May 13, 2021

Prospect Sconsultation

The health experts

Supplement industry responds to new Amazon requirements

9 min read

In December of 2020, Amazon began requiring comprehensive testing and other documentation—covering potency claims, facility GMPs and more—for supplements sold on the giant e-commerce platform. The requirements are a long time coming but appear both overly burdensome and insufficient. Still, say advocates and critics alike, it’s a step in the right direction. Nutrition Business Journal reached out to a posse of industry leaders for their opinions.

Holly Bayne, attorney, Bayne and Associates:

“Amazon’s new requirements for quality control documentation from sellers of dietary supplements are long overdue and, generally, welcomed by the responsible players in the industry. Amazon’s ubiquitous e-commerce platform is a go-to choice for consumers and sellers alike, and without effective oversight by Amazon itself quality cannot be guaranteed. What waits to be seen is whether Amazon will meaningfully engage with the major trade associations and other responsible stakeholders to ensure the requirements are well suited to the task and fit for their intended purpose.

As the program is implemented, refinements may be needed, such as the requirement that CofAs be provided by an ISO/IEC 17025-accredited lab, which is overly broad and may unduly complicate the process. Since the passage of DSHEA and rise of the internet, responsible sectors of the dietary supplement industry have been committed to ensuring that unscrupulous actors selling adulterated and misbranded products are barred from e-commerce sales. Industry is ready and willing to work with Amazon to achieve this shared goal.”

Karen Howard, CEO/executive director, Organic and Natural Health Association:

“Amazon’s sledgehammer approach to cleaning up the marketplace—a goal for all ethical, quality brands—was clearly derived without the benefit of industry expertise and is rife with unintended consequences.

Requiring that analytical test results must come from an ISO 17025 certified lab eliminates labs that are uniquely equipped to test for certain actives. Use of validation by input testing of non-standardized botanical powders demonstrates Amazon’s limited understanding of the inherent challenges involved. Porting over the LegitScript blacklisted products identified by the debunked New York AG “DNA testing” is, at best, ill-informed.

Fortunately, Amazon is seeking industry input. It is essential that all of the industry associations deliver a unified message to Amazon in support of stricter, and sensible, testing requirements. Requirements that both enable legitimate, high-quality products to enter the market and ensure adulterated products are detected and removed from the market.”

Megan Olsen, vice president and associate general counsel, Council for Responsible Nutrition:

“CRN appreciates that Amazon and other large retailers are launching retail standard programs to help ensure that the dietary supplements on their store shelves are safe and unadulterated. We recognize that these programs are necessary, to police the supplement aisle, and appreciate how they highlight the hard work of reputable companies that ensure their supplements are safe and meet regulatory requirements. Multiple standards, however, can create a complicated patchwork of requirements that is difficult for both manufacturers and consumers to navigate. CRN has flagged these concerns for Amazon and other large retailers and asked for these retailers to consider building harmonized standards that allow manufacturers greater flexibility in how they meet retailer requirements.

Amazon updated their supplement requirements in February to provide further clarity, including that manufacturers can use both third-party and in-house labs if the labs are ISO 17025 accredited, as well as clarifying that ISO 17025 accreditation was not needed for every test performed by the lab. CRN applauds Amazon for making these clarifications to help address industry concerns and is hopeful the company will continue to listen to concerns to build more flexibility into their requirements moving forward. CRN strongly believes that flexible standards and harmonization will better benefit both retailers and consumers by eliminating duplicative and costly testing and allowing retailers to confirm a manufacturer’s quality systems that are already in place.”

Michael McGuffin, president, American Herbal Products Association:

“Amazon’s revised dietary supplements compliance program is seen by many supplement brands as moving in a good direction. There is strong support for Amazon taking on an active retailer gatekeeper role and a perception that this will benefit consumers and responsible supplement companies.

One positive part of the program is the new requirement to have product labels visible on each seller’s webpage. AHPA adopted a similar policy in 2006 to encourage product information be provided prior to purchase, so that consumers know what they are buying. 

There are, nonetheless, concerns on some of the program’s details, especially in the new responsibility for submitting evidence of manufacturing compliance. There is general support for this new requirement; if properly applied, it should ensure product quality. We expect Amazon to be receptive to suggestions for clarification and improvement of some details, and we will continue to share our ideas to make the program better.”

Frank Jaksch, co-founder and executive chairman, Chromadex:

“With the robust consumer interest in supplements fueled by the pandemic, now is the time to ensure the health and safety of millions of Americans who trust and rely on dietary supplements for their health.

Overall, ChromaDex is supportive of the new Amazon specifications for dietary supplements, it is a good first step. However, I would not expect these new specifications, on their own, to fix the problems with DS products that are available on Amazon. For example, the quality problems that were reported by NOW Foods will not be fixed with these new specifications. 

We all know it will be easy for companies selling supplements on Amazon to produce the required documents. Truly ensuring the quality of supplements sold on Amazon would require the implementation of a surveillance or testing program. If we use history as our guide, without a mechanism for policing and enforcing these specifications, it essentially does nothing to ensure the quality of products being sold.”

Jim Emme, CEO, NOW Health Group:

“Amazon is coming at this with good intentions—and I appreciate that they sought direction from the trade associations—but it will be interesting to see how they go about enforcing it. Their past record selling products that did not meet labels claims, as our labs showed, means they need to prove those good intentions. We need to see what happens when the rubber hits the road. In a lot of ways, they’re a tech company; they’re not really a retailer. At some point there is going to be clarity, and we’re going to find out real fast which brands aren’t ready.”

Wilson Lau, vice president, Nuherbs:

“I agree with the reasons behind Amazon’s new rules but worry about implementation. Amazon’s processes are highly automated, so if your first submission isn’t perfect, you may get trapped in limbo because you can’t find someone to help complete the process. Another great concern is that Amazon is set up as a marketplace, where the listing may not be controlled by the brand owner, who needs access to update information to reflect compliance. Lastly, even if the brand owner can meet all their requirements, the reseller may be selling other items that may not meet the requirements. If they are buying grey market goods or diverting it from other channels, will that behavior impact the brand owner and their listing?”

Suzanne Shelton, The Shelton Group:

“Amazon has taken a good first step in managing a category that accounts for a significant amount of the supplements people buy and consume. They deserve kudos, even though they delayed until NOW Foods’ tests revealing rubbish products forced their hand. I hear some manufacturers are panicked about meeting the requirements, which reminds me of when the cGMP requirements were first announced. Get it together, peeps. You should be able to comply. Requirements to prove identity and potency might stop no-name brands from selling active-ingredient-free knockoffs of expensive supplements—a practice that hurts everyone.

Proving quality is essential, but Amazon’s requirements could and should be finetuned by industry input. They should also develop a database of reputable manufacturers, and when a newcomer launches a product in a high price product category, give them extra scrutiny. An advisory council from the industry would be a significant information resource for Amazon in managing the category better.”

Mike Bush, CEO, Prenexus Health:

“While it is great that Amazon is focusing on quality and safety in the supplement category, their requirements were apparently developed without enough input from the industry. I am sure everyone in our industry can agree that testing of finished products varies from product to product and category to category. For example, probiotics require vastly different testing procedures than other supplements, and labeling requirements are also quite different, and I see no evidence that Amazon is taking into consideration labeling guidelines developed by well-informed industry groups. CRN and the IPA developed labeling standards for probiotics, but I do not see anywhere that Amazon has adopted or even fully understands the established guidelines and associated testing methodologies; although it would be fantastic if they took the lead and utilized the standards for the millions of dollars of probiotic supplements they sell.”

Len Monheit, CEO, Trust Transparency Center:

“It’s high time that Amazon applied checks on quality and accountability. For years, we at TTC have noted non-compliant Amazon-listed products, and this is a problem and a discredit to the industry.

However, the lack of a regulatory basis for some of their requirements, the opacity and heavy-handedness of their approach and inconsistency in rollout and even the scope of products to which the new rules will be applied (and exactly when), is worrisome as it continues to make it seem like their systems are arbitrary.

Brands are scrambling to do what they should have been doing from the outset—it’s not rocket science; it’s the law. The jury is still out on whether these brands finally take the proper responsibility for the products they put on the market or continue to deflect to their contract manufacturers.”

Elan Sudberg, CEO, Alkemist Labs:

“Amazon’s new requirement for the supplement industry is a terrific movement towards cleaning up their part of this industry.

With the exception of the ISO 17025 lab chokepoint (Alkemist Labs is ISO 17025 certified), the majority of Amazon’s quality documentation requirements should be available and not new. The good companies in our industry already do the work required and have the data. They just need to know where to put it.

To those who think these provisions are unreasonable, perhaps that’s your cue to find another industry to play in, because at some point the FDA is going to notice that your quality program sucks.”

Andy Dahlen, CEO, MegaFood:

“MegaFood applauds and supports Amazon’s objective to upgrade standards for manufacturers in the supplement category. The requirement of ISO 17025 certification, commonly pursued by third party labs, only partially achieves that objective. We believe that Amazon should require manufacturers to be GMP certified so the actual process of manufacturing the products is elevated to higher standards. GMP certification includes a review and validation of the testing process. It is encouraging that Amazon is engaging with the industry via trade associations to find the best approach to upgrade the standards.”

Loren Israelsen, president, United Natural Products Alliance:

“The market power that Amazon can employ is unlike anything our industry has ever dealt with. They use the word “millions” to describe the number of dietary supplement SKUs on their platform. What that scale means for the future of the industry is doing things we’ve never been asked to do before and doing them in ways that are new to us. We need to remember that Amazon is a technology company, not a retailer with shelves to fill. It’s AI, not A and P.  For us, it’s adapt or die.

We should also accept that Amazon is effectively part of our industry now. For the first time, we will know the people who are running these programs. We are going to start seeing them at industry events. There’s been this big gray wall that we’ve never been able to see beyond and this new level of communication could help us understand what’s behind it.

What this scale, technology and engagement means is that Amazon may be able to do what the FDA, the FTC, the trade associations and the plaintiff’s attorneys have been trying to do for years, which is to clean up the supplement industry and ensure product quality. What we’ve seen so far is just the first step and it shows us why industry engagement is so crucial. We need to take that first step with them, and all the ones that follow it.”

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