The Food and Drug Administration is investigating cases of high lead levels — including two possible fatalities — that may be associated with a recalled Chinese herbal supplement sold by Chicago-based Ton Shen Health.
All bottles of the company’s Life Rising DHZC-2 tablets were recalled last week after the FDA identified elevated levels of lead in product samples. The company, headquartered near Chicago’s Chinatown neighborhood, also agreed to place a hold on distributing all other Life Rising brand supplements during the investigation.
The Cook County Department of Health first notified the FDA in April of one child with elevated lead levels who “may have consumed” the dietary supplement, according to the agency. After conducting product testing, the FDA worked with Ton Shen to implement a limited recall on Aug 11.
Subsequently, the FDA learned of another child with elevated lead levels and two reported deaths of people who took the supplement. An investigation into the cause of death and any link to the consumption of the recalled product is ongoing, the agency said Monday.
On Aug. 25, after a call with the FDA, Ton Shen Health/Life Rising expanded the recall to include all lots of DHZC-2 tablets and agreed to stop selling other Life Rising dietary supplement products.
The Life Rising products were mostly sold at Chicago-area stores and online. The FDA collected samples at a Ton Shen Health/Life Rising retail location after the initial report and found the product contained 56 times the amount of lead that would pose a health risk for children.
Lead poisoning in children has been linked to learning disabilities, developmental delays and lower IQ scores, according to the FDA.
Ton Shen Health and the Life Rising brand were established in 1985 by Zhengang Guo, a “master herbalist and acupuncturist,” according to the company’s website. In addition to the Chicago office, there are satellite clinics in Northbrook and Westmont.
The company did not respond to multiple requests for comment Monday.
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