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FDA NEWS RELEASE

For Immediate Release: May 1, 2010

Update: On May 24, 2010, the FDA announced that agency test results confirmed the presence of lead in Vita Breath samples at more than 500 parts per million. American Herbal Lab Inc. of Rosemead, Calif., is recalling Vita Breath, a dietary supplement that is marketed at health fairs and on the Internet. (Updated May 24, 2010.)

Media Inquiries: Pat El-Hinnawy, 301-796-4763 or 202-557-6531, patricia.el-hinnawy@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers to Avoid Vita Breath Dietary Supplement
Products may contain high levels of lead

The U.S. Food and Drug Administration is advising consumers not to purchase nor consume Vita Breath, a dietary supplement manufactured by American Herbal Lab Inc. of Rosemead, Calif., and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead.

The FDA was notified by the New York City Department of Health and Mental Hygiene about a patient with lead poisoning who reported taking Vita Breath and two other herbal products. The department analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.

The FDA has collected and is currently analyzing its own samples of Vita Breath.

People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing, and individuals who have taken Vita Breath should talk to their health care providers about testing.

The FDA is working with state officials in New York and California to further investigate Vita Breath.


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