If you look up the term "FDA warning letter" you'll find out that it's not just a communication... it's a step in the process that may result in sanctions, fines, or even the ultimate punishment of being ordered to exit business.
> Our delicious O’s are made from whole grain oats which contain beta-glucan, a soluble fiber that can help lower cholesterol as part of a heart healthy diet
Vodka, combined with a healthy diet, can help lower cholesterol. Their latest scandal, BTW, is that the cereal contains glyphosate.
I've had it with this crap. The government shouldn't be this toothless. Enforcement actions for certain transgressions should start with being ordered to exit business, not end there.
Everywhere I've worked in the life sciences has bent over backwards to follow the rules. And as far as I can tell the Agency has a lot of antibodies against attempts to game the system, which is common, but if you follow the rules they are pretty helpful.
(I've also heard that nothing I said above applies to the ""F" -- "food" -- side of the FDA, but that's hearsay).
When 23andMe got their warnings there was much outcry in the Valley (and on HN) that the FDA was "not receptive to new technologies". But 23andMe took weeks to respond and when they would they often didn't even address the issues raised. The FDA bent over backwards for them because they were a new kind of technology -- those of us making real drugs got no such leeway.
BTW they weren't shut down but were prohibited from making unsubstantiated claims. If you want to print "use of this product will not cause you to grow a third arm" you would have to design a trial to support that claim even if the product is a tongue depressor. FDA will actually let you claim anything as long as you have demonstrated it to their satisfaction.
