by Jon B. Pangborn, PhD, ChE, Syracuse University; founder and president of Bionostics, Inc.; president of Doctor's Data Laboratory; author or coauthor of nine patents and more than 60 publications; member of NOHA's Professional Advisory Board; and recipient of the1991 Herbert J. Rinkel Award from the American Academy of Environmental Medicine "in recognition for excellence in teaching the techniques of environmental medicine."

Traditionally, the "Doctor's Corner" has been dedicated to discussion of a single topic. However, imminent changes in our ability to choose or obtain nutritional supplements for optimal health makes it advisable for me to address several topics. My intention is to inform, not editorialize, although I include my opinions—stated as such. You will have to make up your own mind whether you should contact your Congressman or relax and watch. [This view does not express the position of NOHA, which has taken no official position on this issue—Editor.]

In the Senate, Orrin Hatch (Utah) has introduced "The Health and Freedom Act of 1992," S.2835. A corresponding House bill, H.R.5746, has been introduced by Representative Bill Richardson (New Mexico). S.2835/H.R.5746 would define a dietary supplement as a vitamin, mineral, herb, or other similar substance; would prohibit the Food and Drug Administration (FDA) from seizing, banning, or regulating these as drugs or as food additives; and would permit valid, scientifically proven health claims for such dietary supplements. At this writing (end of August), there are 20 cosponsors of S.2835/H.B.5746. These bills are intended to counter earlier bills that were introduced proposing increased regulatory and enforcement powers for the FDA.

Increased FDA "enforcement" bills, H.R.3642 and S.2135, have been introduced in the House by Representatives Waxman (California) and Dingell (Michigan) and in the Senate by Kennedy (Massachusetts). The first version of these bills (since changed) proposed that FDA inspectors could carry guns! (Note that in the raid on Dr. Jonathan Wright's office the FDA brought along gun-toting marshalls but FDA inspectors did not themselves carry guns.) S.2135/H.R.3642 would provide the FDA with increased seizure and embargo powers based on FDA-obtained evidence of need. The FDA already has the ability to enter and search a place of business, unannounced, as an "inspection," and without a search warrant. The bills proposed by Waxman, Dingell, and Kennedy would allow seizure of any material (including perishables) for up to 30 days. In addition, the FDA would be able to impose civil penalties of up to one million dollars for a single violation of any FDA regulation (with a limit of five million dollars for multiple violations) without judge, jury, or court action. The only appeal would be to a United States Court of Appeals.

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If the FDA does limit amino-acid availability to prescription, what then will they do about the sodium salt of glutamic acid (MSG)? And what about "Aspartame," the artificial sweetener that contains aspartic acid and phenylalanine? Glutamic acid, aspartic acid, and phenylalanine are all amino acids. What we don't need is a double standard where the big pharmaceutical houses can sell food additive amino acids but the consumer can't buy OTC nutritional amino acids.

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In my opinion, due process would be subverted by S.2135/H.R.3542. The FDA has plenty of power now and needs wisdom in its use, not more power. As of August, the FDA under Commissioner David Kessler, MD, had about 9,250 employees versus a congressionally determined ceiling of 8,924. Additional biotechnologists and criminal investigators are currently being hired (otherwise there is a hiring freeze).

One expressed intention is to treat amino acids like drugs and to have them dispensed by prescription only. During 1991 and 1992 the FDA commissioned and staffed a "Dietary Supplement Task Force." The report of this task force is not available at this writing, but the commentary of FDA's Gary Dykstra is. Mr. Dykstra is Deputy Commissioner for Regulatory Affairs, and he served as chairman of the task force. On July 26th Mr. Dystra spoke, via teleconference, to the National Nutritional Foods Association (NNFA). The following is a direct quotation as recorded by Citizens for Health, P.O. Box 368, Tacoma, WA:

Let me talk for a minute about the amino-acid section. As most of you know already, and it has not been a well-kept secret, the task force is going to recommend in its report that amino acids be regulated as drugs. That is probably the most contentious recommendation in the task-force report. That is again as I emphasize in the beginning not something that is going to happen overnight. There is going to have to be a lot of discussion and dialogue on that particular issue. People are going to have an opportunity to voice their opinion about that particular recommendation. So please bear with us on that recommendation. I can assure you that the task force agonized long and hard about that recommendation and even to this day I am not sure what the right answer is with regard to vitamins and minerals. Although I will say that I am concerned about them.

Personally, I have mixed feelings about government regulation of amino acids. My opinion is this: For almost everybody, low dosages and balanced blends of free-form amino acids would be safe and could be nutritionally beneficial. Multi-gram quantities (daily) of single amino acids might be harmful and probably should be dispensed by prescription. The vitamin folic acid is regulated this way with prescription doses exceeding 1000 micrograms and so is the mineral potassium with a limit of 99 milligrams per dose in over-the-counter (OTC) or nutritional products. If the FDA does limit amino-acid availability to prescription, what then will they do about the sodium salt of glutamic acid (MSG)? And what about "Aspartame," the artificial sweetener that contains aspartic acid and phenylalanine? Glutamic acid, aspartic acid, and phenylalanine are all amino acids. What we don't need is a double standard where the big pharmaceutical houses can sell food additive amino acids but the consumer can't buy OTC nutritional amino acids.

L-tryptophan is a nutritionally essential amino acid, which means that humans must derive it from their diets. Normally, we do this by digestive proteolysis (the breakdown of protein), which requires proper gastric, pancreatic, and intestinal functions. Uptake of tryptophan can be poor or inadequate in malabsorption syndromes. Therefore, some individuals need and can benefit from L-tryptophan as a nutritional supplement. There is absolutely nothing harmful about ingestion of pure, L-configured tryptophan in amounts that correspond to normal dietary quantities or that are necessary to cause adequate uptake. For tryptophan, essential requirements range from about 60 to perhaps 500 milligrams per day, and the United States National Research Council estimates infant need at 17 milligrams per kilogram of body weight. According to the National Research Council Food and Nutrition Board, adults need 3.5 milligrams per kilogram of body weight. Higher amounts may be needed for therapeutic purposes. As with any other nutrient, metabolic cofactors must be adequate so that the nutrient can be properly utilized. For L-tryptophan, the cofactor of most concern is pyridoxal 5-phosphate, which is the coenzyme form of vitamin B6. Humans have been taking pure L-tryptophan as a dietary supplement for years (decades) without ill effect.

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If we are to have nutritional supplements for optimal health in the future, then we should encourage rigorous quality control, full disclosure of supplement contents and sources, and labeling with nutritionally appropriate doses.

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In 1989, cases of eosinophilia myalgia syndrome (EMS) were documented and connected with supplementation of L-tryptophan. In November and December of 1989, with 475 documented EMS cases, the FDA instituted a "Class I" (100 %) recall of all tryptophan. Investigations connected the EMS cases with tryptophan produced via a new genetic engineering process at Showa Denko Company in Japan. Although known early on, this information did not become public until about April of 1990. In spite of the Class I recall, the FDA never recalled infant formula tryptophan, except a belated recall about a year later of Showa Denko tryptophan. Continuation of pure tryptophan in infant formula, in my opinion, is an admission by the FDA that tryptophan is an essential nutrient.

Many chemical analyses were performed using different techniques by different laboratories during 1990. Indeed, the Showa Denko tryptophan product was "dirty." My information showed it included low levels of:alpha-ketoglutaric acid (harmless), derivatives of ketopropionic acid, formaldehyde, and methylene chloride. By late summer of 1990 laboratory results as reviewed by the Center for Disease Control (CDC) had isolated a prime culprit: a double tryptophan structure called "di-tryptophan aminal of acetaldehyde, DTAA." For confirmation as the cause of EMS, rat tests of tryptophan containing DTAA were conducted in 1990.

In November, authoritative investigators from at least five national centers or institutes (including the CDC and FDA) published that the implicated, contaminated tryptophan produced EMS-consistent symptoms in Lewis Rats. Pure USP (United States Pharmaceutical)-grade L-tryptophan produced no such symptoms in the rats.* So why is pure, L-tryptophan from traditional sources not restored to its former place as an OTC nutritional supplement? Opinion: because the FDA intends to regulate it. This is an unfortunate instance of the nutrition industry not doing proper quality control and the FDA not giving that industry a second chance.

It is conventional FDA practice to identify an unsafe food or product, cause recall and remedial measures, and then allow the pure or corrected product to again be available to the consumer. In this instance, they refuse. Is this in your interest or not? Before you decide, let me inform you that in Canada, prescription tryptophan is available at 120 to 140 (U.S.dollars) per bottle of 100 capsules (500 milligram capsules). The 1989 equivalent cost in the United States for OTC L-tryptophan was 6 to 10 dollars. Too bad there is not some middle ground that includes rigorous quality control.

If we are to have nutritional supplements for optimal health in the future, then we should encourage rigorous quality control, full disclosure of supplement contents and sources, and labeling with nutritionally appropriate doses. Each batch or lot of source ingredient that is processed or manufactured should carry a certificate of analysis. The assay of the ingredient is thus certified to the nutritional house that blends and packages the final product. Foreign-source ingredients should not be excepted, and the FDA should demand analysis and certification from all source processors or manufacturers, domestic and foreign.

If a nutrient is obtained from a natural source but is extracted or concentrated, then quality control should prevent inclusion of harmful extracting agents and added chemicals. If a nutrient is synthetic, then quality control should screen out similarly configured isomers and enantiomers that could be harmful. The FDA should take the lead in defining rigorous test procedures. We, as consumers, should demand United States pharmaceutical-grade (USP-grade) ingredients and we should be prepared to pay for quality. Remember: more is not necessarily better, prescription limits availability and does not guarantee purity or safety, and quality is not cheap.

*Crofford, L. J. , et al, Journal of Clinical Investigations, 86: 1757-63, November 1990.