Supplement manufacturer NOW has expressed concern over the last few years for the number of adulterated products that are being sold on Amazon, conducting independent tests of the products sold on the website to confirm their growing suspicions.
Some of the tests that were conducted by NOW of other supplement products on Amazon found that their contents were inconsistent with the claims on their labels. Their testing program ended up revealing the prevalence of low-quality supplements being sold on Amazon.
NOW’s vice president of global sales and marketing, Dan Richard, stated in a press release that “The requirement to submit a Certificate of Analysis (to Amazon) that verifies those claims, and meets the FDA’s cGMP requirement, is a great step in cleaning up the market. It is in the best interest of Amazon [as well as] the consumer to make it harder for supplement sellers to distribute inferior material. As a business partner of Amazon, we reported all the quality problems we found to them and asked them to take action. Assuming there will be a review of all the CofA’s and other provided documents to confirm they are legitimate; this will go a long way in making sure consumers are getting what they expect when they purchase supplements from Amazon.”
Amazon has new requirements regarding supplement quality that started to roll out near the end of 2020, and suppliers must now supply documents to prove that:
Only ingredients that are lawful and safe are used.
The concentration of active ingredients that are stated on the label are safe for consumption.
The product meets the potency claims that are stated on the label.
The product is manufactured under the Good Manufacturing Practices, listed in 21 CFR Part 111.
The online retailer is also requiring up to date Certificates of Analysis (CofAs) for each product, as well as requiring high resolution images of all sides of the product labels (including legible images of the ingredients list and supplement facts panel). These new requirements do not apply to products that are sold with a Nutrition Facts table, although some products like protein powders and superfood blends can appear very supplement-like in their packaging and overall appearance.
In December 2020, the FDA warned consumers that potentially dangerous products on the market, that may contain active pharmaceutical ingredients that are not listed on their labels. These products can not only cause serious side effects, but could also interact with medications or supplements that the consumer is taking. Of the 26 products that the FDA purchased on Amazon, all of them contained undeclared pharmaceutical ingredients.
The FDA’s laboratory testing demonstrated that these products contained various active ingredients that weren’t declared on the package, including sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein and/or fluoxetine.
Starting in February 2021, Amazon will require full compliance with these new requirements for all supplements that are sold on its platform. Amazon will have the option to remove products from their site, withhold payments to the seller (or suspend them), and even pursue legal action if it’s determined that the requirements are not met.