March 6, 2017
Stephen Ostroff, M.D.
Acting Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease (Docket No. FDA-2013-P-0047)
Dear Dr. Ostroff,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the U.S. Food and Drug Administration (FDA) related to its interim final rule, "Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease (Docket No. FDA-2013-P-0047)," published in the Federal Register on December 19, 2016. Representing over 100,000 registered dietitian nutritionists (RDNs),a nutrition 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 and to providing medical nutrition therapy (MNT) and innovative research to meet the health needs of all citizens.
A. Support for Interim Final Rule
The Academy of Nutrition and Dietetics supports the FDA's interim final rule exempting raw fruits and vegetables from the "low fat" and minimum nutrient content requirements to the dietary saturated fat and cholesterol and risk of coronary heart disease(CHD) health claim. The analysis contained therein is thorough and compelling, and the rationale for the proposed modifications is sound. We agree with the FDA that "the value of these health claims will not be trivialized or compromised by their use on fruits and vegetables because current dietary guidelines emphasize that increased intake of fruits and vegetables is an integral part of creating healthful diets and reducing the risk of chronic disease." Initiating the modifications as proposed has the potential to encourage increased fruit and vegetable consumption and benefit public health; we eagerly anticipate the expeditious use of associated health claims.
B. Total Fat Intake and the Dietary Guidelines for Americans
In addition to supporting the specific modifications in the interim final rule, the Academy encourages the FDA to consider whether the entirety of the low fat requirement and the disqualifying nutrient level for total fat is no longer consistent with the best available current evidence or the recommendations in the most recent Dietary Guidelines for Americans(DGA). Compared to current recommendations, the limitations on total fat content conflict with the FDA's obligation to "establish a list of levels of nutrients in food that, taking into account the makeup of the total daily diet, increase to persons in the general population the risk of diet-related diseases or health-related conditions."1 In short, rather than merely focusing on a food product's total fat content or products with "low-fat" claims, it remains important that Americans are encouraged to reduce saturated fat and replace it with polyunsaturated or monounsaturated fat.
Given the FDA's statement in the interim final rule that "general eligibility requirements that establish which types of foods are able to bear health claims have been typically determined based on the current dietary recommendations and guidelines at the time," we encourage modification of health claims in accord with the most recent federal dietary recommendations. We agree with the FDA's conclusion: "Since we published the final rule for the dietary saturated fat and cholesterol and risk of CHD health claim in 1993, the science related to intake of total fat has evolved, and the current dietary recommendations no longer contain a recommendation encouraging the consumption of diets low in total fat."
In its scientific report, the 2015 Dietary Guidelines Advisory Committee included a "Strong" graded conclusion stating that, "Reducing total fat (replacing total fat with overall carbohydrates) does not lower CHD risk."2 This conclusion was based on a strong body of evidence that replacing saturated fat with carbohydrate intake contributed no benefit whatsoever to cardiovascular disease prevention, and that only the replacement of saturated fat with polyunsaturated fat has been demonstrated to mitigate heart disease risk.3-12 These findings are consistent with the Academy's position that "altering fat consumption, for example, the unsaturated/saturated fat balance, instead of reducing total fat might be more advantageous to health and chronic-disease risk reduction."13 The National Lipid Association made a similar recommendation in 2015:
Dietary saturated fat may be partially replaced with unsaturated fats (mono and polyunsaturated fats) as well as lean sources of protein to reach a goal of <7% of energy from saturated fat. This can be achieved in part by incorporating food high in unsaturated fats such as liquid vegetable oils and vegetable oil spreads, nuts and seeds, as well as lean protein foods such as legumes, seafood, lean meats, and nonfat or low fat dairy products into the diet as replacement for saturated fats.14
These recommendations accord with other consensus clinical guidelines.15-17
Some recent research has also identified a strong inverse relationship between total fat intake and risk for coronary heart disease after robust risk-adjustment.18 Importantly, experimentation with free-living persons instructed to purchase reduced-fat foods has demonstrated that this dietary change leads to replacement of the fat primarily with carbohydrate, as total energy intake and protein intake are only modestly altered.19 Therefore, we are concerned that the current fat restrictions for the dietary saturated fat and cholesterol and risk of CHD health claim may be directing consumers away from foods which are likely to reduce their risk of heart disease.
C. Added Sugars
The 2015 Dietary Guidelines Advisory Committee report also included conclusions that "moderate evidence from prospective cohort studies indicates that higher intake of added sugars, especially in the form of sugar-sweetened beverages, is consistently associated with increased risk of hypertension, stroke, and CHD in adults" and "strong evidence shows that higher consumption of added sugars, especially sugar-sweetened beverages, increases the risk of type 2 diabetes among adults."1 However, 21 CFR § 101.14 and §101.75 provide no restrictions nor disqualifying nutrient levels for sugar or added sugar content. Combined with the limitations on fat content, the current nutrient requirements for the dietary saturated fat and cholesterol and risk of CHD health claim may be directing consumers away from foods which could reduce the risk for heart disease and towards foods which increase the risk for heart disease and other chronic diseases. With the inclusion of added sugars on the Nutrition Facts Panel, FDA should address the impact of added sugars on all relevant health and other labeling claims.
The Academy appreciates the opportunity to comment on the interim final rule, "Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease." Please contact either Jeanne Blankenship at 312/899-1730 or by email at email@example.com or William Murphy at 312/899-1778 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
William Murphy, MS RDN
Academy of Nutrition and Dietetics
aThe Academy 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.
1Food Labeling; General Requirements for Health Claims for Food, 58 Fed. Reg. 2478, 2490 (6 January 1993).
2Office of Disease Prevention and Health Promotion. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines of Americans 2015 to the Secretary of Agriculture and the Secretary of Health and Human Services. Accessed February 24, 2017.
3Hooper L, Summerbell CD, Thompson R, et al. Reduced or modified dietary fat for preventing cardiovascular disease. São Paulo Medical Journal = Revista Paulista De Medicina. 2016;134:182-183.
4Mozaffarian D, Micha R, Wallace S. Effects on coronary heart disease of increasing polyunsaturated fat in place of saturated fat: a systematic review and meta-analysis of randomized controlled trials. Plos Medicine. 2010;7:e1000252-e1000252.
5Farvid MS, Ding M, Pan A, et al. Dietary linoleic acid and risk of coronary heart disease: a systematic review and meta-analysis of prospective cohort studies. Circulation. 2014;130:1568-1578.
6Jakobsen MU, O'Reilly EJ, Heitmann BL, et al. Major types of dietary fat and risk of coronary heart disease: a pooled analysis of 11 cohort studies. The American Journal Of Clinical Nutrition. 2009;89:1425-1432.
7Skeaff CM, Miller J. Dietary fat and coronary heart disease: summary of evidence from prospective cohort and randomised controlled trials. Annals Of Nutrition & Metabolism. 2009;55:173-201.
8Chowdhury R, Warnakula S, Kunutsor S, et al. Association of dietary, circulating, and supplement fatty acids with coronary risk: a systematic review and meta-analysis. Annals Of Internal Medicine. 2014;160:398-406.
9Mente A, de Koning L, Shannon HS, Anand SS. A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Archives Of Internal Medicine. 2009;169:659-669.
10Hooper L, Summerbell CD, Thompson R, et al. Reduced or modified dietary fat for preventing cardiovascular disease. The Cochrane Database Of Systematic Reviews. 2012:CD002137.
11Mensink, R P. Effects of saturated fatty acids on serum lipids and lipoproteins: a systematic review and regression analysis Systematic review. World Health Organization. ISBN 978 92 4 156534 9 (NLM classification: QU 90) WHO Library. Accessed February 22, 2016.
12Li Wang, Peter L. Bordi, Jennifer A. Fleming, Alison M. Hill, Penny M. Kris‐Etherton. Effect of a Moderate Fat Diet With and Without Avocados on Lipoprotein Particle Number, Size and Subclasses in Overweight and Obese Adults: A Randomized, Controlled Trial Journal of the American Heart Association. 2015;4:e001355.
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14Jacobson TA, Maki KC, Orringer CE, et al. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. J ClinLipidol. 2015 Nov-Dec;9(6 Suppl):S1-122.e1. doi: 10.1016/j.jacl.2015.09.002).
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16Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to1727 Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart 1728 Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25):2960-2984. 1729 doi:10.1016/j.jacc.2013.11.003.
17Van Horn L, Carson J, Appel LJ, Burke L, Economos C, Karmally W, Lancaster K, Lichtenstein A, Johnson R, Thomas R, Voss M, Wylie-Rosett J, Kris-Etherton P. Recommended Dietary Pattern to Achieve Adherence to the American Heart Association/American College of Cardiology (AHA/ACC) Guidelines: A Scientific Statement From the American Heart Association. Circulation. 2016;134(22): e505-e529.
18Li Y, Hruby A, Bernstein AM, et al. Saturated Fats Compared With Unsaturated Fats and Sources of Carbohydrates in Relation to Risk of Coronary Heart Disease: A Prospective Cohort Study. Journal Of The American College Of Cardiology. 2015;66:1538-1548.
19Gatenby SJ, Aaron JI, Jack VA, Mela DJ. Extended use of foods modified in fat and sugar content: nutritional implications in a free-living female population. The American Journal Of Clinical Nutrition. 1997;65:1867-1873.