FDA Cites Poor Manufacturing Processes in Supplements Seizure
“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, FDA’s associate commissioner for Regulatory Affairs.
The U.S. Food and Drug Administration recently announced that at its request, 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 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 requirements, FDA reported.
“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, 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 agency reported that its inspection at Life Rising 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. 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, FDA reported. Based on these CGMP violations, FDA issued an Administrative Detention Order to prevent the products from reaching consumers until they could be seized.
In May 2019, 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 tablets) because those products may be contaminated with lead. These products were recalled by the company on May 2, a day before the safety alert was issued.