The Edgewood, NY-based company, which does business under the names ABH Nature’s Products, Inc, ABH Pharma, Inc., and Stocknutra.com, Inc, issued a recall on Jan. 17 under a consent decree it entered into with the US District Court for the Eastern District of New York. The company’s principal is listed by FDA as Dr. Jahirul Islam and was identified by the Long Island-based newspaper Newsday as Mohammed Jahirul Islam.
More than 1,200 products recalled
In a release from the manufacturer associated with the consent decree more than 1,200 individual products and client brand names were listed. The recall consists of all of the products manufactured by the company in the period from January 2013 to November 2019.
The recall is pursuant to a permanent injunction issued by the court at the end of December.
If Islam and ABH wanted to resume operations they would be required under the consent decree to hire an independent expert to inspect ABH’s facility and certify that the facility has corrected all deficiencies and implemented current good manufacturing practices. The decree also mandates that ABH engage a labeling expert to review its product labeling and certify that claims on the products comply with the law.
Assistant Attorney General Jody Hunt of DOJ’s Department of Justice’s Civil Division said the permanent injunction, “[R]eflects 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.”
Laundry list of GMP failures
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.
Sen Chuck Schumer, D-NY, was quoted earlier in January in Newsday about how long it seemed to take FDA to take action in the case.
“How did ... [the companies] get away with constantly violating the law and still continuing to put out their product? We have to make sure that our supplement industry is rigorously policed so that bad actors don't get away with this,” he said.
Attorney Marc Ullman, of counsel with firm Rivkin Radler, and who is based not far from where this manufacturing facility is located, noted that cases like these often result from a failure to respond vigorously to FDA’s observations. The case stretches back to a warning letter issued to Islam and his companies in 2012. That letter included a laundry list of GMP failures relating to testing, specifications and quality control procedures.
Lack of serious response
“When we see cases like this it is an inevitable consequence of not responding seriously in the way FDA expects when you have a regulatory issue relating to GMPs,” Ullman told NutraIngredients-USA.
However, he said there seems to be plenty of blame to go around. In reviewing the case, Ullman noted that there were gaps of months to years in communications between FDA and Islam’s companies.
“When you look at the regulatory history and you see it went on for eight years the question is, how did FDA let this happen? In the history of this interaction there’s a gap of eighteen months and in another case of three years. It would look as if there were problems in this regulatory action both at FDA and at the company,” Ullman said.
The company did not respond to a request for comment.