Baking & Snack - July 2006 - 53

REGULATORY MATTERS

Recognized as Efficacious (GRAE).
As explained by Roger Clemens,
Ph.D., director of the University
of Southern California Analytical
Research and Services Laboratory
and associate director of regulatory science with USC's School of
Pharmacy, GRAE would be similar
to the Generally Recognized as Safe
(GRAS) protocol for food ingredients. Instead of forcing companies
wishing to make qualified health
claims to go through the lengthy
petitioning process, they could selfaffirm a claim as GRAE and submit
it to a third-party panel of scientists
with in-depth knowledge of the
particular subject area.
This very new concept was examined at IFT's 2006 annual meeting,
held at Orlando during late June.
HARMONIZED SAFETY. Finally,
after years of lobbying and months
of dispute, the Senate now controls
the fate of the National Uniformity
of Food Act. In March, the House of
Representatives passed bill H.R. 4167
and referred it to the Senate Committee on Health, Education, Labor
and Pensions as bill S. 3128, where it
has been read twice. No further action has taken place, as of this writing in late June.
The food industry strongly supports this legislation. It provides
a platform that makes food safety
standards and warning language the
same across the nation.
Robb Mackie, president and c.e.o.,
of the American Bakers Association
described the bill as "common-sense
legislation." The group noted that
it would "provide consumers with
a single set of consistent, sciencebased food safety regulations for
food products sold in all 50 states."
With California's Proposition 65
in mind, the Snack Food Association
stated, "S.3128 is extremely important
because it addresses the acrylamide
issue for potato chip manufacturers
by superseding varying and conflicting state food safety laws."
Ⅲ

56 / BAKING & SNACK / July 2006

ᮣ These nutrition bars make both a authorized
health claim ("helps lower cholesterol") and nutrient content claims ("good source of whole grain"
and "good source of fiber").
NATURE VALLEY

Basics and Bases
The Food and Drug Administration divides claims made on food
labels into different categories. Some are based on the amount of
scientific proof, or lack thereof, that supports the statement, while
others deal with the amount and/or quality of the nutrient involved.
Another class covers claims concerning effects on the human body.
"Health claims describe a relationship between a food component
or dietary supplement ingredient and reducing the risk of a disease
or health-related condition," FDA stated in a background document
issued by its Center for Food Safety and Applied Nutrition.
Authorized health claims, the first category to be developed,
link specific food components with a specific risk of a disease.
Before approving the claim, which is usually submitted as a petition,
FDA conducts an extensive review of the scientific literature. Authorization requires that the agency apply the significant scientific
agreement (SSA) standard to determine that the nutrient/disease
relationship is well established. Only foods may carry authorized
health claims, not dietary supplements.
Health claims based on authoritative statements are allowed
by FDA when based on statements from a scientific body of the US
government or the National Academy of Sciences. Only foods can
use this type of claim, not dietary supplements.
Qualified health claims originated with FDA's 2003 Consumer
Health Information for Better Nutrition Initiative. Prompted by the
Pearson vs. Shalala court decision, the agency recognized that evidence linking certain foods, food components and dietary supplements with reduced risks of diseases or health-related conditions
may not be well-enough established to meet the SSA standard yet
is still valuable to consumers. Qualifying language must be included
in such claims to indicate that evidence supporting it is limited.
Both conventional foods and dietary supplements can employ
qualified claims.
Nutrient content claims are different from health claims. They
characterize the level of nutrient in a food and use terms such as
"free,""high" and "low," or they compare the level of a nutrient in a
food to that in another food with terms including "more,""reduced"
and "lite." Most content claims apply to nutrients listed by the Nutrition Facts panel.
Structure/function claims also differ from health claims. While
some foods claim to have effects on the body, structure/function
claims made for dietary supplements come under special FDA
regulatory procedures. Such claims describe the role of a nutrient or
dietary ingredient intended to affect normal structure or function in
humans. The manufacturer is responsible for ensuring the accuracy
and truthfulness of such claims; they are not pre-approved by FDA.
A structure/function claim must be accompanied by a disclaimer
that FDA has not evaluated the claim.
(Adapted from "Claims That Can Be Made for Conventional Foods
and Dietary Supplements," issued in September 2003 by FDA.)

Baking & Snack - July 2006

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