Questions and Answers Regarding Trans Fat

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November 7, 2013

1. What is FDA announcing?

FDA has made a preliminary determination that partially hydrogenated oils (PHOs), the major dietary source of trans fat in the processed food supply, are no longer Generally Recognized as Safe, or GRAS. If FDA makes a final determination that partially hydrogenated oils are not GRAS, a company could not use PHOs in food without approval from the FDA, although it may take some time for the change to be fully implemented.

2. Why did FDA make this preliminary determination?

FDA made this preliminary determination because trans fats have significant adverse health effects. Scientific evidence has shown that consumption of trans fat raises low density lipoprotein (LDL-C or “bad) cholesterol, which increases the risk of developing heart disease. Trans fat may also have other adverse health effects, including lowering high-density lipoprotein cholesterol (HDL-C). Considering only the effects of trans fat from partially hydrogenated oils on levels of LDL-C, “bad” cholesterol, the Centers for Disease Control and Prevention estimates that eliminating intake of trans fat from partially hydrogenated oils could prevent up to 20,000 cases of coronary heart disease (CHD) and up to 7,000 deaths annually.

3. What are partially hydrogenated oils and why are they used?

Partially hydrogenated oils are formed during food processing when hydrogen is added to vegetable oil (a process called hydrogenation) to make it more solid. Partially hydrogenated oils are used by food manufacturers to improve the texture, shelf-life and flavor stability of foods. About half of the trans fat Americans consume is formed during food processing, and partially hydrogenated oils are the main source of trans fat in the U.S. food supply.

4. What types of foods are more likely to contain partially hydrogenated oils and trans fat?

Partially hydrogenated oils, and therefore trans fat, can be found in baked goods such as cakes, cookies and pies; snack foods such as microwave popcorn; frozen pizza; some fast food; margarine and other spreads, coffee creamer; vegetable shortenings and stick margarines; and refrigerator dough products such as biscuits and cinnamon rolls.

5. Is all trans fat the same?

No. The trans fat found in foods can either be natural or artificial. Naturally occuring trans fat is produced in the gut of some grazing animals, and that is why small quantities can be found in animal-based foods such as milk, milk products, and certain meats. FDA’s action would not affect these foods.

Artificial trans fat is formed during food processing through hydrogenation of vegetable oils.

6. Is trans fat worse than saturated fat in terms of contributing to heart disease?

FDA agrees with expert groups such as the Institute of Medicine and the American Heart Association, that trans fatty acids have a stronger effect on the risk of coronary heart disease than saturated fatty acids.

7. What is a food additive and what does it mean to be “Generally Recognized as Safe” (GRAS)?

In general, under the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive and is subject to approval and review by FDA before it can be marketed. However, the legal definition of “food additive” has several exceptions, including those substances that are Generally Recognized as Safe (GRAS) for an intended use.

A substance is GRAS if, through scientific study, it is generally recognized among qualified experts to be safe for its intended use. This is an important distinction because, unlike food additives, the use of a substance that is GRAS does not have to be approved by FDA before it may be lawfully added to food. Instead, a manufacturer must determine that the use of the substance is GRAS. To establish general recognition of safety, there must be a consensus among qualified experts that the substance will not be harmful under the intended conditions of use. A substance in use prior to 1958 can be considered GRAS as a result of scientific study or experience derived from its common use in food.

8. Are you asking for comments on this action?

Yes. FDA is seeking, through a Federal Register notice, additional scientific data and information, including comments about the following:

  • our preliminary determination that partially hydrogenated oils are no longer GRAS;
  • possible approaches to addressing the use of partially hydrogenated oils in food, such as setting an allowable level for trans fat in food; the time needed to reformulate products to eliminate partially hydrogenated oils from the food supply or challenges in reformulating certain foods; and
  • any prior sanction for the use of partially hydrogenated oils in food.

9. Should I eliminate trans fat from my diet?

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 consumptions of trans fat should be as low as possible while consuming a nutritionally adequate diet. Further, the 2010 Dietary Guidelines for Americans recommends that individuals keep consumption of trans fat as low as possible.

10. How can I tell if my food contains partially hydrogenated oils?

Consumers should look at both the trans fat level on the Nutrition Facts label and the ingredient list. Since 2006, the FDA has required that trans fats be declared on the Nutrition Facts label of foods. Products listed as “0 g trans fat” contain 0 to less than 0.5 g/serving trans fats. This means that foods labeled “0 g trans fat” may still contain some artificial trans fat. The ingredient list will provide information on whether the product contains partially hydrogenated oils.

11. Does the FDA intend to adjust this 0.5 g limit to a lower level?

At this time, the agency has no plans to make such an adjustment. If finalized, the preliminary determination would result in a lowering of actual levels in foods. At this time, the Agency does not have validated analytical methods to reliably test food products at such low levels of trans fat, but it is working on methods to reliably test food products at levels as low as 0.1 g trans fat per serving.

12. How does the reduction of trans fat intake relate to reducing obesity?

Reducing trans fat intake is more about cardiovascular health than obesity. Even individuals who maintain a healthy weight are susceptible to cardiovascular diseases. It is well accepted that trans fat consumption contributes to heart disease, the leading cause of death in the U.S. Today’s action is an important step toward addressing factors that contribute to everyone’s cardiovascular disease risk.

13. Have trans fats been restricted in other countries?

Yes. In 2004 Denmark restricted trans fat levels in oils and fats used in locally made or imported food. Trans fat must constitute no more than 2% of a product’s fat content. In 2008 Switzerland enacted a national trans fat ban with similar restrictions, and Canada has reduced trans fat consumption through voluntary reduction targets.

In the United States, some jurisdictions such as the state of California, New York City, the City of Baltimore, and Montgomery County, Maryland, have imposed restrictions on the use of trans fat ingredients in food service establishments. Generally, these regulations do not permit food service establishments to sell or distribute foods, and in some cases, use ingredients, containing greater than 0.5 g trans fat per serving. In New York City, by 2008 an estimated 98 percent of restaurants were not using ingredients containing artificial trans fat, compared with 50 percent in 2005.

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