Still Nervous About Amazon’s New Dietary Supplement Policy? Let Nuherbs’ Lisa Thomas Lay It All Out for You – Part Two
Amazon’s policy has been updated, and the industry has responded. As a highly collaborative, safe and supportive industry, we can meet these requirements together with additional clarity.
Nuherbs and Chief Commercialization Officer Lisa Thomas are here to help you through the process, comply with the new requirements and increase consumer confidence. Let’s Lay it Out Further…
Let’s get back to how you need to comply and by when
As a reminder, there are four main components that must be met on an annual basis, detailed directly from the Amazon Policy as follows:
- GMPs audit: Products are manufactured in a facility compliant with Good Manufacturing Practices (GMPs) set forth by the FDA (cGMPs, 21 CFR 111/117 or equivalent)
- The GMP audit must be performed by an accredited third-party.
- Contaminant screen: Products do not contain contaminants that may pose a human health or regulatory concern
- Content claims screen: Products contain the ingredients claimed on the product label
- Active pharmaceutical ingredient screen: Products do not contain undeclared active pharmaceutical ingredients (APIs)
Amazon will only accept all the above documentation through each seller’s “Manage Your Compliance” dashboard that will show which dietary supplement listings require action, as well as due dates. Amazon will “suppress” product listings that don’t have verification from a third-party Testing, Inspection, and Certification (TIC) organization by your company’s product due date on your dashboard.
Time to break it down further
This updated requirement is specific to dietary supplements (for now - in sexual enhancement, weight loss/management, and sports nutrition and bodybuilding categories) and is pulled directly from the Amazon requirements listed on your Amazon Seller Central Policy page Amazon Dietary Supplement Policy Update.
GMPs audit for Amazon verification
The Amazon verification system in your “Manage Your Compliance” dashboard accepts GMP programs, including but not limited to the following: Eurofins GMP, NSF/ANSI 455-2, 229 GMP, UL GMP, USP GMP, SAI Global, SGS, Intertek, TGA, SQF Dietary Supplements Food Safety Code, GFSI, and SSCI.
Your GMP audits must be performed by an accredited third party. Private audits, first-party audits, consulting audits, FDA inspections, and ISO standards will not be accepted. The GMP certificate must be in good standing and cannot be expired.
A 21 CFR 110 audit for manufacturing, packing, or holding human food will not suffice, as this requirement is specific to dietary supplements. Your audit must therefore comply with 21 CFR 111/117 or equivalent.
Contaminant screen for Amazon verification
Products must be tested for the presence of heavy metal and microbial contaminants, and based on a review of the finished product components may also be tested for pesticides and THC in accordance with requirements outlined in NSF/ANSI 173-2024 or according to USP <2021>, <2022>, <62>, <561>
Content claims screen for Amazon verification
Products must contain dietary ingredients according to tolerances listed in 21 CFR 101.36 and 101.9(g)(3) & (g)(4).
Active pharmaceutical ingredient screen for Amazon verification
Products classified as sexual enhancement, weight management, or sports nutrition and body building must undergo testing for known adulterants outlined in NSF/ANSI 173-2024 5.3.5.1- 4
Product labeling and claims for Amazon verification
Products must clearly show facts panel, ingredient list, identity statement, appropriate FDA disclaimers, and relevant product warnings. Products must not contain illegal or disease claims that are not authorized by the FDA.
Reminder - Amazon has also noted that Certification to NSF/ANSI 173, NSF 229 or NSF Certified for Sport already satisfies the requirements of the Amazon Dietary Supplement Testing/Verification Program; however, even those products that are currently Certified in any of those programs still need to follow the verification process on your Amazon Seller Central portal.
Remember, all dietary supplements need the Dietary Supplement Health and Education Act (DHSEA) statement with an asterisk after any structure/function claims on your label (which extends to your website!), as follows:
“*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Nuherbs can help you through this!
We will be monitoring any updates from Amazon or the three Amazon-approved testing, inspection, and certification (TIC) bodies and posting more information on our site, pertaining to GMPS, micro and pesticide testing, the difference between supplement facts content claims, and label structure/function claims, so stay tuned! New requirements can be daunting, but Nuherbs is here to guide you expertly through the process. Whether you're looking to optimize your current manufacturing operations or seeking compliant new partners, we're committed to supporting you at every stage. Reach out to us today.