essential vitamins and minerals as well as the benefits the food substances can provide in bodily processes and functions. As an example,
FDA has stated that the nutritive value of plant sterols is in the regulation of cholesterol. If a manufacturer is considering a claim that is new
to the food, it would be a good idea to confer with a competent adviser as to whether this criterion is met.
What is the difference between functional foods and dietary supplements? Technically, dietary supplements are defined and functional
foods are not. The term “functional food” is informally applied to
foods that bear claims for health benefits beyond those of the typical
benefits of conventional nutrients. Some people include dietary supplements in “functional food.” The products described as “functional
foods” are generally foods that bear claims for benefits of inherent
components (like flavonoids) or foods fortified with substances that
provide a health benefit (like orange juice with phytosterols). These
are foods and can be represented for use as part of a meal or a snack.
On the other hand, the definition for dietary supplements states that
dietary supplements are not represented as conventional food. If a dietary supplement resembles a conventional food, it must be carefully
labeled to avoid being “represented” as a conventional food.
FDA has issued a statement that expresses concern about “novel in-
gredients” added to conventional foods. “Novel ingredients” are sub-
stances like many herbs and other
botanicals that have not previously
been used in conventional foods and
that may not be legally safe for use in
conventional foods. Companies with
an ingredient that is not an approved
food additive or generally recognized
as safe (GRAS) will need to deter-
mine whether it should be marketed
as a dietary supplement or a food.
There would likely need to be a safety
determination for food use but per-
haps not for the dietary supplement.
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GET CONNECTED. BE A PART OF OTA.
The Organic Trade Association (OTA) is a membership-based association
for the organic business community in North America, representing the
organic industry to policy makers and the general public.
Learn more at ota.com
Call (413) 376-1219
Elizabeth Campbell is vice
president of EAS Consulting
group.com). She spent 35
years working at the FDA in
various capacities such as acting director
in the Office of Food Labeling at the Center for Food Safety and Applied Nutrition.
Much of her time at the FDA was spent in
developing regulations for food, including
her instrumental role in writing the regulations under the Nutrition Labeling and Education Act (NLEA) in the 1990s. She also
helped to develop current FDA policies on
claims under the Dietary Supplement
Health and Education Act, and the FDA
Modernization Act of 1997. Campbell participated in the NAF TA Technical Working
Group on Packaging and Labeling as the
head of the U.S. delegation, and in several
Codex Alimentarius committees. She also
served as a U.S. delegate to the Codex
Committee on Food Labeling. She is able
to review your food labels for compliance
with FDA regulations and, work independently to give you expert advice and strategies. You can reach her at