DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

RIN 0910-ZA30

\[Docket No. 2006N-0168\]

\[Docket No. FDA-2008-N-0040\]

**General Comment**

The Centers for Disease Control and Prevention (CDC) appreciates the
opportunity to review and provide comment. If requested, the CDC would
be interested to collaborate with US Food and Drug Administration to
provide the public health perspective as they go through the process to
update food labels.

As a general overarching premise, CDC supports the recommendations from
the 2003 Institute of Medicine report on Dietary Reference Intakes:
Guiding Principles for Nutrition Labeling and Fortification.[^1] New
knowledge following publication of the IOM report, especially science
regarding consumer behaviors and understanding of labels, should also be
considered.

Based on the initial consumer research conducted by FDA, CDC supports
the placement of adjectives (e.g., high, medium, or low) next to the
nutrition information, with standards for use of these terms, as a way
to help consumers understand the significance of a product's nutrition
information. Other world regions have used a modified approach to
informing consumers with placement of adjectives. The United Kingdom,
for example, has initiated a voluntary front of package label for
nutrients of public health concern including fat, saturated fat, sugar
and salt. These nutrients are labeled as low, medium or high and colored
to correlate to a traffic light. Utilizing the front of package labeling
principles such as this one provide consistency for consumers and may
aid in consumer understanding and ability to make an informed
choice.[^2] This may be especially important for low-literate
populations.

CDC supports the continued use of a 2,000 calorie diet as reference for
standard food labels, but we also recommend labeling that reflects the
portion commonly consumed. For example, a label for a product such as a
20oz bottle of soda in which a consumer typically drinks all the
contents should include food label information for the total contents as
packaged.

Sodium

Food Labeling: Revision of Reference Values and Mandatory Nutrients

We urge the FDA to take the following measures to reduce the enormous
human and economic costs of cardiovascular disease in the United States.

**I. FDA should change the DV for sodium to 1,500 mg.**

FDA should base the daily value (DV) for sodium on the Adequate Intake
(AI), in keeping with the population-coverage approach. (The Institute
of Medicine sets an AI when it has insufficient data to set a
Recommended Dietary Allowances.) The IOM set the AI at 1,200 mg for men
and women over 70 and 1,300 mg for men and women aged 51 to 70. The AI
for younger men and women is 1,500 mg.

-   Judging by those recommendations, it would be imprudent to set a DV
    at 2,300 mg, the IOM's Tolerable Upper Intake Level (UL). The U.S.
    Dietary Guidelines recommend 1,500 mg a day for people who are
    middle-aged or older, African-American, or hypertensive.[^3] Those
    groups comprise approximately 50 percent of the population,
    according to data from the National Center from Health Statistics.

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-   For most nutrients, an individual's intake ≥ the AI can be assumed
    adequate. This does not hold true for sodium. Increased sodium
    generally means higher blood pressure. The strength of the
    association between salt consumption and high blood pressure is
    strong. Maintaining blood pressure within a normal range reduces
    one's risk of heart disease, congestive heart failure, stroke and
    kidney disease.

    -   The DASH-Sodium trial clearly showed that reducing sodium intake
        reduces systolic blood pressure. Reducing from a high to an
        intermediate level of sodium consumption reduced systolic blood
        pressure; reducing intake from an intermediate to a low level of
        sodium consumption caused a greater decrease in systolic blood
        pressure.[^4]

    -   We recognize that reaching 1,500 mg a day is difficult with our
        current, high-sodium food supply. However, labels should not
        mislead consumers to believe that 2,400 mg is an ideal daily
        intake, especially when experts estimate that a 50% reduction in
        sodium in the nation\'s food supply over the next 10 years would
        save at least 150,000 lives per year.[^5]

    -   The physiologic requirement for sodium is estimated to be 500mg
        or less.[^6]

    -   Other nutrients, such as calcium, are labeled in accordance with
        their adequate intake (1,000mg) and well below their upper limit
        (2,500mg).

**2. Labels should continue to express sodium content in milligrams.**

-   **Changing to grams might create the impression that sodium levels
    are inconsequential.** While fat, carbohydrates, and certain other
    nutrients are declared in grams, the amounts in those foods span a
    wide range (e.g., roughly 0 to 50 grams for carbohydrates and 0 to
    25 grams for fat and protein). In contrast, the amounts of sodium in
    food are present in a narrow range, 2 grams or less, and a dietary
    change of mgs can have a significant impact on health. Further, if
    the reporting format is changed to grams a critical level of detail
    is lost. Changing to grams might lead some people to think that the
    levels in food---typically tenths of grams---are inconsequential.
    (The %DV would remain the same, but many people do not use it).

-   **Consumers need accurate information regarding the sodium content
    of their food**. Sodium is a micronutrient and therefore needs to be
    represented in an appropriate unit of measurement. Converting it to
    grams could lead to misinterpretation among the public. Accurate
    information is needed for consumers to make informed purchasing
    decisions about the sodium content of their foods. Even a small
    population reduction in sodium consumption could impact
    cardiovascular disease rates.

-   **Advice from researchers, physicians, dietitians, etc. is given in
    milligrams.** Americans have long been accustomed to seeing sodium
    expressed in milligrams, and many do not understand the relationship
    between milligrams and grams. Taking on the unnecessary task of
    re-educating people to think of sodium in grams instead of
    milligrams would be costly if it is done well and ineffective if it
    is done poorly. If FDA revises the Nutrition Facts label, the agency
    would have to re-educate people about enough changes in the label
    without adding new sodium units to the list.

**3. Sodium should not be listed with the macronutrients on the food
label.**

-   Positioned differently on the food label will aid in the
    understanding that sodium recommendation is actual and not a value
    proportional to caloric intake.

[^1]: IOM, "Dietary Reference Intakes: Guiding Principles for Nutrition
    Labeling and Fortification," Washington, DC: National Academies
    Press, pp. 1 to 17, 2003.

[^2]: Food Standards Agency. Signposting. United Kingdom Food Standards
    Agency, website. Available at
    <http://www.food.gov.uk/foodlabelling/signposting/>

[^3]: U.S. Department of Health and Human Services and U.S. Department
    of Agriculture, "2005 Dietary Guidelines for Americans," 6^th^ ed.,
    Washington, DC: U.S. Government Printing Office, 2005.

[^4]: [Sacks FM, et.
    al.](http://www.ncbi.nlm.nih.gov/pubmed/11136953?ordinalpos=105&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum)
    "Effects on blood pressure of reduced dietary sodium and the Dietary
    Approaches to Stop Hypertension (DASH) diet." N Engl J Med. 2001 Jan
    4;344(1):3-10.

[^5]: [Havas
    S](http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term="Havas S"%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus),
    et. al. Reducing the public health burden from elevated blood
    pressure levels in the United States by lowering intake of dietary
    sodium. [Am J Public
    Health.](javascript:AL_get(this, 'jour', 'Am J Public Health.');)
    2004 Jan;94(1):19-22.

[^6]: National Research Council (U.S.). Committee on Diet and Health.
    "Diet and Health: Implications for Reducing Chronic Disease,"
    Washington, DC: National Academy Press, 1989.