FDA’s Hostile Take-Over of GRAS, Part III: It Started Earlier Than We Think
You would think any application of the GRAS1 process would be a legitimate pathway to federal compliance unless expressly prohibited by statute (e.g., color additives, dietary supplements) or by regulation (e.g., 21CFR2§184.1(b)(2));3 the latter of which requires a food additive petition (FAP) be filed for any additional use, use levels or changes to the manufacturing process of an otherwise GRAS affirmed substance.4 So far, so good for many food ingredients, until you get to