Academy Comments to FDA/CFSAN re Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements

February 5, 2018

Susan Mayne, Ph.D.
Director, Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740

Re: Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements (Docket No. FDA-2017-N-5094)

Dear Dr. Mayne,

The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration (FDA) at the U.S. Department of Health and Human Services (HHS) related to its open docket regarding "Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements (Docket No. FDA-2017-N-5094)," published in the Federal Register originally on December 8, 2017, with an extension published December 6, 2017. Representing over 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 and to providing medical nutrition therapy (MNT) and nutrition research and counseling that enhance America's food safety and promote effective, informative nutrition labeling.

The Academy strongly supports the proposed information collection and offers both general and specific comments below about CFSAN's current and future compliance with the purposes and intent of Executive Orders 13771 and 13777 to "change [CFSAN's] regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations."2

A. Achieving Public Health with Minimal Burdens

The Academy has worked closely with CFSAN as it seeks to most efficiently and effectively "regulate human food (including dietary supplements)," and notes CFSAN's balanced, consensus approach working with stakeholders from industry, public health groups, researchers, and health care providers to produce limited, minimally burdensome regulatory regimes. We also note many other comments responsive to this information collection also remark upon CFSAN’s science-based and risk-based approach to regulations and its commitment to consulting with and truly listening to all involved parties when promulgating, finalizing, and implementing regulatory actions. This approach speaks to the success of your leadership and CFSAN's effectiveness in advancing science to make an important public health impact.

We have seen CFSAN's effective approach to regulatory policy manifested in its ongoing implementation of FSMA, in the reduction of acute foodborne illnesses and their long term health effects, in developing training options for local food production systems and tribal operations, in the process of updating the Nutrition Facts Panel and listed serving sizes to reduce chronic diseases linked to poor food consumption patterns, and in conducting and coordinating research to improve America's health in a rapidly changing food production and consumption. We agree with CFSAN's goal with regards to research "to be disseminating the research findings to make the food supply healthier and safer."3

B. Total Fat content

1. Health Claims and the Dietary Guidelines

The Academy's position paper on functional foods highlighted a critical challenge for efforts to improve purchasing and eating habits: "Eating for health and wellness can be an elusive goal for many consumers, especially given the complex marketplace and the influx of mixed messages from varied information outlets."4 There is enormous potential to cut through the cacophony of confusing, conflicting, and often-false information made about food and nutrition by establishing a scientifically sound health claim that consumers actually understand, trust, and use once educated on its meaning and strategies for using it. A well-designed health claim leverages the awesome power and reach of the federal government and organizes stakeholders with often-conflicting concerns and opinions to support achieving its worthy purpose. The DGA 2015-2020 edition, in its role as "the cornerstone of Federal nutrition policy and nutrition education activities," identified significant problems and concerns with Americans' food and nutrition intake.5 The 2015-2020 DGA made healthy diet patterns its primary focus and the Academy believes it was wise to move beyond a singular focus on particular nutrients. In conjunction with forthcoming revisions to the Nutrition Facts Label, the focus on choosing and maintaining healthy diet patterns provides the predicate for updating definitions of nutrient content claims to reflect the best available scientific evidence.

2. Background and Concern re Outdated Health Claim Regulation

To assist CFSAN in its mission to promote public health through the appropriate labelling of our nation's food supply while implementing executive order 13777, the Academy respectfully suggests amending a regulation that has become sufficiently outdated such that CFSAN may help serve its mission through the modification of this regulation to repeal a specific component.

Since the time when the health claim "Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease" (21 C.F.R. 101.77) was first finalized in 1993, the science of determining healthy eating patterns has advanced and the Dietary Guidelines for Americans have changed to align with the current science. As stated in 21 C.F.R. 101.77(b)(4), the dietary guidelines at the time encouraged "decreased consumption of dietary fat, especially saturated fat and cholesterol, and increased consumption of fiber-rich foods to help lower blood LDL-cholesterol levels."6 In the 2015 Dietary Guidelines7, however, this recommendation was revised to read "A healthy eating pattern limits: saturated fats and trans fats, added sugars, and sodium." Notably, the restriction on total fat intake has since been removed and the list of foods encouraged as part of a healthy eating pattern has also been updated with the addition of oils. As such, 101.77 (c) (2) (ii) (B), which requires that any food bearing the soluble fiber health claim must also meet the requirements for a "low-fat" food has become outdated. CFSAN recognized the need for this update in making an interim final rule revising 101.75 to exempt raw fruits and vegetables from the same "low fat" requirement.8

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,"9 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."10

A consequence of the current regulation is that the approved use of the health claim is likely directing consumers away from some foods for which the Dietary Guidelines identified a need for increased intake. For example, foods made from whole soy beans can contain well over the 0.6g of soluble fiber required for the health claim, and they also would contribute towards intake of both oils and legumes, two categories in which average American intake is well below ideal. However, the fat content of soybeans, i.e. the oil itself, would preclude the use of the health claim as currently regulated.

3. Proposed solution

We propose that CFSAN repeal the regulation that foods must meet the requirements for a "low fat" nutrient content claim to bear the health claim for fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. Specifically, we propose that CFSAN revise 101.77 (c) (2) (ii) (B) to remove "low-fat" from the list of nutrient content requirements.

C. Conclusion

The Academy appreciates the opportunity to comment on the information collection "Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements." The Academy looks forward to continuing to work with CFSAN to advance our shared initiatives to improve the health of Americans through food and nutrition Please contact either Jeanne Blankenship at 312/899-1730 or by email at or Pepin Tuma at 202/775-8277 ext. 6001 or by email at 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.
Senior Director
Government & Regulatory Affairs
Academy of Nutrition and Dietetics

1 The 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.

2 82 FR 42505.

3 "Meet Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition." FDA website. Available at Accessed February 5, 2018.

4 Crowe KM, Francis C. Position of the academy of nutrition and dietetics: functional foods. J Acad Nutr Diet. 2013;113(8):1096-103.

5Dietary Guidelines. Center for Nutrition Policy and Promotion website. Available at Accessed February 3, 2018.

6 21 C.F.R. 101.77(b)(4).

7 U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015–2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at

8 81 F.R. 91716. "Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease." December 19, 2016.

9 Ibid

10 Ibid