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The Long Reach of FDA Accusations

Regulators don't only pick on the biggest companies. In a world of complicated chains of commerce involving multiple actors making and moving and bringing packaged products to market, no link of the supply chain is entirely safe from scrutiny.

Eric F. Greenberg
Eric F. Greenberg

For those of you who think that regulators only pick on the small companies, have I got a story for you. And this story is also eye-opening if you have wondered who the government is most likely to go after when a problem arises, in a world of complicated chains of commerce involving multiple actors making and moving and bringing packaged products to market.  

The short version of the story is that the Food and Drug Administration took action against Amazon for products sold on its website. Yes, that Amazon, the one with the big website where you can buy essentially everything for handy delivery. And this wasn’t the first time FDA has warned Amazon about products available on its popular website.

In November of 2023, FDA wrote to Amazon, warning the huge seller of things that seven companies’ products that Amazon helped sell were unlawful “new drugs.” FDA alleged that Amazon had violated the law by “introducing or delivering these products for introduction into interstate commerce” via Amazon’s fulfillment service. FDA also sent similar letters to at least five of the seven companies whose products were involved.  

That “introducing or delivering … for introduction” business is derived from the Federal Food, Drug and Cosmetic Act, the key law FDA enforces. 

I suspect that the common understanding about how FDA works goes like this. When it believes a product is unlawful in some way, it typically targets the company whose brand is named on the label. But that isn’t necessarily so. Probably that’s the most common scenario, but FDA considers a number of factors in deciding who to take action against, including the seriousness of the alleged violation, and how it appears to have been caused.

This FDA letter to Amazon is an excellent reminder of the all-encompassing nature of the Federal Food, Drug and Cosmetic Act. I often remind clients of the fact that essentially any role with respect to an allegedly violative FDA-regulated product is covered by the Act, and that as a result you can find a “prohibited act” listed in the law that describes pretty much any and every function. It’s an important fact to keep in mind for those we might not think of as first in line for FDA scrutiny, including service providers like Amazon, and also contract packagers and manufacturers, and those who transport and store FDA-regulated products such as foods, drugs, devices, and cosmetics.

Just because FDA might usually try to figure out who is most responsible for a product and take action against that company only, or first, that doesn’t mean they can’t also go after all the other companies that had anything to do with that violative product being on the market. 

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