NOW tests creatine gummies, identifies limitations in third party gummy testing

Photo © iStockphoto.com/nito100

NOW recently announced that its acclaimed testing program has turned its attention to creatine gummies, revealing some interesting QC challenges. To start, the company tested 12 brands of creatine gummies using high-performance liquid chromatography (HPLC), and used a creatine reference standard of a known concentration for creating quantitation. Of the 12 brands tested, six brands met or exceeded label claims, namely: Bear Balance, Bod, Effective Nutra, Iron Labs Nutrition, Peach Perfect, and Zhou. (see results in Figure 1)

Figure 1: Creatine gummy test results. Chart courtesy of NOW.

The remaining six that failed, included the brands: Astro Labs, Beast Bites, Create, Con-Cret, Greabby, and Njord. In Figure 2, the 12 products are lined up. NOW observed that three of the bear-shaped products, (sample 1, 8, and 10), which failed to meet label claims, appear to be made by the same supplier, though they differ slightly in color and potency. Samples 4, 7, and 11 also appear to be made by a single supplier, though these samples met label claims.

NOW also tested the products for creatinine content, an unwanted creatine metabolite. Creatinine, explains the company in a press release, is a waste product that naturally build up in blood when muscles are exercised. The reason creatine is so often in powder form, is because it’s a stable medium, while when creatine is added to water, it can convert to creatinine, making it difficult to correctly dose creatine gummies since they’re made with water. NOW detected levels of creatinine in all the gummies that failed to meet creatine content claims.

Photograph of gummy samples tested: 1-Astro Labs, 2-Bear Balanced, 3-Beast Bites, 4-Bod, 5-Create, 6-Con-Cret, 7-Effective Nutra, 8-Greabby, 9-Iron Labs Nutrition, 10-Njord, 11-Peach Perfect, 12-Zhou. Most samples were opaque, but 1-Astro Labs, 3-Beast Bites, 6-Con-Cret, 8-Greabby, and 10-Njord, were translucent. It is worth noting that Bod and Peach Perfect were likely distributed by the same company and that Bod, Peach Perfect, and Effective Nutra had identical formulations and were likely made by a single manufacturer. Courtesy of NOW.

More surprising than the results of the tests, said NOW, was that the company appears to have one of the few industry labs that can accurately test gummies. Usually, NOW uses reputable third party labs to offer a second unbiased test result. In this case, the company was unable to find a third party lab equipped to test gummies.

“It’s concerning that NOW was not able to identify a third-party lab to test the gummies, given the rapid growth of that delivery system and the regulatory requirement to confirm label compliance,” said NOW senior director of quality, Katie Banaszewski, in a press release. “With NBJ reporting that 47% of new supplement users prefer gummies and as the fastest growing dosage form, the industry needs to find a solution to this lack of quality confirmation and regulatory compliance.”

In response to NOW's publicized test results, Vireo Systems, parent company for Con-Cret creatine hydrochloride gummies criticized the results, calling them inaccurate and questioned the whether NOW used the proper methodology, sample prep, or molecular profiling to achieve accurate results. They explain that these processes differ for creatine hydrochloride vs. creatine monohydrate. The company told Nutritional Outlook that Con-Cret's gummy has been tested in at least two trials using an independent, ISO/IEC 17025:2017-accredited laboratory, and the trials demonstrate that the creatine HCl content in the gummy was well above the 250 mg creatine HCl per 4 g label claim. Its products are also carried by CVS Caremark, which extensively tests products to ensure integrity before accepting them for sale. The company has also furnished certificates of analysis from Eurofins and Certified Laboratories showing tested products that met label claims, though they were not for the specific lot testing by NOW. Vireo System's CEO Mark Faulkner has a laboratory background, having headed a forensic toxicology lab earlier in his career, and has expressed the utmost confidence in his products' quality and consistency. He also said the company intended to replicate the tests conducted by NOW through respected third party labs they know can accurately test gummies.

Dan McCormick, co-founder and CEO of Create Creatine, which also tested below label claims based on NOW's tests, recently published the results of potency testing conducted by Eurofins on LinkedIn. This tests showed that its Blue Raspberry gummy had 1491 mg per gummy (99.4% of claim), its Watermelon flavor had 1525 mg per gummy (101.6% of claim and its Orange flavor had 1404 mg per gummy (93.6% of claim).

"We are very pleased with these results which we believe, within any reasonable standard, confirms our label claims. From a functional perspective, our customers are actually getting what they are sold. The experience of taking a creatine gummy that contains 1404 mg is virtually the same as taking a creatine gummy that contains 1500 mg of creatine," McCormick wrote in his LinkedIn post. "That said, we're perfectionists. Margin of error, while reasonable, is not something we hang our hat on. And I'd rather be giving people 5% more creatine than 5% less creatine per serving."

He goes on to explain the measures the company is taking to improve the creatine levels of its Orange flavor.

NOW is standing by its results. In a statement from March 8, 2024, NOW senior director of quality Katie Banaszewski said:

"We are not questioning the methods/development process or extensive testing performed for CVS and others. We tested a single lot, and this lot is not passing the label claim. It would be great if Vireo could provide a reference to the ISO lab and testing results of this lot. Are those lab’s accreditation Vireo mentioned for creatine gummies specifically? Because if they are not, the ISO accreditation point is immaterial.

"The method used for analysis, HPLC, cannot distinguish between creatine monohydrate and creatine hydrochloride since it only looks at creatine. The counterion/hydrate form is not relevant for HPLC analysis. Although the reported results may differ slightly due to HCl having a slightly larger molecular weight than water, this would not significantly alter the results. Therefore, this would not be the difference between a passing or failing result in CON-CRET’s case.

"The material point is that the contract labs NOW views as the industry's most competent apparently do not have validated testing methods for gummies. This raises the question that perhaps the fastest growing dosage form has gotten ahead of itself. If Vireo would like to contribute their claimed expertise to an industry initiative to bring gummy testing to the standards to which they should be held, we would welcome working with them."

Updated on March 13, 2024 at 8:03 PST to reflect additional commentary from Con-Cret, Create Creatine, and NOW following the initial publication of the study results.