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Amazon Requiring Regulatory Compliance for Dietary Supplements

TagOne:Engage Helps Process With CofA and Ingredient Quality Sharing


The dietary supplement industry has faced ongoing challenges as quality companies that provide safe, healthy solutions face competition from organisations that don't properly test or know the source of their ingredients. In order to ensure customer safety, Amazon released a new policy for dietary supplement companies that must be followed in order to be allowed to sell on the site. While most insiders welcome this new requirement, this does require additional legwork to organise and submit this information. Here is an abbreviated overview on Amazon's requirements as well as solutions to streamline the process, and take advantage of this with consumers.

For full guidelines and details, click here.

Certificate of Analysis

Amazon Requirements for Dietary Supplements

A valid Certificate of Analysis (CofA) is the first regulation that will be required for any dietary supplements sold on Amazon. The CoA must come from an ISO/IEC 17025 accredited laboratory and include the batch/lot number, matching information between the product label and CoA, and the laboratory method utilised for testing.

Product Images

High quality images must also accompany these supplements. The complete name must be visible on the label, clear view of the nutritional fact panel and ingredient list, and the name and address of brand owner.

Letter of Guarantee

The last necessity is a written letter of guarantee provided from the brand owner that outlines: the product name as written on the label, assurance that the product is manufactured under current Good Manufacturing Practices (cGMP's) as listed in 21 CFR Part 111, assurance that lawful and safe ingredients are used in the product, and assurance that a safe concentration of ingredients makes up the final product.

Requirements like these have been long anticipated from many in the food and supplement industry, especially since the FDA has begun to roll out efforts like the New Era of Smarter Food Safety. President of MC Squared, and long time food industry expert Mark Carter comments in a podcast with TagOne that "the data requirements aren't going to be any less stringent on the small business level" now that regulations like these are being imposed by the FDA - and now Amazon. Large and small businesses alike must begin putting measures in place that allow them to be prepared to provide CoA's and other information to their sellers, and consumers. Two years ago, TagOne hosted a discussion with the leaders in the dietary supplement supply chain to brainstorm ideas to bring more transparency into their industry. TJ Gupta commented, "when you combine the capabilities of mobile solutions to capture data, cloud infrastructure to share and store data, and blockchain technology to make it secure, we now have the ability to deliver game-changing transparency solutions."

TagOne's solutions, are squarely focused on simplifying the process of collecting, organising, analysing, and sharing data and documents. TagOne:Enterprise serves as a central repository for a dietary supplement company's supply chain information, and regulatory documents. Probably even more relevant is TagOne:Engage, which allows supplement companies to upload their photos, CofA's, ingredient information, lot info along with videos and photos to help differentiate them from competition and meet retailer requirements.

For more information on Engage, scan the QR Code above, or click here.


For more information on Amazon's new dietary supplement regulations, visit their site here.

For more information on TagOne:Engage, visit our site here.


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