On October 28, 2022, the United States Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) issued warning letters to both Walmart Inc. and Amazon.com, Inc. (collectively, “the Warning Letters”) for selling on their websites drug products deemed to be illegal under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
In the Warning Letters, FDA states that both Walmart and Amazon are:
“…responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of [a] product, which is an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, this product is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).”
Here, FDA is holding these retailers responsible for introducing and/or delivering into interstate commerce products that are misbranded because they make impermissible arthritis-related medical treatment claims and adulterated because the products contain diclofenac, an FDA-approved non-steroidal anti-inflammatory drug, that was not listed in the products’ ingredients.
The Warning Letters are notable because, historically, FDA actions against retailers are rare. FDA does have authority over retailers and distributors – as the Warning Letters note, it is unlawful under the FD&C Act to introduce or deliver into commerce an adulterated or misbranded drug and this prohibition applies to retailers and distributors. However, FDA typically only holds the manufacturer of a violative product responsible as it is most frequently the manufacturer who is responsible for adulterating and/or misbranding the product and then introducing the product into commerce.
Now, both Walmart and Amazon have fifteen (15) business days from October 28, 2022, to respond to the FDA demonstrating that they have removed the illegal products from their online markets. If they do not respond, both Walmart and Amazon could face legal consequences.
It is important to note, that the reasoning in these Warning Letters is not limited to drugs. The FD&C Act contains similar prohibitions applicable to the introduction and delivery into commerce of foods, dietary supplements, cosmetics, and medical devices. Thus, the logic follows that online and in-person distributors and retailers of any misbranded and/or adulterated FDA-regulated product could similarly be deemed to violate the FD&C Act.
To reduce the risk of such adverse regulatory actions, retailers and distributors should generally, as a best practice, obtain guaranties from suppliers that FDA-regulated products comply with the FD&C Act. Other routine best practices can also help manage such risks, including good communication with suppliers, up-to-date records keeping, and team-member management and training.
Please contact OFW Law if you have any questions, comments, or concerns.