- For Immediate Release:
A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in a consent decree.
The U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction with Riddhi USA, Inc. and Mohd M. Alam, president and owner of Riddhi USA, Inc., for selling adulterated and misbranded dietary supplements. The permanent injunction requires the defendants to cease directly or indirectly manufacturing or distributing dietary supplements.
“Dietary supplement companies put the public’s health at risk when they repeatedly fail to follow good manufacturing practice regulations and omit required information about the product in their labeling,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will continue to take action to protect the American public when companies violate the law.”
Riddhi USA is a manufacturer that distributes dietary supplements wholesale. It does not market or advertise under its own brand. According to the complaint filed with the consent decree, the company violated the Federal Food, Drug, and Cosmetic Act because their products were prepared, packed or held in violation of current good manufacturing practice regulations (cGMP). The violations included failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplements; inadequate master manufacturing and batch production records; lack of quality control procedures; and lack of procedures to investigate product complaints. Additionally, the products’ labeling failed to declare dietary ingredients, allergens and the manufacturer’s place of business.
In 2016, the FDA issued a warning letter to Riddhi USA after a facility inspection identified violations of good manufacturing practice regulations and for failing to declare all ingredients on the products’ labels.
Riddhi USA is not currently manufacturing any dietary supplements. Should they wish to begin manufacturing again, the consent decree prohibits Riddhi USA from receiving, processing, manufacturing, preparing, packing, holding and distributing dietary supplements until they hire an expert to ensure that they are following all cGMP regulations and following an inspection, receive FDA approval to resume operations.
The U.S. Department of Justice filed the complaint on behalf of the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also 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.
- Stephanie Caccomo