The new requirements started rolling out last week. They mandate among other things that a supplement seller submit documentation to prove:
- That the product meets the potency claims specified on the label.
- That the product is manufactured under current Good Manufacturing Practices as listed in 21 CFR Part 111.
- That only lawful and safe, as defined in section 402 (f) of the FD&C Act, ingredients are utilized.
- That concentration of active ingredient(s) as stated on the label and labeling is safe for consumption.
Up-to-date COAs required
Among the documentation the online retailer is requiring are up to date Certificates of Analysis specific to each product. In addition, Amazon is requiring high resolution images of all sides of the product labels, including legible images of the Supplement Facts panel and ingredient list.
The new requirements do not apply to products sold with Nutrition Facts panels even though some of these, such as some functional beverages, protein powders, superfood blends and others are very supplement-like in their packaging, ingredient choices and marketing.
Long time coming
Scott Steinford, CEO of contract manufacturer Health Wright Products, said the change has been a long time coming.
“It started rolling out at the end of last week,” Steinford told NutraIngredients-USA. “It seems they are starting with the larger sellers and will work down to the smaller ones. From what we understand, companies have until February to comply with providing all of this information. It’s implied that if you can’t, you will no longer be allowed to sell through their site.”
“It seems that all of the noise created about their product assurance is having an impact and Amazon is responding,” Steinford added.
“These new requirements allow Amazon to start a dialogue with vendors to ensure that those seeking to sell through the Amazon platform are compliant,” said Elan Sudberg, CEO of Alkemist Labs, a prominent analytical laboratory that does a lot of work for supplement brands.
NOW’s testing program revealed prevalence of low quality products
One of the biggest noise makers has been supplement manufacturer NOW. Over the years NOW has built up an extensive analytical laboratory at its main manufacturing site and headquarters in Bloomingdale, IL. In 2020 NOW made a decision to use that expertise to test the quality of supplements sold on Amazon, test results which were verified by third party labs.
NOW bought products sold on Amazon and tested them for potency. They have tested sets of CoQ10, SAMe, phosphatidylserine and alpha lipoic acid (ALA) products and compared them to NOW’s own offerings in those categories.
The results were abysmal. Few products in any category came close to meeting label claim for potency of the stated active ingredients, and a number of the bottles contained almost none of the active ingredient.
Dan Richard, NOW’s vice president of sales and the executive who managed the Amazon testing effort, said in each case the test results had been forwarded on to Amazon. In each case the company received an equivocal response that amounted to an acknowledgment that the results had been received.
Richard: Efforts have been rewarded
Richard said it’s gratifying that NOW’s work has seemed to have resulted in positive action at Amazon, though he said Amazon did not consult with NOW before issuing the new requirements. He said he’s aware that Amazon has a difficult task ahead, as many thousands of different supplement products are sold through the site.
“ This seems to be what we’ve been asking for. We’ll see how Amazon can manage this process. It will be quite a challenge on their side. I think this is a great step by Amazon to try to fix their problems,” Richard said.
But the devil will be in the details, Richard said. COAs are complex documents and can hide as much information as they reveal, depending on how they’ve been assembled. It remains to be seen how many employees in Amazon’s Seller Support department will have the necessary expertise.
“These requirements do a good job of raising the bar for quality. It will be interesting to see how many brands are able to meet these qualifications, and how Amazon will manage the entire process. It’s a huge undertaking! Certificates of Analysis vary greatly in substance and accuracy, so tests ‘by input’ are really no test at all, but can appear this way in documents. It will be very hard and time-consuming for Amazon to determine which documents are valid and which ones are improper,” Richard said.
Lab spec might complicate compliance for brands
One requirement that might need some refining is Amazon’s call for a “Certificate of Analysis (COA) from an ISO/IEC 17025 accredited laboratory for each dietary supplement you are applying to list.” Aaron Secrist, NOW’s executive vice president of quality, R&D and operations, said that while requiring that certification might seem as if Amazon mandating only the highest capability labs be used, the specification is actually both limiting and potentially misleading and might complicate the process.
“ISO 17025 certification is a bit misleading because although ISO 17025 accreditation is robust, the scope is very limited. This means that a contract laboratory might have ISO accreditation for testing Fats in Milk but certainly not for testing ginsenosides in Ginseng Root. If they were to ask for ISO 17025 accreditation for the specific test, then there would be almost zero acceptable labs. We could do what many of the contract labs do and get ISO 17025 for a specific analyte in a specific matrix and then advertise that we are an ISO 17025 accredited laboratory. This would be true of course but it doesn’t really tell the full story,” Secrist said.
Sudberg agreed that the lab testing requirment is one area that will get a lot of attention from sellers on Amazon.
“I think the ISO accreditation requirement is likely to be controversial, because that’s not a simple ask. Companies should look for ISO accreditation for the testing area appropriate to their needs, but are not going to find it for every single ingredient or from the majority of labs. Alkemist Labs has flexible scope ISO/IEC 17025 accreditation all plants, but that’s a very rare designation. This is going to take some fine tuning on Amazon’s part, with input from the top companies, which is probably why they are starting with the largest brands,” he said.
Industry ought to welcome changes
Subberg said even with the potential sticking point of the lab requirement, above board companies ought to welcome the changes Amazon has implemented. There might be some attrition of brands selling on the site, he said.
“This will eliminate the vendors who are not able to meet designated requirements set forth by Amazon, which legitimate brands meeting regulatory requirements should be able to fulfill. Any dietary supplement company that works with vendors understands the critical need for proper vetting and qualification. We’re all aware of the industry’s evolving need for more rigorous requirements on vendor evaluation. It will be interesting to watch the changes that may occur in the number and quality of supplement products sold through Amazon when vendors are reviewed through the lens of Amazon’s new requirements,” Sudberg said.
Amazon did not respond to a request for comment in time for publication of this article.
