November 1, 2016
Dr. Robert M. Califf
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20093
Re: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Docket No. FDA-2014-D-0055.
Dear Commissioner Califf:
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Food and Drug Administration's (FDA's) "Draft Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods" ("Draft Guidance"). Representing more than 100,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition across the lifecycle.
Given the preponderance of scientific evidence linking excess sodium intake to hypertension and increased risk of heart attack, stroke, and kidney disease, as well as the fact that the voluntary nature of the targets will more effectively facilitate compliance, the Academy strongly supports this Draft Guidance to set voluntary sodium-reduction targets and upper bound concentrations for commercially processed, packaged, and prepared foods. In addition, we strongly encourage the FDA to finalize it without delay.
The Academy would like to highlight the following major points explained in greater detail below:
- Given successful population-wide sodium-reduction efforts in several other countries and the variation in sodium concentration within similar types of foods, the Academy strongly believes the sodium-reduction targets are feasible and highly reasonable.
- The Academy recommends that the modest two-year sodium-reduction targets be finalized by the end of 2016 in order to meet the urgent need to continue to reduce excessive sodium in foods and ameliorate the attendant harm.
- The upper bounds for categories should be maintained because they are the one element of the FDA proposal that provides specific guidance on individual products and because they ensure that foods do not contain unsafe levels of sodium. The maximums also enable consumers and health officials to identify foods with excessive sodium and to determine whether companies are complying with this element of the program.
- Many restaurant meals contain one or even several days' worth of sodium, though the amount of sodium per 100 grams might meet FDA's targets. Therefore, the FDA should set maximum sodium levels for these three major food categories (Sandwiches, Mixed Ingredient Dishes, and Other Combination Foods) for a whole serving as well as inclusion of sodium values per 100 gram servings. The FDA should also urge restaurants to publish the weight (in grams) of their dishes in materials available to consumers upon request.
- The Secretary of Health and Human Services should seek funding for a national, comprehensive public education campaign that includes all stakeholders and especially focuses on the communities most at risk from consuming excessive sodium.
- The Secretary of Health and Human Services should establish comprehensive sodium monitoring activities in communities at high risk for hypertension, heart disease, stroke, and kidney disease, including biennial nationally representative 24-hour urinary sodium tests. Moreover, these activities should enable sufficient monitoring and assessment of at-risk communities and populations. These activities are necessary to maximize the potential public health benefits that could be achieved by significantly reducing sodium intake — as many as 44,000 to 92,000 deaths from heart attacks and strokes could be prevented each year and potential health-care-cost savings range from $10 billion to $24 billion annually.2
The Academy respectfully submits the following comments to address specific questions in FDA's June 2, 2016, Federal Register notice.
I. Sodium Intake and Health Consequences
The 2015–2020 Dietary Guidelines for Americans recommends that healthy adults limit sodium consumption to no more than 2,300 milligrams (mg) per day. In FDA's update to the Nutrition Facts Label, the Daily Value for sodium was reduced to 2,300 mg per day. The Dietary Guidelines also notes that those with high risk—including those with hypertension and pre-hypertension — may wish to limit their sodium consumption to 1,500 mg per day for greater blood pressure reduction.3 The Academy, however, notes a distinct and growing lack of scientific consensus on making a single sodium consumption recommendation for all Americans, owing to a growing body of research suggesting that the low sodium intake levels recommended by the DGAC are actually associated with increased mortality for healthy individuals.4,5 Despite those and previous similar recommendations, the 2011–2012 National Health and Nutrition Examination Survey (NHANES) showed that the average American consumes more than 3,400 mg of sodium per day (and even more considering underreporting).6 Furthermore, a recent pilot study by the Centers for Disease Control and Prevention to assess the feasibility of NHANES' collection of 24-hour urine samples found average estimates of sodium intakes of 3,657 mg (first day of urine collection) and 3,773 mg (second day of collection) per day.7 The goal of 3,000 mg per day with the 2-year targets is most reasonable. In addition, the proposal to set voluntary targets to reduce sodium intake by the 10-year targets to 2,300 mg per day is warranted and necessary for packaged and restaurant foods, which both contribute to current high levels of sodium consumption.
A quarter-century-old report found that almost 80 percent of the sodium in the average American’s diet comes from processed and restaurant foods, meaning that sodium intake is largely out of the consumer's control. Excess sodium consumption boosts blood pressure. High blood pressure, or hypertension, is a leading cause of cardiovascular disease, accounting for two-thirds of all strokes and half of all cases of heart disease.9 Fortunately, cutting sodium intake helps lower blood pressure, and blood pressure responds with greater decreases at increasingly lower levels of dietary sodium intake.10 While the effects of high sodium intake on blood pressure are well-documented, the effects of such intake may be immediate and somewhat durable. In a 2012 study conducted in normotensive volunteers, consumption of a single high-sodium meal (2400 mg sodium) adversely increases blood pressure within an hour, and the effect continues for an additional two hours.11 Dickinson et al showed that consumption of a single meal with a sodium content of 1500 mg also adversely impairs flow mediated dilation within 30 minutes vs a low sodium meal (115 mg) in healthy normotensive subjects.12 The effect endures for at least two hours. Consumption of a high-sodium diet (3450 mg/day) over time also reduces artery expansion in response to increased blood flow as compared to a low sodium diet (1150 mg/day) in normotensive overweight and obese subjects. Therefore, the authors conclude, "These findings suggest additional cardio protective effects of salt reduction beyond blood pressure reduction."13
Researchers estimate that reducing current sodium intakes by 1,200 mg a day (which would bring most people close to the 2,300 mg per day goal of FDA’s long-term targets) would prevent 60,000 to 120,000 cases of coronary heart disease, 32,000 to 60,000 cases of stroke, and save 44,000 to 92,000 lives per year.14 Reducing sodium intake to 2,300 mg per day would save an estimated $10 billion to $24 billion in health-care costs annually.15
II. Representativeness of Sodium Concentration in the Food Supply
While FDA did not include no-, low-, or reduced-sodium products in its baseline calculations, the Academy supports the agency including them in future assessments of the marketplace in order to better represent the sodium concentration in the food supply.
Approximately 50 percent of chain restaurants were excluded from FDA's baseline and target calculations due to missing serving-size weights. Those omissions are critical, especially because restaurant foods largely make up the top three contributors (Sandwiches, Mixed Ingredient Dishes, and Other Combination Foods) to sodium intake. Therefore, the Academy strongly recommends that FDA urge restaurants to provide gram weights in their nutrition data, and that FDA establish maximum sodium levels per serving of restaurant foods to encourage restaurants to reduce sodium levels or serving sizes of large portions that are high in sodium.
A. The Academy proposes maximum sodium levels per serving of food for Sandwiches, Mixed Ingredient Dishes, and Other Combination Foods.
To encourage sodium reductions in restaurant foods, the Academy recommends that FDA set long-term maximum sodium levels per serving for foods that fall under Sandwiches (Food Category ID: 118–127), Mixed Ingredient Dishes (ID: 128–137), and Other Combination Foods (ID: 143–147). Setting a maximum sodium level per serving of menu items addresses two major issues. First, it would extend the sodium-reduction efforts to all restaurant foods in these categories, regardless of whether the restaurants have gram-weights available. Secondly, this recommendation would address the large portion sizes of restaurant foods, which, unlike multi-serving packaged foods, are often consumed in one sitting. A large sandwich, burger, individual pizza, burrito, or serving of fried rice, pad Thai, spaghetti & meatballs, enchiladas, and many other mixed dishes may contain an unhealthy level of sodium even if the sodium content per 100 grams of food is within the proposed targets.
The Academy encourages the FDA to evaluate the distribution of sodium per serving in each of the three categories using the restaurant data used to calculate the mean targets and upper bounds. The distributions should help inform the maximum sodium targets, just as similar distributions did for the sales-weighted-mean targets.16
As documented in FDA's June 21, 2016 webinar, Sandwiches, Mixed Ingredient Dishes, and Other Combination Foods contribute a total of 45 percent of U.S. sodium intake (Figure 1).17 The three categories are subdivided into 27 subcategories and include primarily restaurant foods, indicated by the proportion of packaged foods (683 items) and restaurant foods (3,314 items) used in the baseline calculations. Those three categories are the greatest contributors of sodium, and limiting their sodium levels would yield the greatest public health impact. For Americans to reduce their sodium intake to between 1500 mg and 2300 mg per day, there needs to be a substantial shift in current eating patterns. One way is to encourage Americans to consume fewer processed foods. While sodium chloride alone accounts for roughly 90% of the dietary sodium, roughly 75% of which is added to foods during processing.
Figure 1. Contribution to U.S. Sodium Intake by Foods Targeted in FDA's Sodium Guidance
Setting a maximum sodium level per serving might also discourage the growing portion sizes—and sodium content—of restaurant foods and meals.18 Portion sizes have grown since the 1970s, and some table-service and fast food restaurant menu items are now two to five times larger than similar foods were two decades ago.19> The average entrée in non-chain restaurants has roughly 1,300 calories.20> FDA's current targets might lead to sodium concentrations that met the targets per 100g of food, but failed to meet the public health goals of reducing sodium intake.
Setting a maximum sodium level per serving could also increase the ability of industry to comply with the targets by effectively including all restaurant meals regardless of whether the restaurants supply gram weights. The hypothetical model, described by FDA in Section 5.5 Estimated Impact of the Supplementary Memo, in which all members of the food industry choose to adopt the sodium-reduction targets, could not be achieved if 50 percent of chain restaurants did not have the necessary data.
B. Additional Food Categories Considerations
The Academy suggests several recommendations for clarifying items in the food categories:
- Soy Sauce: Noting that many examples are provided for other food categories, we suggest noting that "soy sauce" includes tamari sauce, which is a form of soy sauce, but is perceived by many consumers to be different. Clarifying would help.
- RTE (Ready to eat) cereal: Current categories are flakes and puffed, but certain other ready to eat cereals may need to be included (e.g., granola, nuggets such as Grape Nuts) and consideration given as to whether it makes sense for ready to eat cereals with heavy added ingredients like nuts or dried fruit to be identified separately since mg sodium per 100 gm would be affected for a given cereal volume.
- Salads (items 138 and 139) note "not taco salads," but it is unclear where taco salads do fit. The Academy presumes they fit under grain/vegetable salads (#142) but to clarify, this should be listed as "including taco salads."
- Poultry: Since this effort is on "commercially processed, packaged and prepared foods," it is unclear why fresh and plain frozen poultry is actually here, as it is normally regulated by USDA and not FDA. However, we note this can be an important hidden source of sodium necessitating the addressing of sodium content in unbreaded poultry (both bone-in and boneless) that has been injected with saline or sodium-rich broth. We question whether creating a baseline of average sodium content that is based on both uninjected and injected poultry is practicable, so perhaps these should be separated to make it possible to set goals for gradual reduction of sodium in injected poultry or changes in this practice.
III. Feasibility of Reduction Targets
The Academy strongly supports the proposed short-term sodium-reduction targets. We recognize the various factors that impact the feasibility of each reduction target, including taste preference, technological requirements, reformulation, and food safety. In general, the targets appear to represent reasonable reduction efforts from the packaged food and restaurant industries. However, the Academy also encourages the industry to provide FDA with category-specific data and additional detailed evidence regarding purported barriers to sodium reduction so that the Agency could revise particular targets as necessary.
IV. Monitoring Sodium Intake
The Academy recognizes the FDA's commitment to monitoring the impact of the voluntary guidance by collaborating with other agencies to measure changes in sodium consumption. FDA should ensure that NHANES continues to collect nationally representative 24-hour urine samples and begin undertaking other measures to track sodium consumption as possible. Without such data, FDA and the public would not know the extent to which consumers are reducing sodium intake. The FDA also should periodically assess the distribution of sodium levels in various categories of food to know where progress has been adequate and where companies need help in lowering sodium or where the targets, especially the longer-term targets, warranted adjustment.
V. Education Campaign
To effectuate the FDA's voluntary approach to reducing sodium, as well as the 2010 recommendation by the Institute of Medicine for a national public education campaign21 and given the successful educational effort in the U.K.,22 the Secretary of Health and Human Services should ensure sufficient funding for a comprehensive, long-term, national public-education campaign that involves all stakeholders and especially focuses on the communities and cohorts most at risk from excessive sodium in the food supply.
A recent consumer survey indicates that 59 percent of Americans are "not concerned" about their sodium intake.23 And despite significant publicity that processed and restaurant foods are by far the greatest sources of dietary sodium, 46 percent of adults believe that table salt is the main source of sodium in American diets.24 The fact that labeling a product as "reduced sodium" sometimes turns off consumers and reduces product sales signals a critical gap in public awareness of and concern over health risks.
A sodium-reduction education campaign should encourage consumers to read labels and menus and choose lower-sodium products. It would thus encourage consumers to help themselves, and by doing so also indirectly encourage companies to lower sodium levels. An effective campaign should also encourage consumers to eat fewer high-sodium foods and to prepare more meals from scratch.
The FDA also should launch a sodium-reduction campaign that publicly encourages companies to lower sodium levels. After all, the voluntary nature of the FDA's sodium-reduction targets might make it unrealistic to reach the "hypothetical scenario" in which all manufacturers and restaurants voluntarily adopted the targets (see Section 5.5 Estimated Impact). The FDA should applaud the numerous companies making major sodium reductions (or who meet the targets without needing to reduce sodium), and it should highlight those companies that do not make significant reductions. FDA should also make special efforts to reach smaller manufacturers and restaurant to encourage and enable them to meet the standards.
The three-stage approach to educating consumers implemented by the U.K. through Consensus Action on Salt and Health, a non-governmental organization, and the Food Standards Agency, the equivalent of the FDA, provides a framework for success.25 The public awareness campaign included three stages: 1) educate consumers about health consequences associated with excess sodium intake; 2) inform adults of the daily recommended sodium intake; and 3) encourage consumers to check package labels to compare sodium levels in different brands when they are shopping.26 Surveying consumer knowledge after the U.K. campaign demonstrated that the number of individuals cutting down on sodium increased by 26 percent, the number of adults checking labels increased by 72 percent, and the number of people aware of the daily recommended limit increased ten-fold.27 The U.K. campaign, largely cited as a principal contributor to the sodium reductions that country has achieved, demonstrated the importance of engaging consumers. We note that the consumer education campaign was just one component of the Food Standards Agency's sodium-reduction initiative, which also included the development of voluntary sodium targets to encourage reformulation, as the FDA is currently doing, and strongly and sometimes publicly encouraging companies to meet those targets.
The Academy strongly supports the FDA's proposal to set voluntary sodium-reduction targets for commercially processed, packaged, and prepared foods. We urge the agency to finalize the proposed targets, especially the 2-year targets, as quickly as possible so that companies know what is expected of them and can calibrate their sodium-reduction efforts appropriately so that the public can benefit from less sodium in their foods at the earliest reasonable date.
Given that restaurant targets are based on information from only about half of all chain restaurants, we recommend that the FDA urge restaurants to provide the weights of all their offerings. Whether or not those restaurants comply, it is indisputable that many restaurant meals are enormous, with some providing one or more days' worth of sodium, even though their sodium content per 100 grams may not be excessive. Therefore, we urge the FDA to set maximum sodium levels per serving, not just per 100 grams, for three key categories (Sandwiches, Mixed Ingredient Dishes, and Other Combination Foods).
The Academy sincerely appreciates the opportunity to offer comments regarding the draft guidance for voluntary sodium reduction goals. The Academy strongly supports the FDA targets. Enhancing the framework with these recommendations, coupled with efficient monitoring and effective education campaign, would enable Americans to eat a healthier, lower-sodium diet. Please contact either Jeanne Blankenship by telephone at 312-899-1730 or by email at email@example.com or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2Bibbins-Domingo K, Chertow GM, Coxson PG, et al. (2010). Projected Effect of Dietary Salt Reductions on Future Cardiovascular Disease. The New England Journal of Medicine, 362(7): 590-599.
3U.S. Department of Health and Human Services and U.S. Department of Agriculture. (2015). 2015 – 2020 Dietary Guidelines for Americans. 8th Edition.
4Graudal N, Jürgens G, Baslund B, Alderman M. Compared with usual sodium intake, low- and excessive-sodium diets are associated with increased mortality: a meta-analysis. American Journal Of Hypertension [serial online]. September 2014;27(9):1129-1137. Available from: MEDLINE Complete, Ipswich, MA. Accessed October 4, 2016.
5O'Donnell M, Mente A, Yusuf S, et al. Urinary sodium and potassium excretion, mortality, and cardiovascular events. New England Journal Of Medicine [serial online]. August 14, 2014;371(7):612-623. Available from: CINAHL Complete, Ipswich, MA. Accessed May 4, 2015.
6NHANES. (2011–2012). What We Eat in America. USDA ARS.
7Terry AL, Cogswell ME, Wang C, et al. (2016). Feasibility of collecting 24-hour urine to monitor sodium intake in the National Health and Nutrition Examination Survey. American Journal of Clinical Nutrition, ajcn121954.
8Mattes RD, Donnelly D. (1991). Relative contributions of dietary sodium sources. Journal of the American College of Nutrition, 10(4), 383-393.
9He FJ, MacGregor GA. (2009). A comprehensive review on salt and health and current experience of worldwide salt reduction programmes. Journal of Human Hypertension, 23(6), 363-384.
10Sacks FM, Svetkey LP, Vollmer WM, et al. (2001). Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. New England journal of medicine, 344(1), 3-10.
11Suckling RJ, He FJ, Markandu ND, MacGregor GA. Dietary salt influences postprandial plasma sodium concentration and systolic blood pressure. Kidney Int. 2012 Feb;81(4):407-11.
12Dickinson KM, Clifton PM, Burrell LM, Barrett PH, Keogh JB. Postprandial effects of a high salt meal on serum sodium, arterial stiffness, markers of nitric oxide production and markers of endothelial function. Atherosclerosis. 2014 Jan;232(1):211-6.
13Dickinson KM, Keogh JB, Clifton PM. Effects of a low-salt diet on flow-mediated dilatation in humans. Am J Clin Nutr. 2009 Feb;89(2):485-90.
14Bibbins-Domingo, Chertow, Coxson, op cit.
15Bibbins-Domingo, Chertow, Coxson, op cit.
16Food and Drug Administration. (2016). Sodium in the U.S. Food Supply for Products in 2010. Docket number: FDA-2014-D-0055-0351.
17Food and Drug Administration. (2016). Sodium Reduction: FDA's Voluntary Initiative. Docket number: FDA-2014-D-0055-0001.
18Young, LR, Nestle M. (2002). The contribution of expanding portion sizes to the US obesity epidemic. American journal of public health, 92(2), 246-249.
20Urban LE, Lichtenstein AH, Gary CE, et al. (2013). The energy content of restaurant foods without stated calorie information. JAMA Intern Med. 173(14):1292-9. doi: 10.1001/jamainternmed.2013.6163.
21Taylor CL, Henry JE. (Eds.). (2010). Strategies to reduce sodium intake in the United States. National Academies Press.
22Food Standards Agency. (2011). U.K. salt reduction initiatives. Accessed July 8, 2016.
23International Food Information Council. (2011). Assessing The Sodium Situation: The Consumer's Perspective. Accessed August 5, 2016.
24American Heart Association. (2011). Most Americans don't understand the health effects of wine and sea salt, survey finds. Accessed July 8, 2016.
25Op Cit.Food Standards Agency.