GMA submits food additive petition to FDA to seek approval of low-level PHO uses.
- As previously covered on this blog, FDA recently announced that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food. Going forward, PHOs will be regulated as food additives, which — unlike GRAS substances — require FDA approval prior to use in food.
- A leading food industry trade association, the Grocery Manufacturers Association (GMA), has submitted a food additive petition to FDA seeking the Agency’s approval of specific low-level uses of PHOs. GMA asserts that scientific data — including diet intervention studies, meta-analyses, and mode of action data — demonstrate that people may consume up to 1.5% of their daily energy from trans fat without adversely affecting “bad cholesterol” levels. GMA indicates that consumers would not exceed the 1.5% consumption threshold if FDA approves its petition.
- Submission of the food additive petition is just the beginning of a long review and approval process. Even if FDA’s review goes smoothly, a final approval still may be two or three years away. GMA officials have indicated that they are currently preparing an environmental assessment (EA) at FDA’s request and that they expect FDA to formally accept (or “file”) the petition after the EA has been submitted. In the meantime, the food industry continues to grapple with the legal and practical challenges that exist in the wake of FDA’s declaration that PHOs are not GRAS.