"FDA Foodborne Illness Outbreak Investigation Update."  There is new information available on this topic at the URL below, and for your convenience the update is also provided below.

http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm518288.htm

FDA Investigates Elevated Lead Levels Linked to Ton Shen Health/Life Rising Dietary Supplements

August 26, 2016

On this page:

• Fast Facts
• What is the Problem and What is Being Done About It?
• What is Lead?
• What are the Symptoms of Lead Exposure?
• What Specific Products were Recalled?
• What Do Retailers Need To Do?
• What Do Consumers Need To Do?
• Who Should be Contacted? 

The U.S. Food and Drug Administration and the Cook County Department of Health (IL) are investigating elevated lead levels linked to Life Rising dietary supplements produced by Ton Shen Health/Life Rising.

Fast Facts

• Consumers should not purchase or consume recalled Life Rising brand dietary supplement product DHZC-2 tablets because they have been found to contain high levels of lead. FDA is investigating the DHZC-2 tablets for lead and other hazardous material and is also investigating to see if other Life Rising products from this company may be similarly affected. Consumers should not purchase or consume these products out of an abundance of caution.
• The FDA and the Cook County Department of Health are investigating a cluster of four adverse events associated with Life Rising dietary supplements from Ton Shen Health/Life Rising. FDA was informed by the Cook County Department of Health of two children with elevated lead levels who may have consumed the recalled dietary supplement. In addition, FDA is also investigating reports of two fatalities of individuals who consumed this product.
• After speaking with the FDA on August 25, 2016, Ton Shen Health/Life Rising agreed to expand its August 11, 2016 recall to include all lots of DHZC-2 tablets and cease distribution of all Life Rising products until September 1, 2016. FDA is reviewing regulatory options to remove all potentially unsafe Life Rising dietary supplement products from the market.

What is the Problem and What is Being Done About It?

The U.S. Food and Drug Administration and the Cook County Department of Health are investigating elevated lead levels linked to Life Rising dietary supplements from Ton Shen Health/Life Rising.

FDA was informed by the Cook County Department of Health of two children with elevated lead levels who may have consumed the recalled dietary supplement. In addition, FDA is also investigating reports of two fatalities of individuals who consumed this product. It is not clear if the deaths are associated with the product.

FDA collected product samples at the Ton Shen Health/Life Rising retail location in response to the initial adverse event report. FDA analysis confirmed that the samples contained 56 times the amount of lead above that which would pose a health risk for children according to the Provisional Total Tolerable Daily Intake (PTTDI). This finding prompted Ton Shen Health/Life Rising, on August 11, 2016, to initiate a recall of “DHZC-2” Tablets after FDA identified elevated levels of lead in product samples. The product comes in a 1.6 ounce, white plastic package marked with lot # 2163-844 on the bottom. The UPC code: 616042102727 can be found on all recalled DHZC-2 bottles. The products were mostly sold in the Chicago metropolitan area in stores and online.

During a FDA assessment of the effectiveness of the recall, the agency learned of additional adverse events linked to the consumption of the product. On August 25, 2016, following a call with the FDA, Ton Shen Health/Life Rising expanded their recall to include all lots of “DHZC-2” tablets and agreed to place a hold on the distribution of all other Life Rising dietary supplement products.  

FDA continues to investigate the DHZC-2 tablets for lead and other hazardous material and is also reviewing other Life Rising products at Ton Shen Health/Life Rising to see if they may be similarly affected. FDA will provide updated information as it becomes available.

What is Lead?

Lead is a toxic substance present in our environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water. In general, the small exposure to lead within the U.S. population does not pose a significant public health concern. However, exposure to larger amounts of lead can cause lead poisoning.

What are the Symptoms of Lead Exposure?

While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age. Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of lead that may not result in obvious symptoms of lead poisoning. A child with lead poisoning may not look or act sick.

Lead poisoning in children has been linked to:

• learning disabilities
• developmental delays
• lower IQ scores

What Specific Products were Recalled?

On August 11, 2016, Ton Shen Health/Life Rising initiated a recall of “DHZC-2” tablets after FDA identified elevated levels of lead in product samples. The product comes in a 1.6 ounce, white plastic package marked with lot # 2163-844 on the bottom. The UPC code: 616042102727 can be found on all recalled DHZC-2 bottles. The products were mostly sold in the Chicago metropolitan area in stores and online.

On August 25, 2016, following a call with the FDA, Ton Shen Health/Life Rising expanded its recall to include all lots of “DHZC-2” tablets. The UPC code: 616042102727 can be found on all recalled DHZC-2 bottles. Ton Shen Health/Life Rising also agreed to place a hold on the distribution of all other Life Rising brand dietary supplement products.

What Do Retailers Need To Do?

Retailers should not sell Life Rising brand dietary supplement products from Ton Shen Health/Life Rising. Retailers should contact any customers that have bought the recalled products in last 36 months and inform them of the recall. 

Retailers are encouraged to discontinue the sale of other Life Rising products from Ton Shen Health/Life Rising while the investigation is ongoing.  

What Do Consumers Need To Do?

Consumers should not purchase or consume recalled Life Rising brand dietary supplement DHZC-2 tablets from Ton Shen Health/Life Rising because they have been found to contain high levels of lead.

FDA is also investigating to see if other Life Rising products from this company may be similarly affected. Consumers should not purchase or consume these products out of an abundance of caution.

If you are unsure of your risk, ask your healthcare provider.

Who Should be Contacted?

Consumers with questions may contact the company at 1-312-842-2775, Monday to Friday, from 9:30AM to 5:00PM central standard time.

Contact your healthcare provider if you think you may have become ill from consuming the recalled tablets.

Health care professionals and consumers are encouraged to report any adverse events potentially related to the use of any Ton Shen Health/Life Rising brand products to FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.