Did you know consumers are willing to pay 11% more for certified supplements? This explains why Amazon supplement requirements continue to tighten for nutraceutical products.
Amazon’s dietary supplement policy now requires third-party verification for all products sold on its platform, effective April 2, 2024. High-risk categories face particular scrutiny, including sexual enhancement, weight management, and sports nutrition supplements. The good news? Meeting these requirements is entirely possible with proper preparation and knowledge.
Many supplement brands struggle when facing these new compliance measures. Our guide breaks down the essential components – from testing protocols to documentation requirements. We cover every aspect of the approval process, including microbiological testing, heavy metals screening, and ingredient verification for your nutraceutical products.
Ready to secure your supplement listings on Amazon for 2025 and beyond? Let’s explore the exact steps you need to follow to maintain compliance and continue selling your products successfully.
Amazon’s supplement policy changed dramatically starting April 2, 2024, reshaping the landscape for nutraceutical sellers in 2025. Grasping these updated requirements proves essential for maintaining your product listings and avoiding costly delays or removals.
The most critical shift in Amazon’s dietary supplement requirements is the mandatory third-party testing and verification for all supplements sold on the platform. While Amazon previously accepted documentation reviews, they now demand physical product testing through approved Testing, Inspection, and Certification (TIC) partners.
Key changes include:
Physical product testing by authorized TIC partners (NSF, UL Solutions, Eurofins)
More comprehensive documentation requirements including manufacturing information
Stricter enforcement of ingredient verification and label accuracy
Implementation of random sampling and testing even after initial approval
The compliance timeline accelerated compared to previous policy changes. Amazon announced these changes in late 2023, with full implementation beginning April 2024 and enforcement becoming increasingly stringent throughout 2025.
Not all supplements face equal scrutiny under these new requirements. Amazon uses a risk-based approach focusing on several high-risk categories:
Weight management supplements undergo extensive testing for hidden pharmaceutical ingredients historically found in these products. Sports nutrition products, particularly those making performance claims, require additional verification for banned substances. Sexual enhancement supplements receive heightened scrutiny due to frequent contamination issues.
All products classified as dietary supplements under FDA regulations must meet these requirements. This includes vitamins, minerals, herbs, botanicals, amino acids, metabolites, protein, collagen, energy products, and other dietary substances intended to supplement the diet.
Amazon’s move to mandatory third-party testing stems from several factors. The supplement industry faces mounting regulatory pressure following reports of contaminated or mislabeled products. By implementing stricter standards, Amazon protects both consumers and its own liability.
Third-party testing addresses four key concerns:
Consumer safety: Independent verification identifies potentially harmful ingredients or contaminants
Regulatory compliance: Testing ensures products meet FDA and other regulatory guidelines
Brand protection: Amazon maintains consumer trust by minimizing problematic products
Competitive advantage: Certified products command higher consumer confidence and sales
This process benefits compliant sellers by creating barriers to entry for competitors unwilling to invest in quality assurance. Despite initial testing costs ranging from $300-$1,500 per product (depending on complexity), this investment typically pays off through increased consumer trust and reduced competition.
The verification process assesses multiple aspects simultaneously, including identity testing of active ingredients, potency verification, contaminant screening, and label claim validation. For sellers committed to quality, these requirements simply formalize what responsible nutraceutical manufacturers already practice.
Amazon’s supplement policy for 2025 represents a shift toward professionalization of the supplement marketplace, eliminating sellers unwilling to meet basic quality standards while rewarding those who prioritize product integrity.
Successful navigation of Amazon’s supplement testing process begins with proper preparation. Before submitting your products for third-party verification, you’ll need to gather specific documentation, ensure your labeling meets requirements, and verify your formula contains no restricted substances.
Thorough documentation forms the foundation of a successful supplement approval process. Amazon’s guidelines require sellers to compile several essential documents before requesting third-party testing:
ASIN (Amazon Standard Identification Number): Your product’s unique identifier in Amazon’s system
GTIN (Global Trade Item Number): Typically your UPC or EAN barcode number
Product brand name: Exactly as displayed on Amazon
Product description: Including package sizes and counts
Manufacturing facility information: Complete name and address
Most importantly, you must obtain a valid Good Manufacturing Practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111, 21 CFR 117, or both. This certificate must be current (issued within the last 12 months) and from an approved certifier such as NSF/ANSI 455-2, NSF/ANSI 173 Section 8, UL GMP, USP GMP, or another recognized organization.
Amazon no longer accepts private audits, first-party audits, consulting audits, or FDA inspection reports as proof of GMP compliance. Instead, certification must come from recognized third parties to ensure impartiality.
Your nutraceutical label must clearly display several required elements to pass inspection. First, verify that your label includes a complete and accurate “Supplement Facts” panel that lists all ingredients and their quantities.
The label must also feature:
The product name and identity statement
Total quantity of the supplement (tablets, capsules, etc.)
Complete ingredient list
Name and address of the manufacturer, packer, or distributor
Appropriate FDA disclaimers and warnings
Examine your label for any disease claims, as these are strictly prohibited unless approved by the FDA. Examples include claims that your product diagnoses, cures, mitigates, treats, or prevents disease. Avoid using terms that suggest your supplement has the same effects as prescription drugs or controlled substances.
Also note that effective December 6, 2021, sexual enhancement and weight loss dietary supplements cannot be sold in single or double-pill packs.
Amazon maintains an extensive list of prohibited ingredients and claims for supplements. Before submission, carefully review your formula to ensure it contains no banned substances. Common restricted ingredients include:
DMAA (1,3-dimethylamylamine)
DMBA (1,3-dimethylbutylamine)
DMHA (2-amino-6-methylheptane)
Phenibut
SARMs (Selective Androgen Receptor Modulators)
Pure powdered caffeine
Additionally, ensure your products like protein, collagen, energy supplements, capsules, gel packs, antioxidants, pre-workouts, and post-workouts don’t contain undeclared active pharmaceutical ingredients or controlled substances like CBD. These are among the most common reasons for rejection.
Regarding claims, avoid language suggesting your supplement works like a pharmaceutical drug. Furthermore, steer clear of using terms like “FDA approved” or displaying the FDA logo on your packaging or marketing materials.
Preparing thoroughly before submission significantly reduces approval delays. By gathering all required documentation, reviewing your label for compliance issues, and verifying your formula contains no restricted ingredients, you’ll position yourself for a smoother review process with Amazon’s third-party testing partners.
With your documentation prepared, now comes the critical step of submitting your supplements for third-party testing – the gatekeeping process that determines whether your products can remain on Amazon’s marketplace.
Amazon has authorized only three Testing, Inspection, and Certification (TIC) organizations to verify supplement compliance. Each offers distinct advantages:
NSF International provides both testing and certification options. Their dedicated Amazon Seller support center operates from 7:30 am to 8:30 pm EST on weekdays and can be reached at +1 313 456 8832. Products already certified to NSF/ANSI 173 or NSF 229 standards automatically meet Amazon’s requirements, potentially saving you time and additional testing costs.
Eurofins operates over 900 labs across 62 countries and assigns each seller a dedicated Client Services Specialist to guide you through the process. Their state-of-the-art ISO 17025 accredited laboratories specialize in handling complex nutraceutical matrices.
UL Solutions offers comprehensive regulatory compliance testing with expertise in supplement safety verification.
Choose based on factors like existing relationships, specialized testing needs, turnaround time requirements, or cost considerations. If you already have a product certified by one of these organizations, that’s typically your most efficient option.
The submission process follows a specific pathway:
Log into your Amazon Seller Central account and navigate to the “Manage Your Compliance” dashboard
Identify which of your supplement listings require action (focus is currently on sexual enhancement, weight management, sports nutrition, and joint health products)
Select “Add or appeal compliance” to begin the testing request process
Choose your preferred third-party TIC organization from the approved list
Complete the test request form for each product SKU requiring verification
Submit all required information including ASIN, GTIN, product description, and manufacturing facility details
After submission, you’ll receive an email notification from your chosen TIC organization within two business days to initiate the testing process. Remember, each product (including different flavors or package sizes of the same formula) requires separate verification unless your TIC partner approves “bracketing” for similar products.
Once your testing request is submitted, prepare for:
Timeline: The verification process typically takes 3-5 weeks from sample submission to completion. Factors that may extend this timeframe include out-of-specification investigations, communication delays, or incomplete documentation.
Sample requirements: Most TIC partners request at least 4 unopened retail packages of each product, plus additional units if needed to meet minimum sample weight requirements. Products must be sealed as they would be sold.
Testing procedures: Your nutraceutical products will undergo multiple assessments:
GMP certification validation for your manufacturing facility
Contaminant screening (heavy metals, microbials, pesticides)
Label claim verification to ensure ingredients match what’s stated
For high-risk categories, additional testing for undeclared pharmaceutical ingredients
Cost considerations: Testing fees vary significantly based on product complexity and ingredient profile. There is no flat fee per ASIN. Costs are typically broken down by contaminants, adulterants, and label claim verification components.
Upon completion, test results are provided simultaneously to you and Amazon. Only products receiving compliant results will remain eligible for sale on the platform. If issues are identified, some organizations offer Corrective and Preventive Action (CAPA) pathways for certain types of failures – though detection of pharmaceutical adulterants or pathogenic organisms typically results in permanent rejection.
Remember that compliance verification is valid for only one year – annual renewal is required to maintain your nutraceutical listings on Amazon.
Once you’ve submitted your supplements for testing, receiving and understanding the results becomes your next critical step in meeting Amazon’s supplement requirements.
The third-party TIC organization examines each element of your submission against Amazon’s criteria. Test results are reported simultaneously to you and Amazon with a straightforward pass or fail status [5]. A passing result indicates your product meets all requirements for contaminants, label claims, and ingredient verification. Products that pass testing immediately become (or remain) eligible for sale on Amazon’s platform [6].
Specifically, pass outcomes confirm your product:
Contains ingredients in quantities matching label claims
Is free from unacceptable levels of contaminants
Contains no undeclared pharmaceutical ingredients
Meets all labeling requirements
If your product fails verification, don’t panic. First, review which specific parameter caused the failure. Next, initiate a Corrective and Preventive Action (CAPA) document with your testing partner [7]. This CAPA must include sound justification that implementing the corrections will yield different results.
You may pursue retesting and verification after addressing:
Out-of-specification ingredient levels
Minor labeling issues
Certain contaminant findings
Some failures have no resolution pathway—including detection of pharmaceutical adulterants or positive results for pathogenic organisms like Salmonella, Staphylococcus aureus, or pathogenic E. coli [7]. These result in permanent rejection.
Once verified, your product’s compliance status remains valid for exactly 12 months [6]. Following this period, you must complete the entire verification process again to maintain your Amazon listing status.
Should an ASIN’s compliance status expire without renewal, Amazon may suppress the listing until new verification is completed [7]. We recommend establishing a tracking system for your verification expiration dates, initiating renewal testing approximately 4-6 weeks before expiration.
For optimal compliance management, regularly check your “Manage Your Compliance” dashboard in Seller Central to monitor all affected products and their respective due dates [5]. This proactive approach helps ensure continuous availability of your supplement products like protein, collagen, energy products, and other nutraceuticals on the Amazon marketplace.
Even experienced Amazon supplement sellers face listing rejections or delays. A recent study found that more than half of a sample of immune-boosting supplements purchased on Amazon had contents that didn’t match their labels [9]. Recognizing these pitfalls early saves you considerable time and resources.
Providing current and comprehensive documentation proves critical to approval success. Amazon now requires a valid GMP certificate from an accredited third-party certification body rather than private audits or FDA inspection reports. Outdated certificates result in immediate rejection.
Your Certificate of Analysis must come from an ISO/IEC 17025-certified lab and be issued within the requested timeframe. Many sellers mistakenly use a 21 CFR 110 audit (for food) instead of the required 21 CFR 111/117 certification specifically for dietary supplements [1].
FDA frequently issues warning letters to Amazon regarding supplement sellers making prohibited disease claims [10]. Phrases suggesting your nutraceutical can “cure,” “treat,” or “prevent” specific conditions trigger automatic rejections.
Avoid overly scientific-sounding claims without proper substantiation. Fifteen products in the sample study used terms like “research based” or “clinically studied” without providing evidence [9]. Even subtle implications that your product addresses medical conditions can delay approval. Terms like “reduces inflammation” or “lowers blood pressure” should be avoided.
Ingredient declaration transparency remains essential yet commonly overlooked. Among analyzed supplements, 13 had ingredients listed on labels that weren’t detected in testing, ranging from 1-6 missing ingredients per product [9]. Conversely, 9 products contained substances not declared on their labels [9].
Ensure your Supplement Facts panel precisely matches your formula. Commonly mislabeled ingredients include plant extracts like Aloe vera leaf extract, astragalus root, eleuthero root, and ginger root extract [9]. Vitamin B12 and folate were frequently missing despite being listed [9].
Amazon’s systems now detect potentially hazardous ingredients or undeclared active pharmaceutical ingredients that could pose health risks to consumers [11]. For products like protein, collagen, energy supplements, capsules, gel packs, antioxidants, pre-workouts, and post-workouts, accuracy in ingredient declaration is critical to maintaining your presence on Amazon.
Meeting Amazon’s supplement requirements demands careful attention to detail and thorough preparation. Most importantly, sellers must focus on obtaining proper third-party testing certification, maintaining accurate documentation, and ensuring complete ingredient transparency.
The path to compliance might seem challenging with stringent testing protocols, documentation requirements, and annual renewals. Establishing a systematic approach to track expiration dates and maintain proper documentation helps avoid listing suppressions or rejections.
Success lies in avoiding common pitfalls such as incomplete documentation, unsubstantiated health claims, and ingredient mislabeling. Uniwell Labs offers support to ensure a 100% listing approval rate for your nutraceutical products including protein, collagen, energy products, capsules, gel packs, antioxidants, pre-workouts, and post-workouts. Our expertise helps you stay competitive in the marketplace while meeting all regulatory requirements.
These requirements serve a greater purpose – protecting consumer safety and building trust in the supplement marketplace. Sellers who embrace these standards position themselves for long-term success on Amazon’s platform while delivering safe, high-quality nutraceutical products to their customers. The investment in proper compliance protocols ultimately supports both brand integrity and consumer wellbeing.
Q1. What are the key changes in Amazon’s 2024 supplement policy update? The main change is the requirement for mandatory third-party testing and verification for all supplements sold on Amazon. This includes physical product testing by authorized TIC partners, more comprehensive documentation requirements, stricter enforcement of ingredient verification, and random sampling even after initial approval.
Q2. How do I choose a TIC partner for testing my supplements? Amazon has authorized three Testing, Inspection, and Certification (TIC) organizations: NSF International, Eurofins, and UL Solutions. Choose based on factors like existing relationships, specialized testing needs, turnaround time requirements, or cost considerations. If you already have a product certified by one of these organizations, that’s typically your most efficient option.
Q3. What documentation is required for Amazon supplement approval? You’ll need to gather your product’s ASIN, GTIN, brand name, description, and manufacturing facility information. Most importantly, you must obtain a valid Good Manufacturing Practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111, 21 CFR 117, or both.
Q4. How long does the supplement verification process take? The verification process typically takes 3-5 weeks from sample submission to completion. Factors that may extend this timeframe include out-of-specification investigations, communication delays, or incomplete documentation.
Q5. What happens if my product fails the verification process? If your product fails, review which specific parameter caused the failure. You can initiate a Corrective and Preventive Action (CAPA) document with your testing partner for certain issues. However, some failures, such as detection of pharmaceutical adulterants or pathogenic organisms, result in permanent rejection with no resolution pathway.
[1] – https://sellercentral.amazon.com/seller-forums/discussions/t/c23c51e6-159c-4d01-b297-9836d7d16419
[2] – https://www.nsf.org/knowledge-library/amazon-dietary-supplements-policy-compliance-faq
[3] – https://www.eurofinsus.com/food-testing/services/compliance-verification-for-amazons-dietary-supplements-policy/compliance-verification-for-amazon-s-dietary-supplements-policy-faq/
[4] – https://pmc.ncbi.nlm.nih.gov/articles/PMC9366544/
[5] – https://sellercentral.amazon.com/help/hub/reference/external/G55N3JF2WQS7RVNE?locale=en-US
[6] – https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023
[7] – https://www.npr.org/transcripts/894825441