FDA Backgrounder
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 [Updated
Information], 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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Additional Information
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