Federal District Court Orders New York Company to Stop Distributing Adulterated and Misbranded Dietary Supplements
The U.S. District Court for the Eastern District of New York permanently enjoined ABH Nature’s Products, Inc., ABH Pharma, Inc., StockNutra.com, Inc. (together, "ABH"), each of Edgewood, New York, and their owner, Mohammed Jahirul Islam ("Islam") of Flushing, New York from distributing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act, the Department of Justice announced today.
The injunction requires ABH and Islam to destroy, within 15 days, dietary supplements that are in their possession, custody, or control. The injunction also orders ABH and Islam to implement several consumer safety measures before resuming the manufacturing or distributing of dietary supplements. Those measures include hiring an independent expert to inspect ABH’s facility and certify that the facility has corrected all deficiencies and implemented current good manufacturing practices. It also mandates that the defendants engage a labeling expert to review their product labeling and certify that claims on their products comply with the law.
"Today’s injunction reflects the Department of Justice’s commitment to protect consumers from adulterated and misbranded dietary supplements," said 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."
"As demonstrated by today’s 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," said U.S. Attorney for the Eastern District of New York Richard P. Donoghue.
"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."
The injunction stems from a complaint the Department filed on Nov. 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 distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations. In particular, the complaint alleged that the FDA had observed several critical deviations from current good manufacturing practice regulations during its inspections of ABH’s manufacturing facility, including failures to verify that certain dietary supplements met the product’s specifications for identity, purity, strength, and composition; to implement a production system that ensured the quality of the supplements; to include necessary information in its production records; and to 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.
The defendants agreed to resolve the complaint and be bound by a consent decree of permanent injunction. The court adopted the agreement and entered the injunction.
The government is represented by Trial Attorney Joshua Fowkes of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Evan Lestelle of the U.S. Attorney’s Office for the Eastern District of New York, with the assistance of William Thanhauser of the FDA’s Office of Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of New York, visit its website at https://www.justice.gov/usao-edny.