Highlights

  • Potential Challenges for Sellers

  • Amazon’s Requirements & What They Mean to the Future

  • Who Benefits From New Requirements?

When it comes to dietary supplements, Amazon has a significant impact on the market. Recently, Amazon updated its requirements; a shift that has the potential to influence the supplement industry even further. Part 1 of our blog series outlined the new requirements for sellers and how they align with Food and Drug Administration (FDA) regulations. Now that we have a better understanding of these new requirements, we will dive deeper into the challenges they pose and future implications for the dietary supplement industry.

Potential Challenges for Sellers

GMP Protocols: GMP audits border on extreme, and for good reason. The FDA understands that the Pharma industry cannot, and will not, become the Wild West; both quantitative and qualitative controls are required to prevent this.  Indeed, Big Pharma appreciates this. They also have the budget and pricing power to meet these standards. But, what about dietary supplements? Remember, the FDA considers supplements food, not Pharma.

So, are smaller companies expected to adopt rigorous, costly, often unwieldy GMP protocols and undertake regular audits? Amazon wants its supplement sellers to ensure consumers that it operates in accordance with generally accepted manufacturing best practices.  This is very different from GMP compliance.  

Certainly, Amazon wants its supplement sellers to ensure consumers that it operates in accordance with generally accepted manufacturing best practices. However, this is very different from GMP compliance. In fact, Amazon recently clarified its position referring to the generally-accepted policies of FDA’s 21 CFR Part 111 as suitable “GMP” guidelines. Compliance with FDA guidelines will suffice.

ISO Accreditation: A testing facility may be ISO 17025 accredited however, not every analysis run will be on their ISO scope. Is Amazon requiring that each test run on every possible active ingredient be on the ISO scope to be considered valid? What about method grouping and so on? What if the accrediting body does not cover a particular method for, say, an esoteric botanical? If each test must be on the ISO scope, compliance will be next to impossible. Sellers with complex formulations or unusual actives will have to send various ingredients for the same formulation to different labs. This increases cost and labor. Of course, a lab may be able to add a particular analysis to their ISO scope but would probably only do so if the volume/value proposition was there.

Again, this disproportionately impacts smaller companies. As with GMP, Amazon recently clarified its position on ISO accreditation as well stating,

“We only require that the laboratory (in-house or third-party) currently holds an ISO/IEC 17025 accreditation. Although we do not require accreditation specific to a certain test, the fact that the laboratory holds any ISO/IEC 17025 accreditation demonstrates general competence of performing tests and calibrations.”

Testing Methodology: With thousands of possible ingredients, some quite esoteric, testing will inevitably run into a few brick walls. For example, there may be no Certified Reference Material (CRM) available for testing control. Qualitative analysis may be manageable while quantitative may be far more difficult or undoable by conventional methods. Similarly, there may be no commonly-accepted or peer-reviewed methods available. What then? There are ways to manage this, but will they be compliant with Amazon’s new requirements? It is suspected that they want testing done at labs that are ISO 17025 accredited but do not require all analyses to be on scope.

Some clarity from Amazon would be helpful here, and they’ve recently provided it.

“Industry-recognized laboratory assays of finished product should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, then you must provide either a CoA for the raw materials or additional information (such as ingredient identity testing) that can verify that the ingredients meet their specifications for identity, purity, strength, or composition as claimed on the label without testing, as permitted by 21 CFR 111.75(c).”

In other words, if there is no test available, a seller may submit supporting documentation from their supplier(s). This shifts the burden up the supply chain. Although this doesn’t remove the requirement that all active ingredients be tested, it takes much of the weight off the shoulders of sellers.

Ingredient Nomenclature: Matching active ingredient names on the supplement facts panel to the active ingredient name on the CoA may pose a challenge. Many ingredients are tested by the constituent parts rather than the popular compound name. This means that the reported results will not always match the active ingredient name on the facts panel. This remains an issue that Amazon may address in the future.

Shaping the Future

On the face of it, Amazon’s requirements for analytical claims validation are outstanding and well-intentioned. It is no industry secret that, in the absence of stricter government regulation, supplements can sometimes fall far short of consumer expectations. However, there are a few challenges here, and Amazon has recently provided critical clarification in a timely fashion.

Analytical testing provides empirical evidence that claims are legitimate, and Amazon is taking the lead in providing its customers with the assurances they expect and deserve while also meeting growing demands for surveillance over what is sold on their platform (in much the same way there is a growing demand for social media to monitor what transpires on their platforms).

In establishing new requirements for safety, labeling, and verification, Amazon gives consumers’ interests a high priority, establishes harmony with FDA regulations, and ratchets up the scrutiny on sellers who sell products that don’t meet regulatory or consumer expectations.

Another interesting implication is the net effect Amazon’s requirements will have on product development. If Amazon decides to operate as tightly as possible, this can have a deep impact on the ingredients used in the formulation. For example, will products include only those active ingredients that are readily and cheaply testable? Will labs adjust to meet the testing requirements of more esoteric ingredients if there isn’t a lot of business there? Will large companies file proprietary testing methods with Amazon and be the sole providers of ingredients that are not readily testable elsewhere?

The initial impact will be beneficial, as Amazon helps support the Dietary Supplement industry.

What can Mérieux NutriSciences do for you?

Contact us to learn more about how these changes could affect your product.

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