Australia - Callinan Lawrie - misc. correspondence

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General Mills believes it is reasonable, within the general claims framework established by FDA, to set criteria for the following specific nutrient

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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 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

    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

    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,


    /s/ John Luedke

    John Luedke


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