July 9, 2003 -- U.S. Department of Health & Human Services Secretary Tommy G. Thompson announced today that food labels will be required to list the amount of unhealthy trans fatty acids, or trans fat, to give consumers better information when choosing their foods.
The new requirement through the Department's Food and Drug Administration (FDA) will mean that manufacturers of most conventional foods and some dietary supplements will have to list in the Nutrition Facts panel the trans fat content of the product, in addition to the information about its overall fat content and saturated fat content.
The additional information will give consumers a more complete picture of fat content in foods -- allowing them to choose foods low in trans fat, saturated fat and cholesterol, all of which are associated with an increased risk of heart disease. Reducing the intake of trans fat and saturated fats is recommended by the Federal Dietary Guidelines for Americans.
"We are empowering Americans to make healthier choices about the foods they eat," Secretary Thompson said. "By putting trans fat information on food labels, we are making it possible for consumers to make better educated choices to lower their intake of these unhealthy fats and cholesterol. It's just one more way we're helping consumers lead healthier lives."
The announcement is another step in Secretary Thompson's efforts to give consumers better health information that allows them to take the right steps to reduce their risk of disease, including making sound dietary choices.
Under the new FDA regulations, by Jan. 1, 2006, consumers will be able to find trans fat listed on food nutrition labels directly under the line for saturated fat. The new information is the first significant change on the Nutrition Facts panel since it was established in 1993.
The new labeling reflects scientific evidence showing that consumption of trans fat, saturated fat and dietary cholesterol raises low-density lipoprotein (LDL) cholesterol ("bad" cholesterol) levels that increase the risk of coronary heart disease. Nearly 13 million Americans suffer from coronary heart disease, and more than 500,000 die each year from causes related to coronary heart disease.
Trans fat occurs in foods when manufacturers use hydrogenation, a process in which hydrogen is added to vegetable oil in order to turn the oil into a more solid fat. Trans fat is often but not always found in the same foods as saturated fat, such as vegetable shortening, some margarines, crackers, candies, cookies, snack foods, fried foods, baked goods, salad dressings, and other processed foods.
"Our choices about our diets are choices about our health, and those choices should be based on the best available scientific information. This label change means that trans fat can no longer lurk, hidden, in our food choices," said Mark B. McClellan, M.D., Ph.D., commissioner of FDA. "Americans will now be armed with better information to reduce their intake of saturated fat, trans fat and cholesterol - which could significantly lower the risk of heart disease, the leading cause of death in America today."
By providing more useful information to consumers seeking a healthy diet, the new labels are expected to reduce the costs of illness and disease for Americans. The FDA estimates that the changes in regulations will save between $900 million and $1.8 billion each year in medical costs, lost productivity and pain and suffering.
The new label is part of the department's broader efforts to more effectively inform consumers about the health consequences of their dietary choices. The agency hopes to improve the nutrition label to provide clearer, up-to-date guidance on a healthy overall diet. FDA is also working to increase the focus on health in food product development and promotion, as well as encouraging research that would foster greater science-based competition among food producers to improve health.
The National Heart, Lung and Blood Institute (NHLBI) at HHS' National Institutes of Health (NIH) supports the new labeling.
"Trans fat, like saturated fat and dietary cholesterol, raises LDL "bad" cholesterol levels in the blood, which increases the risk for heart disease," said Dr. Claude Lenfant, director of NHLBI. "It is therefore desirable to have food labels display all the information that can help consumers choose foods low in saturated fat, trans fat and cholesterol as part of a healthy diet."
Although some food products already list trans fat on the food label, food manufacturers have until Jan.1, 2006, to add it to the nutrition label. This phase-in period minimizes the need for multiple labeling changes and allows small businesses to use up current label inventories. The FDA will allow manufacturers to implement the change more quickly, and in fact expects many manufacturers to start listing trans fat content soon.
In addition, dietary supplement manufacturers will now need to list trans fat, as well as saturated fat and cholesterol, on the Supplement Facts panel when their products contain more than trace amounts (0.5 gram) of trans fat. Examples of dietary supplements that may contain trans fat are energy and nutrition bars.
The new requirements are included in final FDA regulations to be published in the Friday, July 11, Federal Register.
FDA today also is issuing an advanced notice of proposed rulemaking to solicit information and data that could lead to further changes in nutrition and product labels related to trans fat, saturated fat, and cholesterol.
"While giving consumers accurate information about the trans fat content of their foods is an important step forward, we must do more to help consumers improve their nutrition," said Dr. McClellan. "Consequently, we are also giving notice that we intend to take further steps to increase consumer understanding of the importance of limiting consumption of trans fat, saturated fat, and cholesterol in their diet."
In particular, comments in response to FDA's notice could assist the agency in further action to establish:
* new nutrient content claims about trans fat, for example, claims that a product is "low in trans fat" on its label;
* qualifying criteria for trans fat in current nutrient content claims for saturated fat and cholesterol, lean, and extra lean claims, because the claims currently allowed by FDA in these areas may not appropriately reflect trans fat content; and
* health claims that contain a message about cholesterol-raising fats. FDA is also requesting comments on whether it should consider statements about trans fat, either alone or in combination with saturated fat and cholesterol; as a footnote in the Nutrition Facts panel (for example, to modify the recommended daily amount of trans and saturated fat and cholesterol to encourage limiting intake of all three); or as a disclosure statement in conjunction with claims to enhance consumers' understanding about such cholesterol-raising lipids and how to use the information to make heart-healthy food choices.
Additional information about today's announcements and broader efforts to improve health by providing information consumers can use to make healthy choices is available on FDA's Web site at http://www.fda.gov/oc/initiatives/transfat/.
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