New Amazon policy requires supplements in three categories to have third-party verification

Amazon has formalized a new policy in which sexual enhancement, sports/bodybuilding and weight management products will need third party testing verification prior to sale. Only three testing firms will be certified for the program.

Hank Schultz, Senior Editor

April 19, 2024

3 Min Read

At a Glance

  • Amazon increases testing requirements for some supplements.
  • Sexual enhancement, sports/bodybuilding and weight management are categories covered by program.
  • The program requires results to come through one of three lab firms.

Amazon has announced that sexual enhancement, weight management and sports nutrition/bodybuilding supplements will require third-party testing verification before being sold on its site in the future. 

In addition, the e-commerce retailing giant announced that the testing must be done in or verified by one of only three testing, inspection and certification (TIC) organizations that have been accredited by the company.  

Test verification from one of three lab firms required 

Amazon’s policy mandates that the company must receive documentation directly from one of the three testing firms, which are Eurofins, UL Solutions, and NSF International. Supplement firms that have current reports of test results from ISO 17025 certified labs may provide this documentation to the third-party TIC organization that they are working with to document compliance. 

The policy was announced on April 2 and more broadly disseminated on April 17 via a webinar. In a statement, Amazon said the goals of the program are to ensure that: 

  • Products are manufactured in a facility compliant with current good manufacturing practices (cGMPs, 21 CFR 111/117 or equivalent) as set forth by FDA. 

  • Products do not contain contaminants that may pose a human health or regulatory concern. 

  • Products contain the ingredients claimed on the product label. 

  • Products do not contain undeclared active pharmaceutical ingredients (APIs). 

Related:FDA sends a message with two warning letters to Amazon

FDA has already voiced concerns about the three categories 

Amazon’s focus on these three categories mirrors concerns voiced by the U.S. Food and Drug Administration. The agency has identified these as categories of special concern. FDA has posted this warning for consumers: “When you buy such products, you may actually be getting an illegal product; and that product may contain potentially dangerous ingredients that are not on the label.” 

Via a warning letter issued on Dec. 20, 2023, FDA also singled out Amazon for selling these kinds of products. The letter cited the firm for selling sexual enhancement products that were tainted with the erectile dysfunction (ED) drugs sildenafil (brand name: Viagra) or tadalafil (brand name: Cialis).  

These ED drugs have been safely used for years. But if consumers ingest them unawares, especially when the dosages are not specified, serious safety concerns can result, according to FDA. 

“[Y]our firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs,” the warning letter stated. 

Weight management products have been cited by FDA as being at high risk for being tainted with undeclared APIs such as sibutramine, fenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat and phenolphthalein. 

In the sports nutrition and muscle-building categories, FDA’s primary concern is that the products may contain steroids or steroid-like substances.  

Various kinds of stimulants found in pre-workout products are of concern as well.  In 2022, FDA sent warning letters to 10 companies whose products were found to contain one or more of the following: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl and octopamine. Most of the companies that received warning letters still sell products on Amazon. 



About the Author(s)

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the senior editor of Natural Products Insider since early 2023. He can be reached at [email protected]

Prior to joining the Informa team, he was an editor at NutraIngredients-USA, a William Reed Business Media publication.

His approach to industry journalism was formed via a long career in the daily newspaper field. After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors. The newspaper won two Pulitzer Prizes during his time there.

The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.

Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.

In 2015, Hank was recognized by the American Herbal Products Association with a Special Award for Journalistic Excellence.

When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.

Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.

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