The United States District Court for the Eastern District of New York entered a consent decree today barring Riddhi USA Inc., of Ronkonoma, New York, and its owner, Mohd M. Alam, from distributing adulterated and misbranded dietary supplements pending required remedial action.
The consent decree approved by the U.S. District Judge Leonard D. Wexler requires Riddhi and Alam to destroy, within 15 days, all dietary supplements in their possession, custody or control. The injunction also requires Riddhi and Alam to implement consumer safety measures before resuming the manufacturing or distributing of dietary supplements. This includes hiring an independent expert to perform a comprehensive inspection of Riddhi's facility and requiring the expert to certify that defendants are complying with current good manufacturing practice.
The consent decree resolves a suit filed on October 23, 2017, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, Riddhi and Alam manufactured, prepared, labeled, packed, held and distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations.
"Today's consent decree shows that we will make every effort to ensure that dietary supplement manufacturers comply with good manufacturing practices," stated U.S. Attorney for the Eastern District of New York Richard Donoghue. "This Office is committed to safeguarding consumers from adulterated and misbranded dietary supplements."
"The injunction entered today demonstrates the Department of Justice's continuing efforts to protect consumers from adulterated and misbranded dietary supplements," said Acting Assistant Attorney General for the Justice Department's Civil Division Chad A. Readler. "The Department of Justice will continue to work with the FDA to ensure that dietary supplement manufacturers provide accurate information about what is in their products."
According to the complaint, FDA documented numerous significant deviations from current Good Manufacturing Practice regulations during its 2017 inspection of Riddhi's facilities, including failures to: establish product specifications for identity, purity, strength, and composition of their finished dietary supplements; conduct at least one appropriate test to verify the identity of a dietary ingredient; and establish and follow written procedures for quality control operations. The complaint alleged that an FDA inspection ending in early 2016 found similar violations.
In addition, the complaint alleged that Riddhi and Alam misbranded their dietary supplements by failing to comply with certain labeling requirements in the federal Food, Drug, and Cosmetic Act. For example, as noted in the complaint, the defendants' products are fabricated from two or more ingredients but fail to list any ingredients on their product labels or labeling. The complaint also alleged that some of the defendants' products, including Prenatal Formula, Osteo Gest, Neuroxygen, Inflam-Ease and All-Ease, are misbranded because the products' label or labeling failed to declare the place of business of the manufacturer, packer or distributor.
Riddhi and Alam agreed to resolve the complaint and be bound by the consent decree permanent injunction.
The government is represented by Trial Attorney Monica Groat of the Civil Division's Consumer Protection Branch and Assistant U.S. Attorney Edwin Cortes of the U.S. Attorney's Office for the Eastern District of New York, with the assistance of Associate General Counsel for Enforcement Roselle Oberstein of the Department of Health and Human Services' Office of General Counsel's Food and Drug Division.