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This article applies to selling in: Japan

Dietary Supplements

Note: All foods listed on the Amazon Marketplace must comply with the manufacturing standards, standards, labeling and packaging standards required by the Food Sanitation Law and other related laws, regulations, guidelines.

What is Dietary Supplements?

Dietary Supplements are defined as foods in the form of powders, tablets, liquid drops, oral sprays, etc. that are taken to supplement the dietary intake of nutritional components. These are products that contain vitamins, minerals, herbs, other plants, other animals, concentrate, extracts, or combinations of the aforementioned substances. However, it is not limited to these.

Requirements for listing Dietary Supplements

In Japan, the manufacturing, packaging, storage, labeling, and ingredient inspection methods of dietary supplements are regulated by the Food Sanitation Law, the Health Promotion Law, Food Labeling Low, and the standards for manufacturing or processing foods containing designated ingredients etc. When listing dietary supplements on Amazon.co.jp, the product must be manufactured in a HACCP certified factory and in a GMP certified factory. In addition, all supplement manufacturers and sellers must ensure that the target substances of the dietary supplement are consistent with the content on the product label. In this policy, we mainly targets the content and labeling of the main components contained in dietary supplements. (Hereafter, it is called the target substances)

Amazon requires you to provide the following documentations when listing dietary supplements.

  • HACCP (Hazard Analysis Critical Control Point) certificate(Only made in Japan)and GMP (Good Manufacturing Practice) certificate obtained by the manufacturing plant.
  • Dietary supplements Certificate of Analysis (CoA) and Package labeling (Nutritional Labeling).

Note: Submit a Certificate of Analysis (CoA) and package labeling information for each supplement you plan to list.
  1. A Certificate of Analysis (CoA) must contain the following information:
    1. Product name.
    2. Batch/lot number or date code of the finished product sample tested.
    3. Accredited laboratory name and address.
    4. Analytical results from laboratory to support target substances as claimed in package labeling.
    5. The inspection method must accompany each reported result.
    6. The target substances in package labeling should match the ingredient name(s) on the CoA.
  2. Additional a Certificate of Analysis (CoA) requirements:
    1. CoA submitted to Amazon must have been issued within the past one year.
    2. Laboratory test results of expired product will not be accepted.
    3. CoA documents must be in Portable Document Format (.pdf).
Note: If you have any questions or documents submission regarding this program, please contact the following email address.
Note: Please be sure to send from the seller address registered in Amazon. If you send from an address that is not registered, we cannot reply.
Note: This email address only accepts questions or documents submission about listing dietary supplements on Amazon.co.jp. Amazon can't answer all the laws, regulations, guidelines and requirements regarding dietary supplements. The Ministry of Health, Labor and Welfare or the Consumer Affairs Agency publishes the regulations and requirements related to dietary supplements. For details, please refer to the website of the Ministry of Health, Labor and Welfare or Consumer Affairs Agency.

Ministry of Health, Labor and Welfare - HACCP

Ministry of Health, Labor and Welfare - HACCP Introduction Guide for Dietary Supplements Manufacturing

Ministry of Health, Labor and Welfare - Dietary Supplements

Consumer Affairs Agency - food labeling

Amazon presents these materials for information. If you have any questions regarding these laws and regulations, please contact your legal representative.

Related help pages

Frequently asked questions about Dietary Supplements

What is the target substances?

Amazon defines the ingredients that displayed on the dietary supplements labeling as target substances, except for the five basic nutrients (Calories, Proteins, Fats, Carbohydrates, and Salt equivalent). These are the main targets of investigation based on this policy. The target substances include the following ingredients, but are not limited to the following.

Example:maca, citrulline, arginine, zinc, mamushi, Soft-shelled turtle, NMN (nicotinamide mononucleotide), mulberry leaf imino sugar, chitosan, saponin, hydroxycitric acid (HCA), carnitine, black ginger-derived polymethoxyflavon, kudzu flower-derived Isoflavones, enzymes, lactic acid bacteria, coenzyme Q10, garcinia extract, plantago, obata seed coat powder, etc.

Can a Certificate of Analysis (CoA) be inspected in any laboratory?

We require that the laboratory designated by the Minister of Health, Labor and Welfare (registered inspection agency) or currently holds an ISO/IEC 17025 accreditation. The test results must be from a laboratory that is well-suited for testing and measurement.

Is a Certificate of Analysis (CoA) not the result of inspecting the entire product, but the result of inspecting only the functional ingredients?

The test sample must be the final product and the results must be submitted. However, if the final product cannot be tested due to lack of scientifically valid test methods, please submit the test results for each functional ingredient.

Do I need to submit test results to prove that the amount of active ingredient in the product is accurately represented on the product label? Or do I need to submit the test results for each functional ingredient?

The Certificate of Analysis (CoA) must contain the test results of all the functional ingredients displayed on the product labeling. However, if the entire product cannot be inspected due to lack of a scientifically valid test method, the test results can be submitted according to Q3 above.

My product is an herbal supplement, does it need to have a Certificate of Analysis (CoA)?

You must have a Certificate of Analysis (CoA) with a laboratory assay(s) for each ingredient if the functional ingredients are listed below:

  1. Primary metabolites (such as common sugars, amino acid, or proteins).
  2. Secondary metabolite (such as alkaloids, terpenoids, saponins, phenolic compounds, flavonoids, or tannins).
  3. A whole plant ingredient, plant part(s) such as roots or leaves, in a dried state (such as a powder), must have a CoA containing confirmation of plant identity.
  4. A whole protein ingredient, animal part(s) such as organs or limbs, in a dried state (such as a powder), must have a CoA containing confirmation of animal identity.

Is it necessary to submit a HACCP or GMP certificate even though it is not a product manufactured in-house?

Please check whether the dietary supplement manufacturing factory has obtained GMP and HACCP certification via the supplier, and submit a copy of the certificate obtained by the manufacturing factory.

I received a notification about the suspension of listing, and only the ASINXXXXXX was mentioned in the notification. Is it necessary to suspend the listing of other products as well?

It is basically unnecessary. If you list multiple products, not all products will be suspended. However, if you have listed very similar items, but only some of them are listed in the email, please kindly reply with the content containing that information.

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