Volume 11, Number 4 - April
Hello from Food
No doubt you have heard news about food labels in the
consumer media. From FDA's warning letters to healthcare
reform, food labeling is a topic of discussion. In this
issue we provide insights about FDA's crackdown on
misleading food labels and what you can do to protect your
company. As healthcare reform unfolds we will keep abreast
of what matters in food labeling.
FDA Tightens Control on Food Label Claims
Food labelers beware. Center
for Food Safety and Applied Nutrition (CFSAN) sent warning letters
in February to 16 different companies for false or
misleading food label claims. These warning letters marked
FDA's stepped-up activity to police the industry's
labeling practices and ensure compliance. Highlights of
violations cited in the warning letters are:
Claims that food products
can treat or mitigate disease are not allowed; foods
that carry such claims are unapproved new drugs.
Nutrient content claims
are not allowed on foods intended for infants or
children less than two years of age.
When "0g trans fat" is
stated outside the Nutrition Facts panel
for a product that exceeds threshold levels of total
fat, saturated fat, cholesterol and sodium, then the
disclosure statement "See Nutrition Information for
[name of nutrient] Content" is required.
describing products can be considered labeling and are
subject to the same regulations as product labels.
FDA is scrutinizing the
use of specific nutrient content claims to ensure the
meet regulated definitions and conditions for use.
"high antioxidant" is not allowed without qualification;
"high in monounsaturated fats" is not allowed because
there is no Daily Value for this nutrient; label claims
for "healthy" and "light" were cited because the foods
did not meet qualifying criteria for the definitions.
For more details, read
FDA open letter to the food
industry and access the
Keeping You Current
Healthcare reform legislation
(Section 4205, page 455)
signed into law on March 23rd establishes
requirement for nutrition menu labeling for restaurants with
20 or more locations
National Restaurant Association
press release praises unified menu labeling standards
Medicine to host
second meeting for front-of-pack
labeling April 8th to 10th; public meeting April
two new guidance documents and one new proposed rule related
to claims and label statements are forthcoming during a
presentation at first IOM
shows consumers often read a label the first time they buy a
product, but are skeptical about front-of-pack claims
seeks comments on its
Transparency Task Force
NIH Office of Dietary Supplements
GAO report says FDA needs
to improve GRAS oversight, especially for
While there is new
FDA rulemaking activity underway (specifically related to
dietary guidance statements - see inset above, 4th item), the warning
letters are simply reinforcement of existing regulations. An
understanding of nutrient content claims, health claims,
structure/function claims, dietary guidance statements and
statements of fact is required to develop labeling that
complies with FDA regulations. For guidance, you can search
the FDA website at
www.fda.gov, get a summary
from the Silliker/Food Consulting Company Instructional
Series (see below), or
contact us for help with a
Health Claims on Food Labels:
Instructional Series Part 8 of 10
installment in our ten-part series describes the use
of health claims on food labels. This 10-part
instructional series is based on a 2009 publication
titled "Silliker Nutrient and Health Claims U.S.
Regulatory Guide" that was cooperatively developed
by Food Consulting Company and Silliker, Inc., a
leading provider of laboratory nutrition analysis.
Part 8 of the
Health claims are
pre-authorized by FDA and the wording for these types of
claims is tightly controlled. If a product contains a
disqualifying level of total fat, saturated fat,
cholesterol, or sodium, then you will not be allowed to cite
a health claim. More details can be found in the Guide.
If you missed
earlier parts of the series you can view and download them
Part 7.) The pages from all parts
will add up to the complete booklet.
We have four different flavors of a beverage packaged in
a box. Do we need four different nutritional statements
on the box or can we just put the nutrition info on each
Beverage Supplier, California
The regulations specify
that labeling must be placed on the retail sales
package. This enables the consumer to be informed when
they make their purchasing decision. For a multi-pack,
the labeling needs to be on the outer package...
At Your Service
founded in 1993, provides nutrition analysis, food labeling
and regulatory support to ensure 100% compliance with FDA
regulations. With over 1,000 clients worldwide, Food
Consulting Company's services are ideal for start-up and
established food manufacturers, distributors, food
importers, brokers, and restaurateurs.
Contact Us for more
information about your food labeling needs.
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