FDA Investigates Elevated Lead Levels Linked to Ton Shen Health/Life Rising Dietary Supplements
November 10, 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, the Cook County Department of Health (IL), and the City of Chicago 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, BRAIN-ECM capsules that have been collected and removed from the market or recalled Side Head Regulator TT tablets because they have been found to contain high levels of lead.
- The FDA, the Cook County Department of Health, and the City of Chicago are investigating a cluster of five adverse events possibly associated with Life Rising dietary supplements from Ton Shen Health/Life Rising. Three adverse event reports involve children who may have consumed DHZC-2 tablets.
- Ton Shen Health/Life Rising expanded its August 11, 2016 recall to include all lots of DHZC-2 tablets. On September 15, 2016, the firm agreed to collect and remove BRAIN-ECM capsules from the market. After further testing, on November 7, 2016 the firm recalled all lots of Side Head Regulator TT. The investigation is ongoing.
What is the Problem and What is Being Done About It?
The U.S. Food and Drug Administration, the Cook County Department of Public Health and the City of Chicago Department of Public Health are investigating Life Rising dietary supplements from Ton Shen Health/Life Rising due to elevated lead levels found in some of its dietary supplement products.
Three adverse event reports involve children who may have consumed DHZC-2. All three reports involve children with elevated lead level test results based on blood samples from the children.
The FDA collected product samples at the Ton Shen Health/Life Rising location in response to an initial adverse event report submitted to the agency. FDA analysis confirmed that DHZC-2 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). Stated simply, the PTTDI is the scientifically-established level of a substance (such as lead) that a particular group (such as children) can tolerate before facing health risks.
After being notified that FDA’s analysis found elevated lead levels in the product samples from one lot of DHZC-2 Tablets, Ton Shen Health/Life Rising recalled that lot of DHZC-2 Tablets on August 11, 2016.
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.
Since August 26, 2016, the FDA has learned of a total of five adverse events possibly associated with the consumption of DHZC-2 tablets. These events were reported during FDA’s continued assessment to determine whether the company’s recall of DHZC-2 Tablets was effective.
On September 15, 2016, the firm agreed to collect and remove BRAIN-ECM capsules following positive test results for elevated lead levels in this product.
After further testing, on November 7, 2016 the firm recalled all lots of Side Head Regulator TT. The investigation is ongoing.
Ton Shen Health has stopped distribution and sale of Life Rising products pending results of the firm’s investigation.
The DHZC-2 tablets are sold in a 1.6 ounce, white plastic package. The UPC code 616042102727 can be found on all recalled DHZC-2 bottles. The Side Head Regulator TT tablets come in a 1.6 ounce, white plastic package marked with lot # on the bottom. UPC: 616042101010. The products were sold nationwide in stores and online. The investigation is ongoing and the FDA will provide updated information as it becomes available.
What is Lead?
Lead is a toxic substance present in our environment in small amounts; 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 can cause:
- 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 one lot of DHZC-2 tablets after FDA identified elevated lead levels in product samples.
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 product comes in a 1.6 ounce, white plastic package. The UPC code: 616042102727 can be found on all recalled DHZC-2 bottles. The DHZC-2 tablets were sold nationwide in stores and online.
After further testing, on November 7, 2016 the firm recalled all lots of Side Head Regulator TT. The Side Head Regulator TT tablets come in a 1.6 ounce, white plastic package marked with lot # on the bottom. UPC: 616042101010. The products were sold nationwide in stores and online.
Life Rising Corporation collected and removed BRAIN-ECM, instead of a formal recall, because the product was manufactured for acupuncturist offices associated with the firm’s company and was not distributed to wholesalers for general public purchase.
What Do Retailers Need To Do?
Retailers should contact any customers who bought Life Rising brand DHZC-2 tablets, BRAIN-ECM capsules or The Side Head Regulator TT from Ton Shen Health/Life Rising because these products have been found to contain high levels of lead.
What Do Consumers Need To Do?
Consumers should not purchase or consume Life Rising brand DHZC-2 tablets, BRAIN-ECM capsules or The Side Head Regulator TT from Ton Shen Health/Life Rising because these products have been found to contain high levels of lead.
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.