Analyzing the Guidelines

February 1/Washington -- The Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) released the 2010 Dietary Guidelines for Americans. The Dietary Guidelines will have important implications for federal policymakers, nutrition professionals, and the food industry over the next five years, as federal dietary guidance for the public is required to be consistent with the Dietary Guidelines. The overarching theme of the 2010 Guidelines is the need to reduce the risk of chronic diseases and reduce the prevalence of overweight and obesity through improved nutrition and physical activity. The new Dietary Guidelines encourage Americans to eat more vegetables, fruits, whole grains, fat-free and low-fat dairy products, and seafood, and to consume less sodium, saturated and trans fats, added sugars, and refined grains. This memorandum provides an overview of the Guidelines.

Background
Federal law requires the Secretaries of HHS and USDA to review, update if necessary, and publish the Dietary Guidelines for Americans at least every five years. The 2010 Guidelines are based on the Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010 and consideration of federal agency and public comments. The Advisory Committee’s report was developed over the course of twenty months, during which the Committee held six public meetings. The Committee conducted a thorough review of the scientific literature in making its recommendations.

The Dietary Guidelines are used by federal agencies to make policy changes to dietary recommendations and nutrition advice, however they do not have any enforcement effect. In the coming months, USDA and HHS will revise their nutrition policies and recommendations, such as the Food Pyramid, based on the Guidelines. Additionally, the Dietary Guidelines report states, ”the Dietary Guidelines for Americans has the potential to offer authoritative statements as provided for in the Food and Drug Administration Modernization Act (FDAMA).” Companies should review the report carefully for potential FDAMA claims. In this summary we identify statements in the report that characterize the relationship between certain foods and substances in foods and a reduced risk of chronic disease. These and other statements could serve as future FDAMA claims to the extent the other criteria for FDAMA claims are satisfied.

Key Recommendations and Themes
The Dietary Guidelines include 23 key recommendations for all Americans and six recommendations for specific population groups. The need to confront obesity is an overarching concern throughout the Guidelines. Traditionally, the Dietary Guidelines are intended for healthy Americans ages 2 years and older. However, in light of the issues presented by obesity, the 2010 edition is intended for all Americans ages 2 years and older, including those at increased risk of chronic disease.

The key recommendations in the Dietary Guidelines, which build on this goal of combating obesity, are as follows:

• Balance Calories to Manage Weight. To prevent or reduce the prevalence of overweight and obesity, the Guidelines advise improved eating and physical activity behaviors. This includes the concepts of controlling total calorie intake to manage body weight, increasing physical activity, and avoiding inactivity. The Guidelines emphasize the importance of total calorie intake while identifying certain food categories that are over- and under-consumed.

The Guidelines offer the following guidance for helping consumers balance calorie intake and manage body weight:

o Increase intake of whole grains, vegetables, and fruit;

o Reduce intake of sugar-sweetened beverages;

o Monitor intake of 100% fruit juice for children and adolescents, especially those who are overweight (while recognizing that 100% juice consumption is not associated with higher body weight for most children, the Guidelines state there is limited evidence that such an association may exist for overweight or obese children and adolescents); and

o Monitor calorie intake from alcoholic beverages.

The Guidelines note there is strong evidence in adults and moderate evidence in children and adolescents demonstrating consumption of milk and milk products does not play a special role in weight management.

• Foods and Food Components to Reduce. The Guidelines advise that Americans reduce their consumption of several nutrients and foods because of their potential to increase the risk of certain chronic diseases. Specific recommendations are as follows:

o Sodium—Daily sodium intake should be reduced to less than 2,300mg, which is a 100mg per day reduction from the current daily value of 2,400mg. Notably, this recommendation is more flexible than the 1,500mg daily limit for all Americans recommended by the Advisory Committee. The Guidelines advise that sodium intake should be reduced to 1,500mg among persons who are 51 and older, African American, or have hypertension, diabetes, or chronic kidney disease. The 1,500mg recommendation applies to about half of the U.S. population, including children, and the majority of adults.

o Saturated Fats—Less than 10% of calories should be consumed from saturated fatty acids. Saturated fats should be replaced with monounsaturated and polyunsaturated fatty acids. The Guidelines recognize the type of fatty acids is more important in influencing the risk of cardiovascular disease than is the total amount of fat in the diet.

o Dietary Cholesterol—Daily intake of dietary cholesterol should be limited to 300mg or less. Consuming less than 200mg of cholesterol per day can further help individuals at high risk of cardiovascular disease.

o Trans Fats—Consumption of trans fats should be kept as low as possible by limiting foods that contain synthetic sources of trans fats, such as partially hydrogenated oils, and by limiting other solid fats.

o Solid Fats—The Guidelines report that solid fats represent about 19% of the calories in the typical American diet and recommend reducing the intake of calories from solid fats.

o Added Sugars—The intake of calories from added sugars should be reduced. The Guidelines recognize that the body’s response to sugars does not depend on whether the sugars are added or found naturally in foods. The Guidelines are critical of foods that contain added sugars, however, claiming these foods often supply calories with few or no essential nutrients and no dietary fiber. Added sugars contribute about 16% of total calorie intake and the major sources are identified as soda, energy drinks, sports drinks, grain-based desserts, sugarsweetened fruit drinks, dairy-baked desserts, and candy. Consumption of added sugars can be reduced by selecting versions of foods that have no or are low in added sugars (e.g., sweetened beverages can be replaced with water and unsweetened beverages).

o Refined Grains—Consumption of foods that contain refined grains, especially refined grain foods that contain solid fats, added sugars, and sodium, should be limited.

o Alcohol—Consumption of alcohol should be in moderation, which is up to one drink per day for women and two drinks per day for men.

• Foods and Nutrients to Increase. The Guidelines include several recommendations to assist the public in adopting a healthy eating pattern while staying within their calorie needs. Specifically, the Guidelines recommend that Americans:

o Increase fruit and vegetable intake. While recognizing that 100% juice can be part of a healthful diet, the Guidelines state 100% juice ”lacks dietary fiber and when consumed in excess can contribute extra calories.” The majority of the fruit recommendation should come from whole fruits, including fresh, canned, frozen, and dried forms rather than juice. To limit intake of added sugars, fruit canned in 100% juice is recommended over fruit canned in syrup.

o Eat a variety of vegetables, especially dark-green, red, and orange vegetables, beans, and peas.

o Consume at least half of all grains as whole grains. The Guidelines state “moderate evidence indicates that whole-grain intake may reduce the risk of cardiovascular disease and is associated with a lower body weight” while “limited evidence also shows that consuming whole grains is associated with a reduced incidence of type 2 diabetes.” Individuals that consume all of their grains as whole grains are encouraged to include whole grains that are fortified with folic acid such as whole grain cereals.

o Increase intake of fat-free and low-fat milk and milk products, such as milk, yogurt, cheese, or fortified soy beverages (e.g., soymilk). With regard to the health benefits of consuming milk and milk products, the Guidelines characterize the evidence as “moderate” regarding (1) the link to improved bone health, especially in children and adolescents and (2) the association with a reduced risk of cardiovascular disease and type 2 diabetes.

o Choose a variety of protein foods, such as seafood, lean meat and poultry, eggs, beans and peas, soy products, and unsalted nuts and seeds. Regarding consumption of peanuts and tree nuts, the Guidelines state “Moderate evidence indicates that eating peanuts and certain tree nuts (i.e., walnuts, almonds, and pistachios) reduces risk factors for cardiovascular disease when consumed as part of a diet that is nutritionally adequate and within calorie needs.” Given the calorie content of nuts and seeds, they should be eaten “in small portions and used to replace other protein foods.” Unsalted nuts and seeds are recommended to reduce sodium intake.

o Increase the amount and variety of seafood consumed by choosing seafood in place of some meat and poultry. Eight or more ounces per week or about 20% of total recommended intake of protein foods should be seafood. According to the Guidelines, “Moderate evidence shows that consumption of 8 ounces per week of a variety of seafood, which provides an average consumption of 250mg per day of EPA and DHA, is associated with reduced cardiac deaths among individuals with and without pre-existing cardiovascular disease.” The health benefits associated with consuming a variety of seafood “outweigh the health risks associated with methylmercury, a heavy metal found in seafood in varying levels.” The Guidelines also comment on the benefits of including seafood in the diets of women who are pregnant or lactating stating “moderate evidence” indicates that intake of omega-3 fatty acids, in particular DHA, from at least 8 ounces of seafood per week is associated with improved infant health outcomes, such as visual and cognitive development. Pregnant and lactating women are encouraged to select seafood lower in methyl mercury and to avoid tilefish, shark, swordfish, and king mackerel.

o 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.

o Use oils to replace solid fats where possible.

• Nutrients of Concern: The Guidelines identify the nutrients, discussed below, that are lowenough in the American diet to be of public health concern.

o Potassium—Increased intake of potassium from food sources is warranted. Dietary potassium can lower blood pressure by “blunting the adverse effect of sodium on blood pressure.”

o Dietary Fiber—Children and adults should consume foods naturally high in dietary fiber in order to increase nutrient density, promote healthy lipid profiles and glucose intolerance, and ensure normal gastrointestinal function. Beans, peas, bran, vegetables, fruits, whole grains, and nuts are identified as excellent sources of fiber. “Dietary fiber that occurs naturally in foods may help reduce the risk of cardiovascular disease, obesity, and type 2 diabetes.”

o Calcium—Milk and milk products contribute substantially to calcium intake. The calcium recommendations can be achieved by consuming recommended levels of fat free or low fat milk and milk products.

o Vitamin D—Although vitamin D intake is below recommended levels, the report notesnew data that indicate that more than 80% of Americans have adequate vitamin D blood levels. Most vitamin D is obtained from fortified foods, although it is also available in the form of dietary supplements and the presence of sunlight on the skin enables the body to make vitamin D.

The Guidelines also note nutrients of concern for specific population groups.

• Iron—Substantial numbers of women who are pregnant or capable of becoming pregnant are deficient in iron. They can improve their iron status by choosing foods that supply heme iron (e.g., lean meat, poultry, seafood), which is more readily absorbed by the body, as well as enhancers of iron absorption such as vitamin Crich foods. Iron supplements are recommended for women who are pregnant.

• Folate—Folic acid fortification is credited with reducing the incidence of neural tube defects. However, many women still do not meet the recommended intake. Folate can be obtained from beans and peas, oranges and orange juice, dark-green leafy vegetables and fortification of other foods, such as fortified grain products. Synthetic folic acid from fortified foods and supplements is recommended for women who are pregnant.

• Vitamin B12—Americans ages 50 and older may have reduced ability to absorb naturally occurring vitamin B12 and are encouraged to consume foods fortified with the vitamin, such as fortified cereals, or take dietary supplements.

Although a fundamental premise of the Dietary Guidelines is that nutrients should come primarily from foods, the Guidelines specifically recommend consumption of dietary supplements or fortified foods to increase intake of certain vitamins and minerals. For example, the Guidelines encourage fortification with vitamin D (which is often added to fluid milk, orange juice, soymilk and yogurt), folic acid (enriched grains), vitamin B12 (cereals), and iron (for pregnant women). The Guidelines note that “[s]ufficient evidence is not available to support a recommendation for or against the use of multivitamin/mineral supplements in the primary prevention of chronic disease for the healthy American population.” However, “[s]upplements containing combinations of certain nutrients may be beneficial in reducing the risks of some chronic diseases when used by special populations,” such as calcium and vitamin D supplements for postmenopausal women. Additionally, “high levels of certain nutrient supplements may be harmful, if a nutrient’s Tolerable Upper Intake Level is exceeded.”

• Building Healthy Eating Patterns. The Guidelines contain several principles to adopt to achieve a healthy eating pattern, such consuming nutrient-dense foods. Americans are also advised to “remember that beverages count,” and often add calories to the diet without providing essential nutrients. To limit excess calories and maintain healthy weight, individuals are encouraged to drink water and other beverages with few or no calories, in addition to recommended amounts of low-fat or fat-free milk and 100% fruit juices.

Additionally, to build healthy eating patterns the Guidelines advise Americans to apply basic food safety principles in order to prevent the risk of foodborne illness.

The Dietary Guidelines also include a chapter entitled “Helping Americans Make Healthy Choices,” which encourages all sectors of society to engage in a coordinated system-wide approach to reduce the rates of overweight and obesity. The chapter suggests a framework for action by individuals, families, educators, communities and organizations, health professionals, businesses and policymakers.

Steven Steinborn, Hogan & Hartson LLP, represents food and dietary supplement companies on a range of product development, marketing and regulatory compliance and enforcement issues involving the FDA, the USDA, the FTC and the Consumer Product Safety Commission; SBSteinborn@HHLAW.com.

From the February 7, 2011, Prepared Foods E-dition