The disclosure comes from the latest phase of the company’s product policing program, which exposed confusing poor results related to potency, labeling, contamination, adulteration and heavy metal level issues in more than 150 products that tested so far since 2017. In the case of berberines, the test flagged alarming quality failures in a selection of brands acquired last month from both retail giants.
We buy two bottles of each product from 33 brands, including NOW, which are sold on both Amazon and Walmart.com, said Dan Richard, vice president of global sales and marketing at NOW Health Group. It was clear even before the test that many brands were fraudulently mislabeling the potency on the front label panel and many others had suspiciously high claims.
NOW says it chose to focus efforts on lesser-known brands sold almost exclusively on these platforms because health food store or practitioner brands are less suspect.
Cashing in on the berberine hype
Berberinea yellow-colored alkaloid compound found in plants such as goldenseal, barberry and Oregon grape associated with blood sugar, cholesterol, cardiovascular and anti-inflammatory benefits rose to rapid popularity on social media earlier this year as a natural sub in for the weight loss drug Ozempic.
According to market research firm SPINS, there was a spike in chatter in January that reached true virality on TikTok in May (as #naturesOzempic) and mainstream media in June. At the time, NOW told NutraIngredients-USAAnd its berberine sales increased 623% before running out of stock.
With any rapid increase in popularity comes an opportunity for fraudulent sellers to cash in by offering inferior or adulterated products, NOW said. This has proven true with berberine.
Berberine supplements are usually made in the hydrochloride (HCl) form, which is obtained from the extraction ofBerberis aristatabark, and the 85-90% potency source berberine HCl dihydrate is commonly used.
This means if brands claim 500 mg berberine on a label, and it is in HCl form, the supplier must insert 550-575 mg berberine HCl dihydrate to meet the label claim, NOW explained, and added that the supplement’s full disclosure of facts would read something like : Berberine HCl 500 mg (from 550 mg Berberine HCl dihydrate) instead of just Berberine or Berberine HCl.
The test results
To generate its in-house report on the quality and presence of berberine in each tested product, NOW uses high performance liquid chromatography (HPLC) with ultraviolet light detection (HPLC-UV). It also sent one unopened bottle of each brand to independent botanical testing laboratory Alkemist Labs for HPLC testing.
The results of this round of testing showed serious levels of low potency with every brand testing less than 100% potency, except for NOW, the natural products manufacturer reported. Seven brands contained more than 80% labeled potency, and three brands contained 90-97% potency.
In addition, 18 of the brands contained less than 40% of the labeled potency, and seven of the policing programs’ first-time testees registered 1% or less berberine potency. A quick search indicates that all 33 brands have four-star ratings and are currently available on Amazon.
NOW added that it tested some of the same brands previously in other categories (astaxanthin, bromelain, curcumin, magnesium glycinate, quercetin, CoQ10, glutathione, acetyl-l-carnitine, ALA, phosphatidyl serine and SAMe) and found similar problem. It highlighted that more than 80% of the products tested failed the potency test and that one of the brands “failed eight different rounds of product testing and had the worst record for potency tested of all brand. Full details of the test results are published on NOWs website.
“The atypical part of our industry that continues largely on Amazon’s platform undermines efforts to combat the false narrative that our industry is unregulated, and that our products are untested and unsafe,” said by Elan Sudberg, CEO at Alchemist Labs. “It is disappointing that the FDA and Amazon are not effectively policing what is being sold! Alkemist is honored to partner with NOW to send the message that we see you, we test your products, and the truth will be exposed.”
Despite sharing each round of results with Amazon and Walmart, NOW says it hasn’t received a response or seen any noticeable changes, with both failing brands continuing to sell widely in Amazon, especially, and often as sponsored or advertised brands.
We expect that when NOW presents independent reviews of products that have no potential at least the product will be removed from sale, said Richard. It is better that the product is retested and if it is zero again, the product should be recalled. No such action occurred.
Daniel Fabricant, Ph.D., CEO and president of the Natural Products Association, reiterated that this is not the first time the Food and Drug Administration (FDA) has been notified of these matters.
We’ve been sending them test data from NOW foods like this for years, he said. Their response so far has been to sit on the sidelines, which is unfortunate for everyone and sends a signal that they are not the least bit curious about the industry.
In response to a request for comment on NOW’s berberine trial findings, the FDA said that product integrity is one of the Agency’s strategic priorities for dietary supplements, and “reports of products that too little or too much indicates a problem with product integrity”.
“We appreciate stakeholder efforts to raise awareness of these problems, and the FDA incorporates these types of reports into the work planning process,” an FDA spokesperson said. “If the FDA determines that a dietary supplement is adulterated or misbranded, we take action as appropriate, such as recalls, issuing warnings, or taking enforcement actions, depending on the available resource.”
Amazon and Walmart.com have not yet responded to requests for comment.
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