01.02.20
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, NY, and their owner, Mohammed Jahirul Islam of Flushing, NY, from distributing adulterated and misbranded dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
The injunction requires ABH and Islam to destroy 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.
Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division said the injunction reflects the Department of Justice’s commitment to protect consumers from adulterated and misbranded dietary supplements. "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."
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 injunction requires ABH and Islam to destroy 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.
Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division said the injunction reflects the Department of Justice’s commitment to protect consumers from adulterated and misbranded dietary supplements. "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."
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.
