Many consumers quickly glance at the label on a dietary supplement, blindly purchase it, and never question where it was made or if what’s listed on the label is actually in the bottle. But what if you don’t even know what you’re buying? Has the product been tested to meet label claims, where is it manufactured, and how pure really is it?

Regardless of the myths that surround the supplement industry of ‘not being regulated by the FDA’, this news story will change your mind. Because this one involves a serious indictment after plenty of warning letters, strikes, and failed audits.

FDA indicts major contract manufacturer in ABH Pharma

After years of playing “whack-a-mole” by sending warning letters to small brands, the FDA — and now the Department of Justice — have gone after the root of the supplement industry’s biggest problem: underhanded contract manufacturers. These are the companies that are actually bottling the products, and we have long stated that they are a better “pinch point” for strict enforcement of current Good Manufacturing Practices.

On January 17th, 2020, a major contract supplement manufacturer under the names of ABH Pharma, ABH Nature’s Products, and Stocknutra.com published a press release on BusinessWire issuing a nationwide recall on all lots of dietary supplements manufactured and sold between January 2013 – November 2019, after an indictment was posted in New York on December 26, 2019.

Major offenses over several years

The DOJ indictment, which names Mohammed Jahirul Islam (“Islam”) as the owner of the three companies, alleges that their facilities distributed adulterated and misbranded dietary supplements and unapproved and misbranded drugs. They signed a consent decree forcing Islam to destroy all dietary supplements (and drugs) in their possession within 15 days, which has now also been posted on the FDA’s website.

The DOJ indictment report stated that ABH failed 6 FDA audits over the years, had warning letters dating back to 2012, and neglected to conduct at least one appropriate test for ingredient identity.

The indictment itself (which is linked at the bottom of the DOJ’s report web page) includes new infractions from a November 2018 inspection. Such infractions include some egregious drug claims made on products they manufactured, such as “Whey protein in the form of protein powder can help in reducing the symptoms associated with anxiety and depression”.

In addition, ABH Nature’s products had a voluntary recall in June 2017 and January 2018 due to possible salmonella contamination.

“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.”

— Richard P. Donoghue, U.S. Attorney for the Eastern District of New York

A long time coming

The indictment lists several inspections at the Defendants’ Edgewood, NY facility, including inspections that occurred in or about July 2012, May 2013, August 2013, November 2016, and February 2018, on top of the most recent November 2018 inspection.

The FDA’s warning letter from 2012 lists seven major cGMP (Current Good Manufacturing Practice) violations, such as adulteration, mislabeling, misbranding, failure to verify finished supplements, failure to monitor, and failure to follow control processes, and failure to qualify suppliers.

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