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FDA Acts to Provide Better Information to Consumers on Trans Fats

July 9, 2003

TODAY’S ACTION

Today FDA published a final rule requiring manufacturers to list trans fatty acids, or trans fat, on the Nutrition Facts panel of conventional foods and some dietary supplements. With this rule, consumers have additional information to make healthier food choices that could lower their intake of trans fat as part of a heart-healthy diet.

HIGHLIGHTS OF THE FINAL RULE

This final rule is the first significant change to the Nutrition Facts panel since the regulations implementing the Nutrition Labeling and Education Act were finalized in 1993.

• This final rule requires manufacturers of conventional foods and some dietary supplements to list trans fat on a separate line, immediately under saturated fat on the nutrition label.
• While scientific reports have confirmed the relationship between trans fat and an increased risk of coronary heart disease, none has provided a reference value for trans fat or any other information that FDA believes is sufficient to establish a Daily Reference Value, therefore a % Daily Value (%DV) will not be listed.
• Dietary supplement manufacturers must also list trans fat on the Supplement Facts panel when their products contain reportable amounts (0.5 gram or more) of trans fat per serving. Examples of dietary supplements with trans fat are energy and nutrition bars.
• In finalizing this rule, FDA relied on scientific reports, expert panels, and studies from the Institute of Medicine/National Academies of Science, the National Cholesterol Education Program/NIH, and DHHS and USDA (Dietary Guidelines for Americans 2000). These reports concluded that consumption of trans fat contributes to increased LDL (“bad”) cholesterol levels, which increase the risk of coronary heart disease.
• Food manufacturers have until January 1, 2006 to list trans fat on the nutrition label. This phase-in period minimizes the need for multiple labeling changes, allows small businesses to use current label inventories, and provides economic savings. FDA expects that, now that the final rule has been put forward, many food producers will begin providing trans-fat information on the product label much sooner.
• FDA estimates that by 3 years after the effective date, trans fat labeling would prevent from 600 to 1,200 cases of CHD and 250-500 deaths each year.

HOW CONSUMERS CAN USE THE TRANS FAT LABEL INFORMATION TO IMPROVE THEIR DIET AND HEALTH

• FDA and other health experts advise consumers to keep their intake of saturated fat, trans fat, and cholesterol as low as possible while consuming a nutritionally adequate diet.
• For the first time, consumers will now be able to compare foods by looking at the Nutrition Facts panel and know how much of all three components – saturated fat, trans fat, and cholesterol – are in the foods they choose.
• This additional label information will help consumers make heart-healthy food choices that help reduce their risk of coronary heart disease, one of the leading causes of death in the U.S. today.
• Health experts recognize that eliminating trans fat entirely from the diet is not practical because it is unavoidable in ordinary diets. If consumers were to modify their diet by entirely eliminating trans fat, they would run the risk of getting inadequate protein and other nutrients important for a healthy diet.
• Consumers can reduce the amount of trans fat in their diets by limiting foods that contain “partially hydrogenated” vegetable oils that are found in some margarines, shortenings, crackers, candies, baked goods, cookies, snack foods, fried foods, salad dressings, and other processed foods.
• Good sources of heart-healthy alternatives include monounsaturated fats (like olive and canola oils) and polyunsaturated fats (such as soybean, corn, sunflower oils and foods like nuts and fish).

BACKGROUND

When the 1993 Nutrition Labeling and Education Act regulations were finalized, FDA did not require trans fat to be listed on the Nutrition Facts panel because at that time, the scientific evidence was not conclusive about the relationship between trans fat intake and increased blood cholesterol levels.

In 1994, the Center for Science in the Public Interest, a consumer advocacy organization, filed a petition (amended in July 1998) with FDA requesting that the agency take steps to require trans fat to be listed on nutrition labels.

In response to that petition, FDA issued a proposed rule in the Federal Register on November 17, 1999. In that document, FDA proposed to amend the regulations to require that trans fat be listed on nutrition labels. In response to comments and evolving science, FDA re-opened the comment period on December 5, 2000 and November 15, 2002.

FDA received over 1,650 letters in response to the November 1999 proposal, over 45 letters in response to the December 5, 2000 notice re-opening the comment period, and over 25 letters in response to the November 15, 2002 proposal and notice to reopen the comment period.

FDA has since reviewed the scientific evidence and recommendations of various scientific bodies, including the Institute of Medicine, National Academies of Science; an expert panel for the National Cholesterol Education Program; and the Advisory Committee on the Dietary Guidelines for Americans 2000.

NEXT STEPS:

• Consumer Education - FDA plans to educate consumers on the importance of lowering their intake of saturated and trans fats by developing consumer education materials for its nutrition and food labeling Web site. In partnership with the National Heart, Lung and Blood Institute, NIH and a variety of health and consumer organizations and trade associations, FDA will develop consumer education materials that these outside partners can use to communicate this important message
• Further Improvements in Nutrition Label - FDA is interested in establishing new nutrient content and health claims about trans fat, as well as considering footnote or disclosure statements on the label that could enhance consumer’s understanding about saturated fat, trans fat, and cholesterol in order to help them make heart-healthy food choices. To address this goal, FDA also published today an advance notice of proposed rulemaking (ANRPM) asking for information and data that could be used to draft further rules that would provide for such claims or statements.
• Conducting Research - FDA is also pledging to conduct consumer research on whether a footnote to the nutrition facts panel with dietary advice about saturated fat, trans fat and cholesterol consumption would be a useful way to help consumers control their diet. In addition, FDA will also do a study on whether nutrient content claims could be made for products with either “reduced” or “zero” trans fatty acids in a way that would not mislead consumers when there are significant amounts of saturated fat present.

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