
[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91716-91722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29997]



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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.

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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

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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

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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

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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


