Some of you readers may be aware that tryptophan has not been available on the US market for a number of years (See 'Tryptophan is Back' for more on this). The history of this extremely useful nutritional product, why it was taken off the market and how it came to be available again make a fascinating story.

A BRIEF HISTORY

For more than a decade, billions of dollars worth of tryptophan were sold in America with no health issues or problems of any sort. However, in 1987 a true disaster occurred that involved a batch of contaminated tryptophan. It occurred due to two events. In 1987 the FDA relaxed its purity requirements for amino acid products. Previously, all amino acids were required to meet standards defined as USP grade - pharmaceutical grade. Consequently, the purity of the tryptophan that was available in the early 80s was comparable to the purity of pharmaceutical medications. The FDA subsequently relaxed these standards to a leveled that is described as food grade, which is a lower level of purity.

Unfortunately, one of the primary manufacturers of amino acid products in Japan had introduced a new manufacturing process. While amino acids are often produced through bacterial fermentation, in this case, the manufacturing involved genetically engineered bacteria. These genetically modified bacteria produced toxic byproducts into the tryptophan. The toxins were not detected, apparently because the process was new and toxin byproducts had never occurred in any previous manufacturing process.

That would not have been a problem if the USP purity had still been in place, but these standards had been relaxed. The product (with its undetected contaminants) was able to pass inspection under the new standards for food grade products.

This new tryptophan was sold at a bargain basement price - so a great many companies purchased the product, particularly those oriented to the lower price market. These companies were merchandising outfits that did not understand importance of USP grade amino acids and just saw an opportunity for profit.

The inexpensive tryptophan hit the market and was consumed by hundreds of thousands of people. The nature of the toxins in this contaminated batch of tryptophan was such that not everyone was affected. Only people with certain susceptibilities were injured by it, but unfortunately there were 3 7 deaths, as well as approximately 1,500 serious disabilities. The contaminant was not detected immediately. Historically, there had never been any problem with tryptophan, so there was no reason to suspect that tryptophan or any other amino acid could be a source of these issues. The cases occurred at locations all across the country, so it took awhile for reports of the toxicity to surface and the problem to be clearly identified.

CDC researchers investigated the reports thoroughly and were able to conclusively identify the specific batch of tryptophan from the manufacturer, as well as the toxins that were in that batch. The FDA, which operates independently of the CDC, declared an involuntary recall on all products containing tryptophan. It is important to remember that tryptophan was not only sold as a single ingredient amino acid - it was also sold as a component of amino acid mixtures and a variety of other products such as multivitamin. It was also included as an ingredient in a range products that had specific applications - for example, products designed to raise serotonin in cases of depression, anxiety, pain, or PMS tension. In sum, there was an enormous array of products on the market containing tryptophan - reported to be valued at $2 billion US. All those products were recalled.

The economic impact was devastating and this action by the FDA was always viewed with some concern. All tryptophan was recalled, even though the CDC had thoroughly identified the problematic batch and the companies it was sold to, right down to the particular stores that received the contaminated products. So the recall was viewed as a rather drastic action on the part of the FDA. Billions of dollars worth of products were discarded. The consequences were major, both to the health food industry and particularly to the manufacturers.

The FDA followed the recall with an import warning. At that time until the present, all tryptophan was produced by manufacturing companies in Germany or Japan . The warning has meant that additional steps of quality control screening are required for every batch of tryptophan that is imported. That has not been a problem. However, the economic damage caused by the call-back was so extensive that all the companies previously involved in tryptophan marketing and distribution withdrew their product lines.

Another event that occurred at approximately the same time was the introduction of ProzacT, which was one of the first of the SSRI type antidepressants (selective serotonin uptake inhibitors). These antidepressants work through a different mechanism than tryptophan, but both products are intended to increase serotonin levels. Also, a number of new sleep medications were released on the market at about that time. There are now a large number of drugs that manipulate serotonin chemistry, the action that tryptophan carries out without side-effects or addictive problems.

One of the primary obstacles to the reintroduction of tryptophan has been the considerable investment by manufacturers in order to retool for production. It has also involved negotiating with the FDA to meet all their requirements.

We are impressed by the tremendous effort our supplier has invested in order to bring quality tryptophan back onto the market. This has required years of negotiation with the Japanese manufacturing companies, the importing companies, and the FDA. The tryptophan imported by our supplier is of the very highest quality. This product far exceeds USP standards, and meets the standard of purity required of intravenous medication.

SAFETY AND QUALITY CONTROL

The FDA has gone to considerable lengths to assure the quality of the tryptophan currently imported. Tryptophan is monitored under an import alert, which means that there are additional quality-control requirements for this material. To avoid adulteration, the importer is required to sell only encapsulated products that have been bottled. Currently only a few American vendors have gone through the rigorous evaluations required to import tryptophan. Vendors have signed an agreement not to re-label it, not to sell it in powdered form and not to mix it in other formulas in order to assure the purity of this product.

Only a few sources in the United States currently have met FDA purity requirements in order to market tryptophan. Only these few have taken the time to register with the FDA and submit their product to extensive testing. Other than these few vendors, all the tryptophan available on the Internet is either:

. 5 HPT, which is less effective or

. Veterinary grade, not intended for human consumption.

We strongly recommend buying only tryptophan which is absolutely USP grade or higher. Otherwise, consumers run the risk of using lower-quality products of unknown purity. You will also want the assurance of USP grade for any 5-HTP products or any other form of tryptophan. This site is one of the few sources of pharmaceutical-grade tryptophan currently available through the Internet. The FDA has tested and retested each batch of these products to assure their absolute purity. The most recent tests found a level of purity that exceeds the very highest standards.

Tryptophan is one of the most important of all the amino acids. There is also a particular relevance of this essential nutrient to the kinds of stress Americans undergo in our culture. We now know from extensive research that stress-related issues often reflect low serotonin. Since tryptophan is the raw material from which serotonin is made, this can be a highly effective strategy for improving mood, sleep, and performance. We are grateful for the careful work that has paved the way to bring tryptophan back to the American market.