The Food and Drug Administration is doing a massive find-and-replace across its official rulebook.
They are stripping the word "gender" out of Title 21 of the Code of Federal Regulations.
If you don't know what the Code of Federal Regulations, or CFR, is, just think of it as the giant, binding instruction manual for the entire federal government.
Title 21 is the specific volume of that manual that controls food and drugs.
Every time the word "gender" pops up in those rules, the FDA is going to delete it and replace it with the word "sex."
In some spots, they will just delete the reference entirely to clean up the sentences.
Why is the FDA suddenly caring about word choice?
It traces back to an Executive Order issued on January 20, 2025.
That order, signed by the President, is called "Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government."
It legally forces all executive agencies to use the word "sex" instead of "gender" whenever they are dealing with physical distinctions in federal documents.
The order strictly defines "sex" as a person's biological classification as male or female.
So, what does this actually change in the real world?
For the average citizen, absolutely nothing.
For businesses, drug makers, and medical device manufacturers, it changes almost nothing.
The FDA explicitly notes that this is purely an editorial change.
It does not impact how companies actually manufacture or test their products.
The government's bean counters ran the numbers and expect this rule to cost the industry zero dollars.
It will save zero dollars.
It just changes the paperwork.
Specifically, this edit hits the rules governing Institutional Review Boards.
Those are the committees that approve human testing for new drugs to ensure patient safety.
It also tweaks the reporting requirements for infant formula, prescription drugs, and medical devices.
When pharmaceutical companies submit adverse reaction reports to the FDA, the forms will simply ask for the patient's sex.
When medical device companies run clinical trials for things like cardiovascular software or traumatic brain injury monitors, the demographic data will be sorted by sex.
It is a sweeping linguistic shift, but fundamentally an administrative one.
