> October 2, 2003

Dockets Management Branch

(HFA-305)

Food and Drug Administration

Room 1061

5630 Fishers Lane

Rockville, MD 20852

Re: \[Docket No. 03N-0076\]

Food Labeling: Trans Fatty Acids in Nutrition Labeling;

Consumer Research to Consider Nutrient Content and Health Claims

And Possible Footnote or Disclosure Statements

68 [Federal Register]{.underline} 41507, July 11, 2003

Dear Sir or Madam:

These comments are submitted on behalf of the members of the American
Bakers Association (ABA), the national trade association representing
the wholesale baking industry. ABA membership consists of bakers and
bakery suppliers who together are responsible for the manufacture of
approximately 80 percent of the baked goods sold in the United States.
The purpose of these comments is to request an extension of 90 days for
the comment period associated with the Advance Notice of Proposed
Rulemaking (ANPR) referenced above.

In the past, ABA has submitted several sets of comprehensive comments to
FDA on the *trans* fat labeling issue including comments on the issue of
a *trans* fat footnote as it was proposed by the Agency in November
2002. ABA believes strongly that this complex issue requires a thorough
examination of scientific evidence on the health effects of *trans*
fats, as well as, a careful assessment of the methods by which nutrition
information may be conveyed without increasing consumer confusion.

ABA urges FDA as it has in previous comments on this subject, to
coordinate the rulemaking on *trans* fat declaration with the
development of the Dietary Reference Intake (DRI) studies conducted by
the Food and Nutrition Board (FNB), Institute of Medicine (IOM),
National Academies of Science. As a sponsor of the DRI Studies, FDA
should logically want to consider all of the fact based information
available as it moves forward with developing policy. ABA understands
that this Committee is currently finalizing its report due in this Fall
on the use of (DRI) information in establishing or revising reference
values for the purpose of nutrition labeling. Information expected in
the FNB report, particularly regarding nutrients for which no intake
recommendations have been previously made, including *trans* fats, will
be especially useful to FDA as it collects data requested in its July
11, 2003 ANPR. It seems very logical and practical for FDA to wait until
the FNB Committee Report becomes available so that it can utilize the
essential reference value information it will contain.

By acting prematurely without the benefit of the FNB Committee report,
FDA sets the stage to have an unbalanced and incomplete approach to
*trans* fat labeling. Such action would needlessly subject the food
industry to a potential chain of consecutive labeling changes within a
short span of time. ABA also believes that multiple labeling changes of
this sort would confuse consumers. ABA therefore recommends that FDA
wait until the FNB\'s additional reference value information is
available before making food labeling decisions relative to *trans* fats
so that potential changes to the food label could be incorporated at one
time. Further, the FNB report on nutrient reference values may also
reveal information that prevents unnecessary label changes.

ABA believes strongly that it would be in the best interest of FDA to
extend its comment period of the July, 2003 ANPR by at least 90 days in
order to use the nutrient reference value information that is
anticipated within the report. If the FNB Committee\'s report is late,
then FDA should consider a reasonable additional extension of the
comment period so that this information can be reviewed and considered
by the food industry as it develops comments in response to the July
2003 ANPR with respect to a possible trans fat footnote or other label
information focused on the context for a *trans* fat food label
declaration.

ABA appreciates this opportunity to comment on this important issue to
the baking industry. The Association is hopeful that the concerns
outlined in this request will be useful to FDA. The technical contact
for these comments is Lee Sanders, ABA Vice President, Regulatory and
Technical Services, American Bakers Association, 1350 I Street, N.W.,
Suite 1290, Washington, D.C. 20005-3305 (telephone) 202-789-0300, (fax)
202-898-1164.

Respectfully submitted,

![](media/image1.png){width="2.3944444444444444in" height="0.475in"}

Paul C. Abenante

President & CEO

American Bakers Association