The agency has opened a 60-day comment period on this preliminary determination to collect additional data and to gain input on the time potentially needed for food manufacturers to reformulate products that currently contain artificial trans fat should this determination be finalized. After such finalization, trans fats might be considered as “food additives,” and finally excluded from processed foods unless authorized by regulation.
With great concern over the daily diet of Americans, FDA has announced a preliminary determination to remove artificial trans fats from processed foods.
The use of partially hydrogenated oils (PHOs) in foods, which is the primary dietary source of artificial trans fat in processed foods, will no longer be “generally recognized as safe” (GRAS).
Trans fats, which are included in foods such as french fries, doughnuts, cookies, crackers or pizzas, are consumed daily by Americans in quantities that in most cases surpass the maximum daily recommendation of the American Heart Association, increasing the risk of developing heart disease, stroke and type 2 diabetes.
The agency has opened a 60-day comment period on this preliminary determination to collect additional data and to gain input on the time potentially needed for food manufacturers to reformulate products that currently contain artificial trans fat should this determination be finalized. After such finalization, trans fats might be considered as “food additives,” and finally excluded from processed foods unless authorized by regulation.
Manufacturing companies affected by the measure may submit comments and must identify if their foods can or cannot be processed without including artificial trans fats. Although not expressly stated by FDA, the conclusion of the Institute of Medicine (IOM) on the non-existence of a safe level of consumption of artificial trans fats, leads the agency to presume that a mere reduction of trans fats in processed food will not be enough to comply with this new measure. Accordingly, trans fats will have to be completely removed from food products. FDA estimates that eliminating trans fats will prevent 20,000 heart attacks and 7,000 deaths from heart disease per year in the U.S.
We expect industry will have much to say in response to this preliminary determination in the weeks and months to come.
If you require assistance regarding this, or any FDA-related matter, please contact any of the listed Roetzel attorneys.