To sell any product on Amazon, it must comply with all the federal, state, and local laws of that particular country, state, or area. The compliance requirements get even more tough and stringent in the case of edibles such as dietary supplements. This is to make sure that the health of the consumers remains a top priority. To list and sell any dietary supplements on the Amazon marketplace, it has to go through certain independent supplement tests. For example, before selling a vitamin or dietary supplement product on the Amazon US marketplace, you need to get approval from the US Food and Drug Administration (FDA) which ensures that your product is safe to consume and does not have any adverse effects on the consumers.
Here are some steps that you must follow and the independent supplement tests that you need to carry out before you can start selling any dietary supplements on Amazon.
Certificate of Analysis (COA) – Independent Supplement Test
First off, you need to submit a Certificate of Analysis (COA) from an ISO/IEC 17025 accredited laboratory. The COA must contain the name, batch/lot number, or date code of the product and the name and address of the manufacturer. A quantitative analysis must be carried out by an independent supplement testing laboratory to make sure that the concentration of the active ingredients present in the dietary supplement is exactly the same as that mentioned on the supplement facts panel.
In addition to that, you also need to make sure that the names of the active ingredients mentioned on the supplement facts panel must be similar to those on the COA. The units (i.e., mcg/mg), mentioned on the COA must also be similar to those mentioned on the supplement facts panel. An important point to keep in mind is that this independent supplement test must be carried out and the COA must be issued no earlier than 6 months before your launch.
(Note: The laboratory tests of expired products are not accepted).
Product Images – Independent Supplement Test
Once the independent supplement test is carried out and you have provided Amazon with the required Certificate of Analysis (COA), it then requires you to provide legible images of your product. These images must contain the product’s name, the company’s name, and the company’s address. Images must have all the sides of the product label visible. Moreover, a clear image of all the supplemental/ nutritional facts and the active ingredients of the product must also be provided. This is to make sure that the list of all ingredients and all the necessary dietary information is mentioned on the product, and the information mentioned on the product matches with that listed in the Certificate of Analysis (COA).
Letter of Guarantee – Independent Supplement Test
Next, a letter of guarantee is required on the manufacturer’s part. The letter of guarantee should contain the product name as mentioned on the label and labeling. It must be on the manufacturer’s letterhead. Moreover, the letter of guarantee must provide certain assurances such as:
- The product is manufactured in accordance with the current good manufacturing practices (cGMPs) as listed in 21 CFR Part 111.
- The ingredients used in the manufacturing of the product are safe to use and lawful as defined in 402 (f) of the FD&C Act.
- The concentration of active ingredients, as mentioned in the product labeling, is generally safe to consume.
It is also to be noted, that Amazon is now accepting limited COAs for products that are cGMP certificated facilities. The certification list is limited and specific.
Final Thoughts
The independent supplement test is an important but complex process. There is a high chance that you may miss some important certifications, requirements, or approvals and get your list suspended or removed by Amazon. Once this happens, it gives a major blow to your business which, in some cases, is not easy to recover from. However, getting your supplements manufactured by an experienced and aware manufacturer such as BL Bio Lab makes the process easy and smooth for sellers.
BL Bio Lab has experience in manufacturing dietary supplements and has the relevant knowledge of all the requirements, certifications, and independent supplement tests. Our facility follows compliance requirements. Having your dietary supplements manufactured by BL Bio Lab guarantees peace of mind and allows you to focus on your core business without worrying about certifications, requirements, and approvals.
