Amazon has implemented stringent testing criteria for dietary supplements sold on their platform, aligning closely with the guidelines established by the U.S. FDA[1][4]. These supplements, encompassing vitamins, herbs, amino acids, and botanicals, among others, are rigorously evaluated to ensure they meet safety and quality standards without making unfounded health claims[1].
In 2021, Amazon further tightened its compliance policies for dietary supplements, focusing on weight management, sexual enhancement, and sports nutrition, signaling a significant shift towards upholding good manufacturing practices and safeguarding consumer interests[2][3].
Amazon’s Dietary Supplements Compliance Policies
Ensuring Compliance Through Rigorous Testing
Amazon has instituted a comprehensive framework to ensure that dietary supplements sold on its platform adhere to the highest safety and efficacy standards. This includes mandatory testing in ISO 17025-accredited laboratories before a product can be listed and annually thereafter to confirm ongoing compliance[1]. Additionally, Amazon mandates that all dietary supplements must not contain prohibited substances like pure powdered caffeine or CBD, aligning its policy with stringent regulatory standards[1].
Documentation and Verification
To further fortify consumer trust and product authenticity, Amazon requires sellers to submit a letter of guarantee from the product manufacturer. This letter must confirm adherence to current Good Manufacturing Practices as outlined in 21 CFR Part 111, and assure that only safe, lawful ingredients are used and that the concentrations of active ingredients are accurate and safe for consumption[6]. Amazon has also updated its policies to necessitate third-party Testing, Inspection, and Certification (TIC) organization verification for all dietary supplements, ensuring an additional layer of scrutiny and quality assurance[7].
Proactive Compliance Management
Amazon assists sellers in managing their compliance through the ‘Manage Your Compliance’ dashboard, which displays necessary actions and deadlines for dietary supplements. Sellers are required to initiate testing with approved third-party TIC organizations and ensure that their listings are updated and compliant by the specified deadlines to avoid removal from the platform[7]. This proactive approach helps maintain a safe and reliable marketplace for dietary supplements, focusing on critical categories like weight management, sexual enhancement, and sports nutrition[7].
Top Three Categories Under the Microscope
Amazon’s focus on dietary supplements extends deeply into three specific categories: weight management, sexual enhancement, and sports nutrition, each tailored to meet the stringent standards of quality and safety.
Weight Management Supplements
Amazon offers a diverse array of weight management products, including appetite suppressants, metabolism boosters, and fat burners. Popular brands such as NatureWise, Optimum Nutrition, and Cellucor provide options that vary significantly in price, from as low as $10 to over $100, with many products boasting customer ratings of 4 stars and above[17]. Notably, the Hydroxycut Hardcore Weight Loss Supplement, which contains C. canephora robusta, is backed by scientific studies and is known for its energy-boosting caffeine content equivalent to 3 cups of coffee per serving[19].
Sexual Enhancement Supplements
In the sexual enhancement category, Amazon lists products for both men and women, with brands like GNC, Stamina Rx, and Magnum Nutraceuticals leading in popularity. These supplements, which aim to improve libido, stamina, and performance, range in price from $15 to over $200. However, customer reviews vary, indicating differing levels of satisfaction and effectiveness[17]. Each product listed under this category undergoes rigorous testing for specific compounds in sexual enhancement at ISO 17025 accredited laboratories like LGC/Informed Sport[3][14].
Sports Nutrition Supplements
The sports nutrition section on Amazon features a wide selection of products designed to enhance athletic performance, including protein powders, energy drinks, and performance supplements. Top brands such as Optimum Nutrition, BSN, and MusclePharm offer products ranging from $20 to over $100. These supplements are favored for their high customer review ratings, often 4 stars and above, and are tested for over 250 banned substances, ensuring compliance with rigorous manufacturing quality audits[17][3].
Navigating the Testing Process
To ensure compliance with Amazon’s stringent dietary supplement standards, sellers must navigate a detailed testing and documentation process. Here’s how it typically unfolds:
Certificate of Analysis (CoA) Requirements
- Initiation of Testing: Manufacturers must start by collaborating with an ISO-certified lab that specializes in dietary supplement testing[21]. The process involves a variety of analyses such as identity testing, potency analysis, microbiological testing, and heavy metal analysis to ascertain the safety and quality of the supplements[21].
- Submission of CoA: After the laboratory completes the testing, a detailed report is generated. Manufacturers need to use this report to furnish the CoA, which Amazon requires for listing the products on their platform[21]. This certificate must be updated annually to ensure continuous compliance with Amazon’s policies[21].
Partner Laboratories and Compliance
- RL Food Testing and American Testing Lab: These labs offer specialized services that include ingredient testing, potency verification, and contaminant analysis, all crucial for meeting Amazon’s compliance requirements[5][21]. They also help in preparing the necessary documentation that demonstrates adherence to the standards[5].
- Third-Party Testing Organizations: Sellers must engage with third-party Testing, Inspection, and Certification (TIC) organizations through Amazon’s ‘Manage Your Compliance’ dashboard. This step is vital for initiating the tests required for each product and ensuring that the listings remain updated and compliant[7].
Ensuring Ongoing Compliance
- Annual Updates and Accreditations: The CoA is not a one-time requirement but needs annual updates to reflect continuous compliance. Additionally, labs like those accredited by ANAB to ISO/IEC 17025:2017 play a critical role in this ongoing process. ANAB also supports the GRMA certification scheme, which is part of ensuring high standards in dietary supplements[15].
- Contaminant Analysis: It is crucial for manufacturers and Online Distribution Leaders (OLDs) to identify and quantify any contaminants that could adulterate the product, ensuring it meets Amazon’s safety criteria[1].
Navigating Amazon’s testing requirements demands meticulous attention to detail and a proactive approach in choosing the right partners and laboratories. By adhering to these steps, sellers can effectively manage their compliance and continue to offer safe, high-quality dietary supplements to consumers.
Future Implications for Sellers and Consumers
The integration of Informed Choice certification into Amazon’s dietary supplement policy not only ensures that products meet stringent testing standards but also positions certified brands for greater visibility and trust on the platform. Over 150 brands are now certified, showcasing a commitment to quality that could influence consumer choices significantly[3]. This certification involves rigorous testing for over 250 banned substances and a thorough audit of manufacturing processes, setting a high standard for market entry[3].
However, the requirement for third-party testing could impose additional financial burdens on sellers, especially smaller brands. These costs might restrict their ability to compete, potentially limiting the variety of products available to consumers[7]. On the other hand, this policy could enhance consumer safety and product transparency, making it easier for buyers to make informed decisions[7].
Amazon’s expansive reach in the dietary supplement market is notable, with over 17,500 brands compared to significantly fewer on other platforms[12]. This dominance is further supported by innovative sales tools such as A+ Content, Amazon Stores, and the Subscribe and Save feature, which collectively enhance product visibility and consumer engagement[11]. These tools, along with stringent testing and certification requirements, are set to shape the future landscape of dietary supplement sales on the platform[11][12].
FAQs
1. What are the FDA’s requirements for dietary supplement labeling?
The FDA mandates that the Supplement Facts panel on dietary supplement packages must clearly display the serving size and the total number of servings per container. It must also list each dietary ingredient contained in the product. For ingredients that are not part of a proprietary blend, the panel should include the amount of each dietary ingredient per serving.
2. Are dietary supplements approved by the FDA for safety and effectiveness before being sold?
No, the FDA does not approve dietary supplements for safety, effectiveness, or labeling before they are available for sale. It is the responsibility of the dietary supplement manufacturers to ensure that their products are safe and that the labels provide accurate information.
3. What are some credible certification programs for dietary supplement purity?
Consumers should look for certifications from reputable programs when assessing the purity of dietary supplements. These include the ConsumerLab.com Quality Certification Program, NSF International Product Certification Program, and the USP Dietary Supplement Verification Program.
4. What should you look for on a dietary supplement label to ensure its quality?
When checking a dietary supplement label, it is advisable to look for certifications such as the USP or NSF seal, check the expiration date, and ensure the formula is suitable for your age and gender.
References
[1] –https://blog.certified-laboratories.com/en/cl-blog/amazon-dietary-supplement-requirements-for-laboratory-testing
[2] –https://www.element.com/nucleus/2022/what-you-need-to-know-about-amazon-dietary-supplement-testing-requirements
[3] –https://choice.wetestyoutrust.com/amazon-testing
[4] –https://a2la.org/what-are-amazon-safety-and-compliance-requirements-for-dietary-supplements/
[5] –https://www.american-testing.com/testing-lab/navigating-amazons-nutraceutical-testing-requirements/
[6] –https://blog.aemtek.com/guide-to-amazons-dietary-supplement-coa-requirements
[7] –https://sellercentral.amazon.com/seller-forums/discussions/t/c23c51e6-159c-4d01-b297-9836d7d16419
[8] –https://www.nsf.org/knowledge-library/amazon-dietary-supplements-policy-compliance-faq
[9] –https://www.amazonsellers.attorney/blog/new-requirements-for-amazon-sellers-of-supplements
[10] –https://www.linkedin.com/pulse/new-amazon-policy-could-impact-dietary-supplement-sales-daren-garcia
[11] –https://www.linkedin.com/pulse/selling-dietary-supplements-amazon-swiftstartinc
[12] –https://www.wholefoodsmagazine.com/articles/14167-the-amazon-effect-on-dietary-supplements
[13] –https://www.nutritionaloutlook.com/view/amazon-s-new-policy-for-supplement-sellers-can-go-a-long-way-to-protect-consumers-says-now
[14] –https://www.wetestyoutrust.com/news/amazons-supplement-testing-requirements-what-you-need-know
[15] –https://anab.ansi.org/resource/dietary-supplements-seller-requirements/
[16] –https://sport.wetestyoutrust.com/news/amazon-supplement-testing
[17] –https://us.amazon.com/Vitamins-and-Dietary-Supplements/b?ie=UTF8&node=3764441
[18] –https://www.amazon.com/Vitamins-and-Dietary-Supplements/b?ie=UTF8&node=3764441
[19] –https://www.amazon.com/Hydroxycut-Supplement-Metabolism-Booster-Weightloss/dp/B0CJN1RMHY
[20] –https://www.amazon.com/Athletic-Support-Supplement-Cognitive-Increases/dp/B081ZJF52J
[21] –https://www.rlfoodtestinglaboratory.com/navigating-the-process-obtaining-an-amazon-certificate-of-analysis-for-dietary-supplements/
[22] –https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9366544/
[23] –https://www.amazon.com/thrive-Diet-Sports-Nutrition-Health-Household/s?k=thrive&rh=n%3A3764441
