March 8, 2014
Margaret Hamburg, MD
Commissioner, Food and Drug Administration
5100 Paint Branch Pkwy
College Park, MD 20740
RE: Tentative Determination Regarding Partially Hydrogenated Oils (FDA-2013-N-1317)
Dear Dr. Hamburg:
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments for the Food and Drug Administration's (FDA's) November 8, 2013 comment request related to its tentative determination regarding partially hydrogenated oils (PHOs). The Academy is the world's largest organization of food and nutrition professionals, with more than 75,000 members comprised of registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists. Every day we work with Americans in all walks of life—from prenatal care through end of life care—providing nutrition care services and conducting nutrition research. We are committed to evidence-based strategies for improving the nation's health through food and nutrition.
The Academy supports FDA's tentative determination that PHOs do not meet the legal standard to be generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives."
The impact of trans fat intake is generally undisputed and the Academy agrees with the FDA's determination that "there is no longer a consensus among qualified scientific experts that PHOs, the primary dietary source of industrially-produced trans fatty acids (TFAs), are safe for human consumption, either directly or as ingredients in other food products." As FDA notes, "[u]nder sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive."2
It is the position of the Academy that there is convincing evidence that consumption of commercial partially hydrogenated vegetable oils increases CHD risk factors, as well as metabolic syndrome and diabetes risk.3 Other scientific experts and leading organizations agree that Americans either substantially reduce or eliminate the use of TFAs, demonstrating the growing consensus that precludes a finding of "general recognition."
- The 2005 Daily Reference Intake has not set an Adequate Intake or Recommended Dietary Allowance for TFAs and no upper limit is set, as any TFA intake increases CHD risk; in light of this, the Institute of Medicine recommends intake of TFA should be kept as low as possible.4
- The 2010 Dietary Guidelines for Americans recommend TFA consumption to be as low as possible, especially by limiting foods that contain synthetic sources of TFA, such as partially hydrogenated oils, and by limiting other solid fats.5
- The AHA's Diet and Lifestyle Recommendations advocate that TFA be <1% of calories.6
The Academy is pleased to note that TFA intake is declining; a recent comparison using NHANES data indicated a 58% decrease in serum TFA levels from 2000-2009.7 The FDA's "analysis showed that many food products have been reformulated to eliminate or to substantially reduce the amount of industrially-produced trans fatty acids." The proposed tentative determination will expedite the health benefits from reducing consumption of harmful TFAs and, as FDA notes, will yield significant economic benefits as a result. The Academy encourages FDA to finalize its tentative determination without delay, and appreciate that FDA may set a reasonable compliance date of up to eighteen months to allow manufacturers sufficient time to further reformulate products.
The Academy appreciates the opportunity to comment on this important initiative; please contact either Jeanne Blankenship at 202/775-8277, ext. 6004 or by email at email@example.com or Pepin Tuma 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
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics
1 The 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.
2 Food and Drug Administration. Generally Recognized as Safe (GRAS). Accessed February 23. 2014.
3 Vannice G, Rasmussen H. Position of the academy of nutrition and dietetics: dietary fatty acids for healthy adults. J Acad Nutr Diet. 2014;114(1):136-53.
4 Food and Nutrition Board Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Dietary Fats: Total Fat and Fatty Acids. Washington, DC: National Academies Press; 2005:422-541.
5 US Department of Health and Human Services, US Department of Agriculture. Dietary Guidelines for Americans 2010. Updated 2012. Accessed February 21, 2014.
6 American Heart Association Nutrition Committee, Lichtenstein AH, Appel LJ, et al. Diet and lifestyle recommendations revision 2006: A scientific statement from the American Heart Association nutrition committee. Circulation. 2006;114(1):82-96.
7 Vesper HW, Kuiper HC, Mirel LB, Johnson CL, Pirkle JL. Levels of plasma trans-fatty acids in non-Hispanic white adults in the United States in 2000 and 2009. JAMA. 2012;307(6):562-563.