Dietary Supplement Approval Requirements on Amazon: Everything You Should Know

Jared Mason

June 18, 2021

It’s been a rollercoaster year for sellers on Amazon, and one category that has experienced significant whiplash over the past few months is vitamins and supplements.

Since December, Amazon has dramatically changed their dietary supplement approval requirements, making it more difficult for distributors to get approval to sell their products on the platform. These policy changes have prompted widespread head-scratching and frustration for third-party sellers in the market, and they continue to evolve, making it especially important for brands to keep up.

If you’re selling dietary supplements on Amazon and caught up in the confusion, here’s a brief rundown with everything you should know about recent approval policy changes and their implication for your brand.

Previous supplement approval requirements

Historically, there’s been a pretty clear and consistent standard for selling dietary products on the Amazon marketplace, which is why recent changes have been so jarring.

Amazon has been selling vitamins and supplements for a very long time, and any time there was any type of complaint or problem with a vitamin, Amazon, as they do with any product, would pull the listing down and then ask for documentation about that product to verify that it is in good standing, high quality, and things like that.

One of the common forms of documentation Amazon requests from brands is a Certificate of Analysis (or COA). COAs are the standard quality assurance certification in the industry, and they confirm that a product meets the following FDA regulations:

  • 21 CFR 101.36 - Nutritional Labeling of Dietary Supplements
  • 21 CFR 111 - Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements
  • 21 CFR 117 - Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk Based Preventive Controls (HARPC) for Human Food

Before Amazon’s recent policy changes, many manufacturers were able to conduct lab analysis on their own products to prove they were in compliance with product labeling. If a bottle claimed there was 1000mg of Vitamin D in a product, for example, a manufacturer could provide their own lab analysis and produce a COA that proved to Amazon that their product did in fact contain 1000mg of Vitamin D.

After submitting a COA through Seller Central and getting the green light from Amazon, brands were then approved to sell their dietary supplements.

Recent supplement approval policy changes

Until recently, the COA approval process was pretty straightforward. Then in December 2020, Amazon announced that every vitamin and supplement distributor on the platform would be required to get their products reapproved by February 2021 in order to continue selling.

As part of the reapproval process, brands would still need to submit a COA, but that COA could only come from an ISO/IEC 17025 accredited third-party or in-house laboratory. That caveat eliminated many manufacturers’ ability to produce COAs themselves and threw thousands of sellers across the platform for a loop.

Unfortunately, the reality is few laboratories have that certification. It is a standard requirement for certain types of labs, but is not an industry standard for vitamins and supplements. This resulted in many vitamin and supplement manufacturers saying, ‘Wait, what? How are we supposed to deal with that?’

So, why did Amazon change the rules?

The short answer is that Amazon has been trying to increase consumer confidence in the marketplace’s ability to deliver high quality dietary products, but sadly recent changes in Amazon’s supplement requirement policy have largely been arbitrary and created more problems than they’ve solved.

Amazon wanted to up their game. They wanted to be a bit more official looking and make sure that the supplements on their platform were high quality, so they put together this policy that unfortunately had no bearing in reality and caused lots of issues.

Brands expressed concerns such as, ‘We don’t want to get ISO certified when we don’t need ISO certification for anything else. We’re a 100 year-old brand. We’ve been selling high-quality vitamins forever. Why is Amazon requiring this?’ And that was part of the problem.

The fallout

Brands did not sit quietly over Amazon’s abrupt changes. The company received significant pushback from vitamin and supplement distributors, including Pattern, which has been involved in ongoing conversations with Amazon since the start of the year to find solutions for our brand partners.

Since Pattern began conversations with Amazon, the company has changed their dietary supplement approval policy four times, pushing back the due dates for documentation and readjusting the requirements for brands.

The good news is that these recent addendums have made reapproval requirements much more lenient, so brands that do not have certification from an ISO certified lab but have other good manufacturing practices certifications are now able to get approved.

Current supplement approval requirements

Amazon is currently accepting any one of the following certifications from brands for reapproval to sell on the platform:

1. A finished product Certificate of Analysis (COA) issued by an ISO/IEC 17025 accredited lab (in-house or third-party). The valid ISO certificate showing name of accreditation body and accreditation number must also be submitted.

2. A finished product Certificate of Analysis (COA) issued by an in-house laboratory that is compliant with current good manufacturing practices (cGMP) per 21 CFR 111 and 117. A valid GMP certificate of the manufacturing facility must also be submitted. Amazon accepts GMP certificates from the following third-party programs: NSF (NSF/ANSI 173 Section 8), GRMA (GRMA 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

3. Evidence of Product/ASIN enrollment or participation in one of the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, UL Brand Certification Program.

Another thing that Amazon has changed is the timeline requirements for a COA to be approved. It used to be required that COAs were six months old or newer, then it went to nine months, and most recently it’s 12 months.

Because of seller feedback, Amazon has continued to adjust and amend dietary supplement approval requirements. While we can expect more change to happen in the future, one way brands can be prepared for it is to partner with a distributor like Pattern who stays on top of these changes and helps brands compile all of the needed documentation required by Amazon.

Only time will tell what the approval process looks like next, but we’ll be on top of it. Lighten the stress on your brand’s dietary supplement approvals and schedule a consultation with Pattern today.

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Global Ecommerce: Weekly News (6th September 2022)
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Global Ecommerce Weekly News: 6th September 2022

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Global Ecommerce: Weekly News (23rd August 2022)
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