How to sell Dietary Supplements on Amazon and how NOL Data Solution will help you

The following article is available for the sellers who want to sell products in the US market with Amazon.com.

If you plan to sell supplements products on Amazon US, you must comply with all US federal, state, and local laws and with Amazon policies applicable to those products and product listings.

NOL Data Solution can strongly help you to comply with all the rules below and avoid you to losed energy and money with this time-consuming tasks.

Update of November 2021 Amazon has amended its dietary supplement compliance program :

Required documentation for all dietary supplements are:

– A valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111 and 21 CFR 117
– A finished product Certificate of Analysis (COA) of declared dietary ingredients issued by an ISO/IEC 17025 accredited laboratory or in-house laboratory located in the above facility that is compliant with current GMPs per 21 CFR 111 and 117. The valid COA must have the ISO accreditation number listed on the certificate being submitted. The COA submitted to Amazon must have been issued within the past 12 months.

OR

Evidence of product enrollment or participation in one of the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, or UL Brand Certification Program.

Compliance Check list

This compliance check list is dicted by amazon but is also the recommended way to prepare your products to be sold on any other markeplace.

  1. Supplements must be sealed in the original manufacturer’s packaging

  2. Supplements must be new and unused.

  3. Supplements must clearly display the identifying codes placed on the packaging by the manufacturer or distributor, such as matrix codes, lot numbers, or serial numbers

  4. Supplements must be labeled in English with the following information :

    – The name of the dietary supplement
    – The total quantity or amount of the dietary supplement (e.g. 100 tablets, 5 mg, 6 oz)
    – A “Supplement Facts” panel
    – The ingredient list
    – The name and address of the manufacturer, packer, or distributor

  5. Supplement labels must not state that the products cure, mitigate, treat, or prevent a disease in humans, unless that statement is approved by the FDA

  6. Supplement labels must not claim that the products have the same effects as controlled substances or prescription drugs (e.g. supplements cannot have names that could be confused with controlled substances or prescriptions drugs, like “Viagrex” or “TestosterX”)

  7. Supplement labels must not claim that the supplements are “FDA approved”

  8. Supplement labels must not use the FDA logo

  9. Supplement labels must not state “tester,” “not for retail sale,” or “not intended for resale”

  10. Detail pages must include the following information:

    – The name of the dietary supplement
    – The ingredient list, including an image of the ingredient list from the product label

  11. Detail pages must not state that the products cure, mitigate, treat, or prevent a disease in humans, unless that statement is approved by the FDA

  12. Detail pages must not include disease names in the keywords

  13. Detail pages must not state that the products have the same effects as controlled substances or prescription drugs (e.g. supplements cannot state that they are alternatives to prescription drugs or that they are just as effective as a prescription drug)

  14. Detail pages must not claim that the products produce an effect similar to that of an anabolic steroid, such as “Legal Steroids”
    Detail pages must not state that the supplements are “FDA approved”

  15. Images associated with detail pages must not include the FDA logo

    Information are available in the “regulatory texts” part of NOL DATA Solution. Customers will find information on labeling, claims, contaminants but also manufacturing and importation (FSMA, FSVP).

  16. Supplements must not be named in an FDA recall or safety alert

    For more information, see: Recalls, Market Withdrawals, & Safety Alerts

  17. Supplements must not contain ingredients prohibited by the FDA

    For more information, see: Dietary Supplement Products & Ingredients
    All dietary ingredient authorized in US are referenced in NOL data solution (ODI, NDI, GRAS, CFR, SCOGS)

  18. Supplements must not be identified as adulterated (e.g. unsafe or lacking evidence of safety) or misbranded (e.g. having false or misleading information on the label) in an FDA warning letter

    For more information, see: FDA Warning Letters
    Nutraveris Quarterly regulatory synthesis will alert (start of shipments in June) the customers to news warning letters and a link will be done to the Warning letters database. Moreover, Warning letters relative to active ingredients (e.g cannabidiol, caffeine…) are referenced in NOL Data Solution.

  19. Supplements must be safe for use and must not be a product that the FDA has determined presents an unreasonable risk of injury or illness, such as products that contain pure powdered caffeine

    For more information, see: Pure and Highly Concentrated Caffeine
    See Regulatory Status on caffeine in NOL Data solution

  20. Supplements must not be named by the Federal Trade Commission (FTC) as making untrue marketing claims (for more information, see: Federal Trade Commission Press Releases)

    See Regulatory texts part in NOL Data Solution

  21. Supplements must not contain controlled substances, such as:

    – Cannabidiol (CBD), a Schedule I Controlled Substance
    – Anything listed in Schedules I, II, III, IV or V of the Controlled Substances Act (for more information, see: Schedules of Controlled Substances)
    – “List I” chemicals or their derivatives as designated by the Drug Enforcement Administration (DEA) (for more information, see: List I and List II Chemicals)
    All dietary ingredient authorized in US are referenced in NOL data solution (ODI, NDI, GRAS, CFR, SCOGS)

  22. Supplements must comply with Amazon policies, including:

    – Supplements that contain ingredients derived from sharks, whales, dolphins, or porpoises are prohibited from sale
    – Supplements that contain more than 12% hydrogen peroxide are prohibited from sale
    – Patches that are marketed as dietary supplements or detox products are prohibited from sale
    – Male enhancement supplements with the brand name Rhino are prohibited from sale
    Dedicated to Amazon

Contact us

Our experts are at your disposal to make your products comply with the regulatory framework and to boost your sales on Amazon.

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