81 FR 91716 - Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 243 (December 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 243 (December 19, 2016)
| Page Range | 91716-91722 | |
| FR Document | 2016-29997 |
[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)] [Rules and Regulations] [Pages 91716-91722] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29997] [[Page 91716]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2013-P-0047] RIN 0910-AH43 Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to permit raw fruits and vegetables that fail to comply with the ``low fat'' definition and/or the minimum nutrient content requirement to be eligible to bear the claim. We are taking this action in response to a petition submitted by the American Heart Association (the petitioner). The amendment expands the use of this health claim to certain fruits and vegetables that are currently ineligible for the health claim. DATES: This interim final rule is effective December 19, 2016. Interested persons may submit either electronic or written comments by March 6, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-P-0047 for ``Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1450. SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action This interim final rule amends the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD). The interim final rule permits raw fruits and vegetables that fail to comply with the ``low fat'' definition and/or the minimum nutrient content requirement to be eligible to bear the claim. Health claims, in general, must meet certain nutrient requirements that we establish to ensure that health claims are used on foods with nutritional value. For example, except where provided for in other regulations, foods bearing a health claim must contain one or more of vitamin A, vitamin C, iron, calcium, protein, or fiber at or above 10 percent of the Reference Daily Intake (RDI) or Daily Reference Value (DRV), before any nutrient addition (Sec. 101.14(e)(6) (21 CFR 101.14(e)(6)). Additionally, for foods bearing health claims related to CHD, the food often must be a ``low fat'' food (see e.g., Sec. Sec. 101.75(c)(2)(ii) and 101.81(c)(2)(iii)(D)). An unintended consequence of these general requirements is that some foods that are generally considered to contribute to a healthy diet are ineligible to bear certain health claims. A small number of fruits and vegetables, for example, are ineligible to bear the dietary saturated fat and cholesterol and risk of CHD health claim because they do not meet the requirement to have 10 percent of the RDI or DRV of certain nutrients and/or they do not meet the definition of a ``low fat'' food. However, consumption of fruits and vegetables is encouraged by dietary recommendations, and low saturated fat and low cholesterol fruits and vegetables should not be excluded [[Page 91717]] from bearing this health claim. To address this unintended consequence, this interim final rule includes provisions that exempt raw fruits and vegetables from: (1) Needing to meet the 10 percent nutrient content requirement in Sec. 101.14(e)(6). (2) Needing to meet the definition for a ``low fat'' food in Sec. 101.62. The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-535) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by clarifying, among other things, FDA's authority to regulate health claims on food labels and in food labeling. Using that authority, in 1993 we issued Sec. 101.75, which authorizes a health claim about the relationship between diets low in saturated fat and cholesterol and a reduced risk of CHD (58 FR 2739, January 6, 1993). Section 403(r)(4) of the FD&C Act (21 U.S.C. 343(r)(4)) establishes a mechanism for any person to petition us to issue a regulation relating to a claim that characterizes the level of any nutrient or the relationship of any nutrient to a disease or a health-related condition. We received a petition, under section 403(r)(4) of the FD&C Act, requesting that we amend the dietary saturated fat and cholesterol and risk of CHD health claim to permit raw fruits and vegetables, as well as single-ingredient or mixtures of frozen or canned fruits and vegetables that contain no added fat or sugars, which fail to comply with the ``low fat'' definition and/or the minimum nutrient content requirement, to be eligible to bear the claim. This interim final rule responds to that petition. Summary of the Major Provisions of the Regulatory Action in Question Under the interim final rule, raw fruits and vegetables are exempt from needing to meet the minimum nutrient content requirement of the general principles for health claims and from the requirement specifically included in the dietary saturated fat and cholesterol and risk of CHD health claim that a food meet the definition for ``low fat'' to be eligible to bear the claim. Current FDA regulations, at Sec. 101.75(c)(1), state that all requirements set forth in Sec. 101.14 must be met. The interim final rule revises Sec. 101.75(c)(1) to provide an exemption for raw fruits or vegetables from meeting the minimum nutrient content requirement in Sec. 101.14(e)(6). Current FDA regulations, at Sec. 101.75(c)(2)(ii), establish requirements regarding the nature of the food, except for fish and game meats; the food must meet all nutrient content requirements of Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low fat'' food. We are amending Sec. 101.75(c)(2)(ii) to provide an exemption from meeting the nutrient content requirements of Sec. 101.62 for ``low fat'' if the food is a raw fruit or vegetable. I. Background A. The Nutrition Labeling and Education Act of 1990 The 1990 amendments amended the FD&C Act in a number of important ways. Among other changes, the 1990 amendments clarified our authority to regulate health claims on food labels and in food labeling. Under this authority, we issued several regulations, including Sec. 101.14, Health claims: General requirements (58 FR 2478 at 2533), which sets forth general principles for the authorization and use of health claims, and Sec. 101.70, Petitions for health claims (58 FR 2478 at 2534), which sets forth a process for petitioning us to authorize health claims about substance-disease relationships, and sets out the types of information that any such petition must include. Among other provisions, the general principles for health claims include requirements for determining the eligibility of a food to bear a health claim. Examples include disqualifying nutrient levels (Sec. 101.14(a)(4)), which are specific nutrient thresholds not to be exceeded by a food bearing a health claim as required by Sec. 101.14(e)(3), and also a minimum nutrient content requirement (Sec. 101.14(e)(6)) to ensure that a food bearing a health claim provide meaningful nutritive value as determined by meeting specific nutrient content levels. B. Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease Health Claim When implementing the 1990 amendments, we also conducted a review of evidence for a relationship between dietary saturated fat and cholesterol and risk of CHD. Based on the totality of the publicly available scientific evidence, we concluded that there was significant scientific agreement among qualified experts that diets low in saturated fat and cholesterol may reduce the risk of CHD. Therefore, we authorized a health claim about the relationship between diets low in saturated fat and cholesterol and a reduced risk of CHD (Sec. 101.75; 58 FR 2739 at 2757, January 6, 1993). Among the specific requirements included in Sec. 101.75 are requirements that, in addition to the general requirements set forth in Sec. 101.14, foods must meet all of the nutrient content requirements in Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low fat'' food in order to be eligible to bear the health claim, except that fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may meet the requirements for ``extra lean'' in Sec. 101.62. II. Petition and Grounds We received a petition from the American Heart Association (Docket No. FDA-2013-P-0047) on October 1, 2012, under section of 403(r)(4) of the FD&C Act. The petition requested that we amend the dietary saturated fat and cholesterol and risk of CHD health claim (Sec. 101.75) to permit raw fruits and vegetables, as well as single- ingredient or mixtures of frozen or canned fruits and vegetables that contain no added fat or sugars, which fail to comply with the ``low fat'' definition and/or the minimum nutrient content requirement, to be eligible to bear the claim. In addition, the petition requested that we issue an interim final rule by which fruits and vegetables that fail to comply with the ``low fat'' definition and/or the minimum nutrient content requirement could be eligible to bear the claim before publication of a final rule. Section 403(r)(4) of the FD&C Act establishes a mechanism for any person to petition us to issue a regulation relating to a claim that characterizes the level of any nutrient or the relationship of any nutrient to a disease or a health- related condition. On January 10, 2013, we notified the petitioner that we had completed our initial review of the petition, that the petition had been filed for further action in accordance with section 403(r)(4) of the FD&C Act, and that the filing date was January 9, 2013. Under the FD&C Act, if we do not act, by either denying the petition or issuing a proposed regulation to authorize the health claim, within 90 days of the date of filing for further action, the petition is deemed to be denied unless an extension is mutually agreed upon by us and the petitioner (21 U.S.C. 343(r)(4)(A)(i) andSec. 101.70(j)(3)(iii)). On April 9, 2013, we mutually agreed with the petitioner to extend the deadline to October 7, 2013. Later, through subsequent agreements, we mutually agreed to extend the deadlines several times, with the last deadline being March 17, 2017. The petitioner explained that some of our requirements for the dietary saturated fat and cholesterol and risk of CHD health claim prevent a number of fruits and vegetables from being eligible to bear the claim. The minimum nutrient content requirement for all [[Page 91718]] health claims requires that, to be eligible to bear a health claim, a food contains 10 percent or more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed (RACC) prior to any nutrient addition (see Sec. 101.14(e)(6)). Although most fruits and vegetables meet this minimum requirement for one or more of the described nutrients, a small number of fruits and vegetables do not meet the minimum nutrient content requirement. For example, grapes, plums, beets, and cucumbers do not contain 10 percent of the RDI or DRV of vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC. Additionally, the dietary saturated fat and cholesterol and risk of CHD health claim requires that a food bearing the claim meet all of the nutrient content requirements of Sec. 101.62 for ``low saturated fat,'' ``low cholesterol,'' and ``low fat'' (Sec. 101.75(c)(2)(ii)). Again, most fruits and vegetables meet the requirement for ``low fat,'' but at least one fruit, avocados, does not meet the requirement and therefore is not eligible to bear the claim, even though the fruit meets the requirements for ``low saturated fat'' and ``low cholesterol.'' The petition requested that fruits and vegetables, as a category of foods, be exempted from meeting the minimum nutrient content requirement and the ``low fat'' requirement for the dietary saturated fat and cholesterol and risk of CHD health claim. The petition asserted that, based on the scientific evidence, fruits and vegetables as a group contribute to reduced risk of CHD regardless of their inherent fat content or their ability to meet 10 percent of the RDI or DRV of vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC. The petition described the scientific evidence relating consumption of fruits and vegetables and risk of CHD, including large observational studies (e.g., the Women's Health Study) (Ref. 1) and intervention studies on fruit and vegetable intake and surrogate endpoints for CHD risk (e.g., low-density lipoprotein concentration) (Ref. 2). Additionally, the petition detailed the numerous current public health recommendations, such as the Dietary Guidelines for Americans (DGA) 2010, published by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) (Ref. 3) and the National Cholesterol Education Program (NCEP) of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) (Ref. 4), which consistently encourage fruit and vegetable consumption as an integral part of a healthful diet, regardless of the specific nutrient contents of individual fruits and vegetables. The petition requested the following specific changes in the regulation governing the dietary saturated fat and cholesterol and risk of CHD health claim: Modify Sec. 101.75(c)(2)(ii) to create a new paragraph (A) and remove ``low fat'' food from the list of nutrient content requirements in Sec. 101.62 a food must meet. Modify Sec. 101.75(c)(2)(ii) to create a new paragraph (B) that provides an exemption to the nutrient content requirements of Sec. 101.62 for a ``low fat'' food if it is a raw fruit or vegetable, or is a single-ingredient or mixture of frozen or canned fruits and vegetables that contains no fats or sugars in addition to the fats or sugars inherently present in the fruit or vegetable product. Modify Sec. 101.75(c)(1) to exempt raw fruits and vegetables, or single-ingredient or mixtures of frozen or canned fruits and vegetables from meeting the requirement of Sec. 101.14(e)(6). In addition, the petition requested that we issue an interim final rule under section 403(r)(7)(A) of the FD&C Act, stating that the evidence is compelling and the potential to encourage fruit and vegetable consumption is important for public health and that issuing an interim final rule would allow affected fruit and vegetable products to become eligible to bear these health claims as expeditiously as possible. III. Decision To Amend the Health Claim A. Current Dietary Recommendations for Fruit and Vegetable Intake The DGA, issued every 5 years by USDA and HHS, sets forth the Federal Government's official recommendations regarding healthy eating and construction of a healthful diet (Ref. 5). The 2015-2020 DGA is the most recent version. At the core of the 2015-2020 DGA, as stated in Chapter 1 (``Key Elements of Healthy Eating Patterns''), ``is the importance of consuming overall healthy eating patterns, including vegetables, fruits, grains, dairy, protein foods, and oils--eaten within an appropriate calorie level and in forms with limited amounts of saturated fats, added sugars, and sodium.'' Key recommendations of the 2015-2020 DGA are to ``Shift to consume more vegetables'' and ``Shift to consume more fruits.'' For example, Chapter 2 (``Shifts Needed to Align With Healthy Eating Patterns'') of the 2015-2020 DGA discusses intakes and states that ``For most individuals, following a healthy eating pattern would include an increase in total vegetable intake from all vegetable subgroups, in nutrient-dense forms, and an increase in the variety of different vegetables consumed over time.'' Chapter 2 likewise states that ``To help support healthy eating patterns, most individuals in the United States would benefit from increasing their intake of fruits, mostly whole fruits, in nutrient- dense forms.'' We note that the recommendations in the 2015-2020 DGA regarding fruits and vegetables are directed at intakes of fruit and vegetables as a group. Particularly, in the discussions on fruit and vegetable intake throughout the report, the 2015-2020 DGA considers fruits and vegetables as a category of foods when discussing the associations between fruit and vegetable intake and reduced risk of cardiovascular disease or other chronic diseases (Ref. 5). Our reliance on dietary recommendations in this rulemaking and in previous health claim regulations is based on provisions of the 1990 amendments that direct us to issue health claim regulations that take into account the role of the nutrients in food in a way that will enhance the chances of consumers maintaining healthy dietary practices (see section 403(r)(3)(A) and (r)(3)(B) of the FD&C Act and previous health claim regulations for plant sterol/stanol esters and reduced risk of CHD (Sec. 101.83) and soluble fiber from certain foods and risk of CHD (Sec. 101.81)). Thus, 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. The requirements are established to include foods and categories of foods that are encouraged to be consumed for their benefits to health, while restricting foods whose consumption is not encouraged from bearing health claims (see 58 FR 2478 at 2490). B. Low Fat Our regulations authorizing CHD-related health claims (Sec. Sec. 101.75, 101.81, 101.82, and 101.83) require, with a few exceptions, that foods bearing such claims meet: (1) The ``low fat'' criterion defined by Sec. 101.62(b)(2); (2) the ``low saturated fat'' criterion defined by Sec. 101.62(c)(2); and (3) the ``low cholesterol'' criterion defined by Sec. 101.62(d)(2). The term ``low fat'' may be used on the label or in the labeling of food, except meal products as defined in Sec. 101.13(l) and main dish products as [[Page 91719]] defined in Sec. 101.13(m), provided that the food has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons and contains 3 g or less of fat per reference amount customarily consumed; or the food has a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and contains 3 g or less of fat per reference amount customarily consumed and per 50 g of food (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50-g criterion refers to the ``as prepared'' form) (Sec. 101.62(b)(2)). The term ``low saturated fat'' may be used on the label or labeling of foods, except meal products as defined in Sec. 101.13(1) and main dish products as defined in Sec. 101.13(m), provided that the food contains 1 g or less of saturated fatty acids per reference amount customarily consumed and not more than 15 percent of calories from saturated fatty acids (Sec. 101.62(c)(2)). The term ``low cholesterol,'' under Sec. 101.62(d)(2), may be used on the label or in the labeling of foods, except meal products as defined in Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m), provided that, for foods that have a reference amount customarily consumed greater than 30 g or greater than 2 tablespoons and contain 13 g or less of total fat per reference amount customarily consumed and per labeled serving, the food contains 20 milligrams or less of cholesterol per reference amount customarily consumed or the food contains 2 g or less of saturated fatty acids per reference amount customarily consumed. The petition noted that a fruit such as an avocado exceeds the 3 g total fat per RACC criterion of the ``low fat'' definition and therefore would never be able to bear the health claim for diets low in saturated fat and cholesterol and reduced risk of CHD. According to our nutrient data on the 20 most frequently consumed fruits (Sec. Sec. 101.42 through 101.45 and appendix C to part 101), avocados contain 4.5 g total fat per RACC and do, indeed, exceed 3 g total fat per RACC. Barring an exemption to the ``low fat'' requirement, avocados (and any other fruit or vegetable with a total fat content in excess of the criteria for ``low fat'') are not eligible to bear the dietary saturated fat and cholesterol and risk of CHD health claim. In the 1993 final rule authorizing the dietary saturated fat and cholesterol and risk of CHD health claim (58 FR 2739), we established ``low fat'' as a qualifying criterion for eligibility for the claim asserting that ``while total fat is not as strongly or directly linked to increased risk of CHD . . . it may have significant indirect effects.'' We discussed how ``low fat foods generally help individuals in reducing their intake of saturated fat and cholesterol'' and how excess calories, of which fat contributes more per gram than the other energy nutrients, is associated with two health-related conditions (obesity and diabetes) that are risk factors for heart disease (58 FR 2739 at 2742). In support of these determinations, we noted that, ``Low fat diets are recommended in all Federal Government and National Academy of Sciences' dietary guidelines for reducing the risk of heart disease'' (58 FR 2739 at 2742). 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. Beginning with the 2000 DGA, recommendations for total fat intake shifted from recommending diets low in fat to diets moderate in total fat (Ref. 6). The recommendations reflected a shift in focus to types of fat consumed (i.e., saturated versus unsaturated fat) and their relation to effects on blood cholesterol concentrations. The recommendations for moderate fat intake continued through the 2005 DGA (Ref. 7) with even more discussion on types of fat in the diet (e.g., polyunsaturated and monounsaturated fats) and their influence on cardiovascular disease. The discussion on total fat intake in the 2010 DGA (Ref. 3) focused on the importance of staying within the Institute of Medicine (IOM) of the National Academies of Science Acceptable Macronutrient Distribution Range (AMDR) for total fat intake of 20 to 35 percent of energy for adults and an AMDR of 25 to 35 percent of energy for children age 4 to 18 years (Ref. 8). The AMDRs are associated with reduced risk of chronic diseases, such as cardiovascular disease, while providing for adequate intake of essential nutrients (Ref. 8). The 2015-2020 DGA does not focus on total fat intake, but instead makes recommendations about types of fat. Chapter 1 (``Key Elements of Healthy Eating Patterns'') states that ``[a] healthy eating pattern limits . . . [s]aturated fats and trans fats . . .'' and contains a key recommendation to ``[c]onsume less than 10 percent of calories per day from saturated fats. . . .'' In this same chapter, the 2015-2020 DGA notes that ``[t]he recommendation to limit intake of calories from saturated fats to less than 10 percent per day is a target based on evidence that replacing saturated fats with unsaturated fats is associated with reduced risk of cardiovascular disease'' (Ref. 5, page 15). As a result of the modifications in the dietary recommendations for total fat intake over the years, we have exempted certain foods at times from needing to meet the ``low fat'' requirement to be eligible to make a health claim related to CHD if those foods are consistent with dietary recommendations. For example, whole oats are exempt from meeting the ``low fat'' requirement to be eligible for ``Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease'' health claim (Sec. 101.81). In providing the exemption, we discussed that consumption of whole oats was consistent with the recommendations regarding fat intake in the 2005 DGA and that consumption of foods such as whole oats was helpful in reducing the risk of CHD (73 FR 23947 at 23951, May 1, 2008). We find that not imposing a ``low fat'' requirement for raw fruits and vegetables is consistent with the 2015-2020 DGA recommendations to increase intake of fruits and vegetables to help support healthy eating patterns (Ref. 5), as well as the 2015-2020 DGA emphasis on types of fat rather than total fat when discussing CHD risk (Refs. 5 and 7). We note that the fruits and vegetables that we are exempting from meeting the definition of ``low fat'' must still comply with general health claim requirements in order to be eligible to bear the claim, including, but not limited to, the requirement in Sec. 101.14(e)(3) that the level of fat must not exceed the disqualifying nutrient level for total fat in Sec. 101.14(a)(4). C. Minimum Nutrient Content In the 1993 final rule on the general requirements for health claims (58 FR 2478), we established the minimum nutrient content requirement for eligibility of foods to bear health claims. We stated that foods bearing health claims should be those consistent with dietary guidelines and that the value of health claims should not be trivialized or compromised by their use on foods of little or no nutritional value. We also stated that claims intended to promote the consumption of food that is incompatible with dietary guidelines would be misleading to consumers (58 FR 2478 at 2521). We developed an approach that would limit health claims to foods that contribute certain nutrients [[Page 91720]] to the diet and, thus, are sources of more than calories (58 FR 2478 at 2521). We concluded that a food must contain one or more of vitamin A, vitamin C, iron, calcium, protein, or fiber at or above 10 percent of the RDI or DRV, prior to any nutrient addition, noting that most foods consistent with dietary guidelines met this criterion. Therefore, we added Sec. 101.14(e)(6) to state that, except for dietary supplements that are not in conventional food form, the food must contain 10 percent or more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed before any nutrients are added. We adopted this requirement in light of Congressional intent that health claims be used to help Americans maintain a balanced and healthful diet consistent with dietary guidelines (58 FR 2478 at 2521). We later published technical amendments to the health claim regulations acknowledging that certain food products that had limited nutritional value may be determined to be appropriate foods to bear a health claim (58 FR 44036, August 18, 1993). We noted that we intended to address such situations in the regulations authorizing specific health claims, such as through an exception to the general requirements expressed in Sec. 101.14(e)(6) (58 FR 44036). Thus, we have recognized that exemptions to the minimum nutrient content requirement may be necessary in certain situations to help consumers construct overall daily diets that conform to current dietary guidelines and that otherwise promote good health. Multiple such exemptions have already been granted. For example, on August 23, 1996, we exempted noncariogenic carbohydrate sweeteners (carbohydrate sweeteners that do not promote the development of tooth decay) from the minimum nutrient content requirement to be eligible for the ``dietary noncariogenic carbohydrate sweeteners and dental caries'' health claim (Sec. 101.80) (61 FR 43433 at 43436). We reiterate that the minimum nutrient content requirements of Sec. 101.14(e)(6) are important, but that an exemption from the minimum nutrient content requirements for fruits and vegetables as a group is warranted for these products to be eligible to bear the health claims authorized in Sec. 101.75, given current dietary guideline recommendations. 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. D. Conclusion We agree with the petitioner that some current requirements for the dietary saturated fat and cholesterol and risk of CHD health claim prevent a number of fruits and vegetables from being eligible to bear the claim. We also agree that fruits and vegetables as a group appear to contribute to a reduced risk of CHD regardless of their inherent fat content or their ability to meet 10 percent of the RDI or DRV of vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC. We previously have exempted foods from needing to meet individual requirements for health claim eligibility when, as here, consumption of the foods is consistent with contemporary science-based dietary recommendations. We conclude that raw fruits and vegetables should be exempt from needing to meet the minimum nutrient content requirement of the general principles for health claims and from the requirement specifically included in the dietary saturated fat and cholesterol and risk of CHD health claim that a food meet the definition for ``low fat'' to be eligible to bear the claim. Although the petition requested that a ``single-ingredient or mixture of frozen or canned fruits and vegetables that contains no fats or sugars in addition to the fats or sugars inherently present in the fruit or vegetable product'' also be exempt from the low fat and minimum nutrient content requirements, we are not including these types of products in the exemptions at this time. We are able to easily determine which foods fall into the category of raw fruits and vegetables. With single-ingredient or mixtures of canned or frozen fruit and vegetable products, however, the categories are very broadly described, and it is difficult to know all of the types of products that may become included in an exemption. There are many food products that could conceivably be considered ``fruit or vegetable products,'' including products with varying degrees of processing, with numerous possibilities of ingredients in a ``mixture,'' or with a number of packaging variations. We determine that providing an exemption for raw fruits and vegetables will affect the public health positively, but it is unclear if all single-ingredient and mixtures of frozen or canned fruits and vegetables that contain no fats or sugars in addition to the fats or sugars inherently present in the fruit or vegetable product would have similar effects. Therefore, we decline to extend any exemptions to this category of fruit and vegetable products at this time. However, we invite comments on this issue. If we receive information related to the possible iterations of canned and frozen fruit and vegetable products and also on their effects on health, we may consider expanding the foods included in the exemption in the future. Indeed, the petition encouraged FDA to proceed with exemptions solely for raw fruits and vegetables if the canned and frozen products required additional consideration. IV. Description of Amendments to Sec. 101.75 We are revising Sec. 101.75(c) to: (1) Provide an exemption at Sec. 101.75(c)(1) for raw fruits or vegetables from meeting the minimum nutrient content requirement in Sec. 101.14(e)(6), and (2) revise Sec. 101.75(c)(2)(ii) to provide an exemption from meeting the nutrient content requirements of ``low fat'' if the food is a raw fruit or vegetable. V. Economic Analysis of Impacts A. Introduction We have examined the impacts of the interim final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the interim final rule. We believe that this interim final rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this interim final rule concerns voluntary claims, we certify that the interim final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in [[Page 91721]] the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This interim final rule would not result in an expenditure in any year that meets or exceeds this amount. B. Summary of Benefits and Costs of the Interim Final Rule This interim final rule amends the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of CHD by expanding its use to raw fruits and vegetables that do not meet the ``low fat'' definition (Sec. 101.62(b)(2)) and/or the minimum nutrient content requirement (Sec. 101.14(e)(6)). We believe that a business will only incur the additional costs of analyzing the health claim requirements and relabeling a previously ineligible product if the additional revenue it anticipates to generate by attracting more customers to its products is greater than these additional costs. This implies zero net costs from this interim final rule to such businesses, as well as to any businesses that decide not to include new CHD health claims on previously ineligible and now eligible fruits and vegetables. We have very little data on the current consumer usage of CHD claims on labels and labeling, how these practices would change in response to this interim final rule, or how the consumers will respond to new CHD claims on raw fruits and vegetables that were previously ineligible for such claims. Because of this data gap, we acknowledge that we do not have sufficient evidence at this point to quantify the benefits and the administrative and labeling costs of this interim final rule. Industry will only use a new CHD health claim on the label and labeling of a previously ineligible product if it believes consumers are willing to pay more for such product or buy more of it due to the new CHD claim. If consumers value such new CHD health information, we expect there to be changes in consumer behavior that would result in public health benefits from the reduced annual number of CHD cases. The benefits therefore will only be realized, and labels will only be changed, if the new CHD information on labels and labeling increases consumer demand for the previously ineligible and now eligible for a CHD health claim fruits and vegetables. Otherwise, the firms will not use the CHD health claim on their labels for these fruits and vegetables. The full analysis of economic impacts is available in the docket for this interim final rule (Ref. 9) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. VI. The Paperwork Reduction Act of 1995 This interim final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. VII. Analysis of Environmental Impact We have determined under Sec. 25.32(p) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VIII. Federalism We analyzed this interim final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the interim final rule will have a preemptive effect on State law. Section 4(a) of the Executive order requires Agencies to ``construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State law conflicts with the exercise of Federal authority under the Federal statute.'' Section 403A(a) of the FD&C Act provides that no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement respecting any claim of the type described in section 403(r)(1) of the FD&C Act made in the label or labeling of food that is not identical to the requirement of section 403(r) of the FD&C Act. This interim final rule amends the existing food labeling regulations on health claims for dietary saturated fat and cholesterol and risk of CHD (Sec. 101.75) in the label or labeling of food under section 403(r) of the FD&C Act. Although this interim final rule has a preemptive effect in that it precludes States from issuing any health claim labeling requirements for dietary saturated fat and cholesterol and the risk of CHD, this preemptive effect is consistent with what Congress set forth in section 403A(a) of the FD&C Act. Section 403A(a)(5) of the FD&C Act displaces both State legislative requirements and State common law duties. We have complied with all of the applicable requirements under Executive Order 13132 and have determined that the preemptive effects of this interim final rule are consistent with Executive Order 13132. IX. Issuance of an Interim Final Rule and Immediate Effective Date We are issuing this rule as an interim final rule, effective immediately, with an opportunity for public comment. Section 403(r)(7) of the FD&C Act authorizes us to make proposed regulations issued under section 403(r) of the FD&C Act effective upon publication pending consideration of public comment and publication of a final regulation, if the Agency determines that such action is necessary for public health reasons. This authority enables us to act promptly on petitions that provide for information that is necessary to: (1) Enable consumers to develop and maintain healthy dietary practices; (2) enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food; or (3) ensure that scientifically sound nutritional and health information is provided to consumers as soon as possible. Proposed regulations made effective upon publication under this authority are deemed to be final Agency action for purposes of judicial review. The legislative history indicates that such regulations should be issued as interim final rules (H. Conf. Rept. No. 105-399, at 98 (1997)). The petition requested that we issue an interim final rule amending Sec. 101.75 to indicate that the evidence is compelling and the potential to encourage fruit and vegetable consumption is important for public health. It noted that we have used this authority to issue interim final rules for health claims a number of times (e.g., 65 FR 54685, September 8, 2000) and using an interim final rule would be consistent with our past practices. We are satisfied that all three criteria in section 403(r)(7)(A) of the FD&C Act have been met for the amendment to the dietary saturated fat and cholesterol and risk of CHD health claim to permit raw fruits and vegetables that fail to comply with the ``low fat'' definition and/ or the minimum nutrient content requirement, to be eligible to bear the claim. First, we conclude that these amendments for eligibility for foods to bear these health claims could help enable consumers to develop and maintain healthy dietary practices. Second, these amendments to this health claim will enable consumers [[Page 91722]] to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food. Third, these amendments to this health claim will ensure that scientifically sound nutritional and health information regarding the benefits of fruit and vegetable intake and reduction of CHD risk can be provided to consumers as soon as possible. The past few editions of the DGA have been moving away from a focus on total fat and have instead communicated to consumers the need to focus on type of fat consumed instead of total amount of fat. Recent editions of the DGA have also encouraged increased intake of fruits and vegetables for a healthful diet. Prompt issuance of an interim final rule that reflects the current recommendations is necessary for consumers to be able to have the most current information on nutrition and diet. Consumers will be better able to construct healthful diets if they have prompt access to information that is consistent with the current recommendations on fat content and on consumption of fruits and vegetables. Therefore, we are using the authority in section 403(r)(7)(A) of the FD&C Act to issue an interim final rule amending the general requirements for the health claim for dietary saturated fat and cholesterol and risk of CHD and to make the interim final rule effective immediately. This regulation is effective upon publication in the Federal Register. We invite public comment on this interim final rule. We will consider modifications to this interim final rule based on comments made during the comment period. We will address comments and confirm or amend the interim final rule in a final rule. X. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Liu, S., J.E. Manson, I.M. Lee, et al. ``Fruit and Vegetable Intake and Risk of Cardiovascular Disease: The Women's Health Study.'' The American Journal of Clinical Nutrition, 72: 922-928, 2000. 2. Appel, L.J., T.J. Moore, E. Obarzanek, et al. ``A Clinical Trial of the Effects of Dietary Patterns on Blood Pressure.'' DASH Collaborative Research Group. The New England Journal of Medicine, 336: 1117-1124, 1997. 3. U.S. Department of Health and Human Services and U.S. Department of Agriculture. ``Dietary Guidelines for Americans, 2010. 7th Edition,'' 2010. Available at http://health.gov/dietaryguidelines/2010/. 4. ``Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report.'' Circulation, 106: 3143-3421, 2002. 5. 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 http://health.gov/dietaryguidelines/2015/guidelines/. 6. U.S. Department of Health and Human Services and U.S. Department of Agriculture. ``Nutrition and Your Health, Dietary Guidelines for Americans,'' 2000. Available at http://health.gov/dietaryguidelines/2000.asp. 7. U.S. Department of Health and Human Services and U.S. Department of Agriculture. ``Dietary Guidelines for Americans, 2005. 6th Edition,'' 2005. Available at http://health.gov/dietaryguidelines/dga2005/document/default.htm. 8. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients).'' Chapter 8, ``Dietary Fats: Total Fat and Fatty Acids,'' 2002. 9. FDA/CFSAN, Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease, Regulatory Impact Analysis, FDA-2013-P-0047. List of Subjects in 21 CFR Part 101 Food labeling, Nutrition, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 101 is amended as follows: PART 101--FOOD LABELING 0 1. The authority citation for part 101 continues to read as follows: Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271. 0 2. Section 101.75 is amended by revising paragraphs (c)(1) and (c)(2)(ii) to read as follows: Sec. 101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease. * * * * * (c) * * * (1) All requirements set forth in Sec. 101.14 shall be met, except Sec. 101.14(e)(6) with respect to a raw fruit or vegetable. (2) * * * (ii) Nature of the food. (A) The food shall meet all of the nutrient content requirements of Sec. 101.62 for a ``low saturated fat'' and ``low cholesterol'' food. (B) The food shall meet the nutrient content requirements of Sec. 101.62 for a ``low fat'' food, unless it is a raw fruit or vegetable; except that fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may meet the requirements for ``extra lean'' in Sec. 101.62. * * * * * Dated: December 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29997 Filed 12-16-16; 8:45 am] BILLING CODE 4164-01-P
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DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/
HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
21 CFR Part 101 electronic and written/paper comments
Written/Paper Submissions received, go to http://
[Docket No. FDA–2013–P–0047]
Submit written/paper submissions as www.regulations.gov and insert the
RIN 0910–AH43 follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
Food Labeling: Health Claims; Dietary written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Saturated Fat and Cholesterol and Risk Dockets Management (HFA–305), Food and/or go to the Division of Dockets
of Coronary Heart Disease and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT:
HHS.
submitted to the Division of Dockets Vincent de Jesus, Center for Food Safety
Interim final rule; request for
ACTION:
Management, FDA will post your
comments. and Applied Nutrition (HFS–830), Food
comment, as well as any attachments, and Drug Administration, 5001 Campus
SUMMARY: The Food and Drug except for information submitted, Dr., College Park, MD 20740–3835, 240–
Administration (FDA or we) is marked and identified, as confidential, 402–1450.
amending the regulation authorizing a if submitted as detailed in
SUPPLEMENTARY INFORMATION:
health claim on the relationship ‘‘Instructions.’’
between dietary saturated fat and Instructions: All submissions received Executive Summary
cholesterol and risk of coronary heart must include the Docket No. FDA–
Purpose of the Regulatory Action
disease (CHD) to permit raw fruits and 2013–P–0047 for ‘‘Food Labeling:
Health Claims; Dietary Saturated Fat This interim final rule amends the
vegetables that fail to comply with the
and Cholesterol and Risk of Coronary regulation authorizing a health claim on
‘‘low fat’’ definition and/or the
Heart Disease.’’ Received comments will the relationship between dietary
minimum nutrient content requirement
to be eligible to bear the claim. We are be placed in the docket and, except for saturated fat and cholesterol and risk of
taking this action in response to a those submitted as ‘‘Confidential coronary heart disease (CHD). The
petition submitted by the American Submissions,’’ publicly viewable at interim final rule permits raw fruits and
Heart Association (the petitioner). The http://www.regulations.gov or at the vegetables that fail to comply with the
amendment expands the use of this Division of Dockets Management ‘‘low fat’’ definition and/or the
health claim to certain fruits and between 9 a.m. and 4 p.m., Monday minimum nutrient content requirement
vegetables that are currently ineligible through Friday. to be eligible to bear the claim. Health
for the health claim. • Confidential Submissions—To claims, in general, must meet certain
submit a comment with confidential nutrient requirements that we establish
DATES: This interim final rule is
information that you do not wish to be to ensure that health claims are used on
effective December 19, 2016. Interested
made publicly available, submit your foods with nutritional value. For
persons may submit either electronic or
comments only as a written/paper example, except where provided for in
written comments by March 6, 2017.
submission. You should submit two other regulations, foods bearing a health
ADDRESSES: You may submit comments
copies total. One copy will include the claim must contain one or more of
as follows: information you claim to be confidential vitamin A, vitamin C, iron, calcium,
Electronic Submissions with a heading or cover note that states protein, or fiber at or above 10 percent
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS of the Reference Daily Intake (RDI) or
following way: CONFIDENTIAL INFORMATION.’’ We Daily Reference Value (DRV), before any
• Federal eRulemaking Portal: http:// will review this copy, including the nutrient addition (§ 101.14(e)(6) (21 CFR
www.regulations.gov. Follow the claimed confidential information, in our 101.14(e)(6)). Additionally, for foods
instructions for submitting comments. consideration of comments. The second bearing health claims related to CHD,
Comments submitted electronically, copy, which will have the claimed the food often must be a ‘‘low fat’’ food
including attachments, to http:// confidential information redacted/ (see e.g., §§ 101.75(c)(2)(ii) and
www.regulations.gov will be posted to blacked out, will be available for public 101.81(c)(2)(iii)(D)). An unintended
the docket unchanged. Because your viewing and posted on http:// consequence of these general
comment will be made public, you are www.regulations.gov. Submit both requirements is that some foods that are
solely responsible for ensuring that your copies to the Division of Dockets generally considered to contribute to a
comment does not include any Management. If you do not wish your healthy diet are ineligible to bear certain
confidential information that you or a name and contact information to be health claims. A small number of fruits
third party may not wish to be posted, made publicly available, you can and vegetables, for example, are
such as medical information, your or provide this information on the cover ineligible to bear the dietary saturated
anyone else’s Social Security number, or sheet and not in the body of your fat and cholesterol and risk of CHD
confidential business information, such comments and you must identify this health claim because they do not meet
as a manufacturing process. Please note information as ‘‘confidential.’’ Any the requirement to have 10 percent of
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that if you include your name, contact information marked as ‘‘confidential’’ the RDI or DRV of certain nutrients and/
information, or other information that will not be disclosed except in or they do not meet the definition of a
identifies you in the body of your accordance with 21 CFR 10.20 and other ‘‘low fat’’ food. However, consumption
comments, that information will be applicable disclosure law. For more of fruits and vegetables is encouraged by
posted on http://www.regulations.gov. information about FDA’s posting of dietary recommendations, and low
• If you want to submit a comment comments to public dockets, see 80 FR saturated fat and low cholesterol fruits
with confidential information that you 56469, September 18, 2015, or access and vegetables should not be excluded
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defined in § 101.13(m), provided that risk of CHD health claim (58 FR 2739), saturated fats. . . .’’ In this same
the food has a reference amount we established ‘‘low fat’’ as a qualifying chapter, the 2015–2020 DGA notes that
customarily consumed greater than 30 criterion for eligibility for the claim ‘‘[t]he recommendation to limit intake of
grams (g) or greater than 2 tablespoons asserting that ‘‘while total fat is not as calories from saturated fats to less than
and contains 3 g or less of fat per strongly or directly linked to increased 10 percent per day is a target based on
reference amount customarily risk of CHD . . . it may have significant evidence that replacing saturated fats
consumed; or the food has a reference indirect effects.’’ We discussed how with unsaturated fats is associated with
amount customarily consumed of 30 g ‘‘low fat foods generally help reduced risk of cardiovascular disease’’
or less or 2 tablespoons or less and individuals in reducing their intake of (Ref. 5, page 15).
contains 3 g or less of fat per reference saturated fat and cholesterol’’ and how As a result of the modifications in the
amount customarily consumed and per excess calories, of which fat contributes dietary recommendations for total fat
50 g of food (for dehydrated foods that more per gram than the other energy intake over the years, we have exempted
must be reconstituted before typical nutrients, is associated with two health- certain foods at times from needing to
consumption with water or a diluent related conditions (obesity and diabetes) meet the ‘‘low fat’’ requirement to be
containing an insignificant amount, as that are risk factors for heart disease (58 eligible to make a health claim related
defined in § 101.9(f)(1), of all nutrients FR 2739 at 2742). In support of these to CHD if those foods are consistent
per reference amount customarily determinations, we noted that, ‘‘Low fat with dietary recommendations. For
consumed, the per 50-g criterion refers diets are recommended in all Federal example, whole oats are exempt from
to the ‘‘as prepared’’ form) Government and National Academy of meeting the ‘‘low fat’’ requirement to be
(§ 101.62(b)(2)). Sciences’ dietary guidelines for eligible for ‘‘Soluble Fiber from Certain
The term ‘‘low saturated fat’’ may be reducing the risk of heart disease’’ (58 Foods and Risk of Coronary Heart
used on the label or labeling of foods, FR 2739 at 2742). Disease’’ health claim (§ 101.81). In
except meal products as defined in Since we published the final rule for providing the exemption, we discussed
§ 101.13(1) and main dish products as the dietary saturated fat and cholesterol that consumption of whole oats was
defined in § 101.13(m), provided that and risk of CHD health claim in 1993, consistent with the recommendations
the food contains 1 g or less of saturated the science related to intake of total fat regarding fat intake in the 2005 DGA
fatty acids per reference amount has evolved, and the current dietary and that consumption of foods such as
customarily consumed and not more recommendations no longer contain a whole oats was helpful in reducing the
than 15 percent of calories from recommendation encouraging the risk of CHD (73 FR 23947 at 23951, May
saturated fatty acids (§ 101.62(c)(2)). consumption of diets low in total fat. 1, 2008).
The term ‘‘low cholesterol,’’ under Beginning with the 2000 DGA, We find that not imposing a ‘‘low fat’’
§ 101.62(d)(2), may be used on the label recommendations for total fat intake requirement for raw fruits and
or in the labeling of foods, except meal shifted from recommending diets low in vegetables is consistent with the 2015–
products as defined in § 101.13(l) and fat to diets moderate in total fat (Ref. 6). 2020 DGA recommendations to increase
main dish products as defined in The recommendations reflected a shift intake of fruits and vegetables to help
§ 101.13(m), provided that, for foods in focus to types of fat consumed (i.e., support healthy eating patterns (Ref. 5),
that have a reference amount saturated versus unsaturated fat) and as well as the 2015–2020 DGA emphasis
customarily consumed greater than 30 g their relation to effects on blood on types of fat rather than total fat when
or greater than 2 tablespoons and cholesterol concentrations. The discussing CHD risk (Refs. 5 and 7). We
contain 13 g or less of total fat per recommendations for moderate fat note that the fruits and vegetables that
reference amount customarily intake continued through the 2005 DGA we are exempting from meeting the
consumed and per labeled serving, the (Ref. 7) with even more discussion on definition of ‘‘low fat’’ must still comply
food contains 20 milligrams or less of types of fat in the diet (e.g., with general health claim requirements
cholesterol per reference amount polyunsaturated and monounsaturated in order to be eligible to bear the claim,
customarily consumed or the food fats) and their influence on including, but not limited to, the
contains 2 g or less of saturated fatty cardiovascular disease. The discussion requirement in § 101.14(e)(3) that the
acids per reference amount customarily on total fat intake in the 2010 DGA (Ref. level of fat must not exceed the
consumed. 3) focused on the importance of staying disqualifying nutrient level for total fat
The petition noted that a fruit such as within the Institute of Medicine (IOM) in § 101.14(a)(4).
an avocado exceeds the 3 g total fat per of the National Academies of Science
RACC criterion of the ‘‘low fat’’ C. Minimum Nutrient Content
Acceptable Macronutrient Distribution
definition and therefore would never be Range (AMDR) for total fat intake of 20 In the 1993 final rule on the general
able to bear the health claim for diets to 35 percent of energy for adults and requirements for health claims (58 FR
low in saturated fat and cholesterol and an AMDR of 25 to 35 percent of energy 2478), we established the minimum
reduced risk of CHD. According to our for children age 4 to 18 years (Ref. 8). nutrient content requirement for
nutrient data on the 20 most frequently The AMDRs are associated with reduced eligibility of foods to bear health claims.
consumed fruits (§§ 101.42 through risk of chronic diseases, such as We stated that foods bearing health
101.45 and appendix C to part 101), cardiovascular disease, while providing claims should be those consistent with
avocados contain 4.5 g total fat per for adequate intake of essential nutrients dietary guidelines and that the value of
RACC and do, indeed, exceed 3 g total (Ref. 8). health claims should not be trivialized
fat per RACC. Barring an exemption to The 2015–2020 DGA does not focus or compromised by their use on foods
the ‘‘low fat’’ requirement, avocados on total fat intake, but instead makes of little or no nutritional value. We also
srobinson on DSK5SPTVN1PROD with RULES
(and any other fruit or vegetable with a recommendations about types of fat. stated that claims intended to promote
total fat content in excess of the criteria Chapter 1 (‘‘Key Elements of Healthy the consumption of food that is
for ‘‘low fat’’) are not eligible to bear the Eating Patterns’’) states that ‘‘[a] healthy incompatible with dietary guidelines
dietary saturated fat and cholesterol and eating pattern limits . . . [s]aturated fats would be misleading to consumers (58
risk of CHD health claim. and trans fats . . .’’ and contains a key FR 2478 at 2521). We developed an
In the 1993 final rule authorizing the recommendation to ‘‘[c]onsume less approach that would limit health claims
dietary saturated fat and cholesterol and than 10 percent of calories per day from to foods that contribute certain nutrients
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![91722 Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Rules and Regulations
to be informed promptly and effectively Group. The New England Journal of § 101.75 Health claims: dietary saturated
of important new knowledge regarding Medicine, 336: 1117–1124, 1997. fat and cholesterol and risk of coronary
nutritional and health benefits of food. 3. U.S. Department of Health and heart disease.
Third, these amendments to this health Human Services and U.S. Department of * * * * *
claim will ensure that scientifically Agriculture. ‘‘Dietary Guidelines for (c) * * *
sound nutritional and health Americans, 2010. 7th Edition,’’ 2010. (1) All requirements set forth in
information regarding the benefits of Available at http://health.gov/ § 101.14 shall be met, except
fruit and vegetable intake and reduction dietaryguidelines/2010/. § 101.14(e)(6) with respect to a raw fruit
of CHD risk can be provided to 4. ‘‘Third Report of the National or vegetable.
consumers as soon as possible. The past Cholesterol Education Program (NCEP) (2) * * *
few editions of the DGA have been Expert Panel on Detection, Evaluation, (ii) Nature of the food. (A) The food
moving away from a focus on total fat and Treatment of High Blood shall meet all of the nutrient content
and have instead communicated to Cholesterol in Adults (Adult Treatment requirements of § 101.62 for a ‘‘low
consumers the need to focus on type of Panel III) final report.’’ Circulation, 106: saturated fat’’ and ‘‘low cholesterol’’
fat consumed instead of total amount of 3143–3421, 2002. food.
fat. Recent editions of the DGA have 5. U.S. Department of Health and (B) The food shall meet the nutrient
also encouraged increased intake of Human Services and U.S. Department of content requirements of § 101.62 for a
fruits and vegetables for a healthful diet. Agriculture. ‘‘2015–2020 Dietary ‘‘low fat’’ food, unless it is a raw fruit
Prompt issuance of an interim final rule Guidelines for Americans, 8th Edition,’’ or vegetable; except that fish and game
that reflects the current December 2015. Available at http:// meats (i.e., deer, bison, rabbit, quail,
recommendations is necessary for health.gov/dietaryguidelines/2015/ wild turkey, geese, and ostrich) may
consumers to be able to have the most guidelines/. meet the requirements for ‘‘extra lean’’
current information on nutrition and in § 101.62.
6. U.S. Department of Health and
diet. Consumers will be better able to * * * * *
Human Services and U.S. Department of
construct healthful diets if they have
prompt access to information that is Agriculture. ‘‘Nutrition and Your Dated: December 9, 2016.
consistent with the current Health, Dietary Guidelines for Leslie Kux,
recommendations on fat content and on Americans,’’ 2000. Available at http:// Associate Commissioner for Policy.
consumption of fruits and vegetables. health.gov/dietaryguidelines/2000.asp. [FR Doc. 2016–29997 Filed 12–16–16; 8:45 am]
Therefore, we are using the authority in 7. U.S. Department of Health and BILLING CODE 4164–01–P
section 403(r)(7)(A) of the FD&C Act to Human Services and U.S. Department of
issue an interim final rule amending the Agriculture. ‘‘Dietary Guidelines for
general requirements for the health Americans, 2005. 6th Edition,’’ 2005. DEPARTMENT OF HEALTH AND
claim for dietary saturated fat and Available at http://health.gov/dietary HUMAN SERVICES
cholesterol and risk of CHD and to make guidelines/dga2005/document/
the interim final rule effective default.htm. Food and Drug Administration
immediately. 8. Institute of Medicine (IOM) of the
This regulation is effective upon National Academies. ‘‘Dietary Reference 21 CFR Parts 878, 880, and 895
publication in the Federal Register. We Intakes for Energy, Carbohydrate, Fiber,
[Docket No. FDA–2015–N–5017]
invite public comment on this interim Fat, Fatty Acids, Cholesterol, Protein,
final rule. We will consider and Amino Acids (Macronutrients).’’ RIN 0910–AH02
modifications to this interim final rule Chapter 8, ‘‘Dietary Fats: Total Fat and
based on comments made during the Fatty Acids,’’ 2002. Banned Devices; Powdered Surgeon’s
comment period. We will address 9. FDA/CFSAN, Food Labeling: Gloves, Powdered Patient Examination
comments and confirm or amend the Health Claims; Dietary Saturated Fat Gloves, and Absorbable Powder for
interim final rule in a final rule. and Cholesterol and Risk of Coronary Lubricating a Surgeon’s Glove
Heart Disease, Regulatory Impact AGENCY: Food and Drug Administration,
X. References
Analysis, FDA–2013–P–0047. HHS.
The following references are on
display in the Division of Dockets List of Subjects in 21 CFR Part 101 ACTION: Final rule.
Management (see ADDRESSES) and are Food labeling, Nutrition, Reporting SUMMARY: The Food and Drug
available for viewing by interested and recordkeeping requirements. Administration (FDA or Agency) has
persons between 9 a.m. and 4 p.m., Therefore, under the Federal Food, determined that Powdered Surgeon’s
Monday through Friday; they are also Drug, and Cosmetic Act and under Gloves, Powdered Patient Examination
available electronically at http:// authority delegated to the Commissioner Gloves, and Absorbable Powder for
www.regulations.gov. FDA has verified of Food and Drugs, 21 CFR part 101 is Lubricating a Surgeon’s Glove present
the Web site addresses, as of the date amended as follows: an unreasonable and substantial risk of
this document publishes in the Federal illness or injury and that the risk cannot
Register, but Web sites are subject to PART 101—FOOD LABELING be corrected or eliminated by labeling or
change over time. a change in labeling. Consequently, FDA
1. Liu, S., J.E. Manson, I.M. Lee, et al. ■ 1. The authority citation for part 101 is banning these devices.
‘‘Fruit and Vegetable Intake and Risk of continues to read as follows:
srobinson on DSK5SPTVN1PROD with RULES
Cardiovascular Disease: The Women’s DATES: This rule is effective on January
Authority: 15 U.S.C. 1453, 1454, 1455; 21 18, 2017.
Health Study.’’ The American Journal of U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
Clinical Nutrition, 72: 922–928, 2000. 243, 264, 271. ADDRESSES: For access to the docket to
2. Appel, L.J., T.J. Moore, E. read background documents or
Obarzanek, et al. ‘‘A Clinical Trial of the ■ 2. Section 101.75 is amended by comments received, go to https://
Effects of Dietary Patterns on Blood revising paragraphs (c)(1) and (c)(2)(ii) www.regulations.gov and insert the
Pressure.’’ DASH Collaborative Research to read as follows: docket number found in brackets in the
VerDate Sep<11>2014 20:05 Dec 16, 2016 Jkt 241001 PO 00000 Frm 00080 Fmt 4700 Sfmt 4700 E:\FR\FM\19DER1.SGM 19DER1](https://thefederalregister.org/doc/81_FR_91959/page/7.svg)
Document Created: 2016-12-17 03:15:06
Document Modified: 2016-12-17 03:15:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Interim final rule; request for comments. | |
| Dates | This interim final rule is effective December 19, 2016. Interested persons may submit either electronic or written comments by March 6, 2017. | |
| Contact | Vincent de Jesus, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1450. | |
| FR Citation | 81 FR 91716 | |
| RIN Number | 0910-AH43 | |
| CFR Associated | Food Labeling; Nutrition and Reporting and Recordkeeping Requirements |
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