U.S. Marshals seized more than 300,000 containers of dietary supplements from Life Rising Corporation in June 2019 at the request of the FDA. The seized goods included tablets, capsules, and teas. The brand names for some of the 500 products are Life Rising, Holicare, or HopeStream.
The U.S. District Court for the Northern District of Illinois found that 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,” according to the FDA news release. The FDA issued an Administrative Detention Order in May 2019 to prevent these products from reaching consumers until they could be seized based on these violations.
Melinda K. Plaisier, the FDA’s Associate Commissioner for Regulatory Affairs said in a statement, “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. 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 found that 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.” In addition, there were no written procedures for pest control and for maintaining, cleaning, and sanitizing equipment and/or surfaces that come into contact with the supplements.
A safety alert was issued by the FDA for three Life-Rising products in May 2019 for possible lead contamination. Those products are Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets. Another recall was issued by the company for certain dietary supplement products in 2016 for elevated lead levels. In May 2017, the FDA issued a warning letter to Life Rising, citing CGMP violations.
