If the FDA’s preliminary determination is finalized, then partially hydrogenated oils would become food additives subject to premarket approval by the agency. Foods containing unapproved food additives are considered adulterated under US law, meaning they cannot be sold legally.
“If FDA determines that PHOs are not GRAS, it could, in effect, mean the end of artificial, industrially-produced trans fat in foods,” said Dennis Keefe, Ph.D., director of the FDA’s Office of Food Additive Safety. “FDA is soliciting comments on how such an action would impact small businesses and how to ensure a smooth transition if a final determination is issued.”
The FDA has the authority to act when it believes an ingredient is, in fact, not GRAS, and that’s what the agency said its preliminary determination is doing now with PHOs. A Federal Register notice will be published on Nov. 7 announcing the preliminary determination that PHOs are not GRAS, which includes the opening of a 60-day public comment period.