Twenty four years have gone by since the nutrition industry dropped the ball. If we could go back in time and correct the mistakes that our industry committed, over one thousand victims today would still be thanking us. These were the victims of a non-military war… an on-going tug-of-war between consumer safety and predatorial business practices. Today, history is repeating itself… just checking to see if we have learned our lesson. So far, the answer still is unclear.
For almost two decades, Lidtke has been documenting the increasing hazard caused by the low-cost, low-quality Tryptophan that is entering the United States. There is no single country it is coming from, and according to the FDA, the latest fast-buck manufacturers are producing it from avian (bird) sources, reputedly from countries where it is being extracted from duck feathers.
If you are not familiar with Tryptophan, it is an essential amino acid that for decades has been added to baby formulas to support a growing infant's health and life. Tryptophan is essential to life and to health, and its range of benefits is truly amazing. For starters, Tryptophan is shown to support healthy sleep, relieve occasional depression, ease work-related stress, and relieve common craving for carbohydrates.
Our company, Lidtke, is a specialty manufacturer of dietary supplements, and one of our more important ingredients is Tryptophan. Clearly, we have a big interest in this issue. On the one hand, we believe there is room in this world for competition, and I would not deny any honest competitor access to the marketplace, but a few disturbing facts have been concealed from the public.
Twenty four years ago, shipments of contaminated Tryptophan began arriving in the United States from a careless and cost-cutting manufacturer headquartered in Tokyo, Japan (abbrev. SDKK). In truth, this could have happened in any country. Marketed under many different brand names, it was sold to health-food stores and pharmacies. Not long afterward, people began falling ill. Because this tainted ingredient was being sold under so many different brands, it took months to identify the source.
In a decisive reaction to the problem, the FDA issued an Import Alert in the Spring of 1990, effectively banning the importation of Tryptophan into this country for use as a dietary supplement. For the next four years, many private and government agencies worked to identify the toxic agent. Unfortunately, no appropriate animal species could be found that reacted in the same way humans did, so the exact contaminant responsible for the poisonings has never been identified.
Nevertheless, the Import Alert was lifted in April of 2005, and an avalanche of low-cost, low-quality Tryptophan -- some of it lower than cattle or "feed" grade but mislabeled as “pharmaceutical grade” -- began coming through U.S. Customs and began to be bottled and sold over the internet and in health-food stores. Literally, tons of it wound up in consumer products.
Before long, more than a dozen brands found their way onto health-food store shelves. Sophisticated chemical tests of 13 popular brands revealed a disturbing fact. Some brands contained levels of contaminants nearly as high as the toxic material that poisoned consumers in 1989 and 1990. By chance alone, not every contaminant found in manufactured food products is highly toxic, but most contaminants are so poorly understood that their impact on health may not be detected or understood for many years.
Below is a graph of these thirteen brands of Tryptophan; their identity is encoded.
These tests prove that contaminated L-Tryptophan -- which once came from a single manufacturer, SDKK -- began coming from an increasing number of hard-to-pin-down sources. The risk merely shifted as more manufacturers jumped into the marketplace. What the unsuspecting public mistakenly assumed was that much stricter quality controls were in place. Although many controls have since been implemented, the food and pharmaceutical purity standards for Tryptophan have hardly moved an inch in the USA, and the same material that poisoned consumers in 1990 could still be sold today as "pharmaceutical grade."
It is correct to say that government and industry quality-control standards are becoming stricter, but compliance still depends, to a large degree, on the honor system, and some safety standards are decades out of date. It is a fact, though, that the Europeans have taken the issue far more seriously than either the United States or Japan, and the European Pharmacopeia (EP), a compendium of pharmaceutical standards of purity, has made numerous adjustments since 1990.
The Economics of Profit
As in every other marketplace in the world, the biggest herd rushes to the cheapest prices. The problem, though, is that clean Tryptophan -- Tryptophan that is free from contaminants -- is expensive to produce. Producing clean L-Tryptophan is not rocket science and was being done before our company was founded in 1994. The only issue, really, is cost. The fact is: safe, well-made products cost more to produce. Purification is an expensive process when done properly.
Evading Border Controls
Ten years ago, the Tryptophan being smuggled into Southern California and being sold in supplements, as mentioned before, was lower than feed grade -- unacceptable even for cattle. This material was transported into the United States by bottlers using forgeries of documents, using the names of respected manufacturers, to evade U.S. Customs and the FDA.
Now, ten years later, many bottlers appear to be importing much better quality material; however, ensuring better quality still requires vigilance. As the FDA realizes, the only way that a manufacturer can sell drums of raw material at unbelievably low prices is simply to ignore safety and do minimal purification. The FDA cannot stop this. They have said so.
To illustrate their challenge, from 2003 until the Import Alert was lifted in 2005, tons of Tryptophan were shipped from China into Japan, relabeled, and then forgeries of Certificates of Analysis and Bills of Lading – on fake letterhead from reputable companies – were attached to the drums. Foreign manufacturers sometimes helped their American accomplices by using obscure or incorrect chemical names to confuse US Customs.
Now that the Import Alert has been lifted, there is no need for this kind of legal evasion, and bottlers are free to import nutritional ingredients with fewer restrictions.
Today, the FDA is working with foreign manufacturers to qualify their methods and products before they even reach our shores, and once drums of raw materials are inside the United States, there are increasing controls, but in years past American bottlers could “private-label” under dozens of brand names, claiming to offer a “pharmaceutical grade” product. At the end of the day, the American bottler would have multiple false documents, mostly originating in other countries, that provided him with plausible deniability, thus allowing him to squirm out of any liability issues if there were a problem.
There still are enormous economic forces working to move products around the world that are unfit for human use. And, unfortunately, the public has few ways of informing itself in advance of these health issues. As much as the nutrition industry dislikes federal regulation, there seems to be no other way to protect the public. Although less than perfect, the FDA Import Alert did slow the flood of uncontrolled material, and for several years it helped prevent a recurrence of the poisonings that occurred in 1990. ● ●
These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.
Disclaimer: This website is intended for educational purposes only and is not intended to replace the diagnosis or recommendations of a health-care professional. The opinions expressed in this website belong to the author only.