FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
 
T97-5                           Judith Foulke (202) 205-4144
January 21, 1997     
                                Consumer Hotline (800) 532-4440
 
FDA ALLOWS WHOLE OAT FOODS TO MAKE
   HEALTH CLAIM ON REDUCING THE RISK OF HEART DISEASE
 
     FDA will display at the Federal Register a final rule allow-
ing health claims on the labels of foods containing soluble fiber
from whole oats (rolled oats, oat bran and oat flour) noting that
these foods, as part of a diet low in saturated fat and choles-
terol, may reduce the risk of heart disease.  The following may
be used to answer questions.
     FDA regulates health claims on food labels under provisions
of the Nutrition Labeling and Education Act of 1990 to ensure
that claims are accurate and not misleading to consumers.  The
law allows the agency to authorize a health claim only if there
is significant scientific agreement that the claim is true.
     In allowing this health claim, FDA concluded that the beta-
glucan soluble fiber of whole oats is the primary component
responsible for the total and LDL blood cholesterol-lowering
effects of diets that contain these whole oat-containing foods at
appropriate levels.  This conclusion is based on review of
scientific evidence indicating a relationship between the soluble
fiber in these whole oat-containing foods and a reduction in the
risk of coronary heart disease.
     Food products eligible to bear the health claim include oat
 bran and rolled oats, such as oatmeal, and whole oat flour.  Oat
bran and rolled oats were the two food products named in a
petition submitted by The Quaker Oats Company in March 1995.  FDA
added whole oat flour to this final rule in response to data
provided in comments following the agency's publication of the
proposed rule on January 4, 1996.  The data submitted showed that
whole oat flour is nutritionally equivalent to rolled oats and,
more importantly, has similar effects on serum lipids.
     In the final rule, FDA acknowledges that sources of beta-
glucan soluble fiber other than from whole oats, and certain
soluble fibers other than beta-glucan, are also likely to affect
blood lipid levels.  However, FDA must await evidence on these
other sources before making a judgment on their effects.
     To qualify for the health claim, the whole oat-containing
food must provide at least 0.75 grams of soluble fiber per
serving.  The amount of soluble fiber needed for an effect on
cholesterol levels is about 3 grams per day.  Adding whole oat
flour to the list of substances eligible to be the subject of a
claim means that many products will qualify for the claim, thus
making it possible that oat-containing products could be consumed
as many as 4 times a day.
     Examples of how the newly allowed health claim may be used
are:
       "Soluble fiber from foods such as oat bran, as part of a
       diet low in saturated fat and cholesterol, may reduce the
       risk of heart disease."  or
       "Diets low in saturated fat and cholesterol that include
       soluble fiber from oatmeal may reduce the risk of heart
       disease."
     The words, "Diets low in saturated fat and cholesterol" must
be included in any such health claim because FDA concluded, after
reviewing comments, that consumers might otherwise be misled into
thinking that eating a diet high in oats is all that is necessary
to reduce the risk of heart disease.
     The final rule will be published later this week in Federal
Register.
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