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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.
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).
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.
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