Excitement around Urolithin A has been growing in recent years as the science deepens our understanding on its benefits for mitochondrial function. The compound is generated by gut microflora from ellagitannins found in food such as pomegranate. The compounds are first hydrolyzed in the stomach into ellagic acid, which is then converted by the gut microflora into urolithin A. However, not everyone has the right microflora to be able to make the metabolite.
As reported previously by NutraIngredients-USA, Swiss life sciences company Timeline has developed a method to deliver finely calibrated doses of urolithin A. Preliminary data published in Nature Medicine indicated that urolithin A may improve mitochondrial function by stimulating mitophagy, a process by which damaged mitochondria are recycled to permit a renewal with healthy mitochondria. These potent beneficial effects have been demonstrated in several different organisms, including in human clinical trials.
Most of the data to date has focused on the ingredient’s benefits for muscle health, with clinical trials in a range of population and age groups. Recently, results of a randomized clinical trial with 88 healthy people published in Cell Reports Medicine (2022) showed that Urolithin A supplementation boosted exercise endurance and physical performance.
Timeline has commercialized its proprietary urolithin A and branded the ingredient as Mitopure. The company launched its own dietary supplements under the Timeline brand, while there is also an agreement with Nestle Health Science for Mitopure to be used in NHSc’s food and supplement products, such as their Celltrient and Pure Encapsulations brands.
On the regulatory side, Mitopure Urolithin A has a letter of no objection from the US Food and Drug Administration (FDA) for its GRAS (generally recognized as safe) status (GRAS No. 791).
Speaking to Nutraingredients-USA, Federico Luna, Chief Marketing & E-Commerce Officer at Timeline, told us that, to Timeline’ knowledge, Mitopure is the only Urolithin A that has been clinically tested, has the FDA’s favorable review of its GRAS notification, and finished consumer products that comply with that FDA GRAS standard. Additionally, Timeline products are NSF for Sport certified and are manufactured under the FSSC 22000 food safety certification.
While Timeline dominates a search on Amazon for Urolithin A, there are several other brands of Urolithin A-containing dietary supplements present on the platform.
Luna told us that Timeline has tested two different products that are selling on Amazon that claim to contain highly pure Urolithin A. One of the products is in softgel form and the other is in hard capsule form, he said. “We couldn’t find any trace of Urolithin A in either product.”
“Testing was performed by two contract industry labs and one academic lab (independent of our testing),” he said.
“Our analysis to date has really focused on understanding the Urolithin A ingredient content and purity first. We are planning to expand the testing of other supplements in the future to include testing on heavy metals, toxic solvents, and other impurities that might be a safety risk,” added Luna.
Luna confirmed that the company has shared its finding with eCommerce giant, and “are awaiting a response from Amazon”. NutraIngredients-USA contacted Amazon for comment but did not receive any response prior to publication.
The goal of its testing and sharing those results is to “raise awareness of the fact that customers are being misled and potentially exposed to a safety risk by fraudulent Urolithin A products that are sold on Amazon and other ecommerce sites in the US,” said Luna.
So, what’s next? “We’ll continue to test potentially fraudulent unsafe products and raise awareness for the fact that Mitopure is the only Urolithin A you can really trust,” he said.
Timeline/Amazentis is not the first to test the quality of dietary supplement products on Amazon. Illinois-based NOW has performed 15 rounds of testing of lesser-known brands on the platform, putting a range of supplement segments under the proverbial microscope. NOW’s program was recognized by the Editors of NutraIngredients-USA with the 2021 Award for Industry Initiative of the Year. ChromaDex has also raised questions about the quality of NMN supplements on Amazon.