Volume
7, Number 3 - March 2006
IN THIS ISSUE:
|
About Food Consulting Company
"As a new food entrepreneur, I can't thank you enough for your insightful knowledge
and professionalism in helping me understand
compliance issues and for getting my label
ready for market. You made everything seem
so easy, and your turn-around time was
incredibly swift! "
– Vivian Poutakoglou
Vivi's Original Sauce, LLC
|
Dear Readers,
Each issue of Food Label News is a journey in
continuing education for the Food Consulting
Company staff. Every month staff members search
various sources to find food label regulatory
news and information that keeps our readers
up-to-date and Food Consulting Company staff
sharp on the regulatory issues. We do this so
you can count on us to be your expert assistant
for accurate, on-time food labeling help!
www.foodlabels.com |
FDA on "Whole Grain" Statements on Food Labels
On February 17, 2006, FDA issued a draft
guidance on "whole grain" label statements;
stakeholders are asked to comment by April 18,
2006.
In part the guidance:
-
defines whole grains as intact, ground,
cracked or flaked cereal grains that contain
the starchy endosperm, germ and bran in the
same relative proportions as they exist in
the intact state of the grain
-
identifies amaranth, barley, buckwheat,
bulgur, corn (including popcorn), millet,
quinoa, rice, rye, oats, sorghum, teff,
triticale, wheat, and wild rice as examples
of cereal grains
-
explains that legumes (e.g. soybeans,
chickpeas), oilseeds (e.g., sunflower seeds), and
roots (e.g., arrowroot) should not be
considered whole grains
-
states that factual statements about whole
grains, such as "10 grams of whole grains,"
"1/2 ounce of whole grains," and "100% whole
grain oatmeal," can be used on food labels
as long as the statements are truthful and
not misleading and do not imply a particular
level of the ingredient, i.e., "high" or
"excellent source"
-
reminds that labels may bear a health claim
based on an authoritative statement of a
scientific body relating whole grains with a
reduced risk of heart disease and certain
cancers if the food meets certain
qualifications
Read the
guidance.
Commentary: The FDA guidance on whole
grain label statements is not establishing new rules
regarding the term; rather its purpose is to
establish a common understanding of the existing
regulations.
In response to numerous inquiries about using
"whole grain" and related terms on food labels
in the last year, Food Label News has reported
on FDA's stand for these terms several times
since August 2005. Food labelers may find the
following
Food Label News archived issues
helpful: August
2005, December 2005, January 2006.
|
FDA Proposes Study on Trans Fat Claims/Footnotes
FDA is seeking comments on two proposed studies
related to trans fat information on food labels.
In separate studies, FDA will investigate:
-
how consumers might interpret possible
disclosure requirements (for example, about
trans fat, either alone or in combination
with saturated fat and cholesterol) to
accompany nutrient content claims about
trans fatty acids that could help consumers
make heart-healthy food choices
-
the communication effectiveness of possible
footnotes that would help consumers
interpret quantitative trans fat information
on the Nutrition Facts panel (for example,
an asterisk in the %DV column for trans fat
that is tied to the same symbol at the
bottom of the Nutrition Facts box with a
statement such as "Intake of trans fat
should be as low as possible.")
The findings of both studies will be used to
help FDA formulate decisions and policies
affecting labeling requirements for trans fat on
foods.
See the
studies.
Commentary: Currently, FDA does not
allow nutrient content claims about trans fat
content on food labels; however, the Agency does
allow statements of fact that are truthful and
not misleading. Creating FDA-acceptable
statements can be tricky. For example, it is
okay to use the statement "0g trans fat;" but it
is not okay to say "zero grams of trans fat,"
with zero spelled out, because according to FDA
regulations "zero" is reserved for use in
FDA-defined nutrient content claims.
|
FDA Guidance
Establishes Common Understanding
Periodically FDA issues guidance documents to
describe the Agency's current thinking on a
policy or regulatory issue. The guidance
documents are developed for use by FDA staff,
industry, and the public to establish common
understanding of regulatory issues and related
matters.
FDA is required to issue guidance documents
whenever regulatory expectations are not readily
apparent in newly published statutes or
regulations. Also, members of the public can
suggest that FDA draft a new guidance document
or revise or withdraw an already existing
guidance document.
Guidance documents do not establish legally
enforceable rights or responsibilities; however,
since they are expressions of FDA's thinking on
existing regulations, alternative approaches by
industry (other than those outlined in the
guidance) must comply with the relevant statutes
and regulations.
Learn more about
FDA guidance.
Commentary: FDA recently issued two
guidance documents that address food labeling
issues that are of high interest to Food
Consulting Company clients and Food Label News
readers. The February 17, 2006, draft guidance
for "whole grain" label statements is reported
in this issue of Food Label News. The December
2005 guidance for requesting an "Extension to
Use Existing Label Stock after the Trans Fat
Labeling Effective Date of January 1, 2006" is
reported in both December 2005 and January 2006
issues of
Food Label News.
|
FYI: Are you
spending too much time searching for answers to
food label regulatory questions? Reduce this
time by ordering a prepaid annual plan for
regulatory support from Food Consulting Company.
You will have more time to do the things you do
best and perhaps enjoy most.
See the plans; place an
order:
www.foodlabels.com/orders. |
Get more from
Food Label News: Send
topic suggestions.
Need help now? Submit a question for Regulatory
Research or subscribe to an Ongoing Regulatory Support Plan at
www.foodlabels.com/orders.© Food Consulting Company, 2006
13724 Recuerdo Drive, Del Mar, CA 92014 USA
tel 800-793-2844 or 858-793-4658
fax 800-522-3545 or 858-712-3323
www.foodlabels.com |
|