Thank you! The FDA was created under the Food, Drugs, and Cosmetics Act. According to the law, everything they regulate falls into one of these categories. Sort of an animal/vegetable/mineral thing. Interestingly, toothpaste with fluoride is regulated as a drug, and without fluoride as a cosmetic. Not necessarily a big deal to be regulated as a drug... But as I dug into the regulations, I found it is actually still quite difficult to go through all the hurdles to bring a new fluoridated toothpaste to market. Comparatively, a new fluoridated mouthwash is really easy, just basic stability testing. I actually had to submit a Freedom of Information Act request to get a copy of the testing procedures. They were really something. The document I got back was a scanned pdf of a copy of a mimeograph of a typewriter carbon copy. And the testing quite onerous. They actually required animal testing for any new formulation! Pretty crazy given the well understood process of fluoridating toothpaste. So to get a product release, I'm forgoing fluoride in this version that lets me be a cosmetic. The regulations here are much simpler. There's testing, clean room requirements, ingredient safety stuff, but comparatively much easier, and I partnered with a manufacturer with lots of experience that's here in the United States.
Wow, just wow. This seems like one of those regulations that could be changed. Obviously the caffeine isn't a flagged substance: It would seem that a simple chemical composition test would be good enough to qualify a toothpaste - since we've done a lot of research on fluoride itself.
