The U.S. Food and Drug Administration (FDA) is warning consumers not to purchase or consume Vita Breath, a dietary supplement manufactured by American Herbal Lab Inc. of Rosemead, Calif.
The agency says the product, marketed at health fairs and on the Internet for treatment of breathing ailments, 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.
New York authorities 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 said it 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 said it is working with state officials in New York and California to further investigate Vita Breath.