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. 
 
T96-3                                         Brad Stone
Jan. 11, 1996                                 (202) 205-4144
 
       FDA PROPOSES HEALTH CLAIMS FOR OATMEAL AND OAT BRAN
 
     A new FDA proposal would allow manufacturers of foods
containing oatmeal or oat bran to claim on the labels that diets
high in these grain products and low in saturated fat and
cholesterol may reduce the risk of coronary heart disease.  This
proposal was published today in the Federal Register.  The
following may be useful for answering 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 March 1995 Quaker Oats Co. petitioned FDA to allow
claims of health benefits on products containing oatmeal or oat
bran.  In response, the agency reviewed more than 37 clinical
studies on the effects of oatmeal and oat bran in reducing serum
cholesterol levels in the body and lowering risk of coronary
heart disease.
     FDA also reviewed an evaluation of studies on the health
effects of oatmeal and oat bran conducted by the Federation of
American Societies for Experimental Biology (FASEB).  The FASEB
                           - more -
 
                                         Page 2, T96-3, Bran
review was published in a 1987 FASEB report entitled,
"Physiological Effects & Health Consequences of Dietary Fiber."
      FDA found that the studies demonstrated significant
scientific agreement on the beneficial effects of oatmeal and oat
bran.  FDA is in agreement with most dietary experts in its
conclusion that eating oatmeal or oat bran can reduce the risk of
coronary heart disease when part of an overall diet that is low
in saturated fat and cholesterol.
      However, based on the scientific evidence, FDA cannot
conclude that eating oatmeal or oat bran in and of itself reduces
risk of heart disease.
      FDA's model health claim reads as follows:  "Diets high in
oatmeal or oat bran and low in saturated fat and cholesterol may
reduce the risk of heart disease."
     Manufacturers of food products containing oatmeal and oat
bran may develop their own language for the health claim, subject
to FDA review and provided that the wording is in accord with the
evidence indicating that a reduction of heart disease risk is
associated with consumption of oatmeal and oat bran only when
incorporated with other healthy dietary and lifestyle practices.
     In the United States, coronary heart disease is the
underlying cause of more than 500,000 deaths each year, and is a
contributing factor in about 250,000 others.  About 20 percent of
adults from 20 to 74 years old are estimated to have serum
cholesterol levels high enough to put them at high risk for
coronary heart disease.
 
     This proposal was published Jan. 4 in the Federal Register.
Written comments on the proposal may be submitted within 90 days
of that date to the FDA Dockets Management Branch, HFA-305, 12420
Parklawn Drive, Rockville, MD 20857-0001.
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