Amazon is requiring that compliance verification for dietary supplements sold through its storefront be provided directly from one of three third-party organizations: NSF, UL, or Eurofins.
 
However, “the list of third-party testing, inspection, and certification (TIC) organizations is subject to change,” noted Lisa Brines, senior compliance manager at Amazon, during a webinar presentation on Apr. 17 titled “Amazon’s Policy for Listing Dietary Supplements in the US Store.”
 
“Amazon won’t accept any documents, including test results, certificates of analysis (CoA), cGMP certifications, evidence of participating in a quality certification, or anything else directly from sellers or any organization that isn’t one of the third-party organizations (Amazon) is working with,” said Brines.
 
Companies can still use ISO 17025-accredited labs, including in-house ISO labs, but sellers will need to submit testing information to one of the three TIC organizations Amazon has identified. These gatekeepers will validate that products meet Amazon’s criteria that:

• Products are manufactured in a facility compliant with Good Manufacturing Practices set forth by the FDA (cGMPs, 21 CFR 111/117 or equivalent);
• Products do not contain contaminants that may pose a human health or regulatory concern;
• Products contain the ingredients claimed on the product label.

“Amazon policies permit NSF to accept certain data from ISO-accredited labs when NSF can attest that the data is generated using scientifically valid methods meeting the minimum requirements of certain sections of NSF/ANSI 173," said Brandi Reinbold, senior manager, global certification at NSF. "NSF is able to verify the data represents compliant results based on the product label and NSF’s inspection of the documentation to ensure we cannot detect any fraudulent alterations."

Reinbold said NSF has quality agreements "with a number of ISO 17025 laboratories" and that it "will be working to expand that list and to establish authentication procedures for data issued by approved labs."

Reinbold also said NSF is “committed to ensuring no Amazon Seller is subjected to duplicative testing, while upholding Amazon’s rigorous new requirements and ensuring the integrity of any attestations NSF may make regarding compliance.”

Amazon is prioritizing review of sexual enhancement, weight loss/management, and sports nutrition and body building products, which must also be tested for active pharmaceutical ingredients (APIs). The API testing policy will eventually expand to cover more categories outside of this priority area, and sellers will be notified if they’re impacted, Brines said. 

How to Ensure Products Meet New Requirements

Each seller’s “Manage Your Compliance” dashboard will show which dietary supplement listings require action, as well as due dates. Amazon will “suppress” product listings that don’t have verification from a third-party TIC organization by the due date, Brines said.
 
Through the dashboard, sellers are required to select a third-party TIC organization to complete testing of all products to ensure they conform to Amazon’s requirements.
 
Sellers have the sole responsibility of providing third-party TIC organizations with the information required to achieve verification, and after submitting a test request form for a given product, will receive an email from the organization of their choice within two days.
 
Amazon can’t guarantee a maximum turnaround time for a given verification, and there is no flat cost per listing due to variations in product complexity and the amount of testing needed.
 
Turnaround time and cost “is really going to depend on the third-party testing organization, as well as on the product itself,” said Brines. “We encourage all selling partners to reach out promptly when they receive a notification and talk to them about volume, turnaround time, and more.”

Are Any Products Exempt?

If a flagged product was tested recently by a lab with ISO 17025 certification, those testing results can be shared with one of Amazon’s third-party partners, who will then need to validate them against Amazon’s requirements. Products already tested by NSF, UL, or Eurofins within the past year also will be covered.
 
Separate listings, such as varieties of flavor, package size, and more, will each be individually flagged in the dashboard. If those products were all manufactured in the same location, however, sellers can ask their chosen third-party TIC organization to consolidate testing results and eliminate those cost redundancies. 
 
After testing is completed, results will be shared concurrently with Amazon and the seller, via the “Manage Your Compliance” portal. If a product is rejected by the third party, or if more information is needed, Amazon will suppress the sale of that product, Brines said. Sellers can also initiate an appeal process if their product is suppressed through the “Manage Your Compliance” portal.
 
More details on Amazon’s dietary supplement policy as a whole can be found here, while additional information on the new CoA requirements is available here.

Amazon Has More Skin in The Game

Amazon first required dietary supplement sellers to provide it with quality control documentation and certificates of analysis in 2020, to clamp down on the sales of adulterated, counterfeit, and otherwise impure products through its channel. These requirements have been subject to intermittent updates since then.
 
The company has been under more intense scrutiny from regulators, industry, and consumers alike when it comes to the prevalence of adulterated, counterfeit, and low-quality supplements sold on its platform.
 
FDA sent the e-commerce giant a few warning letters in 2023, the most recent of which came after the agency investigated products purchased on its site that were marketed for male sexual wellness. The letter, addressed to Amazon CEO Andy Jassy, said that FDA discovered several products marketed as dietary supplements that contained the erectile dysfunction drugs sildenafil and tadalafil (generic versions of Cialis and Viagra).
 
Amazon was one of a few online retailers implicated in an FDA warning in January that several supplements claiming to be “tejocote” were actually adulterated with toxic yellow oleander, following a similar investigation by FDA and Centers for Disease Control in 2023.
 
Additionally, supplement company NOW Foods has conducted a series of tests in recent years on a variety of products purchased through Amazon, finding that many failed to meet specified potency claims on labels.

Industry Reactions

Some industry insiders have mixed feelings about retailers like Amazon, CVS, and others imposing their own unique quality and testing protocol requirements. For example, a patchwork of unique, retailer-specific requirements can create a burden for small- and mid-size companies in particular.
 
“Our core mission is aligning industry practices from a quality and safety perspective. There are significant advantages there for the broader public’s health, and impressions about how the industry governs itself,” said Allyn Schultis, executive director of the industry nonprofit Global Retailer and Manufacturer Alliance (GRMA). “Often, these programs are privately run, and results won’t always be transferable from one retailer to the next. This ultimately becomes an area we’re really interested in improving, and creating a harmonized approach for these requirements. Our dietary supplement product integrity committee has been working to reduce the variance in these private programs.”
 
According to Elan Sudberg, CEO of Alkemist Labs, all of Amazon’s decisions about its supplements policy to date have been made in a black box, and as a result, aren’t necessarily informed by broader industry consensus.
 
“Aside from Milburn Pennybags and his close friends, all my clients, all the trade associations, and the rest of the industry including me have all been blindsided … I have talked with a few of the largest dietary supplement sellers on Amazon, my clients and friends, and have been briefed on their recent ‘wait, what?’ meetings with Amazon. More data is being released, but this haphazard approach strikes me as ill-considered.”
 
“Generally, I am always pleased to see the industry self-regulate better, but there has to be informed logic to it to be effective,” said Sudberg. “This new quality flex may be a move in the right direction. The downside is that all this was instigated in a vacuum with three of the largest players in the industry outside of the privy of any trade association guidance, so the broader industry feels, and is, a bit sidelined.”
 
“Amazon has a history of going from absolutely no participation in this industry nor show of concern or care about the quality of what’s sold on their platform, to suddenly deploying industry-shaking policy,” Sudberg added.
 
For years prior to this policy, testing labs have struggled to meet the booming demand for services. Sudberg doesn’t expect three labs to be able to handle the massive task as the only gatekeepers for the entirety of Amazon’s dietary supplement category.
 
Further, partnering with just three labs “is a short-sighted move for many reasons, not the least of which is different labs have different areas of expertise,” Sudberg said. “This mandate means brands don’t get to use the best botanical lab in the industry if they want to … Sellers have unique testing plans and specialized methods for complicated products. These are all out the door as the brands that want to sell on Amazon are relegated to two labs to rule them all. It’s not going to work, and it’s not going to help consumers who have been duped on Amazon for years.”
 
“There are plenty of labs that are especially qualified to do work with very unique products out there, with very solid method validation. So, if I was in a manufacturer’s shoes, I’d have a lot of questions about how novel test methods will be considered,” Schultis concurred. 
 
Sudberg said he suspects the new policy guidelines were rushed into effect due to external pressure, and may eventually be rolled back to some degree after being put to the test.  

Standards Harmonization

In the grand scheme of the CPG space, it’s not extraordinary for retailers to have unique quality and testing requirements, and such policies are already common for categories like personal care products, cosmetics, foods, and more. Consumers also largely expect retailers to engage in some level of product vetting, said Schultis.
 
“Reputable retailers feel like they have responsibilities to their consumers,” he said. “It’s a competitive landscape, and so on top of looking for the right selection, quality, price, and convenience metrics, they want to establish requirements for their base of suppliers and sellers … Consumers want to simplify their shopping experience, and don’t want to have to do the homework and think about what facility their product’s been made in, or what tests have been done on it. They want to think about which structure-function claims work best for them. Retailers see this as a means of simplifying the shopping experience.”
 
Despite the challenges ahead, and the fact that consensus still needs to be reached, Schultis said it’s important to remember that these moves speak to the growth of the dietary supplements category. “We’re hoping we’ll be able to engage with Amazon and identify some of the activities our collaborative group has been working on, and how a harmonized approach can help from a transparency perspective while also putting public health at the forefront of what they’re looking to do.”
 
In the years ahead, other retailers might follow Amazon’s lead and only accept quality and manufacturing information directly from a third party, Schultis noted, as a means of improving transparency. “Within our committee, document authenticity and chain of custody is something we’ve been working on, and it’s one of the reasons we’ve partnered with HealthLOQ, which can provide that transparency and traceability. From our perspective, there’s definitely fraud risk out there—creating a phony testing document or a certificate of analysis is probably a walk in the park.” 
 

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About the Author: Mike Montemarano has been the Associate Editor of Nutraceuticals World since 2020. He can be reached at mmontemarano@rodmanmedia.com.