Congressman asks FDA about supplements fraud on e-commerce exposed by NOW Foods
Rep. Jeff Duncan has fired off a letter to the commissioner of FDA, raising concerns about supplement brands on e-commerce platforms that fail to meet FDA requirements for potency claims on product labels.
At a Glance
- Years of testing showing that many supplements fall short of label claims raises a question: What should FDA do about it?
- On Jan. 18, NOW Foods execs and NPA reps met with FDA officials to discuss NOW's testing program that has highlighted fraud.
- Despite the testing results shared with FDA, the same brands continue to be widely sold, a U.S. lawmaker said.
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.