Nervous About Amazon’s New Dietary Supplement Policy?
Let Nuherbs’ Lisa Thomas Lay It All Out for You
We as an industry saw the news break. We made our assumptions. We may have even joined the April 17th, 2024, webinar – “Amazon’s Policy for Listing Dietary Supplements in the US Store”.
And we may still not quite know what to do from here.
Let Nuherbs and Lisa break it down for us all.
What's the big deal about Amazon's new Dietary Supplement Policy?
First and foremost, these new requirements meet a need in our industry to help consumers understand that our dietary supplements/functional foods ingredients and products are indeed regulated by the FDA. And they are regulated by us together as a responsible industry full of experts in health and wellness. This is a collaborative call for safety, science, quality, transparency, and alignment between brands and manufacturers for what is important to our consumers, our family and friends, and ourselves.
Amazon’s decision to further develop their approval process for dietary supplements stems from heightened scrutiny by regulators, industry, etc., including FDA warning letters in 2023. It was also one of a few retailers noted in an FDA warning early this year that several supplements claiming to be “tejocote” were adulterated with toxic yellow oleander, following a similar investigation by FDA and Centers for Disease Control in 2023.
Additionally, NOW Foods conducted tests in recent years on multiple products purchased through Amazon, finding that many failed to meet their label claims for potency. Safety and efficacy is of utmost importance, and Amazon has put this increased verification process into place to protect consumers from those “bad players” in the industry with the positive side effect of highlighting the myriad of honest brands and manufacturers offering invaluable products for health and wellness.
Who needs to pay attention to these changes?
The April 17th Amazon webinar made it clear that – for now – it affects only products on the Amazon US platform that fall into the categories of sexual enhancement, weight loss/management, and sports nutrition and body building products. Also clear was the fact that the product categories could increase in the future as needed, and considering the intro was all about “What is considered a dietary supplement” and that Amazon is “listening to regulatory and customer signals”, this leads us to prepare for other categories to be added.
Ok, but how do we comply and by when?
There are four main components that must be met on an annual basis, detailed directly from the Amazon Policy as follows:
- 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.
- Products do not contain contaminants that may pose a human health or regulatory concern
- Products contain the ingredients claimed on the product label 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.
We already comply with most if not all of that, so what’s new?
- There are currently only three third-party TIC organizations Amazon is utilizing for this verification process:
- You must use your Amazon “Manage Your Compliance” dashboard to initiate a test request form for each product with one of the third-party TIC organizations that Amazon is working with. Once testing is requested, you must work directly with the third-party TIC organization to complete the testing of your products.
- Amazon mentioned that the approved third-party TIC organizations is subject to change, so check your Amazon “Manage Your Compliance” dashboard for any updates.
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.
What does this mean for me?
Amazon has made it clear that this current policy went into effect as of early April. Avoid being suppressed by Amazon and ACT NOW.
How can Nuherbs support me through these changes?
We will notify you with all Amazon policy updates and develop more tools that can help you with cGMPs auditing, micro and pesticide testing, content/label claim testing, API testing, etc.
For Brands
Nuherbs will help you work with your manufacturer(s) to ensure you are set up for success throughout this process, as Amazon will need the appropriate cGMP Certification through one of the approved third parties. We will also review your formulation(s) and label/content claims and make recommendations, focusing on financial feasibility for the required testing portion of this updated policy.
For Contract Manufacturers
Nuherbs will review all your Amazon customers’ formulations and label/content claims and make recommendations, focusing on financial feasibility for the required testing portion of this updated policy. We can also assist you with promoting your GMP verification for other Brands who need to meet these same requirements.
For Practitioners with your line of products
This may all be new to you, and we can assist in navigating you through the process, helping your current manufacturer, or possibly finding a new manufacturer who meets the GMP and Amazon verification requirements.
Feeling overwhelmed by these new requirements? Reach out to us today, and let Nuherbs expertly guide you through this process, whether it's optimizing your current manufacturing setup or connecting you with compliant new partners. We're here to help every step of the way!
Stay tuned for more from me and how you can meet Amazon’s US Policy and continue your success as a partner in our industry!