The dietary supplements niche is a highly profitable category on Amazon; it is a rapidly growing niche with many revenue generation opportunities for sellers on Amazon. However, the sale of health supplements is heavily regulated by both the FDA and Amazon. Every seller has to comply with stringent criteria to be eligible to sell supplements. These requirements include obtaining certification for product safety, complying with manufacturing standards, proper labeling, product photography, and the purchase invoice.
This post is the second in a series for planning and launching a dietary supplement business on Amazon. The first post explains a broad overview of how to sell health supplements on Amazon. In this part, we will discuss in more detail Amazon’s requirements for selling nutritional supplements and how to meet them. The requirements are:
- Certificate Of Analysis (COA)
- Current Good Manufacturing Practices (cGMP) Certificate
- Health Supplement Labeling Requirements
- Product Photos
- Invoice of Purchase from the Manufacturer
Certificate of Analysis (COA)
A certificate of Analysis (COA) is a certification document that provides information about the quality and purity of the supplements. Amazon Sellers require this certification from an ISO/IEC 17025-certified lab to be eligible for selling dietary supplements.
The lab tests the finished product against declared ingredients and, on successful validation of ingredients, issues the COA. To get a supplement product ready for testing, sellers must review the passing standards and ensure their product falls within that criteria.
List of Approved Labs in the USA
The complete list of ISO/IEC 17025:2017 certified labs can be searched through the database of ANAB by clicking here. We have shortlisted the approved labs, and you can obtain COA for Amazon through any of the following approved labs:
- Eurofins Scientific
- Labcorp Drug Development (Formerly Covance)
- NSF International
- UL Solutions
- ALS Global
- Bureau Veritas
- TÜV SÜD
- EAG Laboratories
Current Good Manufacturing Practices (cGMP) Certificate
Current Good Manufacturing Practices (cGMP) refers to regulations the US Food and Drug Authority (FDA) enforced. This certification ensures that the product (dietary supplements) is produced safely, consistently, and effectively.
Amazon requires an Accredited Third-Party Certification Body to issue the cGMP In Compliance With 21 CFR 111 and 21 CFR 117.
- 21 CFR 111 – cGMP in manufacturing, packaging, labeling, or holding operations for dietary supplements.
- 21 CFR 117 – cGMP, Hazard Analysis, and Risk-Based Preventative Controls (HARPC) for Human Food.
List Of cGMP Certification Bodies In the USA
Amazon accepts GMP certificates from accredited third-party certification bodies. Here is a list of a few third-party bodies that can provide cGMP certifications in the USA.
It is essential to note that this is not a complete list. The organizations mentioned here are all certified with United States FDA regulations and can provide cGMP.
Health Supplement Labeling Requirements
Amazon requires all dietary supplement products to be correctly labeled per the FDA requirements. All parameters of nutritional labeling for dietary supplements are defined in 21 CFR 101.36; however, for a brief overview, the label must have the following five statements:
- Name of the dietary supplement
- Net quantity of contents/amount of the dietary supplement
- Nutrition labeling
- The ingredient list
- The name and place of business of the manufacturer, packer, or distributor.
Proper labeling is a mandatory requirement by the FDA, and Amazon will check for compliance through the product photos submitted to Amazon as part of the approval process.
As part of the approval process for selling dietary supplements on Amazon, you must submit photos of the product and packaging that meets all the labeling and packaging requirements. Here are some of the guidelines set by Amazon for product photos.
- Product photos must be high quality, with all the labels visible and readable.
- Light-colored or white background.
- Well-lit photos without shadows or distractions.
- JPEG or PNG format and at least 1000 pixels.
- No watermark, borders, or decorative elements.
- The image should represent the product accurately in size, shape, and features.
Invoice of Purchase from the Manufacturer
Finally, Amazon may demand a manufacturer invoice to establish that you have a direct contract with the supplier and are an authorized seller. To gain Amazon’s approval, the invoice must meet the following requirements:
- Invoice number.
- The invoice must be dated within the last 180 days.
- The name and address of the Amazon seller.
- The name and address of the manufacturer.
- Product description, SKU number, Quantity, Price.
- Payment details.
Once you have met all the requirements described above, the next step is to list the product on Amazon. Learn more about how to list and sell dietary supplements on Amazon.
Amazon authorizes the sale of supplements only when all requirements have been met while failing to meet these requirements can result in rejection. These policies are subject to change over time, and sellers must keep an eye on the platform’s latest policy announcements regarding supplements niche to stay current.
For any questions or comments, reach out to us through the comment section below or the contact us page.