SILVER SPRING, Md., June 14, 2019 /PRNewswire/ -- At the request of the U.S. Food and Drug Administration, U.S. Marshals seized more than 300,000 containers of dietary supplements, including tablets, capsules, and teas from Life Rising Corporation. The seized goods, which were held by Life Rising or manufactured in the company's facility located in Willowbrook, Ill., consisted of more than 500 products bearing brand names Life Rising, Holicare, or HopeStream, and are valued at approximately $3.5 million. The U.S. 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."
The FDA inspection at Life Rising found that its dietary supplements were prepared, packed, and/or held under conditions that violated CGMP regulations. 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. Based on these CGMP violations, last month, the FDA issued an Administrative Detention Order to prevent these products from reaching consumers until they could be seized.
Last month, the FDA also 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. These products were recalled by the company on May 2, just before the FDA's safety alert. Lead exposure is extremely dangerous and can cause extensive damage to the nervous system and internal organs.
In 2016, Life Rising recalled certain dietary supplement products because of elevated lead levels, and in May 2017, the agency issued a warning letter to Life Rising citing CGMP violations. This action stems from a follow up inspection the FDA conducted to evaluate the company's CGMP compliance. In light of the recalls and safety alerts, as well as the continuing violations of CGMP, the FDA discourages consumers from purchasing or using dietary supplement products bearing brand names Life Rising, Holicare, or HopeStream.
Consumers and health care professionals should report any adverse events related to products from Life Rising to the FDA's MedWatch program by:
downloading the form, completing it and then faxing it to 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.