Amazon is Finally Taking the FDA logo and use of the term FDA seriously
For many years, sellers on Amazon, particularly ones unconcerned about US law and product regulations, have placed the FDA (US Food & Drug Administration) logo on their products with impunity, claiming FDA approval on all kinds of things, from silicone baking mats to skincare products and more – all completely unauthorized and illegal, none of it banned by Amazon.
And now, that’s about to change.
What are the FDA regulations around logo use?
From the US Food & Drug Administration’s website:
The FDA logo is for the official use of the U.S. Food and Drug Administration (FDA) and not for use on private sector materials. To the public, such use would send a message that FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.
What does the FDA approve?
At a high level, the FDA approves drugs, medical equipment, and evaluates the use of ingredients and materials.
If getting approved as a medical device, there is a lengthy pre-approval process, which I won’t get into here.
Not everything requires FDA approval. Quite a few consumer goods are FDA regulated, but aren’t reviewed prior to sale for safety.
What Does the FDA Regulate?
The FDA regulates the obvious items, food and drugs, but also regulates health claims, food ingredients and additives, lasers, eyewear, and costmetics, among others, to a greater or lesser degree.
A (not comprehensive) list of regulated items:
- Prescription drugs for humans and animals
- Over-the-counter drugs
- Biologics (e.g. vaccines, blood products, biotechnology products and gene therapy)
- Dietary supplements (not all are subject to FDA regulation)
- Medical devices (everything from tongue depressors to pacemakers)
- Surgical implants
- Food additives
- Products that give off radiation (e.g. X-rays, microwave ovens)
- Tobacco products
- Infant formula
How Can Sellers Claim FDA Approval?
“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.”
These kinds of products are typically prescription medications, over-the-counter medications, vaccines and Class III medical devices.
Not typical consumer goods.
So how is it that for years, Amazon Sellers have been claiming FDA approval for all kinds of things?
In short, Amazon doesn’t hold itself responsible for the safety and labeling of items sold on the marketplace, rather, they have claimed for years that as a platform, the sellers on marketplace are the ones who are responsible to police themselves.
That results in sellers doing what it takes to get traffic, rather than what is legally permitted.
So What is Amazon Doing Now?
Amazon is now suppressing listings and deleting content for the following reason: “The ASINs have been removed for using FDA marketing claims”.
Based on what Amazon’s statements are in a recent reinstatement we handled, removal of all claims or marketing related to the US FDA is now prohibited.