2010 Dietary Guidelines for Americans: Key Issues for Companies that Make or Market Food, Beverages, or Dietary Supplements for the U.S. Market
Kelley Drye Client Advisory
February 3, 2011
On January 31, 2011, the U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) issued the Dietary Guidelines for Americans, 2010 (2010 Dietary Guidelines). The 2010 Dietary Guidelines makes recommendations aimed at reducing the risk of obesity and other leading diet-related diseases affecting both healthy and unhealthy Americans which are founded on an evidence-based review of the current body of scientific evidence concerning the role that dietary patterns, food and nutrient intake levels play in promoting health and preventing disease.

In simplest terms, the 2010 Dietary Guidelines characterizes the core features of a healthy diet, recommends dietary practices to help Americans achieve and maintain a healthy diet, and identifies food and nutrition priorities where dietary patterns of Americans commonly fall short. The 2010 Dietary Guidelines also include physical activity recommendations to encourage Americans to maintain a balance between the calories they consume and those they expend on an ongoing basis. While a fundamental premise of the Dietary Guidelines is that nutrients should come primarily from foods, the guidelines explicitly recognize that "fortified foods and dietary supplements may be useful in providing one or more nutrients that otherwise might be consumed less than recommended amounts." They also encourage Americans to maintain safe food handling practices to promote food safety and prevent foodborne illness.

The 2010 Dietary Guidelines, like those issued in the past, will have significant implications for U.S. public health and consumer protection policies, including regulatory policies that help determine the conditions under which food, beverages, and dietary supplements may be marketed in the United States. The 2010 Dietary Guidelines recommendations will be promoted to consumers through educational programs that are sponsored by USDA and HHS. In addition, the new guidelines will be considered by FDA, USDA, and FTC as they continue to develop the regulatory and enforcement policies that govern food labeling and marketing claims. Notably, the 2010 Dietary Guidelines report explicitly recognizes that the authoritative statements it contains concerning nutrition and diet-related health matters qualify as a basis for FDA authorization of nutrient content claims and health claims under the premarket notification procedures that were established under the Food and Drug Administration Modernization Act (FDAMA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA).1 The new guidelines also are likely to influence the nutrition quality standards that help determine whether particular food products qualify to be sold through government sponsored food programs (e.g., school breakfast/lunch, WIC, etc.) and regulate the conditions of such use.

The Dietary Guidelines for Americans are jointly issued by USDA and HHS every five years,2 and rely on the extensive evaluation of scientific evidence and public comment that is conducted by a committee of scientific experts called the Dietary Guidelines Advisory Committee (DGAC). The 2010 Dietary Guidelines relies on the report of the 2010 DGAC which was issued on June 15, 2010.3 The 2010 Dietary Guidelines are divided into six chapters and include 23 Key Recommendations for the general population and six additional Key Recommendations for women capable of becoming pregnant, women who are pregnant or breastfeeding, and individuals ages 50 years and older. A list of the recommendations is available here.

In contrast to previously issued dietary guidelines, the 2010 Dietary Guidelines is intended not only to help "healthy" Americans maintain their good health, but also to address the dietary needs of Americans whose health status is compromised in ways that place them at increased risk of chronic disease. This expanded focus of the 2010 Dietary Guidelines is responsive to rising concerns about the health status of the American population, including the prevalence of overweight, obesity, hypertension, and other diet-related disease trends. Consistent with these concerns, the 2010 Dietary Guidelines emphasize the importance of obesogenic environments, noting that "although individual behavior change is critical, a truly effective and sustainable improvement in the Nation's health will require a multi-sector approach that applies the Social-Ecological Model to improve the food and physical activity environment." In turn, the 2010 Dietary Guidelines include both strategies that individuals and families can adopt to achieve dietary intake recommendations and "A Call to Action" outlining strategies that can be implemented by "sectors of influence" to support individuals and families. These "sectors of influence" include industry, educators, communities and organizations, health professionals, and policy makers.

Recommended strategies related to industry include a call to:

  • expand access to grocery stores, farmers markets, and other outlets for healthy foods;
  • initiate partnerships with food producers, suppliers, and retailers to promote the development and availability of appropriate portions of affordable, nutritious food products (including, but not limited to, those lower in sodium, solid fats, and added sugars) in food retail and food service establishments;
  • develop legislation, policies, and systems in key sectors such as public health, health care, retail, school foodservice, recreation/fitness, transportation, and nonprofit/volunteer to prevent and reduce obesity; and
  • strategically promote healthy lifestyles for children through strategies including reducing children's screen (television and computer) time; developing and supporting effective policies to limit food and beverage marketing to children; and ensuring all meals and snacks sold in schools and childcare and early childhood settings are consistent with the Dietary Guidelines.

What central themes have helped shape the 2010 Dietary Guidelines recommendations?

Taken together, the 2010 Dietary Guidelines recommendations encompass two overarching concepts, encouraging Americans to:

  • "maintain calorie balance over time to achieve and sustain a healthy weight," by decreasing calorie consumption and increasing the calories expended through physical activity; and
  •  "focus on consuming nutrient-dense foods and beverages," by reducing intake of sodium and calories from solid fats, added sugars, and refined grains, and increasing consumption of nutrient-dense foods and beverages such as vegetables, fruits, whole grains, fat-free or low-fat milk products, seafood, lean meats and poultry, eggs, beans and peas, and nuts and seeds.

The 2010 Dietary Guidelines take the position that "calorie balance over time is the key to weight management," and that "[t]o curb the obesity epidemic and improve their health, Americans need to make significant efforts to decrease the total number of calories they consume from foods and beverages and increase calorie expenditure through physical activity." In turn, the 2010 Dietary Guidelines set forth the following recommendations regarding calorie consumption, foods and food components to reduce, foods and nutrients to increase, and additional considerations for special populations:

  • Estimated Calorie Needs Per Day by Age, Gender, and Physical Activity Levela

    Gender

    Age (years)

    Physical Activity Levelb

    Sedentary

     

    Moderately Active

     

    Active

     

    Child (f and m)

    2-3

    1,000-1,200c

    1,000-1,400 c

    1,000-1,400 c

    Femaled

    4-8

    1,200 -1,400

    1,400-1,600

    1,400-1,800


    9-13

    1,400 - 1,600

    1,600 - 2,000

    1,800-2,200


    14-18

    1,800

    2000

    2,400


    19-30

    1,800-2,000

    2,000 - 2,200

    2,400


    31-50

    1,800

    2,000

    2,200


    51+

    1,600

    1,800

    2,000-2,200


     

     

     

     

    Male

    4-8

    1,200 -1,400

    1,400 -1,600

    1,600 -2,000


    9-13

    1,600 - 2,000

    1,800 - 2,200

    2,000 - 2,600


    14-18

    2,000 - 2,400

    2,400 - 2,800

    2,800 - 3,200

     

    19-30

    2,400-2,600

    2,600-2,800

    3,000

     

    31-50

    2,200 - 2,400

    2,400 - 2,600

    2,800 - 3,000

     

    51+

    2,000-2,200

    2,200-2,400

    2,400-2,800

    a. Based on Estimated Energy Requirements (EER) equations, using reference heights (average) and reference weights (healthy) for each age/gender group. For children and adolescents, reference height and weight vary. For adults, the reference man is 5 feet 10 inches tall and weighs 154 pounds. The reference woman is 5 feet 4 inches tall and weighs 126 pounds. EER equations are from the Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington (DC): The National Academies Press; 2002.

    b. Sedentary means a lifestyle that includes only the light physical activity associated with typical day-to-day life. Moderately active means a lifestyle that includes physical activity equivalent to walking about 1.5 to 3 miles per day at 3 to 4 miles per hour, in addition to the light physical activity associated with typical day-to-day life. Active means a lifestyle that includes physical activity equivalent to walking more than 3 miles per day at 3 to 4 miles per hour, in addition to the light physical activity associated with typical day-to-day life.

    c. The calorie ranges shown are to accommodate needs of different ages within the group. For children and adolescents, more calories are needed at older ages. For adults, fewer calories are needed at older ages.

    d. Estimates for females do not include women who are pregnant or breastfeeding.

  • Foods and Food Components to Reduce

    Food or Food Component

    2010 Dietary Guidelines Recommendations

    Sodium

    Reduce daily sodium intake to less than 2,300 milligrams (mg) and further reduce intake to 1,500 mg among persons who are 51 and older and those of any age who are African American or have hypertension, diabetes, or chronic kidney disease. 

    Saturated Fat

    Consume less than 10 percent of calories from saturated fatty acids by replacing them with monounsaturated and polyunsaturated fatty acids.

    Cholesterol

    Consume less than 300 mg per day of dietary cholesterol.

    Trans Fat

    Keep trans fatty acid consumption as low as possible, especially by limiting foods that contain synthetic sources of trans fats, such as partially hydrogenated oils, and by limiting other solid fats.

    Solid Fats and Added Sugars

    Reduce the intake of calories for solid fats and added sugars.4 

    Refined Grains

    Limit consumption of foods that contain refined grains, especially refined grain foods that contain solid fats, added sugars, and sodium.

    Alcohol

    If alcohol is consumed, it should be consumed in moderation-up to one drink per day for women and two drinks per day for men-and only by adults of legal drinking age.

  • Foods and Nutrients to Increase

    Foods or Nutrients

    2010 Dietary Guidelines Recommendations

    Fruits and Vegetables

    Increase vegetable and fruit intake and eat a variety of vegetables, especially dark-green and red and orange vegetables and beans and peas.

     

    Whole Grains

    Consume at least half of all grains as whole grains.  Increase wholegrain intake by replacing refined grains with whole grains.  A food is considered to have a "substantial amount" of whole grain if at least 51% of the total weight of the food is whole-grain ingredients, or the food contains at least 8 grams of whole grains per ounce-equivalent.  For most Americans, the recommended amount of whole grains is about 3 ounce-equivalents per day.   To ensure nutrient adequacy, individuals who consume all of their grains as whole grains should include some that have been fortified with folic acid. 

    Milk and Milk-products

    Increase intake of fat-free or low-fat milk and milk products, such as milk, yogurt, cheese, or fortified soy beverages.

     

    Protein

    Choose a variety of protein foods, which include seafood, lean meat and poultry, eggs, beans and peas, soy products, and unsalted nuts and seeds.  Replace protein foods that are higher in solid fats with choices that are lower in solid fats and calories and/or are sources of oils.

    Seafood

    Increase the amount and variety of seafood consumed by choosing seafood in place of some mea and poultry.  An intake of 8 or more ounces per week (less for young children), about 20% of the total recommended intake of protein foods, of a variety of seafood is recommended.

    Oil

    Use oil to replace solid fats where possible.  For example, individuals can use soft margarine instead of stick margarine, replace some meats and poultry with seafood or unsalted nuts, and use vegetable oils instead of solid fats, such as butter, in cooking.

    Potassium

    Choose foods that provide more potassium, dietary fiber, calcium, and vitamin D, which are nutrients of concern in American diets.  These foods include vegetables, fruits, whole grains, and milk and milk products

    Dietary Fiber

    Calcium

    Vitamin D

  • Additional Recommendations for Special Population Groups

    Special Population

    2010 Dietary Guidelines Recommendations

     

    Women capable of becoming pregnant

     

    Choose foods that supply heme iron, which is more readily absorbed by the body, additional iron sources, and enhancers or iron absorption such as vitamin C-rich foods.

    Consume 400 micrograms (mcg) per day of synthetic folic acid (from fortified foods and/or supplements) in addition to food forms of folate from a varied diet.

    Women who are pregnant or breast feeding

     

    Consume 8 to 12 ounces of seafood per week from a variety of seafood types.

    Due to their methyl mercury content, limit white (albacore) tuna to 6 ounces per week and do not eat the following four types of fish:  tilefish, shark, swordfish, and king mackerel.

    If pregnant, take an iron supplement as recommended by an obstetrician or other health care provider.

    Individuals ages 50 years and older

     

    Consume foods fortified with vitamin B12, such as fortified cereals, or dietary supplements.

    Reduce sodium intake to 1,500 mg per day.

    African Americans

    Reduce sodium intake to 1,500 mg per day.

    Persons of any age who have hypertension, diabetes, or chronic kidney disease

    Reduce sodium intake to 1,500 mg per day.

Recommended Eating Behaviors

The 2010 Dietary Guidelines report places much greater emphasis on the role eating behaviors play in promoting healthy dietary intake patterns, and provides concrete recommendations concerning the types of eating behaviors that may help Americans achieve overall dietary intake patterns that conform with the 2010 Dietary Guidelines recommendations. For example, to help increase intake of fruits and vegetables, the new guidelines encourage Americans to fill up "half their plate" with fruits and vegetables. To help limit calorie intake in ways that support the nutrient density of the overall diet, the new guidelines encourage Americans to "drink water and other beverages with few or no calories," rather than "sugar-sweetened beverages" in addition to consuming recommended amounts of low-fat or fat-free milk and 100% fruit juice. The guidelines also recommend replacing solid fats (such as butter or margarine) in the diet with oils and increasing the amount of seafood consumed by choosing seafood in place of some meats and poultry.

Supplementary Materials

USDA and HHS issued several supporting documents accompanying the 2010 Dietary Guidelines including:

Questions and Answers on the 2010 Dietary Guidelines
Backgrounder regarding the History and Process for the Dietary Guidelines , and
Selected Messages from Consumers

More information regarding the 2010 Dietary Guidelines is available here.

Kelley Drye & Warren LLP

Kelley Drye's team of Food and Drug lawyers strives to integrate our clients' business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients' goals without running afoul of regulatory requirements. With close knowledge of FDA's enforcement priorities and deep experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.

For more information about this Client Advisory, please contact:

Sarah Roller
(202) 342-8582
sroller@kelleydrye.com


1 See FDCA section 403(r) [21 U.S.C. 321(r)].
2 P.L. 101.-445, Title III, 7 U.S.C. 530.
3 See Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010 issued June 2010, available at http://www.cnpp.usda.gov/DGAs2010-DGACReport.htm.
4 Most fats with a high percentage of saturated and/or trans fatty acids are solid at room temperature and are referred to as "solid fats." Common solid fats include butter, beef fat (tallow, suet), chicken fat, pork fat (lard), stick margarine, and shortening. "Added sugars" are sugars added to foods during processing, preparation, or at the table. Common added sugars include high fructose corn syrup, white sugar, brown sugar, corn syrup, corn syrup solids, raw sugar, mal syrup, maple syrup, pancake syrup, fructose sweetener, liquid fructose, honey, molasses, anhydrous dextrose, and crystal dextrose. See 2010 Dietary Guidelines at 27.