Supplement manufacturer avoids recall
A New York-based manufacturer of dietary supplements was recently ordered to shut down its operations for violating FDA regulations, but it avoided a worse fate.
Editor’s note: This is part two of a series of articles examining a lawsuit against a manufacturer of dietary supplements for cGMP violations. Read part one here.
A contract manufacturer of dietary supplements ordered to cease operations for violations of cGMPs (current good manufacturing practices) cautioned a judge that a mandatory recall of all its products would have cost the company millions of dollars and put it out of business permanently.
On March 3, U.S. District Judge Edward R. Korman entered an order of permanent injunction against Confidence USA Inc. and its two executives, Helen Chian and Jim Chao. The order prohibited the defendants from manufacturing supplements until they meet several conditions in the injunction related to cGMPs and get permission from FDA to resume operations.
The outcome could have been much worse for Confidence, a supplement manufacturer in Port Washington, N.Y., sued in 2019 by the U.S. Department of Justice (DOJ).
Government lawyers proposed an injunction order that would have required the company to recall and destroy all supplements prepared, packed, repacked, labeled, held or distributed after March 23, 2016. (During a recent hearing, the government later amended its request to apply to supplements prepared, held or distributed after February 2018).
Korman denied the government’s request to order a recall and destruction of Confidence’s products over the last three years. Such an order was unnecessary to protect the public health, and other provisions of the government’s proposed injunction were adequate to ensure the manufacturer’s compliance with the Federal Food, Drug and Cosmetic Act (FD&C) in the future, the judge reasoned.
Korman pointed to the three-year shelf life of the company’s dietary supplements and fact that Confidence had produced its products starting in 2018 under the guidance of a regulatory consulting firm, REJIMUS, and its chief operating officer, Jim Lassiter.
During a Feb. 17 court hearing, Lassiter testified that since 2018, his firm had helped Confidence revise its operating procedures.