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US officials seize $3.5 million worth of supplements due to regulatory violations

2019-08-09 11:45 Friday


U.S. Marshals have seized more than 300,000 containers of controversial dietary supplements, including tablets, capsules, and teas, from a local distributor, at the request of the U.S. Food and Drug Administration (FDA) for failing to follow regulatory standards over packaging and storage.

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The goods seized were being held by Life Rising Corporation or manufactured in the company's facility located in Willowbrook, Illinois. The move comes just weeks after the firm was the subject of a consumer product scare over possible lead contamination.

The latest haul consisted of more than 500 products bearing the brand names Life Rising, Holicare or HopeStream. In total, they are valued at around US$3.5 million.

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

“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 Plaisier, the Associate Commissioner for Regulatory Affairs at the FDA.

“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,” she added.

The FDA inspection found that the dietary supplements were prepared, packed or held under conditions that violated CGMP regulations. Among other observed deficiencies, the company failed to establish the identity, strength, purity and composition of each batch.

The company also lacked annotated procedures for pest control and for maintaining, cleaning, and sanitizing equipment or surfaces that came in contact with the product, according to officials. Based on these violations, last month, the authority issued an Administrative Detention Order to prevent such products from reaching members of the public until they could be seized and taken away.

Last month, the FDA also issued an alert on the safety of 3 Life Rising products because it was feared they may be contaminated with lead. The products were recalled by the company in May, just before the safety alert. Lead exposure is highly dangerous and can cause large-scale damage to the nervous system and internal organs.

Three years ago, Life Rising recalled a number of dietary supplement products because of elevated lead levels, and in 2017, the agency issued a warning letter citing CGMP violations. The FDA said it would discourage consumers from purchasing or using dietary supplement products bearing the company's brand names.

The FDA is an agency within the U.S. Department of Health and Human Services. It aims to protect public health in the States by assuring the safety, effectiveness, and security of drugs, vaccines and other biological products for human use, as well as medical devices. The agency also is responsible for national food supply, cosmetics and dietary supplement safety.

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