8, Number 12 - December 2007
IN THIS ISSUE:
About Food Consulting Company
" Just a note to say
last month's issue
is fabulous. The information about trans fat
and sodium is in language that I can share
and be sure that R&D and Marketing will
understand what is going on."
Season's Greetings! We hope this holiday
season includes a break from work along with
joyful time with friends and family. Best wishes
for a happy holiday season from Food Consulting
Q. Does the
nutritional labeling have to be printed in
black? D. F., Manufacturer,
the Code of Federal Regulations, the Nutrition
Facts panel must be in black or one color type
printed on a white or neutral background with
the intent that it is very easy to read.
However... Read more:
Reader Q&A page.
Submit a question
for Reader Q&A (no charge).
FDA Takes Public Step to Revise Nutrition Labels
On November 2, 2007, FDA announced plans to
revise the reference values and mandatory
nutrients used in Nutrition Facts and Supplement
Facts panels. To begin the process, FDA issued
an Advance Notice of Proposed Rule Making (ANPRM)
requesting comments on what new information
should be used to calculate the percent daily
values (DVs) and determine what nutrients should
be mandatory on Facts panels.
In the ANPRM, FDA identifies new information as:
revisions to the Dietary Guidelines for
Institute of Medicine's (IOM's) published
reports on the Dietary Reference Intakes (DRIs)
that update recommendations for the intake
of vitamins, minerals, and macronutrients
IOM report on the application of the DRIs
IOM report on "Guiding Principles for
Nutrition Labeling and Fortification"
The ANPRM details many questions for comment.
Broad categories include:
approach to setting DVs
populations for which DVs are intended
labeling of individual nutrients
consumer and producer use and understanding
Commentary: This ANPRM encompasses many
issues that have been covered by Food Label News
over the years (prominence of calories,
carbohydrate reporting, trans fats and other fat
reporting, just to name a few.) Food Consulting
Company has been asked if this ANPRM will result
in mandatory label changes any time soon. The
answer is no, not for several years. FDA's
process to set regulations is multi-step and includes proposed rules, comment periods,
final rules, and announcement of the uniform
Proposed Rule to Prohibit Omega-3 Nutrient
On November 27, 2007, in response to three
notifications to FDA from industry (in
2004-2005), FDA issued a
Proposed Rule to prohibit certain nutrient
content claims for foods that contain omega-3
fatty acids: alpha-linolenic acid (ALA),
docosahexaenoic acid (DHA), and eicosapentaenoic
acid (EPA). The claims of concern characterize
the level of omega-3 content in products; under
current FDA rules for nutrient content claims
this is prohibited because there is no
FDA-established Daily Value for omega-3 fatty
The claims have been legally
used for several years since, until now, FDA did not respond
to the notifications with an FDA decision that
use of the claims does not comply with nutrient
content claim rules published in the Code of
Federal Regulations. The proposed rule would
prohibit use of the claims effective on the
uniform compliance date for food labeling
regulations that is applicable to the
publication date of the Final Rule.
Also in the Proposed Rule FDA states the
Agency's intention to take no regulatory action
at this time regarding a particular nutrient
content claim contained in one of the
notifications for ALA omega-3 fatty acids;
further, FDA expresses no opinion as to whether
the particular ALA claim is supported by a statement that
satisfies the legal requirements for use.
Commentary: In this Proposed Rule (for
omega-3 fatty acids), FDA calls stakeholders'
attention to the November 2, 2007, ANPRM that
specifically addresses the issues surrounding
reference values which are used as foundation
for nutrient content claims.
Food Labels Qualified Health Claims Update
Food Consulting Company clients have expressed
interest in the earlier Food Label News reports
the measure "No funds in this Act may be used to
authorize qualified health claims for
conventional foods" that is included in the
House version of the Agriculture, Rural
Development, Food and Drug Administration, and
Related Agencies Appropriations Act of 2008.
As of December 1, 2007, the bill is still with
the Senate. If the measure remains in the bill
that the president eventually signs, FDA could
announce that it is no longer accepting requests
for qualified health claims for foods because of
the Appropriations Act restriction.
Commentary: Despite objections from
health advocacy groups, FDA has allowed qualified
health claims in response to legal challenge
that called use of such claims a right under the
U.S. Constitution First Amendment right to free
speech. It is unclear what the future holds for
qualified health claims.
At Your Service: As you reformulate
products to eliminate trans fat, speed up your
arrival to the marketplace by calling on Food
Consulting Company to complete the label
components for you. See
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