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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
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 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
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
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
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
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
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.
GENERAL MILLS INC.
/s/ John Luedke