At the end of January 2020, Kathryn Nelson of Chicago-based LFI Labs—a marketer of dietary supplements for thyroid support, menopause relief and other health conditions—discovered Amazon had removed several of her product listings.
She eventually got to the bottom of Amazon’s decision: A supplement manufacturer in New York that had made some products for LFI Labs had issued a massive recall.
“These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations,” Amazon stated in a Feb. 1 email to LFI Labs. “Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process, resulting in finished supplement products with decreased identity, purity, strength and composition.”
The e-commerce giant advised LFI Labs that businesses selling products on Amazon “must comply with all federal, state and local laws and Amazon policies applicable to those products and product listings.”
However, none of the affected products taken down by Amazon were produced by the contract manufacturer that issued the recall, Nelson said in an interview.
That contract manufacturer is ABH Nature’s Products Inc., whose operations in Edgewood, New York, were shut down after the federal government accused the company of violating regulations intended to ensure products are safe and made to quality standards.
By Feb. 17, LFI Labs resumed selling its products on Amazon after obtaining a letter from ABH’s counsel, who confirmed a vitamin D3 product manufactured for LFI Labs by ABH had been discontinued, while a coenzyme Q10 (CoQ10) product that ABH made in one lot production was being produced by another company not subject to the recall.
“ABH has not manufactured other products for LFI Labs,” David Rosen, an attorney with the law firm Foley & Lardner LLP, stated in a letter on behalf of ABH.
Nelson’s story underscores the far-reaching and unanticipated impacts of a recall announcement that some consultants in the dietary supplement industry described as “unprecedented.”
In emails and interviews, many brands subject to the recall complained ABH wouldn’t return their emails or phone calls. They also said the recall notice was vague and potentially misleading since it didn’t list specific products.
For this story, some brands subject to the initial recall provided letters from Rosen, verifying ABH did not make products for them.
While ABH has removed the initial list of brands affected by the recall as it works to refine the list, many brands reported suffering adverse consequences from the first recall notice, which listed 859 entities.
“I’ve spoken to several people in the industry who had made a product with ABH while making products with several other vendors,” said Steve Finnegan, general manager of Makers Nutrition, a Commack, New York-based manufacturer of dietary supplements, in an interview conducted in February. “And rather than having the product that was made at ABH on the list, they only had their brand name on the list. It implies that they did everything with ABH, which is very far from the truth … and it’s just plain not fair.”
Finnegan said brands faced issues with e-commerce platforms such as Amazon, even if the products manufactured by ABH are not offered for sale on the same platform.
“And that’s patently unfair,” he said. “Again, the list should have been more specific. It says nothing about which products were made or when … and it’s tarnishing every company on the list.”
Makers Nutrition is among the entities on the recall notice. Finnegan suggested Makers Nutrition may have outsourced bottling work to ABH, for example, but he said his employer hasn’t dealt with the company since the beginning of 2016 and shouldn’t have been included on the list.
“We’d buy something from them, but the fact is anything that we did with ABH, whatever it happened to have been, was well beyond the expiration date of anything that could be sold in the marketplace today,” Finnegan said.
The recall, however, affected all of the dietary supplement products manufactured by ABH and sold between January 2013 and November 2019.
Abdul Alkayali is vice president of Certified Nutraceuticals, a manufacturer of nutritional ingredients in Pauma Valley, California. He said his company entered an agreement to source fish collagen from ABH. However, Certified Nutraceuticals didn’t use ABH’s products because the fish collagen was from China rather than from the United States as ABH had represented, Alkayali said in an interview. In a June 3, 2019, email, Alkayali told ABH representatives he would not have requested the material if he knew it was from China.
“The way we are listed [in the recall notice] doesn’t make sense,” Alkayali said. “We never used any of their products.”
Christopher Gatchis is CEO of Axis Labs Inc., a sports nutrition supplement brand in Englewood, Colorado. He said his company purchased one lot of CLA softgels from ABH in 2017 since his usual supplier was out of stock, then the capsules were sold to a private label company overseas.
Gatchis is among brands who are displeased with the way the recall was handled. “We still do not understand exactly what happened,” he said in a Feb. 17 email. “Our calls and emails to ABH go unreturned. We received no notice this was happening until it was publicly posted. The way it was announced, it looks like every product for each brand listed was affected. It has caused mass market confusion, and the people taking the hit are the brands listed, while ABH has gone dark.”
Amazon returned several of Axis Lab’s products without any notice, he added.
“Many retailers called to return their stock as well,” he added. “Fortunately, we have been able to explain the nature of the relationship and clear up the confusion with our direct resellers.”
In a follow-up email, Gatchis provided a letter from ABH’s counsel, verifying ABH never manufactured products for Axis Labs.
“We have slowly been able to get the products that were removed to be relisted,” he stated in a March 11 email. “It's been a long process, and some are still in transit back to Amazon because they were returned to us.”
Cecilia Fan, an Amazon spokesperson, did not respond to requests for comment for this story.
BPI Sports, another brand listed in the recall notice, suggested in an email that ABH made one product for the company that was never even brought to market.
“It’s actually a shame we were included on the list considering we did practically zero business with them,” the company stated in an email.
Another brand listed in the initial recall was New York, New York-based Elysium Health, which produces a supplement known as Basis to support cellular healthy aging and other health benefits. According to its website, Elysium’s scientific advisory board is composed of “more than 25 world-renowned researchers and clinicians, including eight Nobel Prize-winning scientists, who guide the scientific direction of our company.”
Whitney Christopher, a spokesperson for Elysium Health, said Basis has never been subject to a recall by any government or regulatory authority, including FDA, since its 2015 launch.
“Furthermore, since we began producing Basis, Elysium Health has never produced a product with a manufacturer that has either voluntarily or mandatorily issued a recall of its products or third party products that it manufactured,” Christopher said in an email.
In a letter to Elysium Health, ABH’s counsel Rosen said the company was “inadvertently included” on the list of companies impacted by the recall.
Asked to respond to criticism regarding how the recall was handled, ABH said it did its “best to provide information to FDA within the timeframe specified in the consent decree.”
“Unfortunately, our automated information systems contained some information that needed to be further updated,” Mohammed Jahirul Islam, the owner of ABH, said in a March 13 statement that Rosen provided.
ABH’s owner also addressed criticism that companies had difficulty reaching the company following the recall.
“ABH is a contract manufacturer for private label owners and distributors,” Islam stated. “Most of the calls and email are coming from retail customers [from Amazon]. They do not even know if ABH manufactured their products or someone else did. We have over 25,000 emails.”
With no cash flow being generated as a result of the consent decree, ABH had to let go its staff, he explained. Islam said he and his assistant are responding to all phone calls.
“We sent emails and are trying our best to respond to each and every single person,” Islam said, adding his legal team also is corresponding with individuals impacted by the consent decree and recall.
Brandon Griffin is co-founder and CEO of REJIMUS Inc., a regulatory management consulting firm in Santa Ana, California. Griffin has talked to many entities impacted by the recall. While many businesses are taking the recall seriously, he said about half of them he has spoken with are in denial.
“There’s still an element of folks in denial because they’re able to sell,” Griffin explained in an interview. “They’ve been selling. They don’t want to rock that boat and they don’t want to accidentally do something that’s going to make a bigger target of them, even though … their companies were explicitly named in this particular recall.”
Brands that aren’t taking steps in response to the ABH recall could attract the unwanted attention of FDA when the agency inspects their facilities, Griffin warned.
Some brands impacted by the recall “are pretty darn successful,” he said. “They just have not been on the radar of the FDA as of yet.”
One supplement brand, who agreed to speak on condition of anonymity to talk frankly, said he was trying to get his insurance carrier to cover losses and damages related to the recall. He also was considering whether to sue ABH, but expressed skepticism about a positive outcome from such a move.
Islam said ABH is “working diligently to update and improve our quality operations.” ABH, he added, is complying with the requirements outlined in the consent decree and has retained expert consultants to assist with those efforts.
“Again, our goal is to make high-quality products that are in compliance with current good manufacturing practices,” Islam said. “We hope that we can resume operations in the near future and win back the confidence of FDA, our customers and consumers.”