The U.S. Justice Department announced Monday that the government filed a complaint in Eastern New York federal court against Ronkonkoma, N.Y.-based Riddhi USA Inc. and its owner Mohd M. Alam.
An inspection of Riddhi’s facility in January by the Food and Drug Administration found “significant deviations from current good manufacturing practice regulations,” the Justice Department claims, including a failure to establish product specifications for identity, purity, strength and composition.
Riddhi and Alam are also accused of failing to verify the identity of a dietary ingredient and not having adequate quality-control operations.
They also allegedly misbranded their dietary supplements by not complying with labeling requirements outlined in the Food, Drug, and Cosmetic Act.
For example, the label for Riddhi’s Neuroxygen supplement does not disclose that the product contains soy, according to the Justice Department.
Other Riddhi products allegedly fail to declare any ingredients on their labels.
Alam denied the allegations on Monday and said most Riddhi products are not subject to federal law because they are sold outside the United States.
Bridget M. Rohde, acting U.S. attorney for the Eastern District of New York, said in a statement, “Dietary supplement manufacturers that do not comply with applicable laws and regulations designed to protect consumers put those consumers at risk.”
Acting Assistant Attorney General Chad A. Readler, head of the Justice Department’s Civil Division, added that his agency is “committed to ensuring that dietary supplement manufacturers comply with laws designed to protect consumers.”
“The Department of Justice will continue to work with the FDA to protect the public from adulterated and misbranded products, and to ensure that dietary supplement manufacturers provide accurate information about what is in their products,” Readler said.