Author + information
- Mona Fiuzat, PharmD∗ (, )
- Susan T. Mayne, PhD,
- Matt Hillebrenner, MSE,
- Norman Stockbridge, MD, PhD,
- Bram Zuckerman, MD and
- Robert M. Califf, MD
- ↵∗Address for correspondence:
Dr. Mona Fiuzat, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
In recent years, there has been increased recognition of the critical need to improve dietary habits of the general U.S. population as the number of adults with obesity has grown in tandem with the burden of diseases influenced by diet. There is a direct relationship among obesity and hypertension, diabetes mellitus, and coronary heart disease—primary contributors to the development of heart failure (HF) (1). The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition is charged with protecting and promoting public health. A key goal of the Center is to reduce risk factors for and ultimately lower the incidence of nutrition-related chronic disease, and together with the broader agency, actively working on the recent initiatives described briefly in this review.
Data regarding the putative benefits of sodium restriction in HF patients have been mixed, and questions remain following a number of small, inconclusive studies. The 2012 European HF guidelines do not provide recommendations for restricting sodium intake, citing insufficient evidence, whereas the 2013 American College of Cardiology Foundation/American Heart Association guideline does endorse sodium restriction, albeit noting limited data of inconsistent quality (2).
Nonetheless, the vast majority of Americans consume too much sodium, and it has been widely accepted that sodium reduction is an important preventive strategy for HF. The average sodium intake in the United States is approximately 3,500 mg/day (3), far exceeding the American Heart Association’s recommendation of <1,500 mg/day to reduce hypertension, the most common comorbidity in HF patients. Current intakes are almost 50% greater than the target intake of 2,300 mg/day for the general population recommended by the Dietary Guidelines for Americans 2015–2020 (4). Research suggests that reducing average sodium consumption by 400 mg/day, or just 12%, could prevent up to 35,000 heart attacks and 23,000 strokes per year (5), directly affecting the development of HF and thus representing an important preventive strategy for this condition.
Approximately 75% of total U.S. sodium intake comes from processed and commercially prepared (e.g., restaurant) foods. The FDA is addressing this public health concern by developing guidelines to reduce sodium in food—the first time a U.S. government agency has done so. In June 2016, the FDA issued draft voluntary short-term (2-year) and long-term (10-year) goals for reducing sodium content resulting from sodium chloride (“salt”) and other sodium-containing ingredients in commercially processed, packaged, and prepared foods (https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm253316.htm). As part of this effort, the FDA has developed quantitative target mean sodium concentrations for various food categories (approximately 150 in all). The FDA estimates that if industry adopts these proposed guidelines, average sodium consumption could be reduced from 3,500 mg/day to approximately 3,000 mg/day in 2 years and to 2,300 mg/day in a decade.
The Institute of Medicine recommends that consumption of trans fat be as low as possible while consuming a nutritionally adequate diet. Since 2006, the FDA has required that manufacturers include trans fat content information on the Nutrition Facts Label (NFL) of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78% and that the labeling rule and industry reformulation of foods were key factors. After extensive review of the scientific evidence, in 2015 the FDA determined that partially hydrogenated oils, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in human food. The food industry has 3 years to remove partially hydrogenated oils from products or petition the FDA to approve uses through a food additive petition process. An estimated 10,000 to 20,000 heart attacks and 3,000 to 7,000 deaths from coronary heart disease could be prevented each year by removing artificial trans fats from processed foods (6).
Nutrition Facts Labeling
The FDA recently updated and modernized nutrition labeling on packaged foods (the NFL) to better reflect current scientific evidence (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryinformation/LabelingNutrition/ucm385663.htm). These revised labels will be appearing in the near future, as many manufacturers must start using use the new labels by July 2018. Some of the key changes that consumers will soon see on food labels are:
The total number of calories will be displayed in larger, bold font, whereas “calories from fat” will be removed, reflecting the large body of evidence that the type of fat is more important than the amount for cardiovascular risk reduction. Measures of “total fat,” “saturated fat,” and “trans fat” will continue to be required for labels. Trans fat will remain on the label to reflect approved food additive uses and naturally occurring trans fat.
Manufacturers will be required to indicate both “per serving” and “per package” (or “per unit”) nutrition information for multiserving food products that could be consumed in a single sitting. Consumers will be able to better understand how many calories and what nutrients they are getting if they consume the entire package/unit at one time.
Labels will now be required to more accurately reflect what a person would typically consume in 1 sitting.
Total sugars and added sugars
The “total carbohydrate” section of the label will include “total sugars” as well as “added sugars.” A percent daily value will also be shown for added sugars. The Dietary Guidelines for Americans advise consumers to limit intake of calories from added sugars to <10%/day.
Updated nutrients/vitamin labeling
Potassium and vitamin D, nutrients that some individuals lack, will now be listed on labels. In addition, daily values for many other nutrients, including sodium and dietary fiber, have been updated.
Although packaged foods have disclosed information about calorie content, Americans have not necessarily had access to calorie information on foods eaten away from home. Given that Americans now typically consume about one-third of their calories from food prepared outside of home settings, the FDA issued a final rule in 2014 requiring calorie information to be listed on menus and menu boards in chain restaurants and similar retail food establishments to help consumers make informed choices (http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm217762.htm). Menu labeling applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations that do business under the same name and offer for sale substantially the same menu items. In addition, the menu labeling final rule requires covered establishments to provide, upon consumer request, written nutrition information about other key nutrients including total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars, and protein for standard menu items. Covered restaurants and similar retail food establishments must also post on menus and menu boards a short statement about daily caloric intake: for example, “2,000 calories a day is used for general nutrition advice, but calorie needs vary.” The FDA will begin enforcing the menu labeling final rule on May 5, 2017.
In conclusion, the FDA has taken several recent nutrition-related actions: issuing draft targets for sodium reduction, working to reduce exposure to trans fat, updating the Nutrition Facts Label for packaged foods, and working to provide consumers with calorie (and selected nutrient) for foods available through restaurants and retail food establishments. Dietary modifications supported by more informative food labeling and promotion of a healthier food supply are key initiatives to help reduce obesity, hypertension, and coronary heart disease—among the most important risk factors for developing HF.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 14, 2016.
- Accepted December 16, 2016.
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