Many stakeholders in the dietary supplement industry praised and applauded Amazon for imposing documentation requirements to show products are manufactured according to federal regulations and GMPs, but they weren’t thrilled with all the particulars.
Recent policies adopted by Amazon require dietary supplements have been tested and offer an assurance from the manufacturer that the products meet FDA regulations. Amazon’s actions last year drew praise from many industry stakeholders who feel the changes could promote transparency for consumers and improve the quality of supplements sold through the e-commerce giant.
In November of 2020, Amazon notified its sellers and vendors of the policy changes, which require production of three major pieces of documentation in order to sell dietary supplements: a certificate of analysis (CoA) from an ISO/IEC 17025-accredited laboratory for each supplement; product images; and a letter of guarantee from the product manufacturer, including an assurance that the supplement is produced under FDA’s cGMPs (current good manufacturing practices) incorporated in 21 CFR Part 111.
Amazon’s reputation in the supplement space hasn’t been exactly stellar. For example, NOW Health Group Inc. has identified many products of inferior quality, based on third-party lab tests as well as testing conducted by the company, a family-owned manufacturer of natural products since 1968.
The quality of products sold on Amazon varies widely, agreed Elan Sudberg, CEO of Alkemist Labs, a contract testing laboratory specializing in plant authentication, botanical ingredient identification and quantitative analytical services to the food and beverage, nutraceutical and cosmeceutical industries. That reality has vexed established supplement firms that invest heavily in science and regulatory compliance.
“Selling partners are required to comply with all laws and regulations, as well as Amazon’s policies including compliance and testing requirements,” an Amazon spokesperson said. “We have proactive measures in place to prevent suspicious, noncompliant or prohibited products from being listed, and we continuously monitor the products sold in our stores.”
Amazon’s new policies, Sudberg agreed, “will improve the quality of products” purchased on Amazon.
“Ever heard someone try to pronounce GMPs as if it’s a single word with no vowels?” Sudberg asked. “We have, and honestly it freaked us all out that these big companies that sold a ton of products didn’t even know that they are required by law to adhere to regulations.” Many supplement brands selling on Amazon have never seen a CoA and are poised to “get a crash course on the realities of product testing and quality assurance,” Ebersole said.
Among Amazon’s requirements: All sides of the product label must be visible; the Supplement Facts panel and ingredient list must be clearly shown; and the product image must contain the product name, as well as the name and address of the company.
Asked to comment on Amazon’s supplement policies, an FDA spokeswoman said the agency was not familiar with the specific details of the retailer’s program. But “in general, we applaud all efforts by industry stakeholders to enhance the level of overall compliance and ensure that products meet the applicable legal requirements,” she said.
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