In a letter to Amazon’s new CEO Andy Assy on July 26 from Donald Ashley, director of the FDA’s Office of Drug Assessment and Research (CDER) compliance, the agency said the FDA had bought “Dozens of products designed for sexual growth and weight loss”From Www.amazon.com website, “After further laboratory tests, it was found that all the tested products contain components of undeclared potentially harmful drugs. As discussed below, your company is responsible for introducing, delivering or introducing new drugs that are not accepted. ”
Twenty-six sexual enhancements were purchased between December 2019 and February 2020. All but one were sold as dietary supplements. The FDA said laboratory tests had determined their presence “Sildenafil, tadalafil և one or more components of vardenafil”. Amazon later told the FDA that the products were limited, but the agency was able to repurchase one of the products in January 2021, prompting the agency to express concern that Amazon’s filters “Insufficient”.
In March of this year, the agency “On your website, www.amazon.com, you have purchased samples of two additional ‘enhancement և different weight մեկ weight loss products, all of which have been submitted or submitted to Amazon Interstate Trading through your Amazon service.”
The FDA analysis confirmed the presence of tadalafil in sexual enhancement products և the presence of sibutramine in weight loss products.
It should be noted that the letter is not a warning letter. A spokesman for the FDA’s Drug Evaluation and Research Center told NutraIngredients-USA: “The agency acknowledges that Amazon has taken some corrective action in the past when the FDA announced the distribution of unapproved, mislabeled drugs. However, these actions were not enough to properly protect the public, և Amazon continued to distribute products with hidden drug components that endanger the health of American society. The agency wanted to make it clear to Amazon that the corrective action taken so far was not adequate before further action could be taken.
Amazon. “These products have been removed. We will continue to work with the FDA to protect our customers.”
In response, an Amazon spokesman told NutraIngredients-USA: “Amazon’s security is a priority; all products offered in our stores must comply with applicable laws and regulations. The products in question have been removed, We will continue to work with the FDA to protect our customers.
“Amazon regularly requires retailers to review safety և compliance documentation նրանց to ensure that their products meet regulatory standards. For dietary supplements, we require vendors to share certain product information, such as a certificate of analysis. ” The spokesman added.
“By 2020, Amazon has invested more than $ 700 million to protect our customers, including improving vendor scrutiny, scaling up our review of these documents, and more. We provide sales partners with help pages, videos, online webinars և online և telephone support to help them understand their compliance obligations, և continue to invest in opportunities to ensure our sales partners are aware of labeling requirements.
Amazon also continuously scans product details, customer reviews, customer contacts, and third-party sources to identify activity that indicates that the products offered in our store may be of concern. This includes using predictive technology to evaluate hundreds of millions of products in our store, allowing us to find and remove potentially dangerous products before our customers see them. As a result of these proactive product listing requirements, we removed more than 100 million products from our stores last year. ”
Quality characteristics of dietary supplements
The letter comes at a time when the retail giant was about to launch its food supplement quality program, which was first announced in December 2020. Significant update was made in April. Dietary supplement brands were originally required to submit the required documents by May 3, 2021, and Amazon intended to approve them by May 31, 2021, but that date has been delayed several times.
Amin Talat Wasserman, LLP partner Abishek Gurnani told NutraIngredients-USA that Amazon had announced that it would open the bidding process by August 2, 2021, and if they did not apply by October 4, 2021, the lists could to be. removed. “However, our customers tell us that the application process did not actually open on August 2, 2021. So it seems to be delayed again. ”
NutraIngredients-USA understands that the launch may be delayed for 30 to 60 days or more, in light of an FDA letter, as the e-tailer is considering փոփոխ making potential changes to the standards. NutraIngredients-USA asked Amazon for clarification on this issue, but did not receive a response before publication.