The Consumer Guide to L-5 HTP
In this guide... 5-hydroxy-L-tryptophan, or 5-HTP, is a naturally occurring brain chemical the body produces from tryptophan, an amino acid found in many foods. Supplemental 5-HTP boosts levels of serotonin, a body chemical that regulates mood, sleep, and other brain-related functions. Stress, poor eating habits, inactivity, and alcohol and caffeine can all diminish your body’s serotonin supply, and this can lead to depression, migraines, insomnia, obesity, chronic fatigue, or fibromyalgia.
Benefits and uses: Clinical trials have shown 5-HTP to be as or more effective than standard synthetic drugs for addressing conditions related to serotonin-deficiency. L-5-HTP appears to improve anxiety, depression, and obesity. According to noted author Michael Murray, N.D., "Numerous double-blind studies have shown 5-HTP to be as effective as antidepressant drugs, but it is better tolerated and is associated with fewer and much milder side effects." Safety: To date, there have been no confirmed reports of illness caused by 5-HTP. However, in August of 1998, Mayo Clinic researchers discovered, and FDA labs confirmed, the presence of an impurity in several products containing 5-HTP. It is not certain whether these impurities have any connection to illnesses linked to consumption of contaminated L-tryptophan products from Japan, in 1989. We urge you to read the following position papers before taking 5- HTP:
Benefits and Uses
Do Scientists Know How 5-HTP Works?
Safety
FDA Talk Paper
National Nutritional Foods Association (NNFA) Press Release
References
Browse Our Wide Selection of 5-HTP Products
1) FDA TALK PAPER: Food and Drug Administration, August 31, 1998
IMPURITIES CONFIRMED IN DIETARY SUPPLEMENT 5-HYDROXY-L-TRYPTOPHAN
FDA scientists have confirmed the presence of impurities in some 5-hydroxy-L-tryptophan (5HTP) products currently marketed and widely promoted as dietary supplements. These products are being used as aids for insomnia, depression, obesity, and in children with attention deficit disorder. FDA's analytical results are consistent with those obtained and published by researchers from the Mayo Clinic.
- One of these impurities is known as "peak X." Although the significance of finding "peak X" and other impurities in dietary supplements containing 5-HTP is unknown, past experiences with these products suggests vigilance is warranted. "Peak X" was identified in one case of the illness eosinophilia-myalgia syndrome (EMS) associated with 5HTP in 1991. Impurities similar to "peak X" were also found in L-tryptophan that was associated with a 1989 epidemic of EMS. 5HTP and L-tryptophan are related in that 5HTP is synthesized from L-Tryphophan in the body. The exact cause of the 1989 epidemic and of the case of EMS associated with 5HTP remains unclear.
- EMS is a serious systemic illness characterized by elevations of certain white blood cells and severe muscle pain. The Centers for Disease Control and Prevention (CDC) has identified more than 1,500 cases of EMS, including at least 38 deaths associated with the use of L-tryptophan. The medical literature reports approximately 10 previous cases of EMS worldwide associated with use of products containing 5HTP.
- Research has not resolved whether these EMS were caused by L-tryptophan or 5HTP, one or more impurities, or other factors. At this time, FDA is unaware of any recent illnesses associated with the 5HTP products being sold as dietary supplements. The widespread promotion and use of these products, however, began only recently.
- FDA is working closely with its colleagues at CDC and NIH to monitor the situation and is consulting with other professionals and patient groups. To assist in its monitoring efforts, FDA encourages consumers to contact FDA's MedWatch program by calling 1-800-FDA- 1088 to obtain information about how to report serious adverse events.
- Physicians and other health care practitioners are encouraged to report such adverse events to FDA's MedWatch program by phone (1- 800-FDA-1088), fax (1-800-FDA-0178) or mail (using postage-paid form) to FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.
T98-48 Print Media: 301-827-6242
August 31, 1998 Broadcast Media: 301-827-3434
Consumer Inquiries: 800-532-4440
According to the National Nutritional Foods Association (NNFA), a trade association for the natural products industry, the Mayo Clinic researchers’ letter to the scientific journal Nature Medicine, which prompted the FDA’s concern and independent testing of 5HTP, contains more speculation than fact.
"My concerns about this article are far greater than any concerns I have about the safety of 5-HTP," said Michael Q. Ford, NNFA's executive director. "Even a cursory review of this letter raises serious questions about the conclusions reached by the researchers and their impartiality. It's more politics than science."
Concerns raised by Ford include the following:
- "The article begins with an aggressive attack on the Dietary Supplement Health and Education Act (DSHEA) of 1994, showing the authors’ clear bias against the industry. The sensational nature of the article is revealed when the writers state that the deadly outbreak in the late 1980s of eosinophilia myalgia syndrome (EMS), due to contaminated L-tryptophan, typifies the dangers of dietary supplement usage. In fact, the safety record of dietary supplements is enviable when compared with that of heavily regulated prescription and over-the-counter medications.
- The authors state the purity of 5-HTP products is unknown. There are relatively few manufacturers of 5-HTP, which is extracted from the seed of the Griffonia tree. NNFA member suppliers would not accept any raw material, including 5-HTP, without first receiving a certificate of analysis from the supplier attesting to the products' purity.
- The authors cite two cases of EMS "associated" with 5-HTP use, "most recently" in 1991 (reported in 1994) and the other "as far back as 1980." They use data from the former as the benchmark against which to measure potential EMS risk in the current samples of 5-HTP. In fact, these two cases represent the only connections reported in the literature of a link between EMS and 5-HTP, and both are inconclusive. In the words of the authors of the 1994 article, "The role of 5-HTP in the eosinophilia of this patient is (thus) uncertain."
- The authors allege that they have discovered a chemical structure called "peak x," which represents contamination in 5-HTP and can cause EMS. To verify this, NNFA supplier members had various batches of 5-HTP tested by independent laboratories using the same methodology as the Mayo Clinic researchers. While these laboratories were able to identify a distinct peak, none has been able to replicate the Mayo Clinic's findings that this peak is the same or similar to the contaminant found in L-tryptophan.
- The authors concede that "one possible reason" no new cases of EMS-like symptoms have been reported in connection with 5-HTP is due to the low dosage recommendations on the label. Yet they state, "since the intake of supplements is not medically supervised," higher dosages are bound to be consumed. Unless one is a patient in a hospital under close supervision, it is highly unlikely that ingestion of any substance -- food, medication or supplements -- would ever be supervised by a medical professional.
- The authors quote, but do not identify, Richard Wurtman as saying 5-HTP is "another accident (epidemic) waiting to happen." Wurtman is a physician whose company, Interneuron Inc. holds the patent on Redux, a product banned by the FDA last year for causing heart defects. Redux is a serotonin generator; an effect 5-HTP has been reported to induce, raising serious questions about Wurtman's vested interests and bias.
- At the end of their letter, the authors thank several people and institutions, among them Dateline NBC "for supplying commercial preparations" of 5-HTP. It is incredible that an institution with the reputation of the Mayo Clinic would allow such a questionable procedure as obtaining samples from a television newsmagazine for use in testing. Ford said his own association employs the rigorous chain-of-custody procedure sanctioned by the Drug Enforcement Agency in testing commercial samples of member products. That a scientific institute would not use a similar protocol raises serious questions of ethics and bias."
"Clearly, all involved – the researchers, FDA, Dateline NBC and Wurtman -- had a vested interest in a negative outcome in testing 5- HTP," Ford said. "But in the end, any link between alleged contamination of 5-HTP and L-tryptophan remains unproven. This isn't good science and it certainly shouldn't be news."
References: Browse Our Wide Selection of 5-HTP Products
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