FDA Detects Recent Impurities in 5-Hydroxy-L-Tryptophan Supplemen ts

[Kuester, Sarah]

Please pardon my cross-posting.

Hello.  Below is an FDA talk paper regarding the recent
detection of impurities in some 5-hydroxy-L-tryptophan 
dietary supplements.

Thank you,
Sarah Kuester
Public Health Nutritionist
Centers for Disease Control and Prevention
sak2 at cdc.gov
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Source: HTTP://www.fda.gov/bbs/topics/ANSWERS/ANS00891.html

FDA TALK PAPER 

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857 

FDA Talk Papers are prepared by the Press Office to guide FDA 
personnel in responding with consistency and accuracy to questions 
from the public on subjects of current interest. Talk Papers are subject 
to change as more information becomes available. 


T98-48                        Print Media:         301-827-6242
August 31, 1998               Broadcast Media:     301-827-3434
                              Consumer Inquiries:  800-532-4440

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 
remain 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.

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