SILVER SPRING, Md., Nov.19, 2018 /PRNewswire/ -- As Commissioner
of the U.S. Food and Drug Administration, I remain committed to
finding new ways to reduce the burden of chronic disease through
improved nutrition. Using the FDA's labeling tools to foster
innovation toward healthier foods that consumers want is one of the
primary goals of the FDA's Nutrition Innovation Strategy that I
first announced in March.
One tool the FDA has to help bring us closer to this important
goal is the use of "health claims" on food package labels. These
claims serve as efficient signals that consumers can look for on a
product's packaging to determine what benefits a food or beverage
might have. By allowing such claims on food product labels, we at
the FDA also hope to encourage the food industry to reformulate
products.
Recognizing the importance of science-based food decisions,
there are two kinds of health claims on food product packages –
authorized health claims and qualified health claims.
An authorized health claim meets the more rigorous standard of
"significant scientific agreement," meaning that the claim is
supported by the totality of publicly available scientific evidence
for a substance/disease relationship. A qualified health claim
means it is supported by more limited scientific evidence that
doesn't meet the rigorous standard. To ensure qualified claims
aren't misleading, they must be accompanied by a disclaimer to
communicate to consumers the level of scientific evidence
supporting the claim.
Today, the FDA responded to a petition for a new qualified
health claim for edible oils containing high levels of oleic acid,
a monounsaturated fat that's been shown to have cardiovascular
benefits when it replaces heart-damaging saturated fat.
Manufacturers of these oils can choose to include a qualified
health claim on their label stating that "supportive but not
conclusive scientific evidence suggests that daily consumption of
about 1½ tablespoons (20 grams) of oils containing high levels of
oleic acid, may reduce the risk of coronary heart disease." The
claim will also need to make it clear that to achieve this benefit,
these oils "should replace fats and oils higher in saturated fat
and not increase the total number of calories you eat in a
day."
Edible oils must contain at least 70 percent oleic acid to meet
the criteria for this qualified health claim. Specific edible oils
include: high oleic sunflower oil, high oleic safflower oil, high
oleic canola oil, olive oil and high oleic algal oil. Some high
oleic oils were developed as alternatives to partially hydrogenated
oils, which are no longer added to most foods, and will not degrade
when heated to high temperatures, which makes them ideal to use for
baking or frying.
The science behind the new qualified health claim for oleic
acid, while not conclusive, is promising. The FDA evaluated results
from seven small clinical studies that evaluated the relationship
between consumption of oils containing high levels of oleic acid
(at least 70 percent per serving) and improved cholesterol levels,
which indicates a reduced risk for coronary heart disease. Six of
the studies found that those who were randomly assigned to consume
diets containing oils with high levels of oleic acid as a
replacement to fats and oils higher in saturated fat experienced a
modest lowering in their total cholesterol and heart-damaging
low-density lipoprotein (LDL) cholesterol levels compared to
those who ate a more Western-style diet that was higher in
saturated fat. One study showed no significant effect. Importantly,
and as noted in the health claim, none of the studies found that
eating oleic acid-containing oils had beneficial heart effects
unless they replaced other types of fats and oils higher in
saturated fats in the diet.
Consumers should have access to clear, transparent food labels
that enable them to make smart choices that benefit themselves and
their families. Our Nutrition Innovation Strategy employs a broad
approach to support industry initiatives to introduce products that
meet consumer demands for healthier foods.
Key aspects of our new strategy include modernizing and
prioritizing new claims on food labels, as well as updating
ingredient labels and food standards in an effort to make labels
more understandable to consumers. Establishing a framework that
encourages industry to invest in and convey to consumers the
nutritional attributes of their products can support healthier
choices for Americans. Today's action gets us one step closer to
our ultimate goal of improving nutrition and reducing the burden of
chronic disease.
For more information:
Constituent Update: FDA Completes Review of Qualified Health Claim
Petition for Oleic Acid and the Risk of Coronary Heart Disease
FDA Nutrition Innovation Strategy
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
Media Inquiries: Deborah Kotz, 301-796-5349,
deborah.kotz@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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SOURCE U.S. Food and Drug Administration