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G E N E R A L M I L L S

John Luedke

Counsel

Telephone: 763-764-2408

Facsimile: 763-764-5102

> October 9, 2003

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

> 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; Advance notice
> of proposed rulemaking 68 [Federal Register]{.underline} 41507, July
> 11, 2003.

Dear Sir or Madam:

General Mills is a Delaware Corporation with its general offices at No.
1 General Mills Boulevard, Minneapolis, MN 55426. General Mills is a
major packaged-food manufacturer engaged for over 60 years in the
development and production of food products including flour,
ready-eat-cereals, refrigerated dough products, cake and other dessert
mixes, soups, vegetables, snacks and numerous other products.

We have been committed to nutrition labeling for over 25 years beginning
with voluntary labeling in 1974. We currently have nutrition labeling on
more than 1500 retail products. Over the years, we have added additional
information and claims to our products in response to consumer interest
in newer knowledge about the relationship of diet and health. General
Mills firmly supports changes in food-labeling practices that will
provide consumers with nutrition information more relevant to today's
needs.

General Mills previously filed comments on the presentation of *trans*
fat information on the nutrition label in Docket No. 94P-0036, the
docket resulting in the *trans* fat labeling final rule. General Mills
fully intends to comply with that rule, and has begun the process of
evaluating our many products and revising labels as necessary. General
Mills submits these comments to provide input on the issues raised by
the Food and Drug Administration (FDA) in its request for additional
information regarding *trans* fat labeling.

Division of Dockets Management

October 9, 2003

Page 2

######## Extension of Comment Period

General Mills supports the several requests for extension of the comment
period submitted in this docket to allow time for the Institute of
Medicine Committee on Uses of Dietary Reference Intakes in Labeling to
issue its report. Without this crucial information, it is difficult to
properly address nutrient content claims and disqualifying or disclosure
levels for *trans* fat labeling. We note that FDA indicated an intention
to conduct consumer research on the proposed footnote statements.
General Mills believes it is premature to comment on footnote language
prior to the release of the results of the government-sponsored
research. As FDA has not granted these extension requests, General Mills
requests that FDA reopen the comment period in this docket after the IOM
Committee issues its report and after the release of the
government-sponsored research on the footnote language to allow an
opportunity for additional comment based on that important information.

[*Trans* Fat Footnote]{.underline}

At the present time, there has not been sufficient research into the
effects any of the proposed footnote options might have on consumers.
Unless consumer data shows that a footnote statement is necessary, the
potential is great for consumer confusion and misunderstanding, leading
to health decisions based on a misunderstanding of the information
presented with any of the proposed footnotes. It is possible that
consumers could perceive any footnote as a warning statement regarding
the consumption of *trans* fat, leading them to focus too much attention
on *trans* fat levels. At the least, it would seem to draw particular
attention to *trans* fat, at the expense of the other useful information
in the Nutrition Facts box. Currently, there is not enough known about
the impact on consumers' knowledge and behavior for any footnote
statement to be required on the label.

At some point in the future, it may be demonstrated that a footnote
would be useful to consumers in making sound decisions for a healthy
diet. In that event, FDA should ensure that the language in the footnote
is consistent with governmental dietary guidance regarding *trans* fat
intake, including both that from the Dietary Guidelines and the IOM
Committee report. FDA should also ensure that the language is not
misleading in any way, and that the footnote language does not isolate
*trans* fat from the other fatty acids that may have an adverse impact
on consumers. FDA should reopen the comment period to allow for industry
and consumer input into any proposed language.

It is also possible that in the future, consumer knowledge will be
sufficient such that no footnote is required.

######## Nutrient Content Claims

General Mills believes it is reasonable, within the general claims
framework established by FDA, to set criteria for the following specific
nutrient descriptor claims: "*trans* fat free", "reduced *trans* fat"
and "low *trans* fat." It is important to establish these claims, as
doing so will provide useful information to consumers to allow them to
make healthier choices in their diet, particular regarding the fat
content of the foods they consume. Also, providing definitions for these
claims, established at realistic and attainable levels, should encourage
food manufacturers to reformulate their products to have a healthier
nutritional profile to qualify for the claims.

Division of Dockets Management

October 9, 2003

Page 3

For all claims, saturated fat and *trans* fat content should be linked,
as these fats share a unique relationship from both food functionality
and health perspectives. For example, it is possible to reduce *trans*
fat content in foods by increasing the saturated fat content. Thus,
unless the two are linked for purposes of claims, the food selected by
the consumer may not be necessarily a nutritionally better choice, even
though it now purports to be, for example, "*trans* fat free." Clearly,
this is not the intent of the *trans* fat nutrient content claims. To
prevent this, nutrient content claims for *trans* fat should include
criteria for saturated fat and conversely those for saturated fat should
include criteria for *trans* fat.

Although it is premature at this point to establish disqualifying or
disclosure levels of *trans* fat for purposes of health claims, General
Mills believes it is important to consider establishing these levels in
the context of cardiovascular health claims. It is incomplete to address
only saturated fat and cholesterol levels without also considering
*trans* fat levels in the context of heart health.

######## Coordinated Label Changes

The soon-to-be-released IOM Committee report will have significant
impact on all areas of *trans* fat labeling. Given the uncertainty
regarding the footnote language, disclosure or disqualifying levels for
*trans* fat, and trans fat nutrient content claims, it is not yet
appropriate for FDA to require or define these statements for nutrition
labeling. Should FDA set requirements for any of these label statements
in the future, however, General Mills requests that the agency do so in
a coordinated fashion, such that all required label changes can be made
at one time, rather than serially. The cost both in terms of dollars and
personnel resources associated with the current revisions underway to
comply with the *trans* fat labeling rule are enormous, and incurring
those costs repeatedly would be an unnecessary burden, particularly on
small manufacturers. Accordingly, FDA should postpone further required
labeling changes until its position on all these issues has been
resolved.

> Respectfully submitted,
>
> GENERAL MILLS INC.
>
> /s/ John Luedke
>
> John Luedke
>
> Counsel