Posted 05/03/2010] FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene 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.
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.
The FDA is working with state officials in New York and California to further investigate Vita Breath. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Online: www.fda.gov/MedWatch/report.htm1
* Phone: 1-800-332-1088
* Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms2" page, to address on the pre-addressed form
* Fax: 1-800-FDA-0178