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December 16, 2002

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

**Re: Docket No. 94P-0036; Food Labeling: Trans Fatty Acids in Nutrition
Labeling, Nutrient Content Claims, and Health Claims; Reopening of the
Comment Period; 67 Fed. Reg. 69171 (Nov. 15, 2002)**

Dear Sir or Madam:

The Snack Food Association (SFA) appreciates this opportunity to offer
comments concerning the Food and Drug Administration (FDA) proposal on
trans fat labeling announced in the November 15, 2002 Federal Register.
SFA understands that the agency is proposing to require an asterisk (or
other symbol) in the percent daily value column for trans fat---which
the agency intends to designate as a mandatory nutrient---when it is
declared. This asterisk or symbol would be linked to a similar symbol in
the footnote section of the Nutrition Facts panel that would be followed
by the statement, "Intake of trans fat should be as low as possible."

SFA believes this proposal is well-intentioned and shares the agency's
desire to provide consumers with meaningful information regarding trans
fat. The proposed statement, however, is problematic in its content,
format, and presentation. SFA believes that it takes prevailing expert
advice on trans fat intake out of context and will be interpreted by
consumers as a "warning" to avoid all intake of trans fat by any means
necessary to do so. We urge the agency to consider, in lieu of the
proposed statement, undertaking educational efforts to assist consumers
in fully understanding current dietary guidelines for trans fat
consumption.

The Snack Food Association is an international trade association of more
than 700 member companies that represent snack manufacturers and
suppliers to the snack industry. Snacks produced and sold by SFA members
include potato chips, snack bars, tortilla chips, pretzels, cookies,
popcorn, crackers, extruded snacks, meat snacks, pork rinds, snack nuts,
party mix and other snacks. Retail sales of snack foods in the U.S.
total more than \$32 billion annually.

# content and context

In the November 15 proposal, FDA states that the proposed footnote is
intended to assist consumers in using the quantitative trans fat
information to help maintain healthy dietary practices. FDA also states
that the source of the statement is the recent National Academy of
Sciences/Institute of Medicine (NAS/IOM) report, Dietary Reference
Intakes: Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol,
Protein, and Amino Acids (National Academy Press 2002) (the
"macronutrient report").

The NAS/IOM macronutrient report recognizes that a certain amount of
trans fat will be consumed incidental to a nutritionally adequate
diet.[^1]/ The NAS/IOM advises that consumers should not attempt to
adopt the extreme measures that would be necessary to eliminate trans
fat entirely:

Because trans fatty acids are unavoidable in ordinary, non-vegan diets,
consuming 0% of energy would require significant changes in patterns of
dietary intake. Such adjustments may introduce undesirable effects
(e.g., elimination of commercially prepared foods, dairy products, and
meats that contain trans fatty acids, may result in inadequate intakes
of protein and certain micronutrients) and unknown and unquantifiable
health risks. Nevertheless, it is recommended that trans fatty acid
consumption be as low as possible while consuming a nutritionally
adequate diet.[^2]/

The statement proposed by FDA, "Intake of trans fat should be as low as
possible," dramatically oversimplifies these NAS/IOM recommendations.
SFA is concerned that the statement will not convey the intended message
as described in the macronutrient report, but will instead be
interpreted by consumers as a warning that trans fat intake must be zero
under all circumstances. In this regard, the statement amounts to a de
facto daily value of zero for trans fat, which FDA has advised is
inappropriate because it does not have sufficient information upon which
to establish a reference value. [^3]/

# format and presentation 

The proposed statement is of particular concern because it is a new and
unprecedented element in the footnote section of the Nutrition Facts
panel. Because the footnote is a descriptive statement, it constitutes a
departure from the numeric reference values (e.g., %DV declarations)
traditionally used by FDA. SFA anticipates that its novelty will lead
consumers to believe that trans fat is to be emphasized over all other
nutrients, including saturated fat and cholesterol. Indeed, from the
consumer perspective, there will be a "safe" level of saturated fat
because it is assigned a daily value, while trans fat is to be kept "as
low as possible." This presentation indicates that it is acceptable to
choose foods high in saturated fat and cholesterol, so long as trans is
avoided entirely. A message of this type is inconsistent with prevailing
dietary guidelines and FDA's own conclusion that saturated fat and trans
fat pose similar concern from a public health perspective. [^4]/

Also of concern, the November 15 proposal cites no consumer research
regarding the proposed statement, so SFA assumes that the concept may
not have been subject to consumer testing to evaluate its effect on
understanding and comprehension. Under the Nutrition Labeling and
Education Act of 1990 (NLEA), however, FDA is required to ensure that
nutrition labeling is "conveyed to the public in a manner which enables
the public to readily observe and comprehend such information and to
understand its relative significance in the context of a total daily
diet."[^5]/ The original Nutrition Facts panel was based upon extensive
consumer research and related data to ensure that nutrition information
would provide meaningful guidance to consumers.** **[^6]/ An
unprecedented statement of the type FDA is now proposing should be
subject to no less.

# recommendations

In summary, SFA believes the proposed footnote to be a well-intended,
but inappropriate, misleading, and unprecedented statement that will not
achieve the desired objective of providing meaningful unbiased
information to consumers regarding trans fat. SFA acknowledges that some
education will be required to assist consumers in fully understanding
the amount of trans fat consumption that may be incidental to a
nutritionally adequate diet. We believe, however, that it is simply not
feasible to convey such a complex message within the current Nutrition
Facts panel. [^7]/

SFA strongly recommends that the agency withdraw the proposed statement
and instead undertake or support consumer education efforts that can
more effectively convey current dietary guidelines for trans fat
consumption. At the very least, the agency is urged to refrain from
adopting any type of precedent-setting labeling format until (1) it has
the benefit of the forthcoming NAS/IOM report on the use of the new
dietary reference intakes (DRIs) in food labeling, and (2) consumer
testing data are available to ensure that any proposed addition to the
Nutrition Facts panel does in fact enhance consumer understanding of the
desired information.

\* \* \* \* \*

SFA is committed to the development of food labeling policy that
enhances consumer understanding of current recommendations for healthful
dietary practices. SFA looks forward to working with the agency on the
trans fat and other labeling issues and would be pleased to discuss with
CFSAN any of the points made in these comments.

Sincerely,

![](media/image2.png){width="2.111111111111111in"
height="1.207638888888889in"}

James A. McCarthy

President and CEO

[^1]: / NAS/IOM, *Dietary Reference Intakes: Energy, Carbohydrate,
    Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids*
    (National Academy Press 2002), at 8-2.

[^2]: / *Id.* (emphasis added).

[^3]: / 67 Fed. Reg. 69171 (Nov. 15, 2002) ("\[T\]he IOM/NAS report did
    not provide a dietary reference intake (DRI) value for *trans* fat
    or information that the agency believes is sufficient to support its
    establishing a daily reference value (DRV) to assist the agency in
    providing other information on the label, such as a % DV for *trans*
    fat.")

[^4]: / 64 Fed. Reg. 62746, 62753-55 (Nov. 17, 1999).

[^5]: / NLEA § 2(b)(1)(A).

[^6]: / 58 Fed. Reg. 2079, 2115-2123 (Jan. 6, 1993).

[^7]: / *See* 58 Fed. Reg. at 2123 ("\[T\]he agency does agree that the
    nutrition label cannot be the primary vehicle for providing general
    dietary recommendations").