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Vita Breath Dietary Supplement - May Contain Hazardous Lead Concentrationsmer Healthcarens and New Medication Guide Requirement UPDATE

May 3, 2010

FDA is warning consumers against purchasing or consuming Vita Breath due to potentially toxic lead concentrations contained in the product. Vita Breath is a dietary supplement manufactured by American Herbal Lab Inc. in California. Vita Breath was analyzed by the New York City Department of Health and Mental Hygiene after a patient taking Vita Breath developed lead poisoning. The sample of Vita Breath contained 1,100 parts per million of lead, which is significantly above the maximum FDA recommendation for lead in candy. High concentrations of lead in the blood may damage the nervous system and other organs. Patients may be asymptomatic or have symptoms including abdominal pain, nausea or vomiting, diarrhea, weakness, blood in the urine, or decreased urine output.

Consumers taking Vita Breath should discontinue the supplement immediately and consult their healthcare provider about testing for lead poisoning. Children are especially at risk for lead toxicity. Report adverse events related to this product to the MedWatch program. FDA will continue to work with state officials to further investigate Vita Breath.

Additional information is available at the following links:

Updated
May 3, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.