. Consequently, using tryptophan to alleviate insomnia or depression, which were the two main reasons why people were ingesting this essential amino acid, technically makes it a drug.

Amino Add Chronology

Since there is so much information and misinformation concerning tryptophan and EMS, as well as the regulation of amino acids as drugs, the following is a chronological list of key events:

July 26, 1973 The FDA removes amino acids from its Generally Regarded As Safe, or GRAS, list due to "insufficient safety data." The only FDA-approved use of amino acids is to increase the protein quality of intake proteins.

Early 1977 The FDA tries to seize tryptophan tablets but loses the case because it forgot to remove amino acids from the GRAS list, an error that is finally corrected on October 28, 1977.

October 30, 1989 The first reports of EMS come in.

November 17, 1989 The FDA recalls all products that contain 100 milligrams or more of manufactured tryptophan per serving.

December 15, 1989 The Centers for Disease Control report of an EMS patient whose eosinophilia drops from 15 percent to 0 percent when the patient switched to hospital tryptophan. (The normal range is 0 to 4 percent.) This is the first evidence supporting the theory of contaminated tryptophan.

December 28, 1989 An EMS patient recovers completely after switching to noncontaminated tryptophan.

March 22, 1990 The FDA recalls all products containing manufacture tryptophan.

June 13,1990 The number of people affected by EMS reaches 1,511, including 38 deaths, although it is believed that 5,000 to 10,000 people are affected.

July 11, 1990 EMS is traced to one manufacturer, Showa Denko.

July and August 1990 Twenty out of 20 EMS patients who were not improving with medical treatment improve significantly once they start taking noncontaminated tryptophan.

August 9, 1990 EMS is determined to be associated with changes in tryptophan manufacturing by the implicated manufacturer, as 33 substances other than tryptophan are found in contaminated products.

October 3, 1990 Ninety-one percent of EMS patients report that their symptoms began after April 1989. This report also states the following: 1) 3 percent of EMS patients never ingested tryptophan 2)10 percent ingested less than 500 milligrams of tryptophan a day (dietary intake ranges from 500 to 2,000 milligrams); 3) one patient took only 10 milligrams of supplemental tryptophan a day, while another took only 26 milligrams a day; and 4) some EMS patients took tryptophan for up to 10 years without problems, at least until 1989.

November 1990 EMS-like symptoms are found in rats that were fed suspect tryptophan but not in rats that were given noncontaminated tryptophan. The dosage used in this study translates into a human intake of 112 grams a day.

February 4, 1991 A public meeting on the safety of amino acids and related products is held by the Life Science Research Office of the Federation of American Society for Experimental Biologists. Eight people present information, which includes the following:

1) There were no serious side effects in more than 243 human studies that involved the ingestion of amino acids, even in doses of up to 100 grams a day; 2) in every study in which the side effects of an amino acid were compared to that of a placebo, there were no significant differences even when the placebo was Cream of Rice; 3) there was no mention of EMS or EMS-like symptoms in at least 187 human studies that involved tryptophan doses of up to 20 grams a day; and 4) there was no mention of EMS or any serious side effects in more than 20,000 individuals in Great Britain who took six to nine grams of tryptophan daily for months.

March 6, 1991 A letter from the FDA states that 'virtually all EMS patient-associated tryptophan was produced by Showa Denko K.K."

July 1,1991 Ten out of 10 EMS patients in Europe experience total or partial recovery when given non- contaminated tryptophan.

August 25, 1991 The FDA's Dietary Supplement Task Force holds a public meeting. Thirty-four speakers attend, including strong advocates on both sides of the debate.

May 1992 The final report by the FDNs Dietary Supplement Task Force is completed but is not released until June 15,1993.

July 1992 The Life Science Research Office of the Federation of American Society for Experimental Biologists issues its final report on the "Safety of Amino Acids Used as Dietary Supplements," which states that due to insufficient data, the group was "unable to identify a safe upper level of intake for dietary supplements of amino acid for any of the amino acids reviewed in this report." This conclusion is based not on studies identifying serious side effects caused by amino acids but primarily on the lack of studies specifically looking at side effects, which is probably due to the researchers' belief that such substances were safe, since they had been so widely used and investigated.

March 1993 A questionable, rat study finds toxicity in the pancrease of rats that were fed contaminate and even noncontaminated tryptophan. The tryptophan dose was equal to a human intake of 140 grams a day. (The average intake by EMS patients was 1.5 to 1.9 grams a day.)

April 7, 1993 Senator Orin Hatch of Utah introduces the Dietary Supplement Health and Education Act of 1993 (S. 784), a bill that limits the FDA's authority over dietary supplements.

June 18, 1993 The FDA publishes its intent to regulate amino acids, as well as most herbs, as drugs.

June 29, 1993 A hearing is held on dietary supplements by the House Subcommittee on Health and the Environment, which is chaired by Congressman Henry A. Waxman of California.

July 23, 1993 The FDA's Dietary Supplement Task Force holds a meeting largely due to the efforts of the Consumer Coalition for Health Choices, a group whose membership includes some very powerful and politically active organizations, such as the AIDS Coalition to Unleash Power (ACT UP).

Late October 1993 and early '94 At the request of the Consumer Coalition for Health Choices the FDA's Dietary Supplement Task Force holds meetings on the safety of amino acids.

December 15, 1993 The deadline to submit information to the FDA on the safety of amino acids passes.

Some Additional Facts

Although most of the evidence strongly points to contamination and not to tryptophan itself as the cause of EMS, the FDA is still keeping manufactured tryptophan out of the marketplace. Even so, manufactured tryptophan is an ingredient in widely available infant formulas as well as intravenous and other medical preparations.

The fact is that even if tryptophan had been classified as a drug, that would not have prevented the outbreak of EMS, as there have been more than 100 EMS cases in Germany associated with prescription tryptophan. The only distinction between who got EMS and who did not was whether the tryptophan, in whatever form, was originally purchased from Showa Denko, the implicated manufacturer. Furthermore, the regulations to make sure that tryptophan is safe for human consumption are going to be the same whether the amino remains a dietary supplement or becomes a drug.

Some authorities say that tryptophan can not return to the marketplace until the actual contaminant is identified. This appears to be a logical rationale until you consider the case of the toxic oil syndrome, or TOS, that occurred in Spain in 1981, affecting nearly 20,000 people and causing at least 350 deaths. The actual contaminants were not identified and probably never will be, yet canola oil, a refined version of the oil involved in TOS, is widely available.

Meanwhile, the fate of amino acids is still being debated. It's ironic that in this country, where people have more personal freedom than anywhere else in the world and where we have the freedom to smoke as many cigarettes or ingest as much alcohol as we want-even though cigarette smoking alone will kill approximately 450,000 Americans this year-our government wants to regulate the availability of dietary supplements and thus reduce our freedom of choice. Even more ironic is the fact that the accumulating research demonstrates the beneficial effects of these supplements. In other words, it's difficult to understand why the FDA wants to regulate substances that are potentially beneficial to our health and not restrict the intake of substances that are well-known to have lethal effects.