Сòòò½APP

A tightened set of standards and requirements regulating the sale of dietary supplements on the Amazon.com platform was established in 2021.

Quality assurance requirements for supplements have been tightened with the implementation of these new standards, which apply to both new and existing products being sold on Amazon.com. For sellers to be compliant with these new regulations, Amazon specifically states that a Certificate of Analysis (CoA) from an ISO 17025 accredited lab must be provided, and the COA must provide clear information regarding the accuracy and safety of each product. Furthermore, the COA must include a quantitative analysis to support the active ingredient concentration as claimed on supplement facts panel. If retailers fail to provide Amazon with appropriate documentation that meets these new standards, they are at risk of having any current supplement product listings suspended, in addition to other avenues of recourse Amazon may pursue, as detailed in this article.

Frequently asked questions about Amazon’s dietary supplement testing and reporting requirements

What is Amazon’s definition of a “dietary supplement”?

Amazon recognizes that dietary supplements come in many forms, which include:

• Powders;
• Pills;
• Tablets;
• Softgels;
• Capsules;
• Powders;
• Liquids, and
• Oral sprays.

The Amazon dietary supplement testing requirements also reference the US Food and Drug Administration’s (FDA’s) definition of a dietary ingredient, which is “a vitamin, mineral, herb or other botanical, amino acid, dietary substance for use to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.”

Are there any specific products or ingredients that cannot be present within a dietary supplement that is sold on Amazon?

Yes. Amazon has published a list of known prohibited dietary supplement products that do not meet their checklist requirements, which can be found in Amazon’s Seller Central portal. Although the published list is not entirely comprehensive and does not include all supplement products prohibited by Amazon, it does provide a lengthy resource detailing many restricted products. It is important to note that as of December 6, 2021, sexual enhancement and weight loss dietary supplement products cannot be sold on the Amazon platform in single or double pill packs, and Amazon will restrict the sale of both single and double pill pack offerings.

In order to comply with Amazon’s requirements, what are sellers of dietary supplements required to submit to Amazon?

Amazon has stated that sellers must provide the following to sell dietary supplements on the Amazon marketplace:

• A valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111;
• A Certificate of Analysis (CoA) for each finished product, or evidence of product enrollment or participation in a specified third-party quality certification program, and
• Product images.

Sellers need to obtain a CoA from a laboratory to submit to Amazon to be compliant with Amazon’s dietary supplement regulations. Are there specific requirements a partner laboratory must meet for Amazon to accept the CoA?

Yes. Amazon will only accept a Certificate of Analysis (CoA) from an ISO 17025 accredited laboratory that is compliant with current good manufacturing practices (GMPs), 21 CFR Part 111, for products that are a dietary supplement as defined in 21 U.S.C. 321(ff)), or 21 CFR Part 117 for any other human food product as defined at 21 U.S.C. 321(f)), or both. Furthermore, the Certificate of Analysis must either list the ISO accreditation number for that specific laboratory, or a copy of the ISO/IEC 17025 accreditation certificate for the laboratory needs to accompany the CoA.

If a manufacturer or distributor has access to an in-house lab which holds ISO 17025 accreditation, the CoA may be generated within that accredited in-house laboratory. Others who wish to sell dietary supplements on Amazon must contract with a third-party lab to obtain a CoA for each product to be sold on Amazon.com, and the third-party lab must be ISO 17025 accredited. If a product is part of a quality certification program, Amazon will accept that certification in lieu of a Certificate of Analysis.

When manufacturers and distributors are evaluating laboratory partners, they should keep in mind that Amazon does not require accreditation specific to a particular test. Rather, Amazon has stated that “the fact that the laboratory holds any ISO/IEC 17025 accreditation demonstrates general competence of performing tests and calibrations.”

What needs to be included on the required Certificate of Analysis for supplements that are sold on Amazon.com?

Amazon’s requirements state the following must be included on dietary supplement CoAs:

• Complete product name;
• Batch/lot number or date code of the finished product sample tested;
• Name, address, and accreditation number of the ISO 17025 accredited laboratory, along with the laboratory’s authorized representative signature, printed name, and title;
• Results from the laboratory assay to support the dietary ingredient concentration as claimed on the supplement facts panel;
• Laboratory methods must accompany each reported result;
• Ingredient name(s) on the supplement facts panel must match the ingredient names on the COA, and
• The units of measure on the CoA need to mirror the units of measure on the supplement facts panel (i.e., g, mg, or mcg).

The guidelines set forth by the online retailer state that actual data and observations must be documented, rather than non-specific statements such as “passes” or “conforms” on Certificates of Analysis. Furthermore, Amazon requires:

The submitted CoA submitted must have been issued within the past nine months;

• CoA documents must be in Portable Document Format (.pdf);
• CoA documents must be accompanied by legible product images, and
• Laboratory tests of expired product will not be accepted.

Are there additional testing requirements for specific product classes?

Yes. Amazon requires testing for specific compounds found in sexual enhancement and weight loss supplements, as detailed below. For sexual enhancements, CoAs must be submitted annually which report the product has been tested for:

• Sildenafil;
• Tadalafil;
• Vardenafi;
• Sulfoaildenafil, and
• Desmethyl carbodenafil.

Weight loss supplements must be tested annually, with results being reported on a Certificate of Analysis, for:

• Sibutramine;
• Desmethylsibutramine;
• Phenolphthalein, and
• Fluoxetine.

Amazon has the right to require testing for additional substances, as well as increase the frequency of required testing, at their discretion.

What are Amazon’s product image requirements for dietary supplement submissions?

According to Amazon’s dietary supplement requirements, product images must accompany the Certificate of Analysis (CoA) and must:

• Be legible;
• Have all sides of the product label visible;
• Have a clear image of the supplemental fact panel, ingredient list, certification logos, identity statement, use instructions, and any product warnings;
• Contain the name and contact information of the brand owner or manufacturer, and
• Contain the product name.

Amazon will not accept a computer-generated image or mock-up of the product or its packaging, and these images must appear on the detail page for the product being sold.

In addition to Amazon’s specific requirements, what other requirements or regulations do dietary supplements need to meet to be sold on Amazon.com?

In addition to Amazon’s policies that apply to those specific products and product listings, the online retailer states all dietary supplements sold on the Amazon marketplace must meet 21 CFR 101.36 regulations for nutritional labeling of dietary supplements, as well as the regulations within 21 CFR Part 111, which sets standards for current good manufacturing practices in manufacturing, packaging, labeling, or holding operations for dietary supplements, in addition to any applicable federal, state, or local laws.

What is a summary of the requirements of 21 CFR 101.36 Nutritional Labeling of Dietary Supplements?

21 CFR 101.36 sets specific standards for:

• Serving size;
• Servings per container;
• Information on dietary ingredients that have a reference daily intake (RDI) or a daily reference value (RDV) as established in 21 CFR 101.9 (c) and their subcomponents;
• Names and quantitative amounts by weight of each dietary ingredient;
• Amounts of vitamins and minerals, excluding sodium and potassium, included in one serving of the product;
• Percent of the Daily Value of all dietary ingredients declared under 21 CFR 101.36 (b)(2)(i), except that the percent for protein may be omitted, and
• Total fat, cholesterol, sodium, carbohydrates, and protein.

Detailed requirements for declaring calories are also provided in 21 CFR 101.36 (c)(b)(1). It is important to note the guidance states percentages based on RDI’s and on DRV’s shall be expressed to the nearest whole percent, except that for dietary ingredients for which DRV’s have been established, ‘‘Less than 1%’’ or ‘‘<1%’’ shall be used to declare the ‘‘% Daily Value’’ when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the ‘‘% Daily Value’’ when rounded to the nearest percent is zero (e.g., a product that contains 1 gram of total carbohydrate would list the percent Daily Value as ‘‘Less than 1%’’ or ‘‘<1%’’).

If a supplement contains a proprietary blend of dietary ingredients, this must also be included in the list of dietary ingredients described in 21 CFR 1011.36 (b)(3)(i), identified by the term ‘‘Proprietary Blend’’ or another appropriately descriptive term.

Dietary supplement manufacturers and retailers should refer to and reference the guidance to ensure product labeling meets the regulations and requirements detailed within.

What does 21 CFR Part 111 cover?

As a high-level overview, this guidance sets standards for:

• General provisions, including who is subject to the regulation, definitions, and other statutory provisions and regulations that apply;
• Personnel;
• Physical plant and grounds, from sanitation requirements and written procedures to design, construction, and record-keeping;
• Equipment and utensils, including automated, electronic, and mechanical equipment;
• Holding and distribution of dietary supplements;
• Returned dietary supplements;
• Product complaints, investigations and record-keeping, and
• Record-keeping requirements, including what records must be made available to FDA.

Moreover, several production and process control system requirements are defined, including:

• Establishing a product and process control system;
• Quality control system requirements for both personnel and operations;
• Requirements for components, packaging and labels for products that you receive for packaging or labeling as a dietary supplement;
• Master manufacturing records;
• Batch production records;
• Manufacturing operations, and
• Packaging and labeling operations.

Do sellers of supplements that contain proprietary blends need to provide test results for each individual ingredient in the blend, or will Amazon accept test results that demonstrate the total amount of active ingredients in the proprietary blend is accurately represented on the label?

Proprietary blends must be listed on supplement product labels as detailed in 21 CFR 1011.36 (c). There are 2 acceptable routes of reporting on the CoA:

• List quantitative amounts for all ingredients listed in the proprietary blend, or
• List the ingredient “by input” (also known as quantitative amount by weight).

If it is not possible to list the quantitative amounts of all ingredients in the proprietary blend, and the “by input” method is used, a CoA for raw materials must also be submitted to verify that the ingredients present in the proprietary blend meet strength, identity, purity, or composition specifications claimed on the label without testing, as permissible in 21 CFR 111.75(c).

Alternatively, additional information to confirm purity, identity, and composition specifications are met may be obtained by ingredient identity testing or similar methodology.

Is a Certificate of Analysis required for herbal supplements sold on the Amazon website?

A CoA with laboratory assays for each ingredient is required for any herbal supplement sold on Amazon.com if the nutritional facts panel for the product claims:

• A primary plant constituent (e.g., amino acid, proteins, or common sugars), and/or
• A secondary plant constituent (e.g., tannins, flavonoids, alkaloids, terpenoids, saponins, or phenolic compounds), and/or
• Whole plant ingredients, which are explained in more detail below:

A CoA confirming plant identity must be submitted to Amazon for whole plant ingredients, including plant part(s) such as roots or leaves, in a dried state (i.e., powder).

What happens to non-compliant sellers of dietary supplements who fail to provide Amazon with CoAs and other required documentation? What penalties might they face?

If sellers of dietary supplements on Amazon do not provide the information required by the applicable deadline, they may be subject to the following actions:

• Relevant product listings may be removed;
• A seller’s ability to add new products and/or listing privileges may be suspended;
• Payments due to sellers may be withheld, and/or
• Amazon may pursue legal action.

Moreover, Amazon reserves the right to take any further action they deem necessary or appropriate, at their sole discretion.

Сòòò½APP helps sellers of dietary supplements comply with Amazon’s requirements

Сòòò½APP is an ISO 17025 accredited, FDA registered lab, and our team of consultative, expert scientists can design testing programs and assays to produce Certificates of Analysis that meet Amazon’s requirements. Furthermore, for products that contain proprietary blends or botanical ingredients, our depth of expertise and experience allows us to develop and utilize existing methods to report data that meets the reporting standards set forth by Amazon. Our team stays up to date on regulatory and industry guidance, from retailer-specific requirements and standards to FDA guidance, and we have proven success in supporting wellness and dietary supplement product lines throughout the product life cycle.