We're excited to have Brian Yam, VP of Quality & Regulatory Affairs at Blue Ocean Regulatory, share his expertise and deep understanding of Amazon’s supplement policies and new updates that have rolled out in 2025.
Blue Ocean Regulatory is a trusted leader in navigating the complex world of dietary supplement, food, and health product compliance. With over 20 years of experience, their expertise ensures brands can confidently expand into new markets while maintaining compliance.
If you are a brand that is new to compliance in the dietary supplement space & want to learn more, and get free resources, check out their YouTube Channel or work with Blue Ocean Regulatory directly by emailing them at [email protected].
The Growing Challenges of Selling Supplements on Amazon
Selling supplements on Amazon may seem quite alluring especially when there are brands on the platform selling 20,000+ units per month. Rewind several years ago and listing on Amazon was a relatively easy process. Things have changed however, as Amazon has faced regulatory action by the FDA and recently increased its requirements to ensure supplement brands are compliant with FDA requirements.
What Does Amazon Require from Supplement Brands?
Amazon now requires the following as part of the listing process:
- Brands must utilize a manufacturer that has the appropriate third-party cGMP certification to demonstrate compliance against dietary supplement requirements (21 CFR 111 and 117). You will want to ensure that your manufacturer has this document, is in good standing, and that they are authorized to manufacturer the specific dosage form for you.
You’d be surprised, some manufacturers (domestic and overseas) do not have this document as it’s not technically required by FDA, but it is indeed required by Amazon. This exercise alone may reveal that your supplier is actually a broker and that broker should not hesitate to provide you with such documentation. - Supplements are to be tested by Amazon through their testing program. Currently, there are three labs recognized by Amazon: NSF, UL and Eurofins. One mistake that small brands make is that they simply test the product and ‘hope’ that it passes.
While you may take the gamble and pass, you may also fail. In other words, it’s like spinning the roulette wheel and hoping the outcome is in your favor. A sounder approach is to ensure that the manufacturer has engineered your product/formula and your testing specifications to ensure it will meet Amazon’s testing parameters.
You should ask your manufacturer for the product specifications and ensure the right test parameters are built in and that the pass/fail criteria is stringent enough to meet Amazon’s requirements.
If you’re not familiar with analysing a specification or certificate of analysis, be sure to get help from an expert who has this experience. This is an exercise we support supplement brands on which helps ensure better consistency in the quality of their products as well as provides more comfort on whether or not their product passes Amazon’s testing program.
One additional note: the brand may also want to (in fact, we encourage this) test their product with a third-party lab before Amazon requests this to get a sense of whether your product will pass or fail and to smooth out any kinks in the lab method. - Supplements are to be properly labeled as required by FDA and FTC. Label regulatory review is often a step that manufacturers include as part of their services. While it’s better than no review whatsoever, in most cases, the regulatory review is only limited to the ingredient listing and supplement facts table.
The reality is that the brand is responsible for ALL content across the label and that includes content outside of the supplement facts – think of your front of panel claims, your structure/function claims, any call-outs like “dairy-free” or “non-GMO”, which are most vulnerable to litigation, competitor and regulatory enforcement action.
There are some elements of the label that fall outside of FDA but still applies to you, as the brand-owner, so it’s key to have your label reviewed by a compliance expert that is well-versed in dietary supplements.
What to Look For in A Manufacturer
Now while the items above may seem relatively simple to execute, it’s imperative that your brand uses a reputable, cooperative contract manufacturers that will support you when times are tough.
Many manufacturers tout themselves as being “FDA registered” or third party GMP certified, which are all great things to have (and expected!) and their sales rep is by your side when they’re itching for that next purchase order…
But one other factor to keep in mind is to ensure that your manufacturer will support you when things go wrong – when test results fail, when a customer complains to you that they had a horrible side effect taking your product, or when Amazon flags your product for a safety complaint.
If/when Amazon tests your product and the product fails the listing product, will the manufacturer help you? Will they respond to you in a timely manner or will they ghost you? Will that sales rep be an advocate for you or let their ‘quality’ department take care of it?
My point here is that while Amazon’s requirement is focused on testing, proper compliance goes beyond that and expands both upstream (your manufacturer, their raw material testing, etc) and downstream of your entire supply chain (your warehouse, product shipping, traceability).
At the time of writing, Amazon has communicated that much of their testing program requirements will be prioritized to products in the sexual health category, weight loss category, bodybuilding and sports nutrition category, and joint-health product category. That said, as the program continues to be rolled out, it is possible that other supplement categories may be flagged for testing and compliance in the near future.
And regardless of whether your product is in these prioritized categories, it’s important that your brand has the ability to scale and grow for the long-term and be ready for whatever Amazon decides to do in the future - ensuring compliance to FDA requirements will certainly help you in that endeavor.
Whether you’re a startup, an established business, or a global entity, Blue Ocean Regulatory can help you navigate these challenges. With extensive experience and a professional, tailored approach, they ensure compliance aligns seamlessly with building and strengthening your brand’s value proposition. Learn more and get free resources by checking out their YouTube Channel or work with Blue Ocean Regulatory directly by emailing them at [email protected].
