Three Steps to Selling FDA Regulated Products on Amazon

“Is it FDA approved?” This is the most frequent question received by phone and e-mail. It’s also the most commonly asked question by Amazon. The online retailer’s popularity with start-up companies is surging. It allows a quick and conveient means to sell and distribute products across the U.S. Browsing Amazon one will find a range of FDA regulated products – cosmetics products, cosmetic devices, herbal remedies, and dietary supplements of all types (muscle building, weight loss etc.). Amazon works with start-ups to ensure products are FDA approved, but it cannot do the work of the Agency. Amazon listings are a familar subject for FDA Warning Letters. 

 

Here are three steps to consider before selling your product on Amazon:

 

1) Are My Ingredients Approved?

Certain ingredients are classified as over-the-counter (OTC) drugs others may be new food or color additives. It is important to evaluate a product’s ingredients before selling on Amazon. Certain categories of products are also only considered drugs or devices, not matter the ingredients or labeling. 

 

2) Are My Claims Approved?

Classification of a product hinges on claims. Claims provide evidence for the FDA about the intended use, e.g. what the consumer should expect the product to do. It is not enought to add a disclaimer, if your product’s claims qualify as drug or device claims then evidence of pre-market approval will be required.

 

3) Avoid Comparing to Similar Products Listed on Amazon

Some products slip throught the system others may be already engaged in a FDA enforcement action. In any case the FDA will not accept as a defense comparison to a product marketed and sold without the approvals or revisions the Agency is requesting for your product. What matters are the regulations and any statutory defenses. Assess the risks based on your own review of the regulations, not on the risks another company did or did not evaluate.

 

These three steps cover the big areas of compliance. There are other considerations, especially with imported products. It is important to gain a full sense of the regulatory requirements and the risks of FDA enforcement before selling on Amazon. Feel free to contact us for a complientary assessment of your products.

Share this:

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

34 Comments

  1. Christy on April 30, 2019 at 8:08 pm

    Hi
    I make a nut butter using pure ingredients (nothing artificial) from USA farms. I am using a professional commercial kitchen to make my product in and I would like to start selling on online and through Amazon. Is it correct that I need to register with the FDA as a food facility or how does that work if I’m using a professional kitchen? Does a nut butter need a GRAS petition?
    Any advice would be appreciated!

    • Marc Sanchez on May 1, 2019 at 9:25 am

      Hello, Christy, it sounds like you’re manufacturing from an FDA point of view, which does require registration. You’ll only need a GRAS notice for a new or novel ingredient. You can e-mail me (msanchez@fdaatty.com) for more information.

  2. saima chhipa on February 26, 2019 at 7:08 pm

    Hi, I am trying to sell hemp gummies on Amazon. These have no CBD and TCF. Would this be considered a supplement? If so, what paperwork do I need to complete. Also, these are manufactured in USA.

    • Marc Sanchez on February 27, 2019 at 9:55 am

      Thank you for your comment. In many cases, hemp can be used as a food or dietary supplement ingredient. Much depends on ingredient source and labeling. You can e-mail me to learn more about a label/ingredient review and registration (msanchez@fdaatty.com).

  3. Coastal Co on February 4, 2019 at 8:03 pm

    Hi, I am trying to get approved by amazon to sell a natural body oil that is manufactured in China and will shipped to the USA to then sell online. The manufacturer as provided an FDA certificate for the product however amazon will not accept my application to the ‘gated’ topical section. Does the FDA certificate have to be in my company name not the manufacturer?

    • Marc Sanchez on February 12, 2019 at 9:30 am

      Thank you for your comment. Topicals is a tricky category, usually only applicable to OTCs like sunscreens. If your company name is on the label, then you may need a registration. Seller Support may be looking for a registration of your company. Please e-mail me if I can help with the registration (msanchez@fdatty.com).

  4. Alex on November 12, 2018 at 2:51 pm

    Hello!

    Can you tell me: do I need any certificates for selling via FBA Chinese tea, matcha and handmade slay teapots?

    Best regards.

    • Marc Sanchez on November 12, 2018 at 4:19 pm

      Thank you for your comment. Generally speaking, when importing foods, like teas, for consumption in the US both the foreign supplier and the importer must have a valid FDA registration and compliant label if importing in finished package form.

      Feel free to e-mail me for more details (msanchez@fdaatty.com).

  5. Graeme Riordan on September 5, 2018 at 11:21 pm

    Hi Marc, Just a few queries, I’m In Australia, I am developing a unique medical device that treats person who has symptoms of anxiety and panic attacks, the device would have an electronic component in the assembly that would connect via an app to the users smartphone and be able to register the duration of an episode.

    I am wanting to sell the item initially through a crowd funding campaign and then distribute it in the US and sell it on Amazon.

    Are you able to provide assistance in these areas, mainly in terms of compliance with FDA, general time line and costings

    Regards Graeme

    • Marc Sanchez on September 6, 2018 at 1:20 pm

      Graeme,

      Thank you for your comment. Yes, I would be happy to help but private e-mail would be a better place for this discussion. You can e-mail me at msanchez@fdaatty.com.

  6. Yuwei on August 14, 2018 at 9:32 pm

    Dear Mr. Senchez
    I am a Chinese. We want to sell objects on Amazon, but now we do not know which documents should be supply to FDA to get approved. Please help us.
    Many thanks
    Yuwei Zhu

    • Marc Sanchez on August 15, 2018 at 10:36 am

      Yuewei,

      Thank you for your comment. The types of documentation varies depending on the product type (food/supplement, medical device, OTC drug, or cosmetic).

      I would be happy to help. You can e-mail me at msanchez@fdaatty.com

  7. Cezar on April 18, 2018 at 4:11 am

    Dear Mr. Sanchez,
    We want to private label a posture corrector brace from a Chinese manufacturer and market it on the Amazon US. If we were to need FDA approval or a premarket notification 510 (k), could you help us through the entire process?
    Thank you very much!
    Cezar

    • Marc Sanchez on April 18, 2018 at 9:09 am

      Yes, Cezar, I can definitely help. Send me an e-mail with any questions (msanchez@fdaatty.com).

  8. Nick on March 18, 2018 at 12:09 am

    Hello, Mr. Sanchez.

    I’m an American looking into to sell charcoal powder and charcoal toothpaste (teeth whitening items) on Amazon US, via private label and via Chinese manufacturers.

    What kind of FDA requirements/compliance laws would I need with these items? It sounds like those items are cosmetic and I’m having a real hard time understanding if I need actual FDA approval or if I need to go through a different procedure.

    Thank you very much!

    • Marc Sanchez on March 19, 2018 at 10:52 am

      Thank you for the comment, Nick.

      A product that only whitens teeth would be classified as a cosmetic, which means mandatory labeling requirements and voluntary registration. If you’re trying to sell on Amazon, then you’ll most likely need to register with the FDA.

      There are two types of FDA cosmetic registration. I can help you register your company using the FDA VCRP Form 2511 if you or your supplier if either are a packer or manufacturer. If you are a distributor, then I can help you register your products using the FDA VCRP Form 2512.

      Please feel free to send me an e-mail (msanchez@fdaatty.com), if you’d like more information.

  9. Daniel on November 22, 2017 at 5:42 am

    Hi Marc,

    I am looking at importing and selling medical supplies from a Chinese supplier that has a a FDA certificate for the product. I do not live in the US, and will most likely use a freight forwarder, do I still need to register with the FDA?

    Any help would be greatly appreciated.

    • Marc Sanchez on November 22, 2017 at 9:02 am

      Daniel, thank you for your comment. The answer will depend on a couple of questions, like how the shipments are declared to customs and whether you will be private labeling, relabeling or repackaging.

      You can e-mail me at msanchez@fdaatty.com for more information.

  10. Jane on November 8, 2017 at 4:49 pm

    Hi!

    I want to sell OTC drugs on Amazon but seller support is asking me for Proof of FDA registration. Any suggestions or feedback would greatly be appreciated. Thanks!

    • Marc Sanchez on November 10, 2017 at 1:32 pm

      Any OTC drug, like acne treatments or sunscreens, must comply with FDA regulations, including registration.

      I am available by e-mail (msanchez@fdaatty.com) to answer any questions.

  11. Marina Monaco on October 30, 2017 at 12:12 am

    Dear Mr. Sanchez,

    I am a Vancouver resident and I am a partner in a Hypoallergenic Product Company in Brazil.
    I want to sell my cosmetics on Amazon USA and Canada.
    Does it need to be FDA approved?
    if yes, How can I get that approval?

    • Marc Sanchez on October 30, 2017 at 8:40 am

      Hello Marina,

      Currently a true cosmetic is subject to voluntary registration and compliance but as noted in a post last week that may change in the near future to mandatory registration.

      In the meantime, you can register the manufacturer or list the individual products with the Voluntary Cosmetic Registration Program. There is no individual approval of cosmetics only registration.

      Please e-mail me at msanchez@fdaatty.com for additional information or with any additional questions.

      Best,

      Marc

  12. Vincy Choi on July 4, 2017 at 6:55 am

    I wish to sell instant coffee powder on Amazon.

    Does it need to be FDA approved?
    if yes, How can I get that approval?

    What is the procedure?

    • Marc Sanchez on July 5, 2017 at 11:15 am

      The term FDA approval can be confusing. There is no FDA approval, individualized applications for approval and review, for common food products like coffee powder (some new dietary ingredients in supplements may need a NDI and some food ingredients may need a GRAS petition but those are not too common).

      Instead, the FDA requires a food facility registration, proper labeling, and adherence to Good Manufacturing Practices. Amazon also wants documentation of FDA compliance. Typically, this is done by showing a company’s registration status with the FDA. It is important for the name in the Seller Account to match the name on the registration. You can e-mail for more information (msanchez@fdaatty.com).

  13. WYLIE DRUMMOND on April 10, 2017 at 7:18 pm

    We are importing a vegetable based bar soap that is manufactured in Guatemala to sell on Amazon. The ingredients are listed below:

    Sodium Palmate, Sodium Palm Kernelate, Water, Fragrance, Sodium Chloride, Tochopheryl Acetate (Vitamine E), Butyrospermum Parkii (Shea Butter), Cocos Nucifera (Cononut) Oil, BHT, Titanium Dioxide (CI 77891) Tetrasodium EDTA, Yellow 5 (CI 19140), Yellow 6 (CI 155985)

    Each bar of soap is individually wrapped with the ingredients listed on it. Do we need some type of approval from the FDA to sell on Amazon?

    • Marc Sanchez on April 10, 2017 at 7:24 pm

      Typically to sell on Amazon you would need some type of documentation of your status with the FDA. This often means a registration of some sort. If your bar of soap qualifies as a cosmetic, then cosmetic registration either under 2511 or 2512. If a drug (OTC monograph), then drug registration, National Drug Code (NDC) Relabeler request, and drug listing.

      You can send me an e-mail at msanchez@fdaatty.com if you would like more information.

  14. Kendyl Modrich on March 30, 2017 at 2:11 pm

    I am a medical manufacturing company trying to sell nasal cannulas on amazon and they are telling me that my product is prescription only and this is not the case anymore how do I properly classify the FDA part of this to prove that it’s not a prescription required device anymore

    • Marc Sanchez on March 30, 2017 at 2:17 pm

      In this situation, it is often necessary to complete a classification review/justification memo that is provided to Seller Support. If Seller Support doesn’t budge, then I often turn to the corporate counsel in Amazon’s Seattle office. You can send me an e-mail at msanchez@fdaatty.com if you would like more details.

  15. Usman Chaudhary on January 28, 2017 at 5:36 am

    Hi,
    I want to sale dental kits on Amazon.
    Do i need FDA certificate for it?

    Thanks

    • Marc Sanchez on January 30, 2017 at 9:25 am

      It will depend on the intended use. Some dental products are cosmetic and other drugs or devices. Either way you will need a registration for Amazon purposes. Please feel free to contact me for more details (msanchez@fdaatty.com).

  16. Parham on September 22, 2016 at 10:52 pm

    Hi
    I want to make some cookies at home and like so many people put it on Amazon.com for sale.
    Does it need to be FDA approved?
    if yes, How can I get that approval?

    Please explain to me, what will be the process of doing so.

    • Marc Sanchez on September 23, 2016 at 7:49 am

      Hello Parham –

      To sell on Amazon you need to ensure you are registered with the FDA as a food facility and your labels are in compliance with the regulations. Amazon requires proof of registration. This is the only “FDA approval” you can receive – there is no pre-inspection, submission of samples, or FDA review of labels. I can complete both steps for as part of the services offered by my firm. Feel free to send me an e-mail to request more details (msanchez@fdaatty.com).

  17. Ian on August 2, 2015 at 6:56 am

    I would like to import and sell a small oral digital thermometer from a Chinese company that has a FDA certificate for the product. Is this possible or is there further steps needed before proceeding? Would appreciate any advise please.

    • Marc Sanchez on August 3, 2015 at 8:15 am

      Thank you for your comment. Please send an e-mail to msanchez@fdaatty.com for a complimentary initial consultation.

Leave a Comment

You must be logged in to post a comment.

Are you in trouble with the FDA?

Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.

Expert knowledge of FDA regulations that helps you strategically grow your business