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Regulatory Issues Wellness Foods
Marketing Products Using
the Dietary Guidelines
Federal agencies implementing any food, nutrition or health program
are required to promote the Dietary Guidelines.
By Leslie Krasny, Contributing Editor
he Dietary Guidelines for Americans – the
foundation for the federal food and nutrition policy – provides recommendations to
advance health and reduce the risks of major chronic
diseases through diet and physical activity. The U.S.
Dept. of Health and Human Services and the USDA
jointly issue a revised edition every five years.
The 2005 edition was a significant departure from
previous editions because it is based on a more comprehensive, scientific analysis of diet and health data,
including the Dietary Reference Intake (DRI) reports
(published since 2000 by the Institute of Medicine).
This latest Dietary Guidelines contains 41 detailed
recommendations within nine general areas, and
presents marketing opportunities for the food industry
– particularly in conjunction with appropriate nutrient
content, health, and structure/function claims.
The guidelines may be the source of authoritative
statements for purposes of Food and Drug Administration Modernization Act (FDAMA), notifications
to the FDA for nutrient content and health claims,
although only statements in the executive summary
and key recommendations sections of the guidelines,
which reflect a preponderance of the scientific evidence, may be used for FDAMA notifications.
One way the guidelines may be used in marketing
is to reference recommendations for daily consumption. For example, 2 cups of fruit and 2½ cups of
vegetables (an average of 9 servings), 3 cups of dairy
(preferably fat-free or low-fat), and at least 3 ounceequivalents of whole grains are recommended. An
ounce-equivalent of grains is 1 slice of bread, 1 cup
of dry cereal, or ½ cup of cooked rice, pasta or cereal.
A “serving” under the Dietary Guidelines may differ
from the required reference size for nutrition labeling
purposes, which may also be advantageous as a marketing tool if stated in a manner that is not confusing.
Another opportunity is to highlight differences
between daily intakes recommended under the guidelines for specific nutrients and daily values used in
nutrition labeling. The guidelines recommend 4,700
Food Processing’s Wellness Foods™
mg of potassium – far greater than the daily value of
3,500 mg – and 28g of fiber (14g per 1,000 calories),
as compared with the daily value of 25g.
In addition, the guidelines state that intake
levels of calcium, potassium, fiber, magnesium and
vitamins A (as carotenoids), C and E may be insufficient in the diets of adults. This can be effectively
used to promote products.
With respect to overweight and obesity, the
emphasis is that consuming more calories than
expended is a key factor contributing to the obesity
epidemic. It’s noted that if only nutrient-dense
foods are selected from each food group in amounts
recommended, a small amount of calories can be
consumed as added fats or sugars, alcohol or other
foods (“the discretionary calorie allowance”). The
trend is to market snack foods in small, single-serving units to assist consumers in controlling said
discretionary calories.
The guidelines also include statements that identify
dietary patterns or nutrients with health or disease
prevention. Such statements may be dietary guidance,
approved health claims, unapproved health claims,
structure/function claims or may fall in an unsettled
area of the law. The FDA has not clarified the distinctions among food categories, ingredients and nutrients
making it a challenge to identify the classifications in
order to comply with requirements.
Companies must ensure that any marketing use
of the guidelines is truthful and not misleading
within the total context. It’s unclear under what
circumstances “disclosures” may be indicated
when products meet referenced recommendations
of the guidelines, yet aren’t consistent with overall
recommendations. h
Leslie T. Krasny is a partner at the law
firm of Keller and Heckman LLP, San
Francisco office specializing in food
and drug law. She also holds a master’s
degree in cell and molecular biology.
April 2006 | 11