Sunday, January 14, 2007

The Return of L-Tryptophan

By James J. Gormley
In the summer and fall of 1989, there was an epidemic outbreak of eosinophilia-myalgia syndrome (EMS) in the U.S. Symptoms of this heretofore rare disorder included: eosinophilia (high levels of this white blood cell); severe muscle pain; fever as high as 105 degrees F.; weakness; muscle and joint pain; swelling of the arms and legs; rash; shortness of breath; pneumonia; and potentially difficulty talking, memory impairment and trouble concentrating.

This outbreak was associated with L-tryptophan produced by a Japanese pharmaceutical company (Showa Denko K.K.); in fact, according to a 2001 position paper from the U.S. Food and Drug Administration (FDA), “more than 95 percent of the cases of EMS were traced to […] Showa Denko.”

In all, over 1,500 cases of EMS and 37 deaths were associated with this supply of L-tryptophan. Consequently, on November 17, 1989, the FDA and U.S. Centers for Disease Control and Prevention (CDC) issued a nationwide recall of all products containing 100 mg or more of L-tryptophan in a daily dose. That recall was expanded, on March 23, 1990, to all marketed product with certain exceptions, and, on February 19, 1991, was further enlarged to all legal products containing Showa Denko L-tryptophan.

And the Effects on the Category?
I spoke with Steven Bass, CEO of Tarzana-CA-based FTH Nutraceuticals, a maker of vitamins, antioxidants and amino acids, including pharmaceutical-grade Pure L-Tryptophan and Tryptophan Plus B6 and B2, and he had this to say: “The effects that the tryptophan debacle had on the nutritional industry—especially related to amino acids—were devastating. Millions of people who depended on L-tryptophan to boost their serotonin levels, and for other health reasons, were deprived of one of the most important natural supplements. Many had to resort to using side-effect-laden and dependency-creating doctor-prescribed sedatives, antidepressants and other drugs in order to replace the health effects of this nutrient.”

Enter Eli Lilly, the makers of Prozac, who were treated to a cover story in the March 26, 1990, edition of Newsweek magazine, “Prozac: A Breakthrough Drug for Depression,” which came out, coincidentally, only three days after the first expanded FDA recall of all marketed L-tryptophan supplements. Prozac quickly became the drug maker’s fastest rising star in 1989, contributing to windfall company profits of 22.5 percent on overall drug sales of $4.18 billion that year.

A DalĂ­-esque Regulatory Limbo
Despite the fact that U.S.-manufactured L-tryptophan has actually been continually available for sale, statements and testimony by FDA injected confusion early on into the then already unclear regulatory status of this supplement.

In fact, on July 18, 1991, Douglas Archer, Ph.D., then deputy director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said, in testimony before the House of Representatives: “These approved uses [medical and infant formula applications], however, do not allow marketing of LT as a component of a dietary supplement.”

That’s interesting since, in a letter to me dated October 24, FDA spokesperson Arthur Whitmore, who’s with FDA’s office of food safety, defense and outreach wrote, quite clearly: “The agency has not concluded that any particular product is adulterated under the Act; therefore the FDA has taken no steps to limit the availability of dietary supplements containing L-tryptophan produced in the U.S.”

He added: “While we are unaware of conclusive scientific data that would establish that dietary supplement L-tryptophan would be safe, if a firm has information that it believes establishes that a product containing L-tryptophan is safe within the meaning of the Act, it could market such a product as a dietary supplement.”

“In light of the above,” concluded Whitmore, “Import Alert #54-04 was cancelled on April 29, 2005, which means that L-tryptophan intended for use in dietary supplements may be imported into the United States.”

Not only have retailers, manufacturers and suppliers been confused about L-tryptophan’s status, but so has Showa Denko K.K., which discontinued manufacturing and sale of L-tryptophan immediately after the 1989 outbreak. An October 20 note from Sara D. Schotland, of Washington, DC law firm, Cleary Gottlieb Steen & Hamilton LLP—which represents Showa Denko K.K.—noted: “we assume the ban on LT remains in effect.”

“You know, FDA never banned it as such, though several states did,” said Robert Ullman, partner at New York City-based Ullman, Shapiro and Ullman. “Even now, FDA won’t concede that the problem was solely that of a particular manufacturer’s product. At the time, the scope of the liability claims and what would have then been inescapable bad press associated with any attempt to market fully tested product were more than any company was willing to take on.”

A Favored Son of Holistic Practitioners
After the health crisis caused by the bad batch (or batches) from Japan, L-tryptophan stayed on as a continued favorite modality of practitioners and other health providers. It was a supplement that began to occupy a nebulous channel available to health practitioners via a network of progressive (and in many cases courageous) compounding pharmacists.

Julia Ross, M.A., founder of The Recovery Systems Clinic in Mill Valley, CA, and author of The Mood Cure (2002/2003), remembers it this way: “We began using L-tryptophan in 1994, when the compounding pharmacists defied the ban and began supplying it by prescription. We’ve seen over 3,000 clients since then, and a third of whom have used L-tryptophan with benefit.”

Daniel S. Smith, D.C., is the founder of the Alamo Chiropractic Healing Center in Alamo, CA, and president of Genesa Inc., a specialty manufacturer of the Total Amino Solution™ product which includes L-tryptophan and was, according to Smith, just picked up by Whole Foods Market in September.

A big believer in L-tryptophan, Smith said: “At the time L-tryptophan was taken off the market in 1989 I was not using nutritional support in my chiropractic office. The exciting thing, for me, was in 1999, when I discovered the effects of L-tryptophan in myself and my patients, this opened the door for me to really understand the importance of nutritional support as a primary recommendation in my chiropractic service.”

What About L-Tryptophan Today?
“The story of L-tryptophan,” said Marc Ullman, partner at New York City-based Ullman, Shapiro and Ullman, “is a story of the disappearance (and re-appearance) of a beneficial, well-liked ingredient from the marketplace due to a combination of regulatory concerns and marketplace overreaction.”

Marc Ullman added: “It’s a marketplace decision to undertake, or not undertake, the necessary effort to rehabilitate an ingredient, or product, in consumers’ minds.”

That being said, L-tryptophan products are once again being sold as dietary supplements in the U.S.; it seems that they have been rediscovered.

Source Naturals (Scotts Valley, CA) uses FTH Nutraceuticals’ raw ingredient L-tryptophan for its L-tryptophan dietary supplement. In addition, San Clemente, CA-based Doctor’s Best has recently come out with its Best Tryptophan with vitamin B6 & niacinamide. There are also a variety of online sources with product of, in some cases, unclear sourcing provenance, that are best for retailers to avoid.

What is L-tryptophan used for today? “L-tryptophan is commonly used for mood elevation; nervousness, premenstrual syndrome (PMS), jet lag, depression, chemical withdrawal and dieting (since it helps to reduce carbohydrate cravings),” added FTH’s Bass. “What most people don’t realize is that even during the time that it was not available (due to the one bad batch from Japan) it was still added to all baby formula manufactured in the U.S.”

“As consumers become educated about the importance of L-tryptophan and its vital role as it relates to the neurotransmitter, serotonin, I believe that they will want to use it daily as part of their wellness supplementation,” added Dr. Smith.

“The demand for L-tryptophan is increasing dramatically,” observed Bass, “which is one reason why we’re happy to be the largest distributor of L-tryptophan in the U.S.”

[Adapted from an article by James Gormley that was originally published in Vitamin Retailer magazine in December 2006]
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