FDA Moves to Reduce Trans Fats From Processed Foods

WASHINGTONThe U.S. Food and Drug Administration (FDA) today began the process to all but eliminate artificial trans fats from processed foods. The move comes as FDA announced its preliminary determination that partially hydrogenated oils, the primary dietary source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in food.

FDA Commissioner Margaret A. Hamburg said the agencys preliminary determination is based on available scientific evidence and the findings of expert scientific panels. Consumption of trans fat raises low-density lipoprotein (LDL), increasing the risk of coronary heart disease. She said the Institute of Medicine (IOM) has concluded that trans fat provides no known health benefit and that there is no safe level of consumption of artificial trans fat. The IOM also recommends that consumption of trans fat should be as low as possible while consuming a nutritionally adequate diet.

While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern," Hamburg said. The FDAs action today is an important step toward protecting more Americans from the potential dangers of trans fat. Further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each yeara critical step in the protection of Americans health."

trans fat can be found in some processed foods, such as certain desserts, baked goods, microwave popcorn products, frozen pizzas, margarines, snack foods and coffee creamers. FDAs preliminary determination is only with regard to partially hydrogenated oils and does not affect trans fat that naturally occurs in small amounts in certain meat and dairy products.

The agency opened a 60-day comment period to collect additional data and to gain input on the time needed for food manufacturers to reformulate products that currently contain artificial trans fat should the determination be finalized. The official notice of the preliminary determination, including details on the public comment period can be found in the Federal Register. The comment period starts Nov. 8.

Following a review of the submitted comments, if FDA finalizes its preliminary determination, partially hydrogenated oils would be considered food additives and could not be used in food unless authorized by regulation. Foods containing unapproved food additives are considered adulterated under U.S. law, meaning they cannot legally be sold.

If such a determination were made, the agency would provide adequate time for food manufacturers to reformulate products in order to minimize market disruption.

Hamburg said the elimination of artificial trans fats has been an ongoing process. We felt at this time we needed to address this issue and take an affirmative action," she said. We need to ensure the safety and wholesomeness of the food supply."

FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor noted that over the past few years, many food manufacturers and retailers have voluntarily decreased trans fat levels in many foods and products they sell. Since trans fat content information began appearing in the Nutrition Facts label of foods in 2006, trans fat intake among U.S. consumers has declined from 4.6 grams per day in 2003 to about 1 gram per day in 2012.

While food manufacturers already have demonstrated the capacity to reformulate food without trans fats, Taylor said removing trans fat from certain products like canned frostings will present more of challenge for food manufacturers.

He noted the vast majority of trans fats in the food supply are based on self-affirmed GRAS status, an independent judgment of safety fostered by food companies. However, he said FDA has not previously made a ruling on the majority of these cases.

He said the timeline for the phase-out will depend on the comments submitted, as well as information from discussions with industry and other stakeholders. Once FDA issues any final determination, it will again solicit public comment on the steps and timeline for removing trans fats from the food supply. He said the agency will factor in what it knows about the current marketplace, with respect to capacity to reformulate products to no longer contain trans fats.