![](media/image1.jpeg){width="1.6in" height="1.5118055555555556in"}1156
FIFTEENTH STREET NW, SUITE 900 WASHINGTON, D.C. 20005 (202) 785-3232
FAX: (202) 223-9741

E-MAIL: NAMM@kellencompany.com

December 16, 2002

[Via E-Mail - Hard Copy Also Sent Via Courier]{.underline}

Dockets Management Branch

(HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: [Docket No. 94P-0036; Food Labeling: *Trans* Fatty Acids in
Nutrition]{.underline}

[Labeling, Nutrient Content Claims, and Health Claims; Reopening
of]{.underline}

t[he Comment Period]{.underline}

Dear Sir or Madam:

The National Association of Margarine Manufacturers (NAMM) appreciates
this opportunity to comment on the Food and Drug Administration's (FDA)
amended proposed rule to require declaration of *trans* fatty acids in
nutrition labeling. 67 Fed. Reg. 69171 (Nov. 15, 2002). NAMM urges the
FDA to withdraw its amended proposal to require a footnote warning
consumers against consumption of *trans* fat.

Founded in 1936, NAMM is the national trade association representing
manufacturers and marketers of margarine and vegetable oil spreads and
their suppliers. While margarine is defined by a standard of identity
that requires no less than 80 percent total fat, the "margarine"
category is today comprised of a wide variety of non-standardized
vegetable oil spreads that typically contain significantly lower levels
of total fat, saturated fat, and *trans* fat than standardized
margarine. Many of these products have been reformulated to contain
little or no *trans* fat. Therefore, NAMM has a strong interest in
ensuring that nutrition labeling provides consumers with information
about *trans* fat and saturated fat content in an accurate,
non-misleading, and non-alarming way.

NAMM strongly opposes the proposed footnote ("Intake of *trans* fat
should be as low as possible"), because we believe it would be
misleading and would result in consumers making unintended decisions
with respect to healthy food choices. We believe the proposed footnote
is tantamount to a warning statement. Rather than informing consumers as
to the significance of *trans* fat in the daily diet, as FDA suggests,
this footnote would convey a misleading negative impression as to the
relative significance of *trans* fat compared to any other macronutrient
on the nutrition label, particularly saturated fat. By suggesting that
*trans* fat is to be avoided completely \-- the ultimate meaning of "as
low as possible" \-- the proposed footnote puts all the focus on *trans*
fat and defeats the larger purpose of assisting consumers in reducing
the combined total of saturated fat and *trans* fat in their diets.
*See* 64 Fed. Reg. 62746, 62755 (Nov. 17, 1999).

**1. The proposed footnote will be perceived by consumers as a warning
label.**

\"Intake of *trans* fat should be as low as possible\" can only be read
as \"make every effort to eliminate *trans* fat from your diet or
unfavorable consequences will result\". The proposed footnote says to
the consumer that no level of *trans* fat is acceptable for consumption,
and hence, any product containing *trans* fat should be avoided.

This warning is not consistent with the advice of the National Academy
of Sciences' Institute of Medicine (IOM), on which it is based. The IOM
report, in its conclusion, "recommends that *trans* fatty acid
consumption be as low as possible *while consuming a nutritionally
adequate diet*" (emphasis added).[^1] That critical qualifying phrase
(*i.e*., "while consuming a nutritionally adequate diet"), omitted by
FDA in the proposed footnote, is there for an important reason.
According to the IOM, changes in the diet to eliminate *trans* fat would
\"introduce undesirable effects.... and unknown and unquantifiable
health risks\", principally from reducing intake of protein and certain
micronutrients that are often present in formulations also containing
*trans* fatty acids.[^2] If, in response to the proposed footnote,
consumers eliminate *trans* fat from their diets, they will expose
themselves to the "undesirable effects" and "unquantifiable health
risks" that the IOM cautioned against.

The proposed footnote is inconsistent with IOM recommendations in
another respect. The IOM report does not recommend, and provides no
basis for, singling out *trans* fat from saturated fat and cholesterol.
Because the IOM concluded that it could not set a Tolerable Upper Intake
Level (UL) for *trans* fat, FDA determined it could not establish a
Daily Value for *trans* fat. In the absence of a Daily Value, FDA is
proposing this footnote to communicate to consumers the significance of
*trans* fat in the daily diet. There are, however, other macronutrients
that appear on the nutrition label for which the IOM was also unable to
set a UL (*e.g*., saturated fat and cholesterol). In fact, the IOM
advice regarding intake of saturated fat and cholesterol is essentially
identical to its advice regarding intake of *trans* fat.[^3] Yet, FDA is
not proposing a footnote/warning for saturated fat or cholesterol. FDA
has offered no rationale why a footnote/warning should be required for
*trans* fat, but not for these other macronutrients. Warning footnotes
for any of these macronutrients are not justified by their scientific
evaluations.

The IOM advice cannot be accurately summed up by the seemingly simple
"soundbite" in FDA's proposed footnote. NAMM believes that FDA is moving
too quickly to adopt the findings of the IOM Macronutrient Report
without fully thinking through the consequences, particularly since at
this time FDA (together with the U.S. Department of Agriculture and
Health Canada) is sponsoring a study entitled, \"Use of Dietary
Reference Intakes in Nutrition Labeling\". This study, being undertaken
by the IOM, is expressly for the purpose of determining how best to
integrate the new Dietary Reference Intakes (DRI\'s), addressed in the
IOM Macronutrient Report, into regulatory policy. Adopting the DRI\'s
piecemeal is a prescription for confusion and error.

**2. The proposed footnote would confuse consumers about the relative
impact of saturated fat and *trans* fat in the diet and result in
undesirable consumer behavior.**

The proposed footnote conveys a misleading message about the relative
merits of saturated fat and *trans* fat. The proposed footnote advises
consumers that their intake of *trans* fat should be "as low as
possible," meaning eliminate trans fats from their diets. When this
advice is read in the context of the existing nutrition label,
particularly the existing Daily Value of 20 grams (g) saturated fat, the
message to consumers is that a healthy diet consists of up to 20 g of
saturated fat per day, but no *trans* fat.

Using this approach, FDA would be sending consumers a nutrition message
we hope the agency does not intend to communicate. From the beginning of
the *trans* fat labeling rulemaking, FDA has made clear that its purpose
is to encourage consumers to reduce their consumption of the combined
total of saturated fat and *trans* fat. If labeling of *trans* fat with
the proposed footnote were to divert consumers attention away from
reducing total fat and saturated fat along with *trans* fat, as NAMM
believes it would, FDA would defeat its stated purpose. As FDA has
noted, from a public health perspective, saturated fat intake is the
greater concern, because Americans generally consume far more saturated
fat than *trans* fat. According to the agency:

FDA does not want to distract consumers from years of consumer education

messages about saturated fat, especially because the average intake of
saturated fat exceeds the average intake of *trans* fat by about
fivefold (approximately 25g versus 5 g/day, respectively).

See 64 Fed. Reg. at 62755 (Nov. 17, 1999).

The comparison of a serving of a typical tub \"margarine\" product like
a 70% vegetable oil spread with a serving of butter clearly illustrates
the great potential for consumer confusion and undesirable response.

[70% Vegetable Oil Spread]{.underline} [Butter]{.underline}

Total Fat 10 grams 11 grams

Saturated Fat 2 grams 7 grams

*Trans* Fatty Acids 2 grams\* 0 grams

Cholesterol 0 milligrams 31 milligrams

\*Intake of *trans* fat should be as low as possible

The presence of the proposed footnote takes much of the focus away from
the other nutrients declared in the Nutrition Facts box and will result,
in this case, in causing many consumers to choose butter which has
almost twice as much combined saturated fat and *trans* fat as this
popular margarine product in addition to cholesterol which is not
present in margarine products. The National Cholesterol Education
Program and the American Heart Association have repeatedly and
emphatically recommended soft margarine products over butter.

Even a Q&A document issued by FDA in conjunction with its initial
proposal on *trans* fat labeling[^4] clearly states that margarine,
compared to butter, is the healthier table spread, but consumer behavior
\-- measured by market research studies, opinion surveys and purchase
patterns \-- demonstrates that this message is failing to reach
consumers who mistakenly confuse news about *trans* fats. A major effort
by the margarine industry to communicate to the consumer and
considerable progress in substantially reducing *trans* fat in margarine
products have led to reducing this confusion. FDA\'s proposed footnote
would set back these efforts.[^5]

In addition to greater consumption of butter, consumers are also likely
to substitute saturated fat for *trans* fat in their diets generally
because of the proposed footnote. If the nutrition label tells consumers
that the recommended intake of *trans* fat is 0 g and the recommended
intake of saturated fat is 20 g/day, then many consumers are likely to
increase their intake of saturated fat in an effort to avoid *trans*
fat. Because saturated fats are generally derived from animal sources,
this is likely to lead to increased intake of cholesterol as well.

**3. The proposed footnote would result in substitution of saturated fat
for *trans* fat by food processors.**

By stigmatizing *trans* fat, the proposed footnote would create strong
pressure on food processors to remove all, or virtually all, *trans* fat
from many products. To avoid having the footnote, many food processors
are likely to reformulate their products to remove *trans* fat.
Unfortunately, *trans* fat is likely to be replaced largely with
saturated fat. As NAMM explained in earlier comments submitted in this
rulemaking,[^6] the most obvious way to reduce the amount of *trans* fat
in any food product is to increase the amount of saturated fat. While
some proprietary technologies have enabled some food processors,
particularly in the margarine industry, to reduce *trans* fat without
increasing saturated fat, these technologies, in many cases, result in a
product with limited functionality and consumer appeal.

The end result is likely to be products with higher levels of saturated
fat. For example, in order to avoid the *trans* fat footnote, a bakery
given the choice of ingredients might make its product with butter
instead of margarine or vegetable oil spread.

NAMM believes that the quantitative declaration of *trans* fat alone
will create a competitive incentive for food processors within the same
product categories to make every effort to reduce *trans* fat. The
quantitative declaration would accelerate the evolutionary trend away
from *trans* fat that is already underway. The proposed footnote,
however, would turn this trend into a stampede to the easiest substitute
for *trans* fat, saturated fat.

**4. There are already other footnotes on the nutrition label. The
addition of yet another footnote contributes to more clutter and moves
further away from simplicity for consumer understanding.**

Every Nutrition Facts label already has at least one required asterisk
and footnote. That asterisk appears next to the Daily Value heading and
refers to a footnote at the bottom of the Nutrition Facts box, i.e.,
\"\*Percent Daily Values are based on a 2000 calorie diet\". And many
packaged products use asterisks on the nutrition panel and corresponding
footnotes to meet other labeling requirements. Products used for baking,
for example a popular brownie mix, uses asterisks on the nutrition panel
to differentiate nutrient levels in the \"mix\" and \"as prepared\" with
footnotes enumerating the other ingredients upon which the \"as
prepared\" values are calculated. Many products also feature another
footnote at the base of the Nutrition Facts box, i.e., \"Not a
significant source of \[nutrients\]\". All in all, there is already too
much information for the busy consumer to make simple choices without
yet one more footnote and a misleading one at that.

**5. The proposed footnote is subject to challenge on constitutional
grounds**.

As discussed above, we believe that the proposed footnote is misleading
and that a food product bearing the footnote would therefore be
misbranded under § 403(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. § 343(a)). In addition, NAMM believes the proposed footnote
raises First Amendment concerns.

The First Amendment protects "both the right to speak freely and the
right to refrain from speaking at all." *Wooley v. Maynard*, 430 U.S.
705, 714 (1977). For commercial speech, the Supreme Court has held that
government regulation, including regulations that compel speech, must be
calibrated to advance a substantial government interest. *Central Hudson
Gas & Elec. Corp. v. Public Serv. Comm'n. of New York*, 447 U.S. 557
(1980). Under the *Central Hudson* test, a regulatory agency must assert
a substantial government interest, must show that its regulation
directly advances that interest, and must show that its regulation is
not more extensive than is necessary to achieve its purpose.

NAMM believes that the proposed *trans* fat footnote fails the *Central
Hudson* test. While the FDA has asserted a substantial government
interest (*i.e*., providing consumers with information about the amounts
of nutrients that may increase their risk of heart disease, and the
significance of those amounts in their daily diet), the proposed
footnote does not directly advance that asserted interest. As explained
above, the proposed footnote conveys a misleading message by implying
that a healthy diet may consist of 20 g of saturated fat but no, or
virtually no, *trans* fat. In doing so, the proposed footnote would lead
to a substitution of saturated fat for *trans* fat. The net effect is
likely to be an increase in the combined total of saturated fat and
*trans* fat consumed by the average American.

The proposed footnote also fails the final prong of the *Central Hudson*
test. It is more extensive than is necessary to achieve its purpose. The
proposed footnote is tantamount to a warning statement about *trans*
fat.[^7] A government regulation requiring "the functional equivalent of
a warning" is unlikely to pass constitutional muster absent a compelling
public health justification. *See International Dairy Foods Association
v. Amestoy*, 92 F.3d 67, 73 (2d Cir. 1996). While a more recent court
case upheld a government regulation compelling commercial speech, it did
so because the compelled speech in that case was factual and accurate,
whereas the proposed footnote is hortatory and misleading. *See National
Electric Manufacturers Association v. Sorrell*, 272 F.3d 104 (2d Cir.
2001).

**6. The proposal by FDA to exercise its enforcement discretion to
permit labels to include the proposed footnote prior to publication of a
final rule is a mistake.**

Some food processors making products which have no *trans* fats may see
a short-term competitive advantage to tie a quantitative declaration of
zero *trans* fat to the proposed alarming footnote/warning. FDA's
proposal to allow this (*i.e*., declaration of *trans* fat in
combination with the proposed footnote) prior to publication of a final
rule is unwise. In addition to prematurely permitting the proposed
footnote before FDA has the opportunity to review public comments about
it, NAMM believes it is not good regulatory policy to establish such a
precedent-setting label device prior to the issuance of final
regulations. NAMM does not object, however, to the exercise of the
FDA\'s enforcement discretion now with respect to permitting the
quantitative declaration of *trans* fat.

**7. Summary**

In summary, although NAMM supports the quantitative declaration of
*trans* fats on the nutrition label and believes a final regulation
requiring this quantitative declaration should be published as soon as
possible, we believe the footnote proposed in FDA\'s amended proposed
rule of November 15, 2002 to label *trans* fatty acids is not
appropriate for the following reasons:

-   The proposed footnote will be perceived by consumers as a warning
    label.

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-   The proposed footnote will cause consumer confusion about the
    relative impact of saturated fat and *trans* fat in the diet and
    result in undesirable consumer behavior leading to the consumption
    of higher levels of saturated fat.

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-   The proposed footnote will encourage food processors to substitute
    saturated fat for *trans* fat, which consumers will perceive as more
    healthful.

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-   The proposed footnote will result in more label clutter, moving away
    from simple messages needed to influence appropriate consumer
    action.

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-   The proposed footnote is misleading and may, therefore, be found to
    be unconstitutional.

In addition, NAMM believes that permitting food processors to use the
proposed footnote now, under FDA\'s exercise of enforcement discretion,
is premature.

Therefore, NAMM respectfully requests FDA to withdraw its proposed
amendment and to delete the proposed footnote from its final rule on
*trans* fat labeling.

The National Association of Margarine Manufacturers appreciates this
opportunity to comment on this very important issue.

Respectfully submitted,

![](media/image2.png){width="3.1013888888888888in" height="0.725in"}

Richard E. Cristol

President

[^1]: Institute of Medicine, "Letter Report on Dietary Reference Intakes
    for Trans Fatty Acids" (July 10, 2002), p. 14.

[^2]: *Id. See also*, Institute of Medicine, "Dietary Reference Intakes
    for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol,
    Protein and Amino Acids" (IOM Macronutrient Report), p. 8-66.

[^3]: "While increased serum low density lipoprotein (LDL) cholesterol
    concentrations, and therefore risk of coronary heart disease, may
    increase at high intakes of saturated fatty acids, *trans* fatty
    acids, or cholesterol, a UL is not set for these fats because the
    level at which risk begins to increase is very low and cannot be
    achieved by usual diets and still have adequate intakes of all other
    required nutrients. It is thus recommended that saturated fatty
    acid, *trans* fatty acid, and cholesterol consumption be as low as
    possible while consuming a nutritionally adequate diet." IOM,
    Macronutrient Report, p. S-4.

[^4]: FDA, "Questions and Answers on *Trans* Fat Proposed Rule" (Nov.
    1999).

[^5]: In its April 17, 2000 comments, NAMM argued that
    naturally-occurring *trans* fats, including conjugated linoleic acid
    (CLA), present in butter and other dairy foods should be included in
    the regulatory definition of "*trans* fat" and required to be
    declared in the nutrition label. NAMM continues to believe this, and
    we note that the IOM Macronutrient Report includes CLA in the
    definition of *trans* fat. If FDA were to adopt the IOM definition
    of *trans* fat, some butter products would likely exceed the 0.5 g
    threshold for declaration of *trans* fat. Even in that case,
    however, the proposed footnote would still stigmatize margarine and
    vegetable oil spreads by overemphasizing the two products' *trans*
    fat levels and de-emphasizing the more important comparison between
    levels of combined saturated fat and *trans* fat. FDA\'s position
    to-date to not recognize conjugated linoleic acids as *trans* fats,
    as the IOM Macronutrient Report does, has a material bearing on
    whether a product can declare zero trans fat on its nutrition label.
    If FDA is going to follow the advice of the IOM report, the
    agency\'s treatment of conjugated linoleic acid with respect to the
    definition of trans fat should be reconciled with the IOM report.

[^6]: *See* NAMM comments dated April 17, 2000.

[^7]: It is worth noting again that the language in the proposed
    footnote does not accurately reflect the IOM recommendation on
    *trans* fat intake. The IOM Macronutrient Report recommends that
    intake of *trans* fat should be "as low as possible while consuming
    a nutritionally adequate diet." By omitting the words "while
    consuming a nutritionally adequate diet," the proposed footnote
    changes the meaning of the IOM recommendation, suggesting no
    allowance for *trans* fat in a healthy diet.