Dietary supplements to which this policy applies

In the United States, the U.S. Food and Drug Administration regulates the manufacture of dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its subsequent amendments, including the Dietary Supplement Health and Education Act [DSHEA]. , packaging, storage and labelling. The U.S. Food and Drug Administration defines dietary ingredients as: vitamins, minerals, herbal or other plant-based substances, amino acids, dietary substances used to supplement a diet by increasing total dietary intake, or concentrates, Metabolites, components, extracts or combinations. Dietary supplements come in a variety of forms, such as powders, pills, drops and oral sprays, and contain categories such as vitamins and minerals, herbal and plant-based substances, sexual enhancement, weight management, fitness and sports nutrition, and more. Dietary supplements must not contain items approved as new drugs, other undeclared drug ingredients, or making disease claims. Note: According to Amazon's policy, this category is not subject to dietary supplement ingredient lists. However, products with a pharmaceutical ingredient list are exempt from this restriction.Amazon's Dietary Supplement Policy

Amazon may require sellers to submit documentation to demonstrate that the product complies with applicable regulatory or standard requirements, including but not limited to the following regulatory or standard requirements:

Commodity regulations/standard requirements

Dietary Supplements

21 CFR Part 101.36 – Nutrition Labeling for Dietary Supplements

21 CFR Part 111 – Current Good Manufacturing Practices (cGMP) for Manufacturing, Packaging, Labeling, and Storage Practices of Dietary Supplements

21 CFR Part 117 – Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Foods

As of December 6, 2021, sexual enhancement and weight loss dietary supplement products cannot be sold in single or double packs. The Amazon marketplace does not allow the sale of single- or double-packs.

needed file

I. All dietary supplements

For each dietary supplement product or ASIN, you must submit the following documents:

A valid Good Manufacturing Practice (GMP) certificate from an accredited third-party certifier demonstrating compliance with 21 CFR Part 111 (applicable in 21 USC Section 321(ff) Dietary Supplement Products as defined) and/or 21 CFR Part 117 (applicable to any other human food as defined in 21 U.S.C. Section 321(f)). Amazon accepts Good Manufacturing Practice certificates from accredited third-party certification bodies, including /ANSI 455-2, /ANSI 173 Part 8, GRMA 455-2, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA and SSCI.

and

A Certificate of Analysis (COA) of the finished product for the published dietary ingredients issued by an IEC 17025 accredited laboratory or an in-house laboratory located at the above site in compliance with current Good Manufacturing Practice (21 CFR Part 111 [applicable] for dietary supplement products as defined in 21 U.S.C. Section 321(ff)] and/or 21 CFR Part 117 (applicable in 21 U.S.C. (Any other human food as defined in Section (f)]). (For more details on Certificate of Analysis specifications, see [Certificate of Analysis Requirements] or [Frequently Asked Questions] below.)

or

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

II. Supplements for Sexual Enhancement or Weight Loss and Weight Management

In addition to meeting the above requirements, the following documents must be submitted for each dietary supplement product used for sexual enhancement or weight loss and weight management:

For compounds listed in Appendix 1, a Certificate of Analysis (COA) of the finished product issued by a laboratory accredited to /IEC 17025 is required. We do not accept Certificates of Analysis from in-house laboratories for the compounds listed in Appendix 1. A valid certificate of analysis must contain the ISO accreditation number of the issuing laboratory, or an accreditation/IEC 17025 certificate. Note that not all laboratories have the capability to detect these specific compounds. Depending on whether you sell sexual enhancement supplements, weight loss and weight management supplements, or both, you may need to pass multiple lab tests. To our knowledge, the following laboratories offer comprehensive testing services: Covance, Eurofins, Silliker, BSCG, NSF, LGC, USP and UL. For more details on Certificate of Analysis specifications, see the Certificate of Analysis Requirements section below.

III. Supplements for Sports Nutrition (Fitness) Purposes

For compounds listed in Appendix 1, a Certificate of Analysis (COA) of the finished product issued by a laboratory accredited by /IEC 17025 or WADA is required. We do not accept Certificates of Analysis from in-house laboratories for the compounds listed in Appendix 1. A valid certificate of analysis must contain the ISO accreditation number of the issuing laboratory, or an accreditation/IEC 17025 certificate. Note that not all laboratories have the capability to detect these specific compounds. Depending on whether you only sell sports nutrition supplements or both, you may need to use more than one laboratory for testing. To our knowledge, the following laboratories offer comprehensive testing services: Covance, Eurofins, Silliker, BSCG, NSF, LGC, USP and UL. For more details on Certificate of Analysis specifications, see the Certificate of Analysis Requirements section below. Consulting 18122040311 (v)

Certificate of Analysis Requirements

You must submit a finished product Certificate of Analysis (COA) to certify the per-unit ingredient or per-dose ingredient content of each dietary ingredient declared on the applicable ingredient list. Certificates of Analysis submitted to Amazon must have been issued within the past 12 months; must be in Portable Document Format (.pdf); and must contain the following information:

full product name

Lot number, lot number or date code of unexpired finished product samples tested

The name and address of the laboratory that issued the certificate of analysis and the ISO accreditation number

The certificate of analysis must have the signature of the laboratory's authorized representative, the name and title in block letters

Laboratory test results that certify the per-unit ingredient or per-dose ingredient content of each dietary ingredient declared on the applicable ingredient list

A reference to the testing method used for each dietary component listed must be included. If it is a new test method, is not an official method of the American Society of Official Analytical Chemists, or is a revision of an official method of analysis, or is an internal test method, the rationale for the method should be noted (for example: high performance liquid chromatography or gas Chromatography). Actual data and details of observations should be recorded, rather than a general statement of "pass" or "pass". For "Manufacturer Provided Ingredient Content" testing, please see the FAQ below for information on additional documentation.

The dietary ingredient name on the applicable ingredient list must match the ingredient name on the certificate of analysis.

The unit of measure (eg, grams, milligrams, or micrograms) for each dietary ingredient on the applicable ingredient list must match the unit of measure on the certificate of analysis.

Testing requirements for sexual enhancement, weight loss and weight management supplements, and sports nutrition

For sexual enhancement, weight loss and weight management supplements, and sports nutrition, the Certificate of Analysis (COA) must contain test results for the specific compounds described below. Also meet the requirements for the General Certificate of Analysis above.