[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Rules and Regulations]
[Pages 23262-23273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. FDA-2007-0601, FDA-2004-N-0382, FDA-2005-P-0371, and FDA-
2006-P-0224 (formerly Docket Nos. 2004N-0217, 2005P-0189, and 2006P-
0137, respectively)]
RIN 0910-ZA28


Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, 
Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing this rule to prohibit certain nutrient content claims for 
foods, including conventional foods and dietary supplements, that 
contain omega-3 fatty acids, based on our determination that such 
nutrient content claims do not meet the requirements of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action 
in response to three notifications submitted to us. One notification 
concerning nutrient content claims for alpha-linolenic acid (ALA), 
docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was 
submitted collectively by Alaska General Seafoods, Ocean Beauty 
Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors 
notification); a second notification concerning nutrient content claims 
for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the 
Martek notification); and a third notification concerning nutrient 
content claims for DHA and EPA was submitted by Ocean Nutrition Canada, 
Ltd. (the Ocean Nutrition notification). The final rule prohibits the 
nutrient content claims for DHA and EPA set forth in the three 
notifications and the nutrient content claims for ALA set forth in the 
seafood processors notification. FDA is taking no regulatory action at 
this time with respect to the nutrient content claims for ALA set forth 
in the Martek notification and, therefore, these claims will be allowed 
to remain on the market.

DATES: This rule is effective January 1, 2016.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1774.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Pub. L. 105-115) amended the FD&C Act to provide, among other things, 
for the filing of notifications as an alternative to the petition 
process for nutrient content claims set forth in section 403(r)(4) of 
the FD&C Act (21 U.S.C. 343(r)(4)). ``Nutrient content claims'' are 
labeling claims that characterize the level of a nutrient in a food. 
(See section 403(r)(1)(A) of the FD&C Act.) We have stated that the 
Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535), which 
created section 403(r)(1)(A) of the FD&C Act, has three basic 
objectives: (1) To make available nutrition information that can assist 
consumers in selecting foods that can lead to healthier diets, (2) to 
eliminate consumer confusion by establishing definitions for nutrient 
content claims that are consistent with the terms defined by the 
Secretary of Health and Human Services (the Secretary), and (3) to 
encourage product innovation through the development and marketing of 
nutritionally improved foods (58 FR 2302, January 6, 1993). Under the 
notification process that FDAMA established in section 403(r)(2)(G) of 
the FD&C Act, a nutrient content claim is based on an authoritative 
statement published either by a scientific body of the U.S.

[[Page 23263]]

Government that has official responsibility for public health 
protection or research directly relating to human nutrition, or by the 
National Academy of Sciences (NAS) or any of its subdivisions.
    Section 403(r)(2)(G) of the FD&C Act requires that a notification 
for a prospective nutrient content claim be submitted to FDA at least 
120 days before a food bearing the claim may be introduced into 
interstate commerce. The notification must contain specific information 
including: (1) The exact wording of the prospective nutrient content 
claim, (2) a concise description of the basis upon which the notifier 
relied for determining that the requirements for an authoritative 
statement in section 403(r)(2)(G)(i) of the FD&C Act have been 
satisfied, (3) a copy of the authoritative statement that serves as the 
basis for the claim, and (4) a balanced representation of the 
scientific literature relating to the nutrient level for the claim. The 
claim must be an accurate representation of the authoritative statement 
and must be stated in a manner that enables the public to comprehend 
the information provided by the claim and to understand the relative 
significance of such information in the context of the total daily 
diet. Furthermore, the authoritative statement that is the basis for 
the nutrient content claim must be currently in effect and identify the 
nutrient level to which the claim refers.
    In the Federal Register of November 27, 2007 (72 FR 66103), we 
published a proposed rule that would prohibit all of the nutrient 
content claims for the omega-3 fatty acids DHA and EPA set forth in: 
(1) The seafood processors notification submitted on January 16, 2004, 
(2) the Martek notification submitted on January 21, 2005, and (3) the 
Ocean Nutrition notification submitted on December 9, 2005. The seafood 
processors notification set forth ``high'' \1\ nutrient content claims 
for both DHA and EPA,\2\ whereas the Martek notification set forth a 
``high'' nutrient content claim only for DHA \3\ and the Ocean 
Nutrition notification set forth a ``high'' nutrient content claim for 
DHA and EPA combined.\4\ The proposed rule would take this action 
because the nutrient content claims for DHA and EPA set forth in the 
three notifications are not based on an authoritative statement that 
identifies a nutrient level to which the claims refer, as required by 
the FD&C Act.
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    \1\ Nutrient content claims are defined in Sec.  101.54 (21 CFR 
101.54). ``High'' is defined as 20 percent or more of the Reference 
Daily Intake (RDI) or the Daily Reference Value (DRV) per reference 
amount customarily consumed (RACC) (Sec.  101.54(b)). ``Good 
source'' is defined as 10 to19 percent of the RDI or DRV per RACC 
(Sec.  101.54(c)). ``More'' is defined as 10 percent or more of the 
RDI or DRV per RACC than an appropriate reference food (Sec.  
101.54(e)). Synonyms for each of these terms are also set forth in 
the regulations; for example, the terms ``rich in'' and ``excellent 
source of'' are considered to be equivalent to the term ``high'' 
(Sec.  101.54(b)).
    \2\ The seafood processors notification specified that one of 
the following two statements would accompany these claims:
    ``Contains -- mg of [DHA/EPA] per serving, which is -- % of the 
Daily Value for [DHA/EPA] (130 mg).''
    ``Contains -- % of the Daily Value for [DHA/EPA] per serving. 
The Daily Value for [DHA/EPA] is 130 mg.'' As indicated in the 
notification, use of [DHA/EPA] is intended to mean that either EPA 
or DHA can be used as the subject of the claim.
    \3\ The Martek notification proposed the following exact wording 
for these claims: `` `Excellent source of DHA.' (`High in DHA,' 
`Rich in DHA') Contains -- mg of DHA per serving, which is -- % of 
the 160 mg Daily Value for DHA.'' [Products would need to contain at 
least 32 mg of DHA per RACC to qualify for the claim.]
    \4\ The Ocean Nutrition notification proposed the following 
exact words for these claims: `` `Excellent source of Omega-3 EPA 
and DHA.' (`High in Omega-3 EPA and DHA;' `Rich in Omega-3 EPA and 
DHA'). Contains -- mg of EPA and DHA combined per serving, which is 
-- % of the 160 mg Daily Value for a combination of EPA and DHA.'' 
FDA notes that this claim language was incorrectly written in the 
proposed rule, where it was written as `` `Excellent source of 
Omega-3 EPA and DHA.' (`High in Omega-3 EPA and DHA;' `Rich in 
Omega-3 EPA and DHA'). Contains -- mg of EPA and DHA combined per 
serving, which is -- % of the 160 mg EPA and DHA combined per 
serving, which is -- % of the 160 mg Daily Value for a combination 
of EPA and DHA.''
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    The proposed rule also would prohibit the nutrient content claims 
for ALA set forth in the seafood processors notification \5\ because 
the claims were based on a reference value that was determined by a 
different approach than reference values already established for other 
nutrients (i.e., Daily Values (DVs)). In the report entitled ``Dietary 
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, 
Cholesterol, Protein, and Amino Acids'' from the Institute of Medicine 
(IOM) of the NAS (``the IOM report'') (Ref. 1), the IOM identified 
several age-gender group specific adequate intake levels (AIs) for ALA, 
including 1.6 grams per day (g/day) for males 14 and more years of age 
and 1.1 g/day for females 14 and more years of age. (See also 72 FR 
66103 at 66106.) The seafood processors calculated a population-
weighted AI to use as the reference value for their claims. This 
approach differs from our approach, under which reference values are 
set by using the population-coverage approach. (See 58 FR 2206 at 2210 
through 2211, January 6, 1993.) Under a ``population-coverage 
approach,'' we would use the highest Recommended Daily Allowance (RDA) 
or AI for adults and children 4 or more years of age (excluding values 
for pregnant and lactating women) to serve as the label reference 
value. (See, e.g., 72 FR 62149 at 62150, November 2, 2007.) In 
contrast, the seafood processors calculated a population-weighted 
reference value--they looked at the various AIs that the IOM identified 
for different age and gender groups (excluding children under 4 years 
of age and pregnant and lactating women) and averaged out all of those 
numbers, taking into account the predominance of the various groups 
within the population, to arrive at their label reference value. The 
difference, in brief, is that we essentially take the highest number to 
use as the label reference value, while the seafood processors would 
take an average of the various numbers to use as their reference value.
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    \5\ The seafood processors notification proposed ``high,'' 
``good source,'' and ``more'' claims for ALA. The notification 
specified that one of the following two statements would accompany 
``high'' and ``good source'' claims for ALA:
    ``Contains -- mg of ALA per serving, which is -- % of the Daily 
Value for ALA (1.3 g).''
    ``Contains -- % of the Daily Value for ALA per serving. The 
Daily Value for ALA is 1.3 g.''
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    In the proposed rule, we tentatively determined that the seafood 
processors notification's use of a different methodology to set the 
reference values does not enable the public to comprehend the 
information provided in the ALA claim and to understand the relevant 
significance of such information in the context of the daily diet. We 
indicated that we would not take regulatory action at this time on the 
ALA claims set forth in the Martek notification,\6\ which used a 
population-coverage approach that is consistent with the approach that 
FDA has used in determining DVs to date (see 58 FR 2206 at 2211). We 
expressed no conclusions as to whether the ALA claims in the Martek 
notification are supported by an authoritative statement that satisfies 
the

[[Page 23264]]

requirements of section 403(r)(2)(G) of the FD&C Act. Because the 
proposed rule would neither prohibit nor modify the nutrient content 
claims for ALA set forth in the Martek notification, we indicated that 
we would allow these claims to remain on the market at this time (see 
72 FR 66103 at 66104).
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    \6\ The Martek notification proposed ``high,'' ``good source,'' 
and ``more'' claims for ALA. The notification proposed the following 
exact words for these claims:
    `` `Excellent source of ALA.' (`High in ALA,' `Rich in ALA') 
Contains -- mg of ALA per serving, which is -- % of the 1.6 g Daily 
Value for ALA.'' [Products would need to contain at least 320 mg of 
ALA per RACC to qualify for the claim.]
    `` `Good source of ALA.' (`Contains ALA,' `Provides ALA') 
Contains -- mg of ALA per serving, which is -- % of the 1.6 g Daily 
Value for ALA'' [Products would need to contain at least 160 mg of 
ALA per RACC to qualify for the claim.]
    `` `More ALA.' (`Fortified with ALA,' `Enriched with ALA,' 
`Added ALA,' `Extra ALA,' `Plus ALA') Contains -- % more of the 
Daily Value for ALA per serving than [reference food]. This product 
contains -- mg of ALA which is -- % of the Daily Value for ALA (1.6 
g).'' [Products would need to contain at least 160 mg or more ALA 
per RACC than an appropriate reference food and would comply with 
the requirements for relative claims found at 21 CFR 101.13(j).]
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II. Summary of Comments and Agency's Responses

    We invited comments on the proposed rule. The comment period closed 
on February 11, 2008. We received 19 comments, each containing one or 
more issues. The comments were from manufacturers, trade associations, 
and health-related organizations. One comment raised issues that were 
outside the scope of this rulemaking, and we will not discuss it in 
this document. We discuss the remaining comments and our responses in 
part II. For ease of reading, we preface each comment discussion with a 
numbered ``Comment,'' and each response by a corresponding numbered 
``Response.'' We have numbered each comment to help distinguish among 
different topics. The number assigned is for organizational purposes 
only and does not signify the comment's value, importance, or the order 
in which it was received.
    (Comment 1) Several comments stated that the nutrient content 
claims for DHA and EPA should be permitted because the statements from 
the IOM report that were used as the basis for these claims are 
authoritative statements that identify a nutrient level, as required by 
the statute. Specifically, the comments pointed to the following 
statements from the IOM report:
     [EPA] and [DHA] contribute approximately 10 percent of the 
total n-3 fatty acid intake and therefore this percent contributes 
toward the AI for [ALA].
     Small amounts of EPA and DHA can contribute towards 
reversing an n-3 fatty acid deficiency . . . and can therefore 
contribute toward the AI for [ALA]. EPA and DHA contribute 
approximately 10 percent of the total n-3 fatty acid intake and 
therefore this percent contributes toward the AI for [ALA].
     The AMDR [Acceptable Macronutrient Distribution Range] for 
[ALA] is set at 0.6 to 1.2 percent of energy. Ten percent of this range 
can be consumed as [EPA] and/or [DHA].
     Approximately 10 percent of the AMDR for n-3 fatty acids 
([ALA]) can be consumed as EPA and/or DHA (0.06 to 0.12 percent of 
energy).
    The comments asserted that these statements permit a calculation of 
a value for DHA and EPA that can be considered a ``nutrient level.'' 
The comments further asserted that our position regarding the term 
``nutrient level'' goes beyond what the statute requires and is unduly 
restrictive. These comments characterized our position as interpreting 
the term ``nutrient level'' to refer to reference values that are 
similar in type to Dietary Reference Intakes (DRI) or other types of 
defined intake levels that serve as reference values for the basis of 
nutrient content claims. Based on these contentions, the comments 
asserted that the proposed rule was contrary to Congressional intent in 
that we are imposing standards of traditional rulemaking on a process 
that Congress intended to be an expedited process of information 
dissemination. If Congress had intended otherwise, at least one comment 
stated, it could have explicitly indicated that a specific type of 
reference value be required; however, Congress did not do so.
    (Response) We disagree. We consider the term ``nutrient level'' as 
used in section 403(r)(2)(G)(i) of the FD&C Act, to mean a reference 
value that is similar to a label reference value for use in nutrition 
labeling, i.e., that reflects a recommended or defined intake level 
that could serve as a basis for setting a DV that could be used to 
characterize a given level of a nutrient (here, DHA or EPA) for 
purposes of nutrition labeling. To date, our regulations have 
established two types of DVs: RDIs and DRVs (72 FR 66103 at 66104 
through 66105). However, contrary to what some comments suggest, the 
proposed rule would not have the statutory term ``nutrient level'' 
refer only to RDIs and DRVs. Instead, we proposed that the term refers 
to values that could serve as a basis for setting a DV, in that they 
could be used to characterize a given level of a nutrient for the 
purposes of nutrition labeling (72 FR 66103 at 66109). DVs are intended 
to help consumers understand the relative significance of information 
about the amount of certain nutrients in a food in the context of a 
total daily diet and to help consumers compare the nutritional values 
of food products. Permitting nutrient content claims on the basis of 
statements that do not identify the nutrient level to which the claims 
refer results in inconsistent and conflicting claims that can confuse 
consumers. Congress required that an authoritative statement identify 
the ``nutrient level to which the claim refers'' (section 403(r)(2)(G) 
of the FD&C Act) to help ensure consistency among different products 
from different manufacturers.
    Our use of ``nutrient level'' to mean a reference value that 
reflects a recommended or defined intake level that could serve as a 
basis for setting a DV is in keeping with the plain meaning of the word 
``level,'' both alone and in the statutory context in which the term is 
used. The Oxford English Dictionary defines ``level'' in relevant part 
as, ``A position (on a real or imaginary scale) in respect of amount, 
intensity, extent, or the like; the relative amount or intensity of any 
property, attribute, or activity. Freq. preceded by a sb. denoting the 
property, etc., referred to, as danger, energy, noise level.'' (See 
Level Definition, The Oxford English Dictionary (Second Edition 1998) 
(emphasis in the original).) Section 403(r)(2)(G) of the FD&C Act 
states, in relevant part: ``A claim of the type described in 
subparagraph (1)(A) for a nutrient . . . shall be authorized and may be 
made with respect to a food if . . . a scientific body . . . has 
published an authoritative statement . . . which identifies the 
nutrient level to which the claim refers.'' The word ``level'' is 
preceded by the word ``nutrient'' to denote the property referred to. 
The nutrient level serves to identify ``[a] position . . . in respect 
of amount,'' in the words of the dictionary definition; in other words, 
the authoritative statement must identify a specific amount of the 
nutrient in question. This nutrient level is the thing ``to which the 
claim refers,'' and our use of the ``nutrient level'' as a reference 
value is consistent with the plain meaning. The statutory phrase ``the 
nutrient level'' indicates that a single, precise nutrient level must 
be identified by the authoritative statement.
    Moreover, the meaning of the phrase ``nutrient level'' is further 
clarified by the statutory context in which the phrase appears, as well 
as related statutory provisions regarding how nutrient content claims 
function. Section 403(r)(2)(G) of the FD&C Act describes one way that 
claims ``of the type described in [403(r)(1)(A)]'' can be made. The 
type of claim described in section 403(r)(1)(A) of the FD&C Act is a 
claim that ``characterizes the level of any nutrient . . .,'' i.e., a 
nutrient content claim. Such claims characterize the specific amount of 
a nutrient that is found in one serving of a specific product by using 
terms such as ``good source.'' In general, such claims can only be made 
``if the characterization of the level made in the claim uses terms 
which are defined in regulations of the Secretary.'' (Section 
403(r)(2)(A)(i) of the FD&C Act.) We defined terms such as ``good 
source'' in a way that ties each

[[Page 23265]]

term's meaning to the DV that has been established by regulation for 
the nutrient in question--for example, ``good source'' claims can be 
made for foods that contain 10 to 19 percent of the DV for the relevant 
nutrient per reference amount customarily consumed (Sec.  101.54(c)). 
With respect to ``a nutrient, for which the Secretary has not 
promulgated a regulation,'' Section 403(r)(2)(G) of the FD&C Act allows 
for the possibility that a nutrient content claim can still be made, if 
an authoritative statement ``identifies the nutrient level to which the 
claim refers.'' We do not require that this nutrient level be an RDI or 
a DRV, but the nutrient level must be a single reference value or else 
it would be impossible to know when the definition for a term such as 
``good source'' had been met. Moreover, for a nutrient content claim to 
provide a meaningful characterization of the level of the nutrient, the 
reference value must be such that it helps consumers understand the 
relative significance of information about the amount of the nutrient 
in a food in the context of a total daily diet; Congress emphasized the 
importance of this goal in section 403(r)(2)(G)(iv) of the FD&C Act. We 
have determined that a reference value that reflects a recommended or 
defined intake level that could serve as a basis for setting a DV 
serves this purpose and is a ``nutrient level.'' Therefore, the meaning 
of ``nutrient level'' in section 403(r)(2)(G)(i) of the FD&C Act is a 
reference value that is similar to a label reference value for use in 
nutrition labeling, i.e., that reflects a recommended or defined intake 
level that could serve as a basis for setting a DV that could be used 
to characterize a given level of a nutrient for purposes of nutrition 
labeling.
    According to section 403(r)(2)(G)(i) of the FD&C Act, an 
authoritative statement that identifies the nutrient level to which the 
claim refers can be provided by a scientific body of the U.S. 
Government with official responsibility for public health protection or 
research directly relating to human nutrition or the NAS or any of its 
subdivisions, such as the IOM. The IOM provides authoritative 
statements on recommended or defined nutrient intake levels in the form 
of DRIs. DRIs include the Estimated Average Requirement, RDA, AI, and 
Tolerable Upper Intake Level. The IOM report does not establish any of 
these for DHA and EPA. The statements in the IOM report that use the 
terms ``approximately 10 percent'' do not identify a nutrient level for 
DHA and/or EPA. The statements describe the approximate contribution 
that DHA and EPA can make toward meeting the AI for ALA, but they do 
not reflect a recommended or defined intake level of DHA and/or EPA 
that could serve as a basis for setting a DV that could be used to 
characterize a given level of DHA and/or EPA. In fact, the three 
notifications reflect different readings of the IOM's statement: the 
seafood processors notification states that 10 percent of their 
proposed reference value for ALA results in a reference value for DHA 
or EPA; the Ocean Nutrition notification states that 10 percent of its 
proposed reference value for ALA results in a reference value for EPA 
and DHA combined; and the Martek notification states that 10 percent of 
its proposed reference value for ALA results in a reference value for 
DHA alone. (The three notifications also differ in that the Martek 
notification and the Ocean Nutrition notification conclude that 160 
milligrams (mg)/day is the nutrient level that is obtained by dividing 
by 10, while the seafood processors notification arrives at 130 mg/day, 
also by dividing by 10. This difference stems from a dispute as to 
whether 1.6 g/day is the appropriate nutrient level to use in nutrient 
content claims for ALA, or whether 1.3 g/day is the appropriate level. 
Because we find that none of the submitted claims for DHA and/or EPA is 
based on an authoritative statement that identifies a nutrient level 
for DHA and/or EPA, we do not reach the issue of addressing this 
discrepancy in the numbers.) The discrepancy in how the three 
notifications read the IOM's statements underscores the fact that the 
statements in the IOM report do not identify a nutrient level for DHA 
or EPA. Moreover, the statements in the IOM report are explicitly 
approximate, whereas the statutory and regulatory structure requires 
that a ``nutrient level'' be a single, precise reference value. 
Finally, we note that these statements do not appear to meet the 
National Research Council Governing Board of NAS' definition of an 
authoritative statement, in that they do not ``appear explicitly as 
findings, conclusions, or recommendations'' (see Docket No. FDA-2004-N-
0382) (Ref. 2)).
    We note that nutrient content claims may be based on authoritative 
statements from various sources and are not limited to authoritative 
statements from the IOM. Authoritative statements on defined nutrient 
intake levels from the IOM are provided in the form of DRIs and are 
only one source of such statements. Authoritative statements from other 
entities described in section 403(r)(2)(G)(i) of the FD&C Act that 
include nutrient levels that reflect a recommended or defined intake 
level that could serve as a basis for setting a DV also may be used as 
the basis for nutrient content claims. Absent such a statement, the 
FD&C Act allows interested persons to submit a petition for a nutrient 
content claim (section 403(r)(4) of the FD&C Act; 21 CFR 101.69).
    (Comment 2) Several comments asserted that the FD&C Act does not 
require us to use a specific approach to determine a reference nutrient 
value (i.e., population-coverage versus population-weighted). One 
comment noted that IOM recommended the use of a population-weighted 
approach for setting nutrient references values in its 2003 report 
entitled ``Dietary Reference Intakes: Guiding Principles for Nutrition 
Labeling and Fortification'' (hereinafter ``the IOM report on Guiding 
Principles'') (Ref. 3). Finally, the comments requested that we not act 
on current ALA nutrient content claims until after completing the 
rulemaking initiated by our Advance Notice of Proposed Rulemaking 
(ANPRM) on the Revision of Reference Values and Mandatory Nutrients (72 
FR 62149) (``DV ANPRM'') which sought public comment on what new 
reference values we should use to calculate the DVs in the Nutrition 
Facts label and what factors we should consider in establishing these 
new reference values.
    (Response) We disagree with the comments. The FD&C Act requires 
that a claim based on an authoritative statement have a nutrient level 
identified in the statement and be stated in a manner that enables the 
public to comprehend the information provided and to understand the 
relative significance of such information in the context of the daily 
diet (section 403(r)(2)(G)(iv) of the FD&C Act). Using two different 
approaches to set a reference value for ALA (i.e., the population-
weighted approach used in the seafood processors notification and the 
population-coverage approach used in the Martek notification) will 
result in inconsistent and conflicting nutrient content claims on food 
labels. Such inconsistencies make meaningful product-to-product 
comparisons impossible. To enable the public to comprehend the 
information provided in nutrient content claims and to understand the 
relative significance of that information in the context of the daily 
diet, as required by section 403(r)(2)(G)(iv) of the FD&C Act, 
qualifying ALA levels for nutrient content claims in food labeling must 
be based on a single nutrient value

[[Page 23266]]

determined using the same approach for reference values for other 
nutrients, which is currently the population-coverage approach 
established in the 1993 final rule for determining DVs (58 FR 2206). 
Therefore, to prevent inconsistent and conflicting claims on food 
labels, we are not taking regulatory action at this time with respect 
to ALA claims based on the population-coverage approach, but are 
prohibiting claims based on the population-weighted approach.
    We also disagree that we should not act on current ALA nutrient 
content claims until we have completed the rulemaking initiated by the 
DV ANPRM. The concurrent use of two different approaches to set a 
reference value for ALA will result in inconsistent and conflicting 
nutrient content claims on food labels. Because it may be some time 
before any rulemaking related to the DV ANPRM is finalized, we are 
taking action now to prevent inconsistent and conflicting claims by 
prohibiting ALA claims based on the population-weighted approach.
    (Comment 3) Several comments asserted that nutrient content claims 
constitute commercial speech and that, by not allowing the claims to 
appear on labeling, we would violate the First Amendment. One comment 
also noted, with respect to the claims regarding DHA and EPA, that we 
have not done an analysis on each claim to determine if the claims we 
propose to prohibit would be misleading and whether they could be cured 
by disclaimers, nor have we identified any safety concerns or provided 
evidence of consumers being misled by these nutrient content claims. 
Moreover, a number of comments stated that the FD&C Act allows us to 
modify claims to provide more information regarding the basis of the 
claims (for example through use of a disclosure or disclaimer) if any 
of the claims are found to be misleading, yet we have not done so. For 
all of these reasons, the comments asserted that prohibiting these 
claims could violate the First Amendment.
    (Response) FDA disagrees. As the preamble to the proposed rule 
explained (72 FR 66103 at 66104), the 1993 regulations that implemented 
the Nutrition Labeling and Education Act of 1990 (NLEA) created a 
procedure under which a person who wishes to make a nutrient content 
claim not already defined by regulation may petition us to authorize 
that claim under section 403(r)(4) of the FD&C Act (Sec.  101.69). 
Under that process, the petitioner must set forth an explanation of the 
reasons why the proposed claim meets the requirements of the FD&C Act 
and a summary of the scientific data supporting those reasons. (See 
section 403(r)(4)(B) of the FD&C Act.) We can either deny the petition 
or issue a proposed rule to take the action requested in the petition. 
If we issue a proposed rule, the rulemaking must be completed within 
540 days of the date the petition was received. (See section 
403(r)(4)(A)(i) of the FD&C Act).) The U.S. Court of Appeals for the 
Second Circuit upheld this statutory scheme and our implementation of 
it as constitutional. Nutritional Health Alliance v. Shalala, 144 F.3d 
220 (2d Cir. N.Y. 1998).
    FDAMA created an alternate, expedited notification process to allow 
certain nutrient content claims to be made without going through the 
petition process. (See H. Rept. 105-306 (1997) (``It is the Committee's 
intention that the FDA will use this authority primarily for the 
purpose of expediting review of petitions for health and nutrient 
content claims based on authoritative statements.'').) When the 
requirements of FDAMA's expedited notification process (as set out in 
section 403(r)(2)(G) of the FD&C Act) have been met, the claim can be 
made; preapproval by FDA is not required. If the requirements of 
section 403(r)(2)(G) of the FD&C Act have not been met, FDAMA's 
expedited path is not available. In such situations, the petition 
process outlined under section 403(r)(4) of the FD&C Act is the proper 
vehicle for submitting a proposed nutrient content claim to us. (See H. 
Rept. 105-306 (1997) (``The Committee emphasizes that this provision 
maintains the full range of existing FDA enforcement powers with 
respect to claims made in violation of the statutory requirements.'').)
    The petition process set forth in section 403(r)(4) of the FD&C Act 
relates only to two types of labeling claims: ``nutrient content 
claims,'' which are claims of the type described in section 
403(r)(1)(A) of the FD&C Act; and ``health claims,'' which are claims 
of the type described in section 403(r)(1)(B) of the FD&C Act. FDAMA's 
alternate, expedited route also applies only to these two types of 
claims. (See sections 403(r)(2)(G) through (r)(2)(H) and 403(r)(3)(C) 
through (r)(3)(D) of the FD&C Act.) (This rulemaking concerns only 
nutrient content claims.) There are numerous other types of claims that 
can be made on food and supplement labeling, including many types of 
claims that can lawfully be made about the presence of DHA or EPA. (See 
72 FR 66103 at 66109.) Under Sec.  101.13(i)(3) (21 CFR 101.13(i)(3)), 
the label or labeling of a food may contain a statement about the 
amount or percentage of a nutrient if the statement does not, 
explicitly or implicitly, characterize the level of the nutrient in the 
food and is not false or misleading in any respect. For example, a 
conventional food or a dietary supplement may bear a statement such as 
``X mg of EPA and DHA omega-3 fatty acids per serving.'' Also, under 
Sec.  101.13(q)(3)(ii)(A), dietary supplements are permitted to bear 
simple percentage claims (e.g., 40 percent EPA and DHA omega-3 fatty 
acids), and under 21 CFR 101.14(q)(3)(ii)(B), they are permitted to 
bear comparative percentage claims (e.g., ``four times the EPA and DHA 
omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil 
(20 mg)''). Furthermore, in 2003, we announced our intention to 
exercise our enforcement discretion with respect to the following 
qualified health claim, which companies can use to describe to 
consumers the potential health benefits of consuming EPA and DHA: 
``Supportive but not conclusive research shows that consumption of EPA 
and DHA omega-3 fatty acids may reduce the risk of coronary heart 
disease. One serving of [name of food] provides [x] grams of EPA and 
DHA omega-3 fatty acids. [See nutrition information for total fat, 
saturated fat and cholesterol content.]'' See Letter Responding to 
Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3 
Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No. 
2003Q-0401) (available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072932.htm); see also 
Letter Responding to Health Claim Petition dated June 23, 2003 
(Wellness petition): Omega-3 Fatty Acids and Reduced Risk of Coronary 
Heart Disease (Docket No. 2003Q-0401) (available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072936.htm).
    Section 403(r)(2)(G) of the FD&C Act takes place within this 
broader labeling context. Nutrient content claims, such as the ones 
about DHA, EPA, and ALA that the notifiers here seek to make, are just 
one, very specific, statutorily-defined type of labeling claim. When a 
company wishes to make such a claim about a nutrient for which FDA has 
not identified a nutrient level, the company generally must use the 
process set forth in section 403(r)(4) of the FD&C Act; this process 
has been upheld as constitutional. (See Nutritional Health Alliance v. 
Shalala, 144 F.3d 220 (2d Cir. N.Y. 1998).) FDAMA creates an alternate, 
expedited route, but only in

[[Page 23267]]

situations where all of the requirements of section 403(r)(2)(G) of the 
FD&C Act have been met.
    Our application of section 403(r)(2)(G) of the FD&C Act to the 
notifications concerning EPA and DHA and the notifications concerning 
ALA is constitutional, as explained herein:

A. DHA and EPA

    With respect to the proposed claims regarding DHA and EPA, our 
response to comment 1 explains that the notifiers have not met the 
requirement of section 403(r)(2)(G)(i) of the FD&C Act that each 
proposed claim be based on an authoritative statement that identifies a 
nutrient level to which the proposed claim refers. We therefore find 
that these claims may not be used in food labeling.
    When we establish by regulation particular definitions for terms 
(such as ``good source''), the use of such terms without complying with 
the established definitions is inherently misleading, and therefore not 
protected by the First Amendment, see Central Hudson Gas & Elec. Corp. 
v. Public Serv. Comm'n of New York, 447 U.S. 557, 563 (1980); see also 
In re R.M.J., 455 U.S. 191, 203 (1982), because such use implies that 
the definitions and other statutory and regulatory requirements have 
been met, which they have not. See, e.g., Am. Acad. of Pain Mgmt v. 
Joseph, 353 F.3d 1099, 1108 (9th Cir. 2004) (finding that the use of 
the term ``board certified'' is inherently misleading when its use does 
not conform to the statutory definition of that term); see also United 
States v. Articles of Food * * * Clover Club Potato Chips, 67 F.R.D. 
419, 424 (D. Idaho 1975) (``Freedom of [s]peech does not include the 
freedom to violate the labeling provisions of the Federal Food, Drug, 
and Cosmetic Act.''). Furthermore, insofar as the proposed claims state 
or imply that a daily value for DHA or EPA has been established, the 
claims are false, and are not afforded First Amendment protection. See 
Central Hudson, 447 U.S. at 563; see also In re R.M.J., 455 U.S. at 
203.
    The comments seem to suggest that, even if we find that the 
proposed DHA and EPA claims are not based on an authoritative statement 
that identifies a nutrient level as required by statute, the First 
Amendment nonetheless requires us to allow the claims to appear and to 
use a disclaimer to cure the flaw. The comments did not indicate what 
the disclaimer would be, and indeed, we conclude that there is no 
disclaimer that could cure the fundamental flaw of the proposed DHA and 
EPA claims: namely, that the claims are not based on an authoritative 
statement that identifies a nutrient level, as required by statute. Cf. 
Wallach v. Crawford, 2005 U.S. Dist. LEXIS 43700 (S.D. Cal. Mar. 29, 
2005) (``A disclaimer regime simply cannot provide the same protection 
that Congress envisioned. . ..''). One comment seemed to suggest that 
consumer research could help identify an appropriate disclaimer. 
However, the statute does not permit the use of FDAMA's expedited 
process unless an authoritative statement identifying a nutrient level 
has been made. We have concluded that the statutory threshold has not 
been met, and that these claims cannot be permitted under the FD&C Act. 
These conclusions are not amenable to further exploration through 
consumer research. Cf. Alliance for Natural Health U.S. v. Sebelius, 
786 F.Supp.2d 1, 14 (D.D.C. 2011) (``Pearson [v. Shalala], 164 F.3d 650 
(D.C. Cir. 1999)] does not require the FDA to make an empirical showing 
of the inefficacy of a disclaimer before prohibiting a claim'' that is 
``unprotected commercial speech that can be prohibited under the 
threshold step of the Central Hudson analysis.'').

B. ALA

    One comment stated that we would violate the First Amendment by 
prohibiting the ALA claims proposed in the seafood processors 
notification.
    We disagree. Under section 403(r)(2)(G)(iv) of the FD&C Act, ``The 
claim must be an accurate representation of the authoritative statement 
and must be stated in a manner that enables the public to comprehend 
the information provided by the claim and to understand the relative 
significance of such information in the context of the total daily 
diet.'' (See section 403(r)(2)(G)(iv) of the FD&C Act.) As we discussed 
in more detail under Comment 2, we have determined that the proposed 
ALA claims that are based on population-weighted AIs do not enable the 
public to understand the claims' relative significance in the context 
of the total daily diet because using two different approaches to set a 
reference value for ALA will result in inconsistent and conflicting 
nutrient content claims on food labels. The claims therefore do not 
conform to the requirements of the FD&C Act and, like the DHA and EPA 
claims discussed previously, cannot be made.
    Furthermore, the ALA claims that are based on population-weighted 
AIs are inherently misleading, and thus not entitled to First Amendment 
protection, see Central Hudson, 447 U.S. at 563, and In re R.M.J., 455 
U.S. at 203, because the use of two different daily values for ALA 
would result in inconsistent and contradictory nutrient content claims. 
Consumers cannot make meaningful product-to-product comparisons based 
on such claims.
    The ALA claims take place against a backdrop where all other food 
labeling references to nutrient levels are based on the population-
coverage approach. In most situations, the reference value that results 
from the population-coverage approach will be higher than the reference 
value that results from the population-weighted approach; thus, by 
using the latter method, a company can in effect hold itself to a lower 
standard when making claims such as ``good source'' or ``high.'' For 
example, by using population-weighted AIs, a company taking the seafood 
processors' approach could claim, at the point of sale, that the 
reference value for ALA is 1.3 g/day, even while companies taking 
Martek's approach, which uses the population-coverage approach, are 
claiming, based on the same IOM report, that the reference value for 
ALA is 1.6 g/day. Furthermore, on the label of a product that contained 
0.3 g of ALA, those taking the seafood processors' approach would 
declare the product to be ``high'' in ALA, because 0.3 g is 
approximately 23 percent of 1.3 g; however, those taking Martek's 
approach would declare an identical product to only be a ``good 
source'' of ALA, because 0.3 g is only 18.75 percent of 1.6 g. The 
presence of these conflicting claims is inherently misleading. More 
generally, the claim proposed by the seafood processors is inherently 
misleading in the context of FDA's current labeling regime, which 
relies solely on the population-coverage approach, because the seafood 
processors' claim would create contradictory information about the 
meaning of ``good source'' when used to characterize the level of a 
nutrient.
    Even if a disclaimer or other modification were to explain that a 
given claim arose as a result of a certain statistical method for 
computing nutrient levels, this would not change the fact that terms 
such as ``high'' or ``good source'' would have two different meanings 
under this hypothetical regime. This is precisely what Congress sought 
to avoid when it passed the NLEA, and it is what we sought to avoid 
when we issued regulations under that statute, defining terms such as 
``high'' and ``good source.'' See, e.g., 136 Cong. Rec. H5836-01, H5840 
(July 30, 1990) (statement of Rep. Waxman); 136 Cong. Rec. H12951-02, 
H12953-54 (October 26, 1990) (statement of Rep. Madigan). (See also 56 
FR 60421 at 60423, (November 27, 1991) (``Inconsistent use of the same 
term on various products

[[Page 23268]]

could lead to consumer confusion and nonuniformity in the marketplace. 
To ensure that consumers are not misled and are given reliable 
information, Congress found, and FDA agrees, that it is appropriate for 
the Agency to establish specific definitions to standardize the terms 
used by manufacturers to describe the nutrient content of foods.''); 
see also 58 FR 2302. The purpose of FDA-regulated nutrient content 
claims is to provide the public with meaningful information about the 
content of a product within the context of the total daily diet. This 
purpose is only served if terms such as ``high,'' ``good source,'' and 
the other terms defined at Sec.  101.54 (21 CFR 101.54) are given a 
consistent meaning for all nutrients that are the subject of such 
claims, so that consumers have meaningful information to compare.
    We therefore conclude that the ALA claims that are based on a 
population-weighted approach are inherently misleading, and thus not 
entitled to First Amendment protection. But even if the seafood 
processors' proposed claims were not inherently misleading, prohibiting 
the claims would still be permissible under the First Amendment. Though 
we have concluded that the claims are inherently misleading, this 
section nonetheless goes on to analyze this point.
    In Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of New 
York, 447 U.S. 557 (1980), the Supreme Court laid out a four-part test 
to analyze whether a Government restriction on commercial speech is 
constitutional. The first step under Central Hudson is to determine 
whether or not the speech at issue is protected by the First Amendment. 
If the speech is found to be protected by the First Amendment--which we 
do not find to be the case here, but which is a scenario that we are 
nonetheless analyzing--the second requirement of Central Hudson is that 
``the State must assert a substantial interest to be achieved'' by the 
proposed action. Central Hudson, 447 U.S. at 564. Here, the Government 
has a substantial interest in promoting the public health, preventing 
inconsistent and contradictory labeling claims (and thereby preventing 
consumer confusion), and maintaining the integrity of the food label so 
that consumers will have access to meaningful information that they can 
understand in the context of a total daily diet and that will enable 
them to make meaningful product-to-product comparisons so they can 
select foods that can lead to healthier diets (see Pearson, 164 F.3d at 
656; Rubin v. Coors Brewing Co., 514 U.S. 476, 485 (1995); Fleminger v. 
U.S. Dep't of Health and Human Servs., 854 F. Supp. 2d 192, 208 (D. 
Conn. 2012); and 58 FR 2302).
    The next question under Central Hudson is whether the government 
action ``directly advances the governmental interest asserted.'' 
Central Hudson, 447 U.S. at 566. The need for consistent labeling 
claims that would help consumers select healthier foods is the precise 
issue that Congress sought to address when passing the portions of the 
NLEA that address nutrient content claims. See, e.g., 136 Cong. Rec. 
H5836-01, H5840 (July 30, 1990) (statement of Rep. Waxman) (``[Under 
the NLEA,] content claims would have to be consistent with terms 
defined by . . . the Food and Drug Administration. Today, companies use 
terms such as `low' and `light' differently and inconsistently. . . . 
The bill would correct this deceptive and misleading state of affairs 
by requiring that terms such as `light' have a single meaning.'') and 
id. at H5843 (statement of Rep. Madigan) (``Consumers today are 
confronted with a variety of labels that provide them with disjointed 
and confusing information. . . . In the past few years, important 
scientific evidence has been repeatedly reported that clearly links 
dietary habits to good health. For this reason, the need to provide 
consumers with better information about the foods they eat is 
important.''); see also 136 Cong. Rec. H12951-02, H12953-54 (October 
26, 1990) (statement of Rep. Madigan) (``[T]he bill requires that 
content claims such as light, low, et cetera, would have to be 
consistent with terms defined by the FDA. This is to address the 
current problem of companies using these terms differently and 
inconsistently.''). Requiring that all nutrient levels be computed in 
the same way so that words such as ``high'' will have a consistent 
meaning directly advances the goals of preventing inconsistent and 
contradictory claims in food labeling, maintaining the integrity of the 
food label, and promoting public health. The result is labels that 
contain meaningful information that the consumer can understand in the 
context of a total daily diet. Such labels allow consumers to make 
meaningful product-to-product comparisons and to select foods that can 
lead to healthier diets.
    The final question under Central Hudson is ``whether the fit 
between the government's ends and the means chosen to accomplish those 
ends `is not necessarily perfect, but reasonable.' '' See Pearson, 164 
F.3d at 656, quoting Fox, 492 U.S. at 480. The Government's approach 
here is narrowly tailored to advance the Government's interest in 
preventing inconsistent and contradictory claims, maintaining the 
integrity of the food label, and promoting the public health, while not 
unnecessarily infringing speech. Nutrient content claims are not 
prohibited, but instead are permitted under a range of circumstances. 
Nutrient content claims based on an authoritative statement may be 
used, provided that the relevant nutrient reference level is not based 
on an approach that results in inconsistent and contradictory 
information. In this situation, we are taking no regulatory action at 
this time with regard to a nutrient content claim for ALA that uses the 
population-coverage approach to determine the nutrient level; that 
claim may therefore be used. The comments have advanced no argument to 
explain why the use of multiple, inconsistent statistical methods that 
generate inconsistent and contradictory claims would be preferable for 
consumers. Such claims would, in fact, impede the ability of consumers 
to make meaningful product-to-product comparisons, and therefore to 
make informed purchasing decisions. We also note that, in addition to 
the population coverage-based ALA claims about which we are taking no 
action at this time, other opportunities exist for companies to make 
labeling statements regarding ALA in their products; for example, 
labeling that simply states the amount of a nutrient may be made in 
accordance with Sec.  101.13(i).
    Moreover, we have concluded that no disclaimer could cure the 
fundamental contradiction and inconsistency resulting from the proposed 
ALA claims that are based on the population-weighted approach. No 
disclaimer would cure the fundamental flaw presented here: that the use 
of two different daily values for ALA would render the nutrient content 
claims that were based on those reference values inconsistent with one 
another, and would therefore impede consumers' ability to make 
meaningful product-to-product comparisons based on those claims. A 
disclaimer cannot bring clarity to a situation where a fundamental 
contradiction remains. See Resort Car Rental System, Inc. v. FTC, 518 
F.2d 962, 964 (9th Cir.) (per curiam), cert denied, 423 U.S. 827 
(1975); Continental Wax Corp. v. FTC, 330 F.2d 475, 480 (2d Cir. 1964); 
United States v. Millpax, Inc., 313 F.2d 152, 154 & n.1 (7th Cir. 
1963); Pasadena Research Labs v. United States, 169 F.2d 375, 383-84 
(9th Cir. 1948). Labeling that states the amount of a nutrient may be 
made under Sec.  101.13(i);

[[Page 23269]]

the purpose of nutrient content claims is to use words such as ``high'' 
and ``good source,'' which, because they are defined by regulation, 
place that type of information in the context of the total daily diet. 
This purpose is only served if the terms defined at Sec.  101.54 are 
given a consistent meaning.
    (Comment 4) A number of comments suggested that FDA should 
establish, through notice and comment rulemaking, DVs for DHA and EPA 
for use in nutrient content claims and requested that FDA continue to 
allow the current claims for DHA and EPA until DVs can be established.
    (Response) We disagree that we should continue to allow these 
claims, pending a rulemaking to establish DVs for DHA and EPA, for the 
reasons set forth in this final rule for prohibiting such claims. Under 
section 403(r)(4) of the FD&C Act and Sec.  101.69, interested persons 
can submit a petition for the authorization of nutrient content claims.
    (Comment 5) A number of comments stated that we did not respond to 
the notifications in a timely manner and that, as a consequence, many 
manufacturers would be affected financially by a prohibition of certain 
omega-3 nutrient content claims. Several comments stated that there 
could be a possible negative health impact in removing omega-3 claims 
that have existed for some time in the marketplace, including increased 
consumer confusion regarding recommended intakes of omega-3 fatty 
acids. Other comments requested that, because the omega-3 nutrient 
content claims have been lawful and in use in the marketplace for some 
time, FDA should provide a transition period to phase them out (e.g., 1 
year) if the Agency decides to prohibit certain omega-3 nutrient 
content claims.
    (Response) We disagree with the comments asserting that we did not 
act in a timely manner. Section 403(r)(2)(G)(ii) of the FD&C Act, 
permits a food bearing a nutrient content claim based on an 
authoritative statement to be introduced into interstate commerce 120 
days after notifying FDA. The claim may be made until we issue a 
regulation prohibiting the claim, modifying the claim, or finding that 
the requirements of the FD&C Act have not been met, or a district court 
of the United States determines that the requirements of the FD&C Act 
have not been met (section 403(r)(2)(H) of the FD&C Act). We received 
three separate notifications for omega-3 fatty acids over a 2-year 
period ending in December 2005. Because the notifications addressed the 
same issue, we conducted a collective review of the notifications and 
determined that all three notifications should be addressed in the same 
rulemaking, rather than separately. In June 2004, we publicly announced 
our intention to issue rulemaking to prohibit some of the nutrient 
content claims (see Docket No. FDA-2004-N-0382) (Ref. 4) and, less than 
2 years after the receipt of the final notification, we issued the 
proposed rule.
    We agree with the comments requesting a transition period. In this 
final rule, we conclude that certain omega-3 fatty acid nutrient 
content claims set forth in the three notifications do not meet the 
requirements of section 403(r)(2)(G) of the FD&C Act and, therefore, 
are prohibited from use in food labeling. We are providing a period for 
transition, and this rule will become effective on the next uniform 
compliance date for labeling regulations. The next uniform compliance 
date is January 1, 2016, and it applies to food labeling regulations 
issued between January 1, 2013, and December 31, 2014.

III. Summary of the Final Rule

    Given the information discussed in the preamble to the omega-3 
proposed rule and the absence of contrary information in the comments, 
and under our authority under section 403(r)(2)(H)(i)(I) of the FD&C 
Act, FDA is adopting as a final rule, without change, the proposal to 
prohibit the nutrient content claims for DHA and EPA set forth in the 
seafood processors notification, the Martek notification, and the Ocean 
Nutrition notification and the nutrient content claims for ALA set 
forth in the seafood processors notification. We express no conclusions 
as to whether the ALA claims in the Martek notification are supported 
by an authoritative statement that satisfies the requirements of 
section 403(r)(2)(G) of the FD&C Act. We are taking no regulatory 
action at this time with respect to the nutrient content claims for ALA 
set forth in the Martek notification and, therefore, these claims, 
which are set forth in table 1, will be allowed to remain on the market 
at this time.

                        Table 1--Nutrient Claims
------------------------------------------------------------------------
                                         Conditions for making the claim
     Nutrient content claim for ALA                    \1\
------------------------------------------------------------------------
High...................................  >= 320 mg of ALA per RACC (>=
                                          20% of 1.6 g/day)
Good Source............................  >= 160 mg of ALA per RACC (>=
                                          10% of 1.6 g/day)
More...................................  >= 160 mg of ALA more per RACC
                                          than an appropriate reference
                                          food (>= 10% of 1.6 g/day)
------------------------------------------------------------------------
\1\ Nutrient content claims must comply with all applicable FDA
  regulations regarding the making of such claims.

IV. Analysis of Impacts

    We have examined the impacts of the 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 Order 12866 directs Agencies 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 
concluded that this final rule is not a significant regulatory action 
under the Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. We have concluded that this final rule may have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in 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 $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    This final regulatory impact analysis revises the initial 
regulatory impact analysis set forth in the proposed rule (72 FR 66103) 
in response to comments on the proposed rule. Except for the revisions 
that we indicate in this section of the document, the analysis for the

[[Page 23270]]

final rule is the same as the analysis for the proposed rule.

A. Benefit-Cost Analysis

1. The Need for This Rule

    We discuss any comments on the legal and regulatory need for this 
rule in section II of this document.
2. Options
    In the analysis for the proposed rule, we analyzed the following 
two regulatory options: (1) Take no new regulatory action and (2) 
prohibit the DHA and EPA claims and the ALA claims based on a reference 
value of 1.3 g/day, but allow the ALA claims based on a reference value 
of 1.6 g/day.
a. Option 1: Take No New Regulatory Action
    We did not receive any comments on the selection of this option as 
the baseline.
b. Option 2: Take the Regulatory Actions as Described in the Proposed 
Rule
    (Comment 6) One comment asserted that the economic analysis for the 
proposed rule did not fulfill the requirements of Executive Order 12866 
because we said that we could not estimate the public health impacts of 
eliminating nutrient content claims for DHA and EPA because we had not 
yet conducted a review of the scientific evidence concerning the health 
effects of consuming DHA and EPA at various levels. The comment 
suggested that we review the relevant scientific evidence to complete 
the analysis. The comment also noted that we previously reviewed at 
least some of the scientific evidence relating to cardiovascular 
effects in the context of qualified health claims for DHA and EPA. The 
comment said that, on that basis alone, FDA could present a more 
detailed analysis of potential health costs than it presented in the 
analysis for the proposed rule.
    Other comments said that eliminating existing nutrient content 
claims for DHA and EPA would generate public health costs. These 
comments linked DHA and/or EPA to preventing cardiovascular disease, 
reducing cardiac mortality including sudden death in patients with no 
sign of cardiovascular conditions and cardiovascular events in 
hypercholesterolemic patients, growth, neurodevelopment including brain 
and eye development in infants, intelligence quotients, and improved 
mental acuity and overall quality of life for consumers facing age-
related cognitive decline, including Alzheimer's disease. The comments 
also noted possible links to the prevention and treatment of arthritis, 
inflammatory and autoimmune diseases, and cancer. One comment noted 
that current average intake of DHA and EPA is estimated to be 100 to 
200 mg/day in the United States, which is below the intake recommended 
by various organizations.
    (Response) In the analysis for the proposed rule, we said that we 
could not determine whether eliminating existing nutrient content 
claims for DHA and EPA would have any impact on consumer health because 
we had not yet conducted a review of the scientific evidence on the 
health effects of consuming DHA and EPA at different levels. The 
information presented in these comments suggests that eliminating 
nutrient content claims for DHA and EPA could lead to health costs. 
However, because we have not yet conducted a comprehensive review of 
the scientific evidence, we cannot revise the analysis of the final 
rule to account for these potential effects.
    (Comment 7) A number of comments addressed the relative merits of 
nutrient content claims, qualified health claims, and quantitative 
statements. One comment stated that qualified health claims are a poor 
substitute for nutrient content claims and that eliminating nutrient 
content claims would reduce opportunities for firms to communicate with 
consumers about EPA and DHA. The comment looked at health claims 
appearing on new omega-3 fatty acid and DHA and/or EPA products in the 
Mintel Global New Products Database between June 2006 and November 2007 
and found that 24 percent were nutrient content claims, 56 percent were 
quantitative statements, and 20 percent were structure function claims. 
The comment suggested that nutrient content claims and quantitative 
statements predominated because they are relatively simple and easy to 
understand. One comment said that qualified health claims and 
quantitative statements do not enable consumers to consider the 
relative significance of the claims and statements in the context of 
the total daily diet. This comment said that without nutrient content 
claims, consumers would be unable to determine if quantitative content 
differences are significant or to readily identify foods that contain 
meaningful levels of omega-3 fatty acids. Finally, the comment noted 
that removing nutrient content claims would significantly diminish the 
incentives for firms to innovate and to improve the nutritional 
properties of food. One comment noted that we permit qualified health 
claims on products regardless of the level of DHA or EPA in those 
products. The comment said that we did not consider the potential 
health costs generated by consumers switching to products having 
potentially lower levels of DHA and/or EPA. One comment said that 
prohibiting DHA and EPA claims after they have appeared for several 
years would lead consumers to question the dietary value of these 
nutrients. One comment said that allowing quantitative statements about 
the level of DHA and/or EPA in products without providing some context 
of the significance of those levels would confuse consumers.
    (Response) Our analysis for the proposed rule did not claim that 
the availability of qualified health claims implied that eliminating 
nutrient content claims for DHA and EPA would have no impact on product 
innovation, consumption of these substances, or consumer health. We 
said that eliminating nutrient content claims for DHA and EPA might 
result in reduced consumption of DHA and EPA under two scenarios. 
First, consumers might reduce their consumption of these nutrients if 
they choose not to purchase and consume products that do not have the 
relevant nutrient content claims on the label. Second, producers may 
choose not to reformulate products with higher levels of DHA and/or EPA 
if they cannot use nutrient content claims to communicate these higher 
levels to consumers. However, we did not consider potentially reduced 
consumption resulting from the following mechanisms discussed in some 
comments: consumers switching to products with qualified health claims 
that may have lower levels of DHA and/or EPA, consumers who choose not 
to consume products with DHA and/or EPA because they question the 
dietary value of these nutrients due to the disappearance of nutrient 
content claims, and consumers who become confused about the 
significance of particular levels of DHA and EPA due to the 
disappearance of nutrient content claims. Therefore, we revise our 
analysis to include these additional pathways by which this final rule 
may reduce consumption of omega-3 fatty acids, but we still reach the 
same conclusion: Because we have yet to conduct a review of the 
scientific evidence concerning the health effects of consuming EPA and 
DHA at different levels, we cannot determine whether the loss of these 
claims would have any impact on consumer health, either beneficial or 
detrimental.
    (Comment 8) Some comments said that FDA did not present a 
statistically representative portrait of the number of products 
containing DHA and/or EPA and instead relied on products that we found 
in grocery stores in the

[[Page 23271]]

Washington, DC metropolitan area and on Internet grocery stores.
    (Response) We did not present our estimates in the analysis for the 
proposed rule as a statistically representative portrait of the number 
of products containing DHA and/or EPA. Constructing a statistically 
representative portrait would be very costly and would not be 
worthwhile because it would not change the conclusions of the analysis. 
We have estimated that this rule will generate very small costs that 
are considerably below the cutoff for classifying a rule as significant 
under Executive Order 12866, so performing a statistically 
representative study would probably not change the status of this rule 
under that Executive Order. In addition, we were unable to quantify 
benefits, so obtaining more precise cost estimates would not allow the 
Agency to revise its analysis of net benefits.
    (Comment 9) One comment said that we only considered seafood, eggs, 
pasta, and dietary supplement products, and we excluded many of the 
emerging categories of foods that firms enrich with omega-3 fatty 
acids. The comment said that these emerging categories are categories 
that contain foods that traditionally do not contain omega-3 fatty 
acids. According to this comment, food manufacturers tend to rely 
heavily on nutrient content claims to communicate the benefits of DHA 
and EPA enrichment over other products within these categories. The 
comment stated that some of these categories include fresh and shelf-
stable milks, spoonable yogurts, yogurt drinks, fermented milk drinks, 
cheeses, butters, fat-based spreads, juices, juice smoothies, soy 
milks, packaged breads, meats from grass-fed animals, packaged meats, 
baby foods, chocolate confections, cooking oils, packaged soups, ice 
creams, nutritional bars, and frozen pizzas. One comment said that 
firms are currently making nutrient content claims involving ALA, DHA, 
and EPA on dairy products. The comment said that we did not account for 
the costs associated with these products in the analysis for the 
proposed rule. One comment stated that we underestimated the number of 
products and labels affected by the proposed rule. The comment noted 
that, in the analysis for the proposed rule, we said that we found 113 
qualifying dietary supplements in the Dietary Supplements Sales 
Information database, but that when we searched a single retailer, 
Amazon.com, we turned up 2,224 dietary supplement labels (stock keeping 
units or SKUs) containing ``fish oil.'' The comment said that we also 
underestimated the number of SKUs for eggs and seafood.
    (Response) We were unable to locate information on products bearing 
omega-3 nutrient content claims in the specific product categories 
mentioned in this comment. However, we did locate data indicating that 
firms introduced 369 new food and beverage products bearing omega-3 
claims in the United States from 1999 to 2014 (Ref. 5). We do not know 
how many of these products remain on the market, nor do we know how 
many of these products bear one or more of the relevant nutrient 
content claims. Therefore, this number represents the maximum number of 
such products currently on the market.
    In the preamble to the proposed rule, we identified only one 
conventional food product that firms enriched with omega-3 fatty acids. 
We estimated that two such products probably existed on the market, and 
estimated a label change cost of $17,000, or $8,500 per product. If we 
apply this cost to 369 products, we get an estimated cost of 
approximately $3 million. Therefore, in this final rule, we have 
revised the previous estimate of the total cost of labeling changes 
from $0.08 million to approximately $3 million.
    (Comment 10) One comment said that firms launched a significant 
number of products enriched with DHA and EPA in part because they were 
able to communicate some of the benefits of DHA and EPA using nutrient 
content claims. This comment said that we did not consider the loss of 
sales that would result if these firms were unable to communicate the 
relative enrichment levels of DHA and EPA in these products, but that 
we instead only considered the cost of relabeling these products. One 
comment stated that we did not account for the loss of the return on 
investment in product development.
    (Response) Once the final rule becomes effective, firms will retain 
some ability to communicate levels of omega-3 fatty acid content to 
consumers by using amount or percentage statements and qualified health 
claims. These statements might not be as effective as express nutrient 
content claims (e.g., ``high'') in encouraging consumers to buy these 
products. Therefore, sales of these products and the return on 
investment for developing these products may decline. We would classify 
these effects as distributive impacts rather than social costs because 
we have based our rule on the notion that these nutrient content claims 
lack the scientific support that an authoritative statement would 
provide. Therefore, consumer demand based on these nutrient content 
claims does not represent the true demand for these products and 
prohibiting these nutrient content claims will not generate social 
costs for consumers. However, some firms may lose sales and profits and 
some firms may gain sales and profits. We cannot estimate this 
distributive impact because we do not know how much money firms have 
spent developing these products or the impact of eliminating nutrient 
content claims for DHA and/or EPA on the sales of these products. 
However, we revised the analysis by noting that firms that produce 
products or that planned to produce products bearing these nutrient 
content claims may lose profits, while firms producing competing 
products may gain profits.
    (Comment 11) One comment said that we were rejecting the nutrient 
content claims presented in the seafood processors notification based 
on our approach to calculating a nutrient reference value. This comment 
noted that we had published the DV ANPRM (72 FR 62149) inviting 
comments on what new reference values we should use to calculate the 
DVs in the Nutrition Facts label and what factors we should consider in 
establishing such new reference values. The comment noted that if we 
change our position on setting reference values, then we might need to 
reverse our position on the nutrient content claims in the seafood 
processors notification, which would generate additional label changes 
and also confuse consumers.
    (Response) Even if we were to establish, in the future, a 
population-weighted approach for DVs that would allow the nutrient 
content claims in the seafood processors notification and thus allow 
firms to make additional label changes, we can infer that any such 
label changes would be associated with positive net benefits. Firms 
that were using the nutrient content claims in the seafood processors 
notification and that stopped using those claims because of this final 
rule might be able to resume using those claims. However, because such 
label changes would be voluntary, manufacturers would not choose to 
make them unless consumers valued the changes at least enough to cover 
the cost of such changes. Manufacturers are not likely to voluntarily 
make nutrient content claims if the addition would confuse consumers 
and negatively impact sales. We would not allow such label changes if 
we determined them to be false or misleading; therefore, we would infer 
that any additional value consumers placed on such products is related 
to the value of the new information. In addition, changes in product 
labeling are not particularly

[[Page 23272]]

unusual, so it is unlikely that many consumers would be confused if the 
nutrient content claims on particular products disappeared and later 
reappeared.
    (Comment 12) One comment said that a single label change can cost 
dairy processors up to $5,000 per label for a new label design and new 
printing plates. The comment noted that firms would also need to 
dispose of obsolete packaging and that, in the past, companies have 
estimated these costs in the tens to hundreds of thousands of dollars, 
depending on the number of SKUs.
    (Response) In the analysis for the proposed rule, we estimated the 
cost of changing labels using a model developed for us for that 
purpose. The model included designing new labels, producing new 
printing plates, and disposing of obsolete packaging. We estimated 
costs per SKU of between $2,300 and $8,400. This figure implies that a 
large company producing many SKUs could face costs of tens to hundreds 
of thousands of dollars for disposing of obsolete packaging. Therefore, 
this comment is consistent with the analysis for the proposed rule.

B. Benefits

    (Comment 13) One comment said that there is no scientific evidence 
supporting health benefits of 160 mg of DHA and/or EPA per day but 
that, on the contrary, the science supports much higher levels. This 
comment said that to allow the use of an ``excellent source'' claim for 
this level of these nutrients might cause consumers to lose confidence 
in package claims.
    (Response) Some consumers may have experienced a reduction in their 
confidence in package claims based on the discrepancy between nutrient 
content claims describing products with 160 mg of DHA and/or EPA as an 
excellent source of these nutrients and the level of these nutrients 
recommended by some scientific organizations. These consumers may 
experience increased confidence in package claims when this discrepancy 
is eliminated. Increased confidence in package claims could lead to 
health benefits from better dietary choices based on package claims. We 
do not have sufficient information to estimate this potential benefit.

C. Regulatory Flexibility Analysis

    We have examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities. We find that this final rule may have a significant 
economic impact on a substantial number of small entities.
    The Regulatory Flexibility Act requires that FDA present a succinct 
statement of a rule's objectives. We discussed the legal and regulatory 
need for this rule in section II of this document and in section III in 
the preamble of the proposed rule (72 FR 66103 at 66107). The intent of 
this rule is to eliminate certain nutrient content claims that do not 
have the scientific justification that an authoritative statement would 
provide or that are not stated in a manner that enables the public to 
comprehend the information provided in the claim and to understand the 
relative significance of the information in the context of a total 
daily diet. In so doing, the rule enables consumers to identify 
suitable products.
    In the analysis for the proposed rule, we said that the proposed 
rule would not have a significant effect on a substantial number of 
small entities. We based that conclusion on our review of the labels in 
the marketplace. However, one comment on the benefit-cost analysis in 
the proposed rule suggested that we had overlooked a number of 
products. Based on that comment, we estimated a new range of 
potentially affected products in the final benefit-cost analysis. The 
new range of potentially affected products suggests that the final rule 
might have a significant effect on a substantial number of small 
entities.
    In the benefit-cost analysis for this rule, we estimated that the 
final rule would affect a maximum of 369 products. We were not able to 
identify the firms that produce these products. However, in the 
analysis for the proposed rule, we estimated that four products were 
associated with four manufacturers. Therefore, we assume that 369 
products may be associated with 369 manufacturers. We also were not 
able to identify these products, although the comments indicated that 
they include products from the following categories: seafood, pasta, 
eggs, fresh and shelf-stable milks, spoonable yogurts, yogurt drinks, 
fermented milk drinks, cheeses, butters, fat-based spreads, juices, 
juice smoothies, soy milks, packaged breads, meats from grass-fed 
animals, packaged meats, baby foods, chocolate confections, cooking 
oils, packaged soups, ice creams, nutritional bars, and frozen pizzas.
    The Small Business Administration (SBA) publishes size standards 
for small businesses. The SBA size definition for firms producing these 
products defines a small firm to be any firm with 500 or fewer 
employees. We do not know how many employees work at the firms that 
produce the specified products because we cannot identify those firms. 
However, the vast majority of these firms probably meet the SBA 
definition of a small business because nearly all (97 percent) of food 
manufacturing plants have 500 or fewer employees.
1. Options
    FDA considers the following option to reduce the burden of this 
rule on small entities: give small firms more time to comply with this 
rule.
    Option 1: Give small firms more time to comply with this rule
    This rule will become effective on the next uniform compliance date 
for labeling regulations. The next uniform compliance date is January 
1, 2016, and it applies to food labeling regulations that FDA issues 
between January 1, 2013, and December 31, 2014. Using the next uniform 
compliance date always provides firms with at least 1 year and as much 
as 3 years to make any necessary labeling changes. In the analysis for 
the proposed rule (72 FR 66103 at 66109), we based our cost estimates 
on firms having 2 years to change product labels. Providing more time 
to change labels reduces the cost of changing those labels because more 
firms would be able to make the changes during regularly scheduled 
label changes. In the analysis for the proposed rule, we noted that our 
labeling cost model estimates that firms will redesign 67 percent of 
product labels in any 2-year period and all product labels in any 3-
year period. Therefore, if we changed the compliance date for small 
firms so that they had at least 3 years to comply, then we would reduce 
the cost for these firms to zero. To avoid inconsistent labeling on 
products produced by small firms and by other firms, we would need to 
set the same compliance date for all firms. This option would delay the 
benefits of this rule. Therefore, we have chosen not to give small 
firms more time to comply with the final rule.

V. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of the 
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.

[[Page 23273]]

VI. Paperwork Reduction Act of 1995

    We conclude that labeling provisions of this rule are not subject 
to review by the Office of Management and Budget because they do not 
constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520).

VII. Federalism

    We analyzed this final rule in accordance with the principles set 
forth in Executive Order 13132. 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.'' Federal law includes an express preemption provision that 
preempts ``any requirement respecting any claim of the type described 
in section 403(r)(1) [21 U.S.C. 343(r)(1)] made in the label or 
labeling of food that is not identical to the requirement of section 
403(r) [21 U.S.C. 343(r)]. . . .'' Section 403A(a)(5) of the FD&C Act 
(21 U.S.C. 343-1(a)(5)). However, this statutory provision does not 
preempt any State requirement respecting a statement in the labeling of 
food that provides for a warning concerning the safety of the food or 
component of the food (Pub. L. 101-535, Section 6 (1990)). This final 
rule prohibits certain nutrient content claims for certain omega-3 
fatty acids in the label or labeling of food under section 403(r) of 
the FD&C Act.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses, but FDA is not responsible for any 
subsequent changes to Web sites after this document publishes in the 
Federal Register.)

    1. ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, 
Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids.'' Institute 
of Medicine, National Academy of Sciences, 2005.
    2. Letter from the Institute of Medicine of the National 
Academies to FDA/CFSAN. Docket No. FDA-2004-N-0382; Document ID FDA-
2004-N-0382-0035.
    3. ``Dietary Reference Intakes: Guiding Principles for Nutrition 
Labeling and Fortification.'' Institute of Medicine, National 
Academy of Sciences, 2003.
    4. Letter from FDA/CFSAN to Advocates for Better Children's 
Diets. Docket No. FDA-2004-N-0382; Document ID FDA-2004-N-0382-0004.
    5. Data from Mintel Global New Products Database, Mintel Group, 
Ltd., http://www.mintel.com, accessed January 29, 2014.


    Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09492 Filed 4-25-14; 8:45 am]
BILLING CODE 4160-01-P