March 9th, 2021

The FDA has its eyes on Amazon sellers.

As part of a recent crackdown on companies selling supplements marketed to treat depression, the FDA sent warning letters to two Amazon sellers for claims appearing in product listings on the e-commerce giant’s site.

One of those sellers was Enlifta, which in an Amazon listing for its Mood Elevator touted the supplement as “the only natural remedy depression supplement designed & created by a Psychiatrist.”

In its Feb. 18 warning letter to Enlifta the FDA also cited unapproved drug treatment claims appearing on the company website, including that Mood Elevator is “the only doctor designed depression pill.”

A total of 10 companies received warning letters for what the FDA called the illegal sale of supplements that claim to cure, treat, mitigate or prevent depression and other mental health disorders. Before the pandemic, one in five Americans lived with a mental illness; now, the number is two in five.

This is not the first time the FDA has targeted a company in Amazon’s vast ecosystem.

In May 2020, the FDA sent warning letters to five “Amazon associates” that participate in Amazon’s affiliate marketing program citing unapproved claims to treat the coronavirus. The companies included a CBD seller. Amazon was copied on each of the five warning letters.

Find more of our coverage on Amazon here.

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Only drugs can be marketed as having the ability to diagnose, cure, treat, prevent or mitigate a disease, and the only way for a product to gain legit drug status is by getting FDA approval, which means any product that doesn’t get FDA approval can’t say it has the ability to diagnose, cure, treat, prevent or mitigate a disease.

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