A federal court enjoined 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 Department of Justice announced.
The injunction ordered by the U.S. District Court for the Eastern District of New York requires Riddhi and Alam to destroy, within 15 days, all dietary supplements that are in their possession, custody, or control. The injunction also orders Riddhi and Alam to implement various 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 requires the expert to certify that all current good manufacturing practice deviations brought to defendants’ attention have been corrected.
The injunction stems from a complaint the Department filed on Oct. 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.
“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 Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with FDA to ensure that dietary supplement manufacturers provide accurate information about what is in their products.”
“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.”
According to the filed 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 deviations in current good manufacturing practice.
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, defendants’ products are fabricated from two or more ingredients but fail to declare 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.
The defendants agreed to resolve the complaint and be bound by a consent decree of permanent injunction. The district court adopted the resolution and entered a permanent injunction against Riddhi and Alam.
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.