This document was issued in 1999. See Questions and Answers about Trans Fat Nutrition Labeling for more recent information on this subject.
Press Release and Fact Sheet on Trans Fat Proposed Rule
Q: What are fats and fatty acids?
A: Fats are a group of chemical compounds that contain fatty acids. Energy is stored in the body mostly in the form of fat. Fat is also needed in the diet to supply essential fatty acids, substances essential for growth but not produced by the body itself. The terms fat and fatty acids are frequently used interchangeably.
Q: What are the main types of fatty acids?
A: There are three main types of fatty acids: saturated, monounsaturated and polyunsaturated. All fatty acids are chains of carbon atoms with hydrogen atoms attached to the carbon atoms. A saturated fatty acid has the maximum possible number of hydrogen atoms attached to every carbon atom. It is therefore said to be "saturated" with hydrogen atoms, and all of the carbons are attached to each other with single bonds.
In some fatty acids, a pair of hydrogen atoms in the middle of a chain is missing, creating a gap that leaves two carbon atoms connected by a double bond rather than a single bond. Because the chain has fewer hydrogens, it is said to be "unsaturated." A fatty acid with one double bond is called "monounsaturated" because it has one gap. Fatty acids having more than one gap are called "polyunsaturated."
The fat in foods contains a mixture of saturated, monounsaturated and polyunsaturated fatty acids. In foods of animal origin, a large proportion of fatty acids are saturated. In contrast, in foods of plant origin and some seafoods, a large proportion of the fatty acids are monounsaturated and polyunsaturated.
The structure of saturated and unsaturated chemical bonds looks like the diagram below.
| Saturated Fat (i.e., saturated fatty acid) |
Unsaturated Fat (i.e., unsaturated fatty acid) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||||||||||||||||
| Carbon-Carbon Single Bond | Carbon-Carbon Double Bond |
Q: How do saturated and unsaturated fat relate to heart disease?
A: Higher intakes of saturated fat raise low density lipoprotein cholesterol (LDL-C or "bad" cholesterol) in the blood. An elevated LDL-C increases the risk of developing coronary heart disease (CHD). Substituting intake of monunsaturated and polyunsaturated fat for saturated fat decreases LDL-C and the risk of CHD.
Q: What is hydrogenation?
A: Hydrogenation is the process by which hydrogen atoms are added to unsaturated sites on fatty acids, thereby, eliminating double bonds. This process solidifies fatty acids and increases the shelf life and flavor stability of these fats and foods that contain these fats. During "partial hydrogenation" some double bonds remain, but may shift to a different position along a chain and alter their configuration. Partial hydrogenation has been used widely in the United States since the 1940's to make semisolid fat products.
Q: What are trans fatty acids?
A: Trans fatty acids, also known as trans fat, are made during partial hydrogenation of vegetable oils. Usually the hydrogen atoms at a double bond are positioned on the same side of the carbon chain. However, partial hydrogenation reconfigures some double bonds and the hydrogens end up on different sides of the chain. This type of configuration is called "trans" (means "across" in Latin).
The structure of a trans unsaturated chemical bond looks like the diagram below.
| Trans Fat (i.e., trans fatty acids) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |||||||||||||||
| Hydrogens are on opposite sides of the chain of carbon atoms at the carbon-carbon double bond. |
Q: How does trans fat affect the blood cholesterol?
A: Like saturated fat intake, trans fat intake also raises the LDL-C ("bad" cholesterol) in the blood. An elevated LDL-C increases the risk of developing coronary heart disease (CHD).
Q: Do we need trans fat for a nutritious, well-balanced diet?
A: No. Trans fatty acids are not essential fatty acids and the body does not require them to function properly.
Q: Where is trans fat found?
A: Trans fat is found in vegetable shortenings, some margarines, crackers, cookies and many other foods made with or fried in partially hydrogenated fats. The following information is from a 1995 report from the U.S. Department of Agriculture. This information is the most recent data base available on the content of trans fatty acids in foods.
| Food | Trans Fatty Acids grams/serving |
|---|---|
| Vegetable shortening | 1.4-4.2 |
| Margarine (stick) | 1.8-3.5 |
| Margarine (tub, regular) | 0.4-1.6 |
|
Salad dressings (regular) (see corrected information) | 0.06-1.1 |
| Vegetable oils | 0.01-0.06 |
| Pound cake | 4.3 |
| Doughnuts | 0.3-3.8 |
| Microwave popcorn (regular) | 2.2 |
| Chocolate chip cookies | 1.2-2.7 |
| Vanilla wafers | 1.3 |
| French fries (fast food) | 0.7-3.6 |
| Snack crackers | 1.8-2.5 |
| Snack chips | 0-1.2 |
| Chocolate candies | 0.04-2.8 |
| White bread | 0.06-0.7 |
| Ready-to-eat breakfast cereals | 0.05-0.5 |
| (1) Fatty acid data from USDA food composition data, 1995 | |
Q: Is it better to eat butter than margarine because of the trans fat?
A: No. Although some margarines contain more trans fat than butter, the total of trans and saturated fat (the LDL-C raising fats) is always less than the total for butter. The total for butter is much higher because of all the saturated fat that it contains. The chart below shows you the comparisons of the content of these types of fats in butter and in some margarines. It is usually better to eat the softer or liquid margarines that contain lower amounts of saturated and trans fats. Also, nonstick cooking spray may be substituted for other fats when "greasing" the pan. The following information is from the most recently available 1995 report from the U.S. Department of Agriculture and FDA data. Since that time, the margarine industry has reformulated many margarine products to reduce the total fat, saturated fat and trans fat content.
| Product | Total Fat | Saturated Fat | Trans Fat | Saturated and Trans Fats |
|---|---|---|---|---|
| Butter | 10.8 | 7.2 | 0.3 | 7.5 |
| Margarine, stick (82% fat) | 11.4 | 2.3 | 2.4 | 4.7 |
| Margarine, stick (68% fat) | 9.5 | 1.6 | 1.8 | 3.4 |
| Margarine, tub (80% fat) | 11.2 | 1.9 | 1.1 | 3.0 |
| Margarine, tub (40% fat) | 5.6 | 1.1 | 0.6 | 1.7 |
| (*)Butter values from FDA Table of Trans Values, dated 1/30/95. Other values from USDA Composition Data, 1995. | ||||
Q: How much trans fats do we eat a day?
A: The daily intake of trans fat in the U.S. is about 5 grams per person. For comparison, the intake of saturated fat is about 25 grams per person.
Q: Why is the FDA addressing trans fat?
A: Trans fatty acid consumption has been shown to elevate blood levels of LDL-C, or the "bad" cholesterol. High levels of this type of cholesterol increase the risk of coronary heart disease. This proposal would require that information on trans fatty acids be provided on the Nutrition Facts panel of food labels and on the Supplement Facts panel of dietary supplement labels. This proposal also responds, in part, to a citizen petition from the Center for Science in the Public Interest (CSPI) and to recently published human studies on trans fat. This action is being proposed to provide information to assist consumers in maintaining healthy dietary practices and to prevent misleading claims. Although the claim "saturated fat free" has a trans fat limit, other related claims do not. For example, currently the amount of trans fat in a product making a "low saturated fat" claim is not restricted and is not listed in the nutrition label.
Q: How will the nutrition label be different?
A: The FDA proposed rule on trans fatty acids (also called "trans fat") would require that the amount of trans fat be added to the amount of saturated fat per serving so that the amount of saturated fat and the percent Daily Value (%DV) per serving on the Nutrition Facts panel would be based on the sum of saturated and trans fats. When trans fatty acids are present, an asterisk (or other symbol) would be required after the heading "Saturated fat" to refer to a footnote stating that the product "*Includes __ g trans fat." This footnote would be optional on foods that contain no trans fat (i.e., less that 0.5 gram per serving, as analytical methods cannot reliably measure lower levels) except when a fatty acid or cholesterol claim is made. (See figure.)
Q: What about claims?
A: FDA also is proposing that, wherever saturated fat limits are placed on nutrient content claims, health claims, or disclosure and disqualifying levels, the amount of trans fatty acids would be limited as well. In addition, the agency is proposing to define the nutrient content claim for "trans fat free." The proposal covers the following:
"Low Saturated Fat"
Would be permitted only when there is 1 gram or less of saturated fat and less than 0.5 grams of trans fat per reference amount and not more than 15% of calories from saturated fat and trans fat combined.
"Reduced Saturated Fat"
Would be permitted only when there is at least 25% less saturated fat and at least 25% less saturated fat and trans fat combined.
"Cholesterol Claims"
Would be permitted only when, in addition to limits on cholesterol, the food contains 2 grams or less of saturated fat and trans fat combined, instead of 2 grams or less of saturated fat.
"Lean" and "Extra Lean Claims"
These claims are for seafood, game meat products, meal and main dish products.
"Lean" would be permitted only when, in addition to meeting limits on total fat and cholesterol, the food contains 4.5 grams or less of saturated fat and trans fat combined, instead of 4.5 grams of saturated fat.
"Extra lean" would be permitted only when, in addition to meeting limits on total fat and cholesterol, the food contains less than 2 grams of saturated fat and trans fat combined, instead of 2 grams of saturated fat.
"Trans Fat Free"
Would be permitted only when there is less than 0.5 grams of trans fat and less than 0.5 grams of saturated fat per reference amount and per labeled serving.
Disqualifying/Disclosure Levels
In addition, the labeling of foods containing more that 4 grams of saturated fat and trans fat combined per serving would not be able to carry health claims. However, labeling of such foods would be permitted to bear nutrient content claims if they have the following statement by the claim: "See nutrition information for saturated fat content." This statement would not have to accompany nutrient content claims when the food contains 4 grams or less of saturated and trans fat combined.
The FDA notes that it is not proposing a trans fat limit for the claim "Saturated fat free" because the agency has already defined that claim as less than 0.5 grams of saturated fat and less than 0.5 grams of trans fat.
Q: What is the scientific evidence that supports this proposal?
A: Reports in the late 1980's from the Federal Government and the Food and Nutrition Board of the National Academy of Sciences concluded that trans fatty acids did not appear to have harmful health effects. Studies in the early 1990's looked specifically at trans fatty acid intake and LDL-C ("bad" cholesterol) and HDL-C ("good" cholesterol) in the blood. Based on the newer research, a National Cholesterol Education Program publication in 1993, entitled "Second Report of the Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults," stated that research indicates that trans fatty acids raise LDL-C levels nearly as much as cholesterol-raising saturated fatty acids. The report stated that increased LDL-C levels increase the risk of coronary heart disease. It recommended that patients with high cholesterol should limit their intake of foods high in trans fatty acids. Also, the 1995 Dietary Guidelines for Americans recognized that trans fatty acids may raise blood cholesterol levels although not as much as saturated fat.
Recent human feeding studies have shown that consumption of trans fatty acids at levels found in the United States results in a significant increase in LDL-C and may decrease HDL-C. These findings are supported by results from epidemiologic studies (observational studies) that show a positive association between the intake of trans fatty acids and the incidence of coronary heart disease. FDA based its proposal on recent studies that indicate that consumption of trans fatty acids contributes to increased LDL-C levels, which increase the risk of coronary heart disease. Recent information from the American Heart Association indicates that CHD causes about 500,000 deaths annually and is the number-one cause of death in the United States. Thus, the FDA is proposing to provide for information on trans fatty acids in nutrition labeling and nutrient content and health claims in response to its importance to public health.
Q: What are the benefits and costs?
A: Trans fatty acids in the diet contribute to increased blood LDL-cholesterol levels ("bad" cholesterol), which increase the risk of coronary heart disease (CHD). CHD is the number- one cause of death in the U.S. FDA estimated the effects using two methods to consider changes in LDL-C or both LDL-C and HDL-C. FDA estimates that 3 years after the effective date, the proposed rule would annually prevent from 6,300 to 12,800 cases of CHD and 2,100 to 4,200 deaths.
The FDA calculated the present monetary value of benefits for the proposed rule as the reduction in CHD multiplied by the monetary value of preventing both fatal and nonfatal cases of CHD. Industry costs for the proposed regulation included testing, decision making, relabeling and reformulation costs (including inventory loss). Benefit and cost calculations were prepared for three scenarios during the compliance period and for 20 years beyond.
Each scenario assumes that some consumers reduce their consumption of trans fat based on labeling changes. Scenario A assumes that all margarine products will be reformulated to eliminate trans fat. Scenarios B and C assume in addition progressively more reformulation of baked products as well as assuming that all margarine products will be reformulated to eliminate trans fat. The lowest estimated benefits were based on changes in LDL-C levels and the highest benefits were based on changes in both LDL-C and HDL-C levels. This table shows these scenarios and results.
| Low Estimated Benefits | High Estimated Benefits | Estimated Costs | |
|---|---|---|---|
| Scenario A | $24,893 | $50,664 | $401 |
| Scenario B | $26,516 | $55,579 | $628 |
| Scenario C | $27,164 | $59,190 | $854 |
Q: How do I find more detailed information on this proposal?
A: The proposal is on display at the Office of the Federal Register, and at FDA's Dockets Management Branch. It can also be found at the following Web site: http://www.access.gpo.gov/su_docs/.
The public also can learn about new FDA issues that are open for public comment through the agency's Dockets Management Page on its web site or Web site address: http://www.fda.gov/ohrms/dockets/.
Q: Can I comment on this proposal?
A: Yes, comments should be submitted in writing by February 15, 2000 to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The heading of each comment should be identified with the docket number 94P-0036.
This document was issued in November 1999
For more recent information on Food Labeling
See http://www.cfsan.fda.gov/label.html
Corrected information on salad dressings can be found in the Final Rule (68 FR 41433, p. 41469) issued on July 11, 2003.
Hypertext updated by ear/cjm/dms 2006-OCT-02