April 23, 2007

Vincent D Jesus

Center for Food Safety and Applied Nutrition \[HFS---830\]

Food and Drug Administration

5100 Paint Branch Parkway

College Park, MD 20740-3835

**RE: Comments on Proposed Rule: Health Claims; Soluble Fiber from
Certain Foods and Risk of Coronary Heart Disease \[Docket No.
2006P-0069\]**

The American Dietetic Association (ADA) appreciates this opportunity to
submit comments to the Food and Drug Administration (FDA) on the
proposal to amend the regulation authorizing a health claim on the
relationship between soluble fiber from certain foods and risk of
coronary heart disease (CDH) as published on February 6, 2007 in Volume
72, Number 24 of the Federal Register. The ADA has a long history of
supporting the work of the FDA in its statutory responsibility to ensure
that food is neither misbranded nor adulterated and that it is
manufactured in accordance with certain standards; that labels and
associated marketing claims are based on science and are truthful and
not misleading; and that new and novel ingredients are appropriately
reviewed and approved before being introduced into the nation's
marketplace.

**General Comments**

When considering proposed labeling rules, ADA uses the following
principles to guide its comments. These are not exclusive, but are the
foundation for all comments regarding labels:

> A. Label claims should be clear and understandable to consumers.
>
> B. The label must be truthful and not misleading.
>
> C. Content on the label should help consumers make informed decisions
> to build a healthy diet.
>
> D. Label content should have consistent type and format so products
> can be read and consumers can make product comparisons.
>
> E. All claims should include labeling of accurate quantitative
> information about the dietary substance, including percent of Daily
> Values in a single serving of the product, when known, or the daily
> dietary intake necessary to achieve the claimed effect.
>
> F. Consumer research is imperative before making changes to the label.
>
> G. The label is only a source of information, and thus sustained
> support for educational programs and individual counseling by
> registered dietitians is essential.

ADA believes that consumer research is critical in determining whether
labeling formats and contents are understandable and for ensuring that
allowable nutrient and health claims are not misleading. Furthermore,
consumers should be able to understand the information in the context of
their total diet and their individual health concerns.

**Specific Comments**

ADA believes that labeling rules are appropriate if they are truthful,
not misleading, and consistently applied across of food products. With
the rare exception made for naturally-occurring foods, ADA advocates
that such rules should be consistently applied to all categories of food
products that are formulated to achieve manufacturer-driven organoleptic
and nutritional specifications. ADA is concerned that making exceptions
to allow a marketing claim for any single food product that has been
physically or chemically modified to meet manufacturer's product
specifications will create consumer confusion and undermine the intent
of FDA's labeling oversight. Consequently, ADA does not support the
proposed amendment to the rules.

**Conclusion**

ADA has carefully reviewed the proposed amendments for authorizing a
health claim on the relationship between soluble fiber from certain
foods and risk of coronary heart disease (CDH). As the largest
association of Registered Dietitians (RDs) and other food and nutrition
professionals in the United States, with a membership exceeding 65,000,
ADA serves the public by promoting optimal nutrition, health and
well-being using information based on sound science. ADA thus believes
that the maximum benefits achievable in establishing food labeling rules
are those that are consistent and provide consumers with the kinds of
information they need to make food choices that build a healthy diet.

Please feel free to contact me at 202.775.8277, ext. 6007 or at
<mhager@eatright.org> for additional information about these comments.

Sincerely,

/s/

Mary H. Hager, PhD, RD, FADA

Senior Manager, Regulatory Affairs

American Dietetic Association