In a webinar hosted April 17, Amazon also confirmed that sellers of products notified in these categories will be required to achieve third-party verification via NSF International, Eurofins or UL, with testing data and certificates of analyses going straight from the lab to Amazon.
“Amazon requires selling partners to verify though third-party Testing, Inspection, and Certification (TIC) organizations on an annual basis that dietary supplement products offered for sale in our store meet the following criteria,” said the company and listed the criteria as:
- Products are made in a cGMP compliant facility, and
- Products do not contain any harmful contaminants or contaminants that may pose a regulatory concern, and
- Products contain the ingredients listed on the label, and
- Products do not contain any undeclared APIs (active pharmaceutical ingredients)
Regarding the current list of approved TIC organizations, Amazon said that they have “demonstrated success certifying ISO 17065 food and dietary supplement safety programs” and have API testing capabilities.
Sellers are allowed to work with other ISO 17025-accredited labs (including in-house labs) but are still required to submit this information directly to NSF, Eurofins or UL so that those three organizations can verify if the data meets the requirements outlined by Amazon’s policy.
“Amazon will not be accepting any documents directly from you, as a selling partner, or any organization that is not one of the third-party Testing, Inspection and Certification organizations that Amazon is working with,” said an Amazon representative during the webinar.
If a product is already enrolled in NSF/ANSI 173 certification or NSF 229 certification renewed annually, then the product meets Amazon’s policy requirements, the representative added. If a product falls into this category, sellers must still initiate a test request form through their dashboards—in this case specifically to NSF—to comply with the process that requires that the TIC validate and share the compliance information with Amazon.
Problem categories…
There has been some industry chatter about which subcategories of products would initially be subject to the new policy, and Amazon confirmed it would be focusing on sexual enhancement, weight management and sports nutrition/bodybuilding.
These three categories will not be a surprise for most industry stakeholders and observers: FDA has kept a close watch on those three categories for at least 14 years.
In 2021, the U.S. Food and Drug Administration issued a consumer warning about potentially dangerous drug ingredients in certain male enhancement or weight loss products sold through Amazon and other retailers.
In December 2023, FDA sent Amazon a Warning Letter about “energy enhancing supplements or foods” alleged to contain undeclared sildenafil and tadalafil for male sexual performance.
“At this current time, sexual enhancement, weight management and sports nutrition/bodybuilding dietary supplements have been specifically identified for action as part of this policy,” the Amazon representative confirmed. “We continuously monitor regulatory and customer signals and as a result are prioritizing these subcategories of dietary supplements.
“As we expand these requirements, we will notify impacted selling partners accordingly.
“These three categories of dietary supplements require testing confirming the product does not contain undeclared active pharmaceutical ingredients.”
The company defined sexual enhancement products as: “Supplements marketed to enhance erections, desire, sexual performance and increasing the size of sexual organs.”
Weight management is defined as: “Supplements marketed to reduce macronutrient absorption, increase/decrease body fat or weight, and increase metabolism or thermogenesis.”
And sports nutrition/bodybuilding is defined as: “Supplements marketed to increase energy during pre-workout, post-workout, muscle building, bodybuilding and athletics for the purpose of facilitating an increase in lead body mass, weight lifting, weight training, increase in muscle mass through enhanced muscle repair, recovery and growth, etc.”
Bolster consumer safety
Commenting on the new policy, Federico Luna, chief marketing officer for Timeline, told NutraIngredients-USA: “We applaud Amazon for taking this important first step; it is a significant undertaking. To raise the bar of the safety and efficacy of dietary supplements, we need legitimate manufacturers, third-party labs and retailers like Amazon to work closely together.”
“We are optimistic that this new policy will bolster consumer safety and ensure that only high-quality products reach the market,” he added.
As reported by NutraIngredients-USA, Timeline has previously questioned the quality of some dietary supplements on Amazon listing urolithin A on their label.