The Schwan Food Company

115 W College Drive

Marshall, MN 56258

October 9, 2003

Government and Community Affairs Department

Attention: Steve Schwan, Manager, Regulatory Affairs

115 W. College Drive

Marshall, MN 56258

Docket Management Branch

(HFA-305)

Food and Drug Administration

Room 1061,

5630 Fishers Lane

Rockville, MD 20852

> RE: \[Docket No. 03N-0076\] Food Labeling: *Trans* Fatty Acids in
> Nutrition Labeling; Consumer Research to Consider Nutrient Content and
> Health Claims and Possible Footnote or Disclosure Statements\
> 68 [Federal Register]{.underline} 41507, July 11, 2003.

Dear Sir or Madam:

The Schwan Food Company submits the following comments on the docket
referenced above.

Schwan is one of the largest frozen food companies in the world with
products distributed in every state and many other countries. As such,
public health, nutrition, and food safety are high priorities.

Schwan has an unquestionable reputation as a good corporate citizen. The
company has always recognized the importance of working with the Food
and Drug Administration (FDA) on important public health and nutrition
issues. A partnership with the FDA has produced mutually beneficial
results for the agency, Schwan, and the public. Schwan appreciates this
opportunity to respond to the FDA\'s advance notice of proposed
rulemaking (ANPR) published in the July 11, 2003, *Federal Register* on
*trans* fatty acids in nutritional labeling.

**[GENERAL COMMENTS]{.underline}**

Schwan has consistently identified and reacted to emerging nutrition and
public health issues in a timely and responsible manner. By tracking
consumer attitudes, published research studies, and government
regulations, Schwan is able to develop, produce, and distribute products
that meet and/or exceed all food safety and regulatory standards. Recent
science has indicated the potential negative health consequences of
excessive consumption of *trans* fatty acids, and Schwan recognizes the
need to address this issue.

**[PERCENT DAILY VALUE]{.underline}**

Schwan requests that the FDA proceed carefully concerning requiring a
\"%\" Daily Value (DV) declaration for *trans* fatty acids. Currently,
no credible scientific institution has recommended a safe upper limit
for *trans* fat. Schwan therefore recommends that FDA postpone any
rulemaking on % DV for *trans* fats until the National Academy of
Science Institute of Medicine concludes that sufficient scientific data
exist to establish a reference amount.

Additionally, Schwan submits that a requirement for a *trans* fat % DV
declaration be synchronized with other nutrition labeling changes that
will result from the Food and Nutrition Board report on the Use of
Dietary Reference Intakes in Nutrition Labeling. Separate rulemaking
with differing timelines will place an undue financial burden on the
food industry by forcing numerous and costly changes to product labels.
Current data indicates that one copy change for a single product label
will cost Schwan as much as \$1,500. With a total number of products
approaching 2,000, changing all labels to comply with new nutrition
labeling mandates is a multimillion-dollar endeavor. Combining as many
nutrition-labeling changes as possible will reduce the financial burden
that would be incurred if *trans* fat % DV labeling (or footnote
labeling) were instituted in isolation of other nutrition labeling
changes. Schwan therefore urges FDA to coordinate all nutrition labeling
regulatory activities to minimize the financial impact to the food
industry.

**[*TRANS* FAT FOOTNOTE]{.underline}**

Schwan **does not support** the concept of a footnote about intake of
*trans* fat, or any other nutrient, within the context of the Nutrition
Facts Panel. Dietary guidance statements are inconsistent with the
quantitative nutrient data otherwise presented in the facts panel and
may ultimately result in consumer confusion. In addition, Schwan
believes FDA should reopen the comment period for this ANPR when the
results of government sponsored consumer research regarding the
presentation of *trans* fat information becomes available.

Consumer data regarding the usefulness and appropriateness of the
proposed \"footnote\" about intake of *trans* fat are preliminary and
incomplete. Consumer research indicates that use of such a footnote can
mislead consumers, can be viewed as a "red flag" warning statement, and
may result in inappropriate food choices. Preliminary consumer research
conducted by the International Food Information Council Foundation
showed that when a *trans* fat footnote was used, consumers placed a
disproportionately higher value on avoidance of *trans* fat while
disregarding other equally important nutrition information. In the
study, consumers regularly identified food products labeled \"*trans*
fat free\" as healthier, even when high levels of saturated fat were
present in the alternative product. Food choices based on the presence
of a *trans* fat footnote may lead to a nutritionally inferior diet. An
Institute of Medicine report recognized that it is virtually impossible
to avoid intake of *trans* fat while consuming a nutritionally adequate
diet.

Once a safe upper limit for is established, Schwan would support the use
of disclosure and disqualifying levels for *trans* fatty acids for
nutrient content claims and health claims. This alternative approach
would be consistent with the current nutrition labeling regulations
regarding disclosure and disqualifying levels for total fat, saturated
fat, cholesterol, and sodium. Schwan believes that this group of lipids
should be treated consistently in nutrition labeling and advertising in
order to avoid consumer confusion, and strongly encourage FDA to
establish such consistency as a high priority in any subsequent
rulemaking effort.

**[RESPONSE TO SECTION C: \"SPECIFIC QUESTIONS TO BE
CONSIDERED\"]{.underline}**

Schwan considers provisions of information regarding any intended
product reformulations, new product development strategies, or the
discontinuation of existing TFA-containing products to be proprietary
and confidential. In general, however, Schwan can state that in any
industry, the market is shaped by years of comprehensive consumer
research, scientific evidence, and government regulation. These
variables dictate, to a large degree, what products Schwan brings to
market.

It is obvious that the amount of time and resources needed to
reformulate an existing product, create a new product, take a product
off the market, or merely create new labeling for existing products is
considerable. Consequently, the resources Schwan is dedicating to the
*trans* fat issue are significant.

Identification of consumer-friendly product positioning from both a
labeling and marketing perspective is an ongoing process for the food
industry. Given the extensive amount of consumer market research needed,
product design efforts required, and resource-intensive efforts
necessary to realize effective product positioning, full implementation
will take years to achieve. As such, Schwan would encourage the FDA to
consider these realities when determining any effective date prescribed
by this rule.

Thank you for this opportunity to respond.

![](media/image1.png){width="2.0833333333333335in"
height="1.3486111111111112in"}

Respectfully submitted,

> Howard Miller

Vice President, Corporate Relations