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Posted December 27, 2019

Federal Court Shuts Down Three Supplement Companies With Serious Manufacturing Violations

Update: (1/23/20) ABH has issued a recall of all its products, which are sold under various brand names by over 800 distributors and retailers. More details are available in CL's post about this recall. 

On December 26, 2019, the U.S. District Court for the Eastern District of New York ordered supplement manufacturers ABH Nature's Products, Inc., ABH Pharma, Inc., and StockNutra.com, Inc. (collectively known as ABH) and their owner, Mohammed Jahirul Islam, to stop distributing their products and destroy any products still in their possession. The decision follows a complaint filed by the FDA that charged the companies of serious manufacturing violations, including failure to verify that certain dietary supplements met product specifications for identity, purity, strength, and composition and failure to implement a production system that ensured the quality of supplements. The FDA also found that some of the companies' products were misbranded as "new drugs" because their labels indicated they could treat medical conditions such as cancer and heart disease. 

The court injunction bars the companies and their owner from manufacturing or distributing supplements until certain steps are taken, including hiring an independent expert to inspect facilities and certify that all current good manufacturing practices (cGMPs) are being followed and hiring a labeling expert to ensure that product labels comply with the law.

In a news release about the injunction, U.S. Attorney for the Eastern District of New York Richard P. Donoghue stated, "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." 

See related recalls and warnings:

Supplement Company Continues to Make False Claims About Its Products, Says FTC

Federal Court Shuts Down Two Supplement Companies Selling Weight, Joint Health and Other Supplements

Department of Justice Files Complaint to Shut Down Supplement Company Federal Court Shuts Down Maker of Sexual Enhancement Products

Federal Court Shuts Down Seller of Supplement Promoted for Herpes

Supplement Manufacturer Shut Down for Manufacturing Violations

Company Ordered to Stop Making and Selling Supplements

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