April 23, 2007

Food and Drug Administration

Dockets Management
Branch![](media/image1.jpeg){width="8.006944444444445in"
height="1.3930555555555555in"}

(HFA-305)

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. 2006P-0069

Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk
of Coronary Heart Disease

General Mills, Inc. (GMI)[^1] submits these comments in response to the
Food and Drug Administration's (FDA) proposed rule amending the health
claim on the relationship between soluble fiber from certain foods and
risk of coronary heart disease. The amendment specifically proposes to
exempt certain foods from the nutrient content requirement of "low fat"
due to fat content derived from whole oat sources.

GMI recognizes that health claims, such as the soluble fiber and heart
disease claim, are an important tool for communicating health messages
to consumers. We support and encourage changes to health claim
regulations, based on current science, that increase food options to
help consumers reduce risk of heart disease while still communicating
truthful and non-misleading information.

**We support an amendment to the low-fat criterion currently included as
a requirement of the soluble fiber from certain foods and heart disease
health claim.** The proposed rule is consistent with current science
related to the effects of fat on heart health, and may promote the
development and/or marketing of "heart healthy" products for consumers.

**Although GMI generally supports the amendment, we encourage FDA
consider additional changes beyond those described by the petitioner**
(Quaker Oats Company), and specific to reduced-sugar flavored oatmeal.
For example, we believe it is important to consider implications for
other food products made primarily of whole oat sources and consumed
commonly by consumers (e.g., ready-to-eat cereals). Additionally, we
believe it would be prudent for FDA to re-evaluate the necessity of the
low-fat requirement for this health claim given scientific evidence and
changing dietary recommendations for total fat intake.

Our comments pertaining to this proposed health claim focus on the
following areas:

A.  The exemption from the "low-fat" requirement should be extended to
    other substances eligible for the claim

B.  Fat from fortificants should be exempt from the "low-fat"
    requirement when all other fat is derived from beta-glucan soluble
    fiber sources eligible for the claim

C.  FDA should consider whether the total fat (low-fat) requirement is a
    necessary requirement for the claim

D.  FDA should confirm nutrient composition values for whole oat sources
    cited in the proposed rule

**A. The exemption from the"low fat" requirement should extend beyond
whole oat sources**

The amendment, as written, proposes to exempt foods from the nutrient
content requirement of "low fat" when fat content is solely derived from
whole oat sources listed in 101.81 (c)(2)(ii)(A). Whole oat sources
listed in this part include oat bran, rolled oats, whole oat flour and
oatrim. We believe that the exemption from the "low fat" requirement
should be extended to products containing any source of beta-glucan
soluble fiber eligible for the claim. That is, products containing fat
solely from whole oat sources, as well as whole grain barley or dry
milled barley, would be exempt from the "low-fat" requirement.

Barley substances, like whole oat sources, have fat profiles consistent
with fat intake recommendations of the 2005 Dietary Guidleines for
Americans. Although the exemption from the "low fat" requirement may not
be necessary for foods containing solely barley sources due to their
inherently low fat content (e.g., 2.3 g fat/100 g), it may be important
for foods containing a blend of grains (e.g., oats and barley). FDA
should not preclude, from making the soluble fiber and heart disease
claim, products containing an assortment of grains, including, but not
limited to: wheat, corn, barley and rice. By extending the amendment to
include barley, manufacturers may be encouraged to develop different
types of products, thereby providing more food options for consumers
seeking to reduce heart disease risk. *\[Note to Gayle and John: Our
internal decision has been to allow a combination of oats & barley to
contribute toward the 0.75 B-glucan soluble fiber content. In this
section, are we indirectly asking for FDA's interpretation of that?\]*

**B. Fat from fortificants should be exempt from the "low-fat"
requirement**

The proposed rule specifies that a food product that contains any fat
from ingredients other than whole oat sources would not be exempt from
the "low fat" requirement. In addition to extending the proposed rule to
include barley sources, as described above, GMI strongly believes that
it is appropriate to exclude the minimal amount of fat from
fortificants.

The trace, and likely inconsequential, amount of fat contributed through
fortification should not prevent foods from making this heart health
claim. Such a requirement potentially could disincent the food industry
from improving the overall nutritional quality of foods and in turn,
consumers' diets.

As an example, vitamin A palmitate is commonly added to some
ready-to-eat cereals. The 2005 Dietary Guidelines for Americans
recognize vitamin A as a nutrient of concern for Americans. The amount
of fat provided to cereals through the addition of this vitamin is
dietarily insignificant (e.g. \<0.0005 g fat for 10% DV vitamin A in a
30 g serving for certain cereals).

**C. The necessity of the total fat (low-fat) requirement should be
considered**

GMI recommends that FDA consider whether the total fat (low-fat)
requirement is necessary for this heart health claim. Specifically, we
encourage FDA to thoroughly review the scientific evidence, particularly
clinical trials, and the latest public health recommendations pertaining
to total dietary fat intake and heart health.

We believe that, as much as possible, FDA claims should be based on the
latest science and be consistent with dietary recommendations from
government agencies and leading health organizations. Additionally,
updating the claim requirements to reflect current science, if
warranted, may also lessen the filing of petitions requesting individual
exemptions for specific foods from the low-fat requirement. Requiring
manufacturers to go through the process of individual exemption
petitions, similar to the present petition, discourages and/or delays
the use of relevant health communications/claims on foods that can
contribute to a healthy diet and disease risk reduction.

At the time the soluble fiber from certain foods and risk of heart
disease was published, "low fat" was among the standard dietary
recommendations for reducing risk of heart disease. Since then, there
have been numerous scientific advances, including a better understanding
of the relationship between total fat and type of fat on heart disease
risks. Specifically, higher intakes of saturated fat and trans fat, not
total fat, have been shown to be associated with higher heart disease
risk. FDA has recognized this shift in knowledge and dietary advice,
moving away from low-fat requirements for more recent heart disease
claims and including limits for saturated and trans fat.

In the current amendment, FDA describes their rationale for not relaxing
the total fat (low-fat) requirement for fat from all sources. Under this
scenario, FDA adopted the disqualifying level (13 g) for total fat, and
noted that the total fat content of certain products could approach the
disqualifying level and that consumers using such products could
increase their fat intke to levels above those recommended by the 2005
Dietary Guidelines for Americans.

Rather than entirely relaxing the total fat requirement, we encourage
FDA to consider adopting a "more moderate level" as a limit on total fat
content for this health claim, similar to that accepted for the 2004
FDAMA notification for whole grain foods and heart disease
([\<]{.underline}6.5 g total fat/RACC). This level is based on dietary
recommendations for total fat intake from the Institute of Medicine
(Dietary Refereince Intakes) and is also consistent with the 2005
Dietary Guidelines for Americans and recommendations from the American
Heart Association. Minimally, FDA should determine whether there is any
evidence to suggest that adopting a more moderate total fat level for
the claim would have adverse effects on heart health and/or diminish the
effect of B-glucan soluble fiber on total and LDL cholesterol.

As an initial screen of the scientific evidence, we reviewed the
research that FDA considered in reaching their decision about this
health claim (Federal Register Vol. 61, no. 3., January 4, 1996). As
clearly summarized, the majority of clinical studies (10 of 17) upon
which the claim is based were conducted with a diet characterized as a
"typical" or "normal" American diet (approximately 37% of calories from
fat). In fact, 4 of the 5 studies identified as the "strongest evidence"
did not use a "low-fat" diet.

**D. Nutrient composition values for whole oat sources should be
confirmed**

We recommend FDA confirm the values cited in the published rule for
total fat content of whole oat sources and ensure they reflect fat
content of current oat varieties. Of note, is that values from USDA
Handbook 18 are cited, although Handbook 19 was published in 2006. FDA
should also consider that fat content of oat varieties has tended to
shift upwards recent years. We recommend including reference data for
fat (and fatty acid profile), including the analytical method and
moisture basis, in the subsequent rule.

Additionally, FDA should provide the calculation and pertinent reference
data to support the contention that for products that do not meet the
"low fat" requirement due to fat from whole oat sources, the amount of
fat exceeding the "low fat" requirement will be "small." An example of a
product not exceeding 4 g/55 g RACC is used by the petitioner and in the
proposed rule.

**[Other considerations for whole oat sources - "low fat" nutrient
content claim]{.underline}**

We urge FDA to consider an exemption to the 50 g requirement of the
"low-fat" nutrient content claim for products made predominantly from
whole oat sources with small serving sizes ([\<]{.underline}30 g). The
requirement that products with small serving sizes meet the "low fat"
criteria not only on a per RACC and labeled serving size basis, but also
per 50 g, unfairly penalizes certain whole oat products (e.g.,
ready-to-eat cereals) that make a valuable nutrition contribution to
American diets.

Lower-density, predominantly whole oat cereals easily meet the FDA
requirements for the low-fat nutrient content claim (\<3 g fat) per
labeled serving and RACC (30 g). The inherent fat content of oats,
coupled with the recent upward trend in fat content of whole oat
sources, however, is resulting in significant formulation challenges to
maintain "low-fat" status on a 50 g basis. It would be counterproductive
to health objectives to decrease oat content (and thereby beta-glucan
levels) in order to meet the somewhat arbitrary "and per 50 g"
requirement, especially when the naturally occurring fat in grain is
[not]{.underline} a health concern.

As noted earlier, the fat composition of whole oat sources is consistent
with current dietary recommendations. Furthermore, should the 50 g
requirement for the "low fat" nutrient content claim remain, it may lead
to the unintended consequence of manufacturers formulating
lower-density, predominantly whole oat cereals with lesser amounts of
beneficial oat ingredients and more sugar (to displace fat). Whole oat
cereals make an important nutritional contribution to the diet, while
not delivering a significant amount of fat per serving. The 50 g
requirement should not prevent them from promoting their "low fat"
content to consumers.

We appreciate the opportunity to provide comments on this proposed rule.

Respectfully submitted,

Kathryn L. Wiemer, MS, RD

Director/Fellow

General Mills Bell Institute of Health and Nutrition

Regulatory Affairs and Issues Management

[^1]: GMI is a Delaware Corporation with its general offices at No. 1
    General Mills Boulevard, Minneapolis, MN 55426. GMI is a major
    packaged-food manufacturer engaged for over 75 years in the
    development and marketing of food products including flour,
    ready-to-eat cereals, refrigerated dough products, cake and other
    dessert mixes, soups, vegetables, snacks and numerous other food
    products.

    We have been committed to nutrition labeling for over 30 ears
    beginnning 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 increased consumer interest in the
    relationship between diet and health. We support changes in
    food-labeling practices that will provide consumers with nutrition
    information more relevant to today's needs.