Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852

<FDADockets@oc.fda.gov>

\[Docket No. 2003N-0338\]

November 21, 2003

**Comments from the**

**Produce for Better Health Foundation**

**and**

**United Fresh Fruit and Vegetable Association**

**To FDA's Obesity Working Group**

The Produce for Better Health Foundation (PBH) is a non-profit 501 (c)
(3) consumer education foundation whose mission is to create a healthier
America through increased consumption of a variety of fruits and
vegetables. PBH is a member of the National 5 A Day Partnership that is
the nation's largest public-private nutrition education initiative.
PBH's efforts encompass fruit and vegetable research, education,
marketing, and nutrition policy; and their primary purpose is to oversee
industry participation that today includes over 700 members representing
growers, shippers, processors, commodity boards, trade associations,
health insurers, health professionals, and retailers reaching consumers
in 30,000 supermarkets nationwide.

[]{.mark}

United Fresh Fruit and Vegetable Association (United) is the produce
industry's national trade association representing growers, packers,
fresh processors, distributors, and marketers of fresh fruits and
vegetables. Based in Washington, DC, United has worked for the past 100
years to bring together all segments of the produce industry and is
recognized by political and opinion leaders as the voice of the produce
industry in our nation's capitol. Over the last 7 years, United has
partnered with PBH and the nutrition and health community to work with
Congress to gain major funding for the 5 A Day campaign and help promote
produce and nutrition in all federal health programs to combat obesity
and disease.

We applaud FDA's efforts in exploring ways to tackle the obesity
epidemic and related health issues in this country. FDA and other
federal agencies can and do serve an important role in promoting
national public health priorities and we urge you to continue and step
up your efforts to provide consumers, via food labeling, dietary
guidance, and health claims with specific information that will help
them make health-promoting food choices both at home as well as away
from home.

We have provided recommendations in response to several of the agency's
questions from the October 8, 2003 Federal Register notice. These
comments also reflect our recommendations based on the meeting held on
Nov. 20^th^, Exploring the Link Between Food Labeling and Weight
Management. In addition, we have highlighted in an attachment, key
issues regarding fruit and vegetable intake that we hope the FDA's
Obesity Working Group finds useful as they continue to identify ways to
promote healthier choices among consumers.

**PBH/United Responses to Questions Raised by FDA**

*Q2. What are the top priorities for nutrition research to reduce
obesity in children?*

PBH and United encourage FDA to support research on nutrient and energy
density related to helping consumers choose foods that will assist them
in reaching and maintaining a healthy weight. We also strongly support
the need for more behavior-based research to better understand the
mechanisms in play that cause some children to eat more healthfully than
others. We know that diets rich in fruits, vegetables, whole grains and
low fat dairy products provide the basis for a sound diet and help
prevent certain chronic diseases, but we need more information on how
best to communicate this to consumers in a way that prompts actionable
positive steps. We support research that looks at the impact of
labeling, dietary guidance, and health claims so these vehicles can have
maximum impact on healthful food choices. We encourage FDA to support
more research on the role of fruits and vegetables in preventing obesity
in children.

*Q4. Are there changes needed to food labeling that could result in the
development of healthier, lower calorie foods by industry and the
selection of healthier, lower calorie foods by consumers?*

We would like to make several suggestions on how to better communicate
the important role of fruits and vegetables via the food label and other
retail efforts to consumers.

First, vegetables and fruits are among the most nutrient-dense,
low-calorie foods. This critical element must be better communicated to
consumers. Enhanced food labeling that highlights the nutrient profile
of foods, with a particular emphasis on calories and the disease
prevention potential of diets high in fruits and vegetables, must be
developed.

-   **Nutrient/Energy Density:** Including both nutrient density and
    energy density on labels would give consumers the information to
    choose products that provide maximum nutrition with minimum
    calories.

-   **Preserving the Integrity of Fruits & Vegetables as Healthy
    Foods:** Efforts to capitalize on consumer demand for healthier
    foods has led to the on and off label promotion of products that
    contain relatively small amounts of fruits and vegetables and/or
    contain them as part of a product with unhealthy amounts of fat,
    sodium, or refined carbohydrates. These products, such as fruit
    drinks, pop tarts, and highly sugared cereals, are more often energy
    dense than nutrient dense. FDA, working with the FTC, should
    strengthen its guidelines to prevent the promotion of products based
    on their fruit and vegetable content unless these products maintain
    the integrity of fruits and vegetables as healthy foods, and make a
    reasonable contribution to the recommended daily intake for fruits
    and vegetables.

-   **Graphic, Simple Display of Key Information:** Consumers want
    information that is easy to understand and helps them choose a
    healthful diet. The Swedish Government Program that sets criteria
    for several categories and allows foods to use the "Key Hole" symbol
    bears consideration. We urge FDA to consider similar approaches,
    with the underpinning of nutrient quality, and test various graphic
    concepts with consumers.

-   **Dietary Guidance:** PBH and United applaud the agency's recent
    efforts to provide consumers with more specific information on the
    role of fruits and vegetables in chronic disease prevention. In
    response to FDA's recent efforts in this area, PBH has launched a
    Health Claims Initiative to provide the fruit and vegetable industry
    with information on the application of dietary guidance and health
    claims. Both organizations urge the agency to continue efforts to
    better communicate the important role of fruits and vegetables to
    consumers and recommends working with other federal agencies to
    develop additional dietary guidance for chronic diseases such as
    obesity, heart disease, diabetes, and hypertension. We also
    recommend that the agency continue to develop such guidance based on
    strong scientific evidence so as not to mislead consumers.

-   **Added sugar:** FDA should proceed with efforts to set a daily
    value for refined sugars and to list the percentage of the DV on the
    label in addition to the gram amount. Consumers need to be able to
    differentiate between naturally-occurring sugars, that are more
    likely to be associated with nutrient content, and added sugars that
    provide only calories. Added sugar labeling would also allow the 5 A
    Day Program to develop criterion for appropriate amounts of sugar in
    processed foods that are a source of fruits and vegetables. Without
    such information, fruit and vegetable products with any amount of
    added sugar can not carry the 5 A Day logo.

Q*6. Based on the scientific evidence available today, what are the most
important things that FDA could do that would make a significant
difference in efforts to address the problem of overweight and obesity?*

-   Restaurant Initiatives: PBH and United strongly support enhanced
    efforts to educate consumers about the nutrient contribution of
    meals consumed or purchased for take-out in all types of
    restaurants. Nearly 50 percent of all food dollars are spent on
    these foods. Currently, the Nutrition Labeling and Education Act of
    1990 excludes restaurants from nutrition labeling. If we want better
    informed consumers, then we must make every effort to provide them
    with important information. Labeling of key nutrients at point of
    purchase, especially calories, is a critical first step in providing
    consumers with the necessary tools they need to make better food and
    beverage choices.

> PBH has been working with the foodservice industry to develop criteria
> to aid restaurants in creating and promoting healthy items. We urge
> FDA to help in these efforts and fund pilot studies to determine ways
> to create healthier options for foods eaten outside the home. PBH
> welcomes the opportunity to work with FDA on guidance to share with
> foodservice establishments.

-   Point-of-Sale for fresh fruits and vegetables: Given the increasing
    evidence on the importance of consuming a diet rich in fruits and
    vegetables, we urge FDA to work with PBH, United and the fruit and
    vegetable industry to develop more effective point-of-sale
    mechanisms to communicate the health benefits of fruits and
    vegetables. Right now, retailers are required to display, somewhere
    in the produce area, nutrition information on the leading fruits and
    vegetables; sometimes this takes the form of a poster, a notebook,
    or a pamphlet. We need to develop better ways to communicate with
    consumers when they are shopping for food. FDA should consider
    developing additional disease-specific dietary guidance on the
    important risk-reduction benefits of eating a diet rich in fruits
    and vegetables that should be used at point-of-purchase. We welcome
    the opportunity to discuss this and other ideas with FDA.

Both PBH and United stand ready to assist FDA and the Obesity Working
Group in efforts to help consumers make better food and beverage
choices. Please don't hesitate to contact PBH should you need further
clarification on the information provided.

![](media/image1.png){width="2.5618055555555554in"
height="0.4583333333333333in"}

Elizabeth Pivonka, PhD, RD

President

![](media/image2.png)

Thomas E. Stenzel, CEO & President

United Fresh Fruit and Vegetable Association

Attachment:

Key Fruit and Vegetable Findings

**Attachment**

**Key Fruit and Vegetable Findings**

**Benefits:** Higher fruit and vegetable intakes can help reduce the
risk for many chronic diseases, including cardiovascular disease,
cancer, lung disease, and age-related diseases such as osteoporosis and
cataracts.

-   Findings from the DASH Diet, PREMIER Study, Nurses Health Study,
    Health Professionals' Follow-Up Study, World Cancer Research Fund
    and others support the important role that fruits and vegetables
    play in promoting health.

-   Numerous studies have pointed to the importance of fiber in reducing
    cardiovascular disease risk and in promoting weight control and
    weight loss. The average American consumes about 15 grams of fiber
    per day, an amount far less than the 25 grams recommended by the NAS
    for women and 38 grams recommended for men. Encouraging the
    consumption of fruits, vegetables, legumes and whole grains is the
    best way to increase one's fiber intake.

**Quantity:** The current Food Guide Pyramid recommends a range of 5 --
9 servings per day from fruits and vegetables (*Dietary Guidelines for
Americans, 2000*). Consumers and especially children are woefully
under-consuming fruits and vegetables.

-   Based on CSFII data (1994-1996), the average American eats 1.5
    servings of fruits and 4 servings of vegetables per day (this
    includes French fries) and French fries make up 17% of vegetable
    servings for adults 20 and older and 32% for children 2 to 19 years
    old.

-   According to BRFSS data for the year 2000, more than *75%* of U.S.
    residents failed to meet the minimum recommended 5 servings each day
    of fruits and vegetables. A recent study by the NPD group found that
    2 to 17 year old boys and girls consumed far less that the
    recommended 5 to 9 servings of fruits and vegetables. Boys in this
    age group ate 3.0 serving and girls just 2.6 servings per day,
    excluding French fries. The same study noted that single-parent and
    dual-income families with children eat 10 percent fewer fruits and
    vegetables than families with a stay-at-home parent.

**Variety:** Americans currently do not consume a variety of fruits and
vegetables.

-   A limited number of fruits and vegetables provide the majority of
    these foods consumed by average Americans.

    -   Only 3 vegetables (potatoes, iceberg lettuce, and canned
        tomatoes) accounted for almost half (48%) of vegetable
        consumption in the United States in 2000.

    -   Only 3 fruits (oranges, apples, and bananas) contributed
        one-half of total daily fruit servings in 2000, according to ERS
        (Putnam et al, 2002).

-   Every fruit and vegetable has a unique assortment of vitamins,
    minerals, phytochemicals, and fiber. Consumption of a variety of
    fruits and vegetables is likely to be superior to eating a narrow
    range of these foods for health maintenance and disease prevention.
    The best way to maximize the health promoting benefits of fruits and
    vegetables is to eat a variety of them.

**Promotion:** Federal efforts and spending fall short of addressing
public health needs in terms of fruit and vegetable promotion.

-   The gap between the federal government's recommendations for fruit
    and vegetable consumption and the current consumption rates is
    substantial and could take up to 128 years to close. (PBH. *The
    Fruit and Vegetable Consumption Challenge -- Executive Summary.*
    Wilmington, DE: PBH, 2002.)

-   Although fruits and vegetables comprise 33 percent of the total food
    intake recommended by USDA in the Food Guide Pyramid, only 4.5
    percent of total USDA spending in 2000 directly or indirectly
    promoted consumption of fruits and vegetables.

-   A recent General Accounting Office Report confirmed the gap between
    funding of federal nutrition education interventions and efforts and
    federal guidelines on the consumption of fruits and vegetables.
    (Fruits and Vegetables: Enhanced Efforts to Increase Consumption
    Could Yield Health Benefits for Americans, GAO 2003).

**Added Sugar Labeling:** PBH supports the listing of added sugars on
labels because over consumption displaces foods, including fruits and
vegetables that provide disease-preventive health benefits and support a
healthy weight.

-   The alarming increase in rates of obesity and Type 2 diabetes,
    especially among children, has been linked to a 12% (300 calorie)
    increase in average daily calorie intake between 1985 and 2000
    without a lack of concurrent increase in physical activity.^1^
    According to USDA's Center for Nutrition Policy and Promotion, added
    sugar intake accounted for 23% of these the extra calories.

-   The Food Guide Pyramid recommends limiting added sugars to 12
    teaspoons per 2200 calories, however, the average daily intake of
    added sugar in 2000 was 31 teaspoons.^1,2^ Higher intakes of refined
    sugar can negatively impact the health of the 59% of individuals who
    over-consume calories in the US. In persons who are not consumers of
    excess energy, added sugars may displace fruits, vegetables, and
    other nutrient-dense foods, resulting in inadequate nutrient intakes
    that can increase disease risk.^3^

-   Although the 1990 Nutrition Labeling and Education Act requires the
    disclosure of total sugar content on the label, added sugar
    disclosure is not required.^4^ This makes it impossible for
    consumers to determine how much added sugar they actually consume.
    Current FDA labeling efforts through the Consumer Health Information
    for Better Nutrition Initiative are focused to improve consumer
    understanding of the health consequences of their dietary
    choices.^5^ Added sugar labeling contributes to these efforts.

1\. J Putman, et.al. (Winter 2002). U.S. per capita food supply trends:
more calories, refined carbohydrates, and fats. *Food Review*, Vol.25
(3): 2-15.

2\. U.S. Department of Agriculture/U.S. Department of Health and Human
Services (December 1995). Home and Garden Bulletin No. 232. Fourth
Edition.

3\. USDA Center for Nutrition Policy and Promotion (October 2000). Is
Intake of Added Sugars Associated with Diet Quality? *Nutrition
Insights*, Insight 21.

4\. U.S. Food and Drug Administration (1994). Guide to Nutrition
Labeling and Education Act Requirements.

5\. U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition (July 2003). Consumer Health Information for Better
Nutrition Initiative, Task Force Final Report.