[ceejayoz]

> you don't want to go down the road of the "FDA mandating efficacy".

This has long been a thing already.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-c...

> Many OTC medicines, including phenylephrine, are sold because they have an ingredient that FDA generally recognizes as safe and effective (GRASE) when used as recommended on the product labeling, which is documented in an “OTC monograph.” If FDA determined that oral phenylephrine is not effective, the agency would first issue a proposed order removing phenylephrine from this monograph.

https://en.wikipedia.org/wiki/Generally_recognized_as_safe_a...

[lazide]

The funny thing is phenyl ephedrine is actually very effective - when given IV, or directly applied to mucus membranes. Which this OTC drugs will never be used for.

So it is an effective drug, overall. Just not when used this way.

So good luck nailing whichever bureaucrat approved this.