In a July 26 letter to new Amazon CEO Andy Jassy from Donald Ashley, Director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) at the FDA, the Agency states that FDA purchased “dozens of products intended for sexual enhancement and weight loss” from www.amazon.com, “and, after subsequent laboratory analysis, determined that all tested products contain undeclared and potentially harmful drug ingredients. As discussed further below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs”.
Twenty-six sexual enhancement products were purchased between December 2019 and February 2020. All but one of these were marketed as dietary supplements. FDA stated that lab analysis revealed the presence of “one or more of the drug ingredients sildenafil, tadalafil and vardenafil”. Amazon subsequently represented to FDA that the products had been restricted, but the agency was able to re-purchase one of the products in January 2021 leading the agency to express concern that Amazon’s filters are “inadequate”.
In March of this year, the agency “purchased samples of two additional and different sexual enhancement products and one weight loss product through your website, www.amazon.com, all of which were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.”
FDA analysis confirmed the presence of tadalafil in the sexual enhancement products and the presence of sibutramine in the weight loss product.
It should be stressed that the letter is not a warning letter. A spokesperson for the FDA’s Center for Drug Evaluation and Research told NutraIngredients-USA: “The Agency recognizes that Amazon has taken some corrective actions in the past when notified by FDA about the distribution of unapproved and misbranded drugs. However, those actions have not been sufficient to adequately protect the public and Amazon has continued to distribute products with hidden drug ingredients that put the health of the American public at risk. The Agency wanted to make clear to Amazon that the corrective actions it has taken to date are not adequate before taking any further possible steps.”
Amazon: “The products in question have been removed, and we will continue to work with the FDA to protect customers”
In response, an Amazon spokesperson told NutraIngredients-USA: “Safety is a top priority at Amazon and all products offered in our stores must comply with applicable laws and regulations. The products in question have been removed, and we will continue to work with the FDA to protect customers.
“Amazon regularly requests safety and compliance documentation from sellers and reviews them to ensure their products meet regulatory standards. For dietary supplements, we require sellers share certain product information, such as a certificate of analysis,” added the spokesperson.
“In 2020, Amazon invested more than $700 million to protect our customers, including scaling and improving our process for vetting sellers and reviewing this documentation. We provide selling partners with help pages, videos, online webinars and online and phone support to help them understand their compliance obligations, and will continue to invest in opportunities to ensure our selling partners are knowledgeable about proper labeling requirements.
“Amazon also continuously scans product details, customer reviews, customer contacts, and third-party sources to detect activity that indicates products offered in our store might be a concern. This includes using predictive technology to assess the hundreds of millions of products in our store, which allows us to find and remove potentially unsafe products before customers ever see them. As a result of these proactive product listing requirements, last year we removed more than 100 million product listings from our stores.”
Dietary supplement quality specifications
The letter comes at a time when the retail giant was gearing up to launch its dietary supplement quality program, first announced in December 2020. A substantial update was issued in April. Dietary supplement brands initially had until May 3, 2021 to submit the necessary documents, with Amazon aiming to give approval prior to May 31, 2021, but this date has been pushed back several times.
Abhishek Gurnani, a partner at Amin Talati Wasserman, LLP, told NutraIngredients-USA that Amazon had stated it would open the application process on August 2, 2021, and that if they didn’t apply by October 4, 2021, the listings could be removed. “However, our clients are telling us that the application process did not actually open up on August 2, 2021. So, it appears to be delayed again.”
NutraIngredients-USA understands that the launch could be pushed back by 30 to 60 days or more in light of the letter from FDA as the e-tailer reviews and potentially makes changes to the standards. NutraIngredients-USA asked Amazon for clarification on this but did not receive a response prior to publication.