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Case Number: 19-CV-6589
Judge: LaShann DeArcy Hall
Court: United States District Court for the Eastern District of New York (King County)
Plaintiff's Attorney: Evan Lestelle, Joshua Fowkes and William Thanhauser
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Description: Brooklyn, NY - The United States of America charged ABH Nature's Products, Inc., ABH Pharma, Inc., StockNutra.com; and Mohammed Jahirul Islam with distributing adulterated and misbranded dietary supplements and unapproved and misbranded drugs.
The United States District Court for the Eastern District of New York has entered a consent decree barring three corporations, ABH Nature’s Products, Inc., ABH Pharma, Inc., and StockNutra.com, Inc. (together, “ABH”), each of Edgewood, New York, and their owner, Mohammed Jahirul Islam (“Islam”), from distributing adulterated and misbranded dietary supplements and unapproved and misbranded drugs, and requiring them to take remedial action.
The consent decree approved by United States District Judge LaShann DeArcy Hall requires ABH and Islam to destroy, within 15 days, all dietary supplements and drugs in their possession, custody or control. The injunction also requires ABH and Islam 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 ABH’s facility, and requiring the expert to certify that defendants are complying with current good manufacturing practices.
The consent decree resolves a suit filed on November 21, 2019, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, ABH and Islam manufactured, prepared, labeled, packed, held and/or distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations.
“As demonstrated by the consent decree, this Office and the FDA will work tirelessly to protect consumers who take dietary supplements, ensuring that manufacturers comply with good manufacturing practices and do not distribute unapproved and misbranded drugs in violation of the Food, Drug, and Cosmetic Act,” stated U.S. Attorney for the Eastern District of New York Richard P. Donoghue.
“Today’s injunction reflects the Department of Justice’s commitment to protect consumers from adulterated and misbranded dietary supplements,” stated Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice will work with the FDA to ensure that dietary supplements are manufactured according to food safety laws and accurately describe their ingredients.”
“Manufacturers of products labeled as dietary supplements have an obligation to evaluate the safety and labeling to ensure their products are manufactured correctly to meet all federal requirements and are not misleading to consumers,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs. “Americans expect and deserve products that meet appropriate standards, and the FDA remains committed to taking action against companies and owners who place the health of American consumers at risk.”
According to the complaint, the FDA documented numerous significant deviations from current good manufacturing practice regulations during at least six inspections of ABH’s facilities conducted over the past several years, including failures to: conduct at least one appropriate test to verify the identity of a dietary ingredient; verify that finished batches of dietary supplements meet product specifications for identity, purity, strength and composition; include required information in batch production records; and properly review and investigate a consumer complaint.
In addition, the complaint alleged that ABH and Islam further violated the federal Food, Drug, and Cosmetic Act by distributing unapproved and misbranded “new drugs” into interstate commerce. For instance, as alleged in the complaint, ABH made claims on product labeling that such products could be used to treat such medical conditions as cancer, heart disease, HIV and AIDS, even though the FDA had not approved those products for such purported uses, nor were there any published adequate and well-controlled investigations showing that such products are generally recognized as safe and effective for any use.
ABH and Islam agreed to resolve the complaint and be bound by the consent decree of permanent injunction.
ABH NATURE’S PRODUCTS, INC.
Edgewood, New York
ABH PHARMA, INC.
Edgewood, New York
Edgewood, New York
MOHAMMED JAHIRUL ISLAM
Outcome: CONSENT DECREE of Permanent Injunction: it is HEREBY ORDERED, ADJUDGED, AND DECREED as follows that, pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the "Act") and the inherent power of this Court: This Court has jurisdiction over the subject matter and all parties to this action pursuant to 21 U.S.C. § 332 and its inherent equitable authority, and has personal jurisdiction over all parties to this action. (See attachment for details). Ordered by Judge LaShann DeArcy Hall on 12/20/2019. (Ramesar, Thameera) (Entered: 12/23/2019)