Congressman asks FDA about supplements fraud on e-commerce exposed by NOW Foods

A testing program spearheaded by a prominent U.S. supplement company has revealed that American consumers who purchase natural products on e-commerce platforms including Amazon are frequently getting ripped off.

A question raised by industry stakeholders is whether the U.S. regulator principally charged with policing the vast market for dietary supplement products should do something about the fraud.

For years, NOW Foods and other supplement companies and groups have been feeding testing data to the U.S. Food and Drug Administration, showing what’s advertised on product labels often does not match what’s actually in the bottle. The findings demonstrate producers of these brands sold on Amazon and other e-commerce platforms are not meeting FDA regulations, or cGMPs (current good manufacturing practices), intended to ensure supplements are made consistently to quality standards and are free of contaminants.

In communications shared with FDA, NOW “has reported dozens of branded supplements sold almost exclusively on e-commerce platforms that do not meet FDA requirements for potency claims on the label,” Rep. Jeff Duncan, R-S.C., wrote to FDA Commissioner Robert Califf, M.D., in an April 12 letter.

Despite NOW communicating its findings to FDA, “I am told that FDA has seemingly taken no action in response,” Duncan noted. He asked Califf to answer how FDA evaluates information from dietary supplement stakeholders such as the results shared by NOW and whether the agency has acted against fraudulent products.

The congressman’s letter to the FDA commissioner raised concerns and questions about other dietary supplement issues, including why the Reagan-Udall Foundation did not evaluate dietary supplements in its evaluation of the FDA Human Foods Program.

An FDA spokesperson said the agency is reviewing the letter and would respond directly to Duncan.

“Something has to be done about this [fraud], and it’s right in FDA’s wheelhouse with the authority” it possesses, NOW Health Group CEO Jim Emme said in an interview. “If they can’t go after the brands, they can at least go after the contract manufacturers of the brands and investigate them.”

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NOW started testing products sold on Amazon in 2017, after the company noticed its position on the online platform declining — while brands with no or low brand recognition were climbing in popularity, NOW Health Group VP of Global Sales and Marketing Dan Richard previously told Natural Products Insider in a 2023 story highlighting Amazon’s testing program.

Coenzyme Q10 (CoQ10) 400 milligrams (mg) in dry capsules, specifically, stood out.

“From my experience in trying to get this same potency in dry capsules, I knew that CoQ10 is too sticky to encapsulate on high-speed machines,” Richard explained. “When I looked at the prices, which were ‘too good to be true,’ I asked our lab to test these and see if the products were legit. As I suspected, they were not.”

NOW first tested four different CoQ10 products each from two “suspect” brands for potency, Richard said, and “all failed badly.”

NOW’s subsequent testing of other products, including TikTok sensation berberine, also known as “Nature’s Ozempic,” have uncovered equally dismal findings.

“Following the latest round of product policing, NOW Foods has found abysmal testing results tied to potency, labeling, contamination, adulteration and heavy metal level issues across over 150 products tested to date since 2017,” Duncan wrote to Califf.

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On Jan. 18, at FDA’s campus in College Park, Maryland, NOW executives and representatives of the Natural Products Association (NPA) met with agency officials, including the director of the Office of Dietary Supplement Programs, Cara Welch, Ph.D. Emme is a member of NPA's board of directors.

NOW discussed its testing program, including results from testing berberine products. In November 2023, the company purchased berberine products from 33 brands (including NOW) on Amazon and Walmart.com and discovered through testing that 18 of them contained less than 40% of labeled potency. Seven of the tested samples had 1% or less of the labeled berberine potency.

NPA President and CEO Dan Fabricant, Ph.D., who oversaw FDA’s then-Division of Dietary Supplement Programs from 2011 until 2014, said industry representatives at the meeting recommended FDA send brands a letter or visit them for an inspection of their manufacturing facilities.

According to Fabricant, “it was clear” FDA wasn’t going to act on the information. While FDA officials said they’d “love to keep working with NOW Foods,” there was “no real meat on the bone unfortunately,” he added in an interview.

Based on publicly available FDA warning letters, Fabricant maintained there’s no record that FDA has inspected the manufacturers of brands selling products on Amazon tied to the types of problems identified by NOW in its testing program.

“Have we seen a warning letter that says, ‘Hey, you make products for XY and Z brands that are sold on Amazon, and we’ve seen some deficiencies? We did a GMP inspection and found X,’” Fabricant said. “We haven’t seen anything like that. That’s how we know it hasn’t been done.”

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FDA suggested in the meeting that “economic adulteration” isn’t a priority, Emme divulged. He countered in the interview that enforcing the law against “cheaters” is akin to making a free throw in basketball or having a free kick in soccer.

“I felt that the agency at least was trying to look at a way to utilize the information, but when it was all said and done, it was inconclusive and it appeared that they were not going to take any immediate action on anything we’ve done,” Emme shared.

During the Jan. 18 meeting, NOW communicated with FDA that it would continue its testing program and keep sharing the results with the agency, and FDA officials “indicated that was fine,” Emme said.

Emme, who has known Welch for many years and described her as “an honorable person,” said he didn’t consider the meeting a wasted effort.

“The more we talk to each other about our different perspectives and our challenges, it’s [better] for the entire industry,” he reflected.

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FDA in recent years has often been asked questions by the media, researchers and other stakeholders about poor-quality supplements — or products marketed as supplements but adulterated with drugs — sold on e-commerce platforms like Amazon. In response to a recent study that found galantamine supplements on Amazon fell short of label claims, FDA said it’s “committed to using its resources and authorities to identify and remove unsafe and illegal dietary supplements from the market.”

“We monitor the compliance of dietary supplement firms through a variety of surveillance activities and carefully review product complaints and adverse event reports,” an FDA spokesperson said in a Feb. 28 statement to Natural Products Insider. “If FDA determines that a product labeled as a dietary supplement violates the law, the agency takes regulatory action as appropriate, based on public health priorities and available resources, such as issuing warning letters or taking enforcement action.”

One school of thought within the supplement industry is that FDA may not consider “economic adulteration” a high enough priority to initiate an investigation or enforcement action. It’s not a cut-and-dried analysis, though. Citing CoQ10, Emme highlighted an example of economic adulteration that could endanger the health of consumers as well.

According to the Mayo Clinic, CoQ10 has been demonstrated to improve congestive heart failure, and some research suggests that when combined with other nutrients, it may assist recovery in individuals who have undergone bypass and heart valve surgeries.

“Say your doctor tells you, ‘Hey, I need you to take 400 milligrams of Coenzyme Q10 … and you go out there and say, ‘Wow, this product has a good price…' And they buy it, and all they’re buying is rice flower in a gelatin capsule,” Emme observed.

“I guess one could say that could be dangerous to their recovery or impede their recovery, but more importantly, it’s just cheating and that hurts everybody,” he explained. “And it certainly doesn’t help our reputation as an industry when there are those who like to compare us to ‘gas station heroin’ and say that we’re totally unregulated.”

And consider galantamine, which is marketed as a supplement and also approved as a drug by FDA. In a galantamine paper published in JAMA Network in February, researchers including Dr. Pieter Cohen of Harvard Medical School investigated the label accuracy of galantamine products formulated as generic drugs and supplements. The actual content of galantamine in the generic drugs ranged from 97.5% to 104.2% of the labeled content, while the quantity of galantamine in the supplements ranged from less than 2% to 110% of labeled quantity. The galantamine supplements were purchased from Amazon.

“For patients with Alzheimer’s disease, use of galantamine supplements instead of generic galantamine may adversely affect their care,” researchers opined.

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In his letter to the FDA commissioner, Duncan shared NOW’s berberine results and then added, “What troubles me most is that despite sharing each round of testing results with the FDA and the e-commerce platforms in question, I’ve been told that the natural products manufacturer claims they have never received a response or observed changes in the marketplace, with the same concerning brands continuing to be widely sold.”

Kyle Turk, director of government affairs with NPA, called Duncan “a champion of industry,” noting his letter to Califf demonstrated his leadership again.

“Like Rep. Duncan, we have serious concerns when industry leaders like NOW present concerning data regarding adulterated and misbranded products to the agency, but the agency takes no action,” Turk said in an email. “At a time when states are attacking the industry as unregulated, now is not the time for the FDA to be asleep at the wheel. We look forward to seeing the agency’s response and hope they take swift action against products that do not comply with the law.”

An Amazon spokesman declined to comment for this article but provided a link to Amazon’s policy page on supplements. According to the page, Amazon requires its selling partners to confirm dietary supplement products meet its policy through third-party testing verification.

Per Amazon, the policy is intended to ensure products meet cGMPs, do not contain contaminants that may pose a regulatory or health concern, contain ingredients claimed on the product label and do not contain undeclared APIs (active pharmaceutical ingredients).

In response to NOW’s testing program, Amazon has removed products from the platform, though Emme suggested it’s been a fairly slow response in cases of economic adulteration.

“The problem with these brands is they disappear, and they pop up again,” Emme said. “It’s like a game of whack-a-mole with these guys, but we’ve identified some of the most egregious players, which we’ve shared with the agency.”

So far, Emme isn’t aware of FDA moving against these bad actors. He’s fed up with them, however, saying “enough is enough.”

“We’re weighing our options of what else we can do beyond this testing program so stay tuned,” he concluded in the interview. “There might be more to come.”