Washington, DC…The U.S. Food and Drug Administration announced its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in food. The FDA’s preliminary determination is based on available scientific evidence and the findings of expert scientific panels.

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.

“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,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s 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 year – a critical step in the protection of Americans’ health.”

Consumption of trans fat raises low-density lipoprotein (LDL), or “bad” cholesterol, increasing the risk of coronary heart disease. The independent 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. Additionally, the IOM recommends that consumption of trans fat should be as low as possible while consuming a nutritionally adequate diet.

In recent years, many food manufacturers and retailers have voluntarily decreased trans fat levels in many foods and products they sell. Trans fat can be found in some processed foods, such as certain desserts, microwave popcorn products, frozen pizzas, margarines and coffee creamers. Numerous retailers and manufacturers have already demonstrated that many of these products can be made without trans fat.

Thanks to these efforts, along with public education, the consumption of trans fat in American diets has been significantly reduced. Since trans fat content information began appearing in the Nutrition Facts label of foods in 2006, trans fat intake among American consumers has declined from 4.6 grams per day in 2003 to about 1 gram per day in 2012.

“One of the FDA’s core regulatory functions is ensuring that food, including all substances added to food, is safe,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “Food manufacturers have voluntarily decreased trans fat levels in many foods in recent years, but a substantial number of products still contain partially hydrogenated oils, which are the major source of trans fat in processed food.”

Following a review of the submitted comments, if the FDA finalizes its preliminary determination, PHOs would be considered “food additives” and could not be used in food unless authorized by regulation. If such a determination were made, the agency would provide adequate time for producers to reformulate products in order to minimize market disruption. The FDA’s preliminary determination is only with regard to PHOs and does not affect trans fat that naturally occurs in small amounts in certain meat and dairy products.

More information about trans fat and information the FDA is seeking is available through a Federal Register notice. The docket will be open for comment for 60 days.

To submit comments by mail, send to the FDA at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All submissions must include the agency name and docket number.