Supplement brands, Amazon and FDA weigh in on counterfeit products

In April, two supplement brands, NOW and Fungi Perfecti, identified counterfeits of a number of branded products sold on Amazon, the largest retailer of supplement products.

The e-commerce giant, which has come under fire in recent years for failing to act to thwart sales of subpar supplements sold on its site, was effective in blocking the sales of the counterfeit products, the companies reported.

However, industry experts contend issues with supplement counterfeiters on the platform remain, as well as Amazon’s stalwart practice of poor communication.

The counterfeit problem

NOW reported in April that a company operating under the name of A2X1 was selling 11 different counterfeit NOW supplements on Amazon. These included such products as NOW’s Adam Male Multi softgels, D-Mannose 500 mg capsules, and lutein and zeaxanthin capsules, among others.

The products resembled NOW products in appearance, but all of them—including those listed on Amazon as tablets or softgels—contained small white capsules with an odorless white powder later identified by NOW as white rice flour.

Some of the samples tested by NOW contained trace amounts of the pharmaceutical sildenafil. Sildenafil is the active pharmaceutical ingredient found in “Viagra,” which the Food and Drug Administration approved as a new drug in 1998 to treat men with erectile dysfunction.

Also in April, Fungi Perfecti reported multiple counterfeits of four of its Host Defense Mushrooms branded products were being sold on Amazon, including its MyCommunity, Stamets 7, Lion's Mane and Turkey Tail products.

The company said the counterfeit products, which were identified by packaging and ingredient irregularities, were being sold by more than 20 storefronts on Amazon.  

Importantly, some of the counterfeit products tested positive for soy and gluten. These are two known allergens that are not included in any of its authentic Host Defense Mushrooms supplements.

Communication challenges

Dan Richard, vice president of global sales and marketing at NOW Health Group, said NOW contacted Amazon via email on a Friday afternoon following the discovery to report the fraudulent products to the retailer. The company also alerted Amazon by phone for emergency service as a consumer.

“We did view this as an emergency because we did not know what material was in the small white capsules yet, but we knew it was not the correct product,” Richard said.

After following up with more emails to Amazon, NOW “did finally get their attention” to have the products blocked from sale by the following Tuesday.

On April 11, Amazon agreed to block all sales by the seller A2X1.

“Difficulty in communicating with Amazon is a big ongoing concern,” Richard added.

It’s a concern shared by others in the industry. Diana Morgan, vice president of global and regulatory affairs at Nutrabolt, has almost 20 years of experience working in the dietary supplements industry, including time at Pfizer Consumer Healthcare working with one of the world’s leading multivitamins.

“We had a lot of legal issues and, oftentimes with those counterfeit products, they're not what they say on the label,” Morgan shared. “It's [intellectual property] theft on top of that.”

After identifying the counterfeit products on Amazon, she said, Pfizer’s internal teams were charged with working with Amazon to remove the counterfeit products.

“Trying to get ahold of someone at Amazon is very difficult,” she said. “That's a big pain point.”

This is where Amazon needs to “step up,” according to Dan Fabricant, Ph.D., president and CEO of Natural Products Association (NPA).

“When they get notified of this information, they need to do something about it,” he explained. “They're not, and they're also not talking to groups like [NPA]. They're not talking to the manufacturers. You send 'em emails on this, you send 'em information and they go into a hole. How does that resolve anything?”

Amazon’s enforcement

Importantly, Richard said Amazon’s follow-up on the case was “very good.” The response included Amazon’s Counterfeit Crimes Unit, which worked together with NOW to share information.

Within two weeks, Amazon sent a notice to each purchaser about the fake products, Richard said.

“I was a personal buyer of a few of these products and two other NOW employees also purchased fake products,” he continued. “We each received a notice to destroy the product and not return it.” Amazon also issued refunds for the purchases.

In a statement, Fungi Perfecti said it immediately reported its findings to Amazon.

“Amazon has since removed the counterfeit products from their store and notified affected customers,” the company said.

Morgan, too, cited “significant improvements in Amazon in the documentation that they require for brands.”

In 2020, Amazon updated its policies to require supplement brands to maintain three pieces of documentation in order to sell their products on its platform: a certificate of analysis (CoA) from an ISO/IEC 17025-accredited laboratory for each supplement; product images; and a letter of guarantee from the product manufacturer, including an assurance that the supplement is produced under FDA’s current good manufacturing practices (cGMPs) incorporated in 21 CFR Part 111.

The move toward tighter requirements for supplements quality was largely applauded by industry.

However, supplement quality control on Amazon continues to be a concern. A years-long independent testing program of a range of lesser-known supplements on Amazon revealed a number of the products consistently fall below requirements for potency.

“The counterfeiting is really dangerous,” Morgan said, “and I know Amazon has been trying to crack down on it a little bit better, but it still is happening.”

An Amazon spokesperson said in a statement that the company has “a zero-tolerance policy for counterfeit products.”

The e-commerce giant takes “proactive measures” to prevent counterfeit products from being listed and to “continuously monitor” the platform, according to the statement.

“If we identify an issue, we act quickly to protect customers and brands, including removing counterfeit listings and blocking accounts,” the Amazon spokesperson explained. “We will continue to collaborate with brands and law enforcement to protect our customers from bad actors attempting to abuse our store.”

FDA's response

Both NOW and Fungi Perfecti reported their findings of the counterfeit products to FDA, the companies said.

NOW did not receive communication from FDA about the issue, Richard said.

In the case of NOW, they found trace amounts of sildenafil, “which should have been a recall,” Fabricant said.

Fungi Perfecti’s analysis of the counterfeit products identified undeclared allergens, “which, for the food space, which we are part of, is the biggest recall issue for dietary supplements,” Fabricant said. “Yet FDA kind of tried to push the recall off on Fungi Perfecti instead of going after Amazon.”

Fabricant, who was director of FDA’s Division of Dietary Supplement Programs during part of the Obama administration, cited actions by the agency in 2013 involving the supplement Enzyte and a counterfeit product that was found to contain sildenafil.

“The counterfeit had sildenafil analogs … and FDA didn't go after the brand. They went after the counterfeiter retailer,” he said. “They should have done the same thing here. But I think what this has showed us is FDA is scared to death of Amazon, which is concerning in these issues.”

An FDA spokesperson told Natural Products Insider that the agency takes product complaints and adverse event reports “seriously,” including information about possible counterfeit products.

“When these reports are submitted, agency staff review the situation to determine if FDA action is needed to protect public health,” the FDA spokesperson explained. “For example, in the case of counterfeit products, it would be important for the FDA to be aware of products that present a safety concern due to contaminants, allergens or other inaccurate labeling practices.”

However, under current law, the agency has no systematic way of knowing what dietary supplements are on the market or what they contain, the spokesperson said, adding, “Further, the FDA does not have the ability to track counterfeit supplements on the market.”

The FDA spokesperson underlined the agency’s resolve to work “collaboratively with all of our stakeholders” to ensure dietary supplements are safe, accurately labeled and compliant with cGMPs.

Consequences for brands, industry

Richard cited two potential consequences supplement brands face because of counterfeiters: lost sales and decreased consumer confidence.

“We really don’t know what harm it has caused us, and that’s a major concern,” he said. “Lost sales with consumers buying the counterfeit products rather than legitimate NOW offerings aside, has this undermined consumer confidence in NOW quality?”

Morgan, too, highlighted the issue of brand reputation.

“It was really the reputational issue … especially with a multivitamin people are taking every day,” she said of her experience at Pfizer Consumer Healthcare. A counterfeiter could produce “a half-potent [multivitamin], it could be complete placebo, it could be just a sugar pill, and someone's taking it every day thinking that they're supplementing their diet, and they're not getting anything.”

The issue of consumer confidence, Richard contended, isn’t exclusive to brands directly impacted by counterfeiters.

“Has [the issue] made people wary of supplements in general, which undermines the entire industry? It isn’t just NOW’s problem,” he said.

Megan Olsen, senior vice president and general counsel at the Council for Responsible Nutrition (CRN), advised brand owners to tap into the tools that are available to them to help protect themselves against counterfeiters, including strong intellectual property.

This IP “can help not only with e-commerce platforms like Amazon, but it can help where companies are able to pursue bad actors to protect their intellectual property material,” Olsen explained.

Independently purchasing and testing products that are sold on Amazon to ensure they’re authentic and monitoring consumer complaints are other ways brands can be proactive and vigilant against counterfeiters, she said.

Despite Amazon’s position as the largest dietary supplement retailer, the e-commerce platform has been charged with taking a backseat in the industry.

“Amazon was a member of CRN, they never came to any of the meetings,” Morgan, a former CRN board member, said. “No one ever paid an interest. … So, I would like to see them get involved in the industry more.”

Per Fabricant, collaboration between Amazon and industry is also critical to address issues like counterfeiting.

Amazon should “work with the trade,” he said. “They need to work with industry. They need to reach out [and say], ‘We're gonna work with you and eliminate this problem. No one's ever gonna counterfeit a NOW product again. Or no one's ever gonna counterfeit a Fungi Perfecti product again.’ I think that's really where the conversation needs to turn.”

Importantly, Olsen said CRN recently partnered with Amazon to provide its members with an educational webinar about the issue of counterfeit supplements, which means the online retailer may be taking steps toward establishing a more active role.

Amazon declined to share the contents of the webinar for this article.

“[The counterfeit issue] is not something that is going to be able to be addressed by any one organization or company,” Olsen said.

She added, “Coming together—having these discussions with members that are concerned and recognizing problems—is going to be one of the ways that the industry and CRN and manufacturers can help protect themselves and better protect consumers.”