FDA seizes 300,000 products from manufacturer with history of lead contamination

19-Jun-2019 - Last updated on 19-Jun-2019 at 16:07 GMT

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The US Food and Drug Administration has seized $3.5 million worth of adulterated dietary supplements from a manufacturer in Illinois.

The action, which was announced late last week, was taken against Life Rising Corporation. FDA said The seized goods included tablets, capsules and teas manufactured or held by Life Rising at the company’s facility in Willowbrook, IL.

Seizure follows detention order

The seizure is a follow on action to an administrative detention order issued in May. The seizure consisted of more than 300,000 containers with products that bore the brand names Life Rising, HoliCare or Hope Stream.

The US District Court for the Northern District of Illinois determined there was probable cause that the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements.

"This seizure underscores the agency's commitment to taking aggressive action when manufacturers distribute adulterated dietary supplements that have the potential to put consumers at risk," said Melinda K. Plaisier, the FDA's Associate Commissioner for Regulatory Affairs. "The FDA has a variety of enforcement tools at its disposal, and when products don't comply with FDA regulations, we will not hesitate to take appropriate action."

An FDA inspection at Life Rising found that its dietary supplements were prepared, packed, and/or held under conditions that violated CGMP regulations. The agency said that among other observed deficiencies, the company failed to establish product specifications for the identity, purity, strength, and composition of each finished batch of dietary supplement, and for limits on certain types of contamination, to ensure the quality of the supplement. The company also lacked written procedures for pest control and for maintaining, cleaning, and sanitizing equipment and/or surfaces that came in contact with the dietary supplements, among other violations. After the inspection, FDA issued the detention order.

Ongoing lead contamination issue

But among the company’s GMP failures the issue that led to the seizure was an ongoing problem with lead contamination that dates to at least mid 2016. On May 3, FDA had issued a safety alert for three Life Rising products (Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets) because those products may be contaminated with lead.

The products were sold mostly at HoliCare clinics in the Chicago area and a limited amount by mail order. Life Rising had issued a recall on the products the previous day. Lead contamination is a serious public health issue. Lead poisoning is primarily a danger to children and developing fetuses but is also dangerous for adults and can lead to joint and muscle pain, high blood pressure, cognitive difficulties as well as other symptoms.

Life Rising also recalled products in 2016 because of possible lead contamination. In May 2017 FDA issued a warning letter to the company citing GMP violations. That letter also mentioned the lead contamination issue and included the following phrase: “Please continue provide this office with the status of your activities of this on-going recall and any action plan you have to prevent this from reoccurring.”