[Federal Register Volume 72, Number 227 (Tuesday, November 27, 2007)]
[Proposed Rules]
[Pages 66103-66118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 2004N-0217, 2005P-0189, and 2006P-0137]
RIN No. 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: Notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) proposes to issue this 
rule finding that certain nutrient content claims for foods, including 
conventional foods and dietary supplements, that contain omega-3 fatty 
acids, do not meet the requirements of the Federal Food, Drug, and 
Cosmetic Act (the act) and may not appear in food labeling. This rule 
is being proposed in response to three notifications submitted to FDA 
under the act. 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).
    FDA has reviewed the information included in the three 
notifications and is proposing to prohibit the nutrient content claims 
for DHA and EPA set

[[Page 66104]]

forth in the three notifications because they are not based on an 
authoritative statement that identifies a nutrient level to which the 
claims refer, as required by the controlling statutory authority. FDA 
is also proposing to prohibit the nutrient content claims for ALA set 
forth in the seafood processors notification because they are based on 
a daily value that was determined by a different method than daily 
values already established for other nutrients. Because of the 
different methodology used to set the daily value, the ALA claims set 
forth in the seafood processors notification do not enable the public 
to comprehend the information provided in the claims and to understand 
the relative significance of such information in the context of the 
daily diet, as required by the controlling statutory authority. FDA is 
proposing to take no regulatory action with respect to the nutrient 
content claims for ALA set forth in the Martek notification. Therefore, 
if this proposed rule is finalized without change, these claims will be 
allowed to remain on the market.

DATES: Submit written or electronic comments by February 11, 2008.

ADDRESSES: You may submit comments, identified by Docket Nos. 2004N-
0217, 2005P-0189, and 2006P-0137 by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), 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, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

A. Section 403(r) of the Act

    On November 8, 1990, President George H.W. Bush signed into law the 
Nutrition Labeling and Education Act of 1990 (the 1990 amendments) 
(Public Law 101-535), which amended the act. Section 403(r)(1)(A) of 
the act (21 U.S.C. 343(r)(1)(A)), which was added by the 1990 
amendments, states that a food for human consumption is misbranded if a 
claim is made in its label or labeling that expressly or implicitly 
characterizes the level of any nutrient of the type required to be 
declared in nutrition labeling, unless such claim uses terms defined in 
regulations by FDA under section 403(r)(2)(A) of the act.\1\
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    \1\The requirements in section 403(r)(2) of the act for nutrient 
content claims, apply to foods and food labeling unless an exemption 
applies for the food or the claim under section 403(r)(2) of the 
act, another section of the act, or FDA regulations.
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    In 1993, FDA established regulations that implemented the 1990 
amendments (58 FR 2066 to 2941, January 6, 1993). Among these 
regulations, Sec.  101.13 (21 CFR 101.13) sets forth general principles 
for nutrient content claims (see 58 FR 2302, January 6, 1993). Other 
sections in part 101, subpart D (21 CFR part 101, subpart D), define 
specific nutrient content claims, such as ``high,'' ``good source,'' 
and ``more,'' and provide that claims such as these must be made in 
relation to reference values set out in regulations by FDA. For 
example, to bear the claim ``high in fiber'' in its label or labeling, 
a food must contain 20 percent or more of the reference value for fiber 
set out in 21 CFR 101.9(c)(9). Other provisions set forth the 
procedures whereby a person who wishes to make a nutrient content claim 
not already defined by regulation may petition the agency to authorize 
that claim under section 403(r)(4) of the act (see 21 CFR 101.69). A 
petitioner bears the burden of establishing the scientific basis for a 
proposed nutrient content claim.
    On November 21, 1997, President William J. Clinton signed the Food 
and Drug Administration Modernization Act (FDAMA) into law (Public Law 
105-115), which, among other things, added new sections (r)(2)(G) and 
(r)(2)(H) to the act. These sections provide for the filing of 
notifications as an alternative to the petition process in section 
403(r)(4) of the act. Under the notification process, the scientific 
basis for a nutrient content claim or health claim is established 
through reliance on an authoritative statement.
    Section 403(r)(2)(G) of the act requires that a notification of the 
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 
the following: (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) 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 a prospective nutrient 
content claim. An authoritative statement must have been published by a 
scientific body of the U.S. Government that has official responsibility 
for public health protection or research directly relating to human 
nutrition or the National Academy of Sciences (NAS) or any of its 
subdivisions. In addition, an authoritative statement must identify the 
nutrient level to which the claim refers and must be currently in 
effect. Thus, the requirements of 403(r)(2)(G) of the act are not met 
by a statement that does not identify the nutrient level to which the 
claim refers.
    FDA considers the term ``nutrient level'' as used in section 
403(r)(2)(G) of the act to mean a reference value that is similar to a 
label reference value for use in nutrition labeling. To date, FDA has 
established by regulation two sets of label reference values: Reference 
Daily Intakes (RDIs) and Daily Reference Values (DRVs) (see 21 CFR

[[Page 66105]]

101.9(c)(8)(iv) and 101.9(c)(9), respectively). FDA based its RDIs on 
Recommended Daily Allowances (RDAs) and Estimated Safe and Adequate 
Daily Dietary Intakes (ESADDIs) established by NAS. FDA based its DRVs 
on recommendations in the NAS Diet and Health Report, the Surgeon 
General's Report on Nutrition and Health, and the 1990 Dietary 
Guidelines for Americans. FDA uses RDIs and DRVs as Daily Values (DVs) 
for purposes of nutrition labeling. Thus, FDA considers DVs to be a 
specific set of reference values established by regulation (58 FR 2079 
at 2125, January 6, 1993).
    A DV for a particular nutrient is used to calculate the percent DV 
that a serving of food provides for that nutrient, based on the 
assumption of a 2,000 calorie per day diet. The percent DV is listed in 
the Nutrition Facts and Supplement Facts boxes in nutrition labeling 
and provides consumers with an overall reference value for the 
nutrient. 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.
    In the preamble to one of its regulations implementing the 1990 
amendments (1990 preamble), FDA drew a distinction between the term 
``Daily Value,'' or ``DV,'' used as a proper noun, and the term ``daily 
value,'' used in a more generic sense. As noted above, DVs are 
established by regulation. By contrast, ``daily values'' are alternate 
values that are not established by regulation, such as those based on 
alternate daily caloric requirements (i.e., 2,500 calories per day) (58 
FR 2079 at 2125, January 6, 1993). Notwithstanding this distinction 
between ``Daily Values'' or ``DVs'' and ``daily values,'' FDA and 
industry have occasionally used the term ``Daily Value'' or ``DV'' to 
refer to alternate values that are not established by regulation, such 
as the quantity of a nutrient that has been proposed for use in 
nutrition labeling, or that is the basis for the use of a claim with 
respect to which FDA has taken no regulatory action under section 
403(r)(2)(H) of the act (21 U.S.C. 343(r)(2)(H)).\2\
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    \2\See, e.g., FDA's statement titled ``Nutrient Content Claims 
Notification for Choline Containing Foods,'' August 30, 2001, and 
also the notifications addressed by this rulemaking.
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    FDA intends to maintain the distinction between ``Daily Values'' or 
``DVs'' and ``daily values'' that it articulated in its 1990 preamble. 
FDA has not established by regulation any DV for ALA, DHA, or EPA. 
Therefore, this proposal uses the term ``daily value'' when referring 
to the quantity of ALA, DHA, and EPA on which the nutrient content 
claims at issue are based, unless the proposal is quoting a claim 
submitted by one of the notifiers.
    Under section 403(r)(2)(H) of the act, a nutrient content claim 
authorized under section 403(r)(2)(G) may be made beginning 120 days 
after submission of the notification until the following occurs: (1) 
FDA issues an effective regulation that prohibits or modifies the 
claim; (2) the agency issues a regulation finding that the requirements 
under section 403(r)(2)(G) have not been met; or (3) a district court 
of the United States in an enforcement proceeding under chapter III of 
the act has determined that the requirements under section 403(r)(2)(G) 
have not been met.

B. The IOM Final Report

    In 2005, the Food and Nutrition Board of the Institute of Medicine 
(IOM) of the National Academy of Sciences published a report titled 
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty 
Acids, Cholesterol, Protein, and Amino Acids'' (IOM Final Report, Ref. 
1). The report is one in a series that presents a comprehensive set of 
reference values for nutrient intakes for healthy U.S. and Canadian 
individuals and populations. Publication of the IOM Final Report was 
preceded by release in 2002 of a prepublication copy under the same 
title (IOM Prepublication Report, Ref. 2).
    In relevant part, the IOM Final Report establishes Dietary 
Reference Intakes (DRIs) for a number of nutrients that are 
essential\3\ in the human diet (e.g., linoleic acid) or provide a 
beneficial role in human health (e.g., total fiber). According to the 
IOM Final Report, DRIs ``comprise a set of reference values for 
specific nutrients, each category of which has special uses.'' These 
reference values ``include the Estimated Average Requirement (EAR), 
Recommended Daily Allowance (RDA), AI, and Tolerable Upper Intake Level 
(UL).''\4\
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    \3\The criteria for essentiality of a nutrient are that absence 
of the nutrient from the diet results in characteristic signs of a 
deficiency disease and these signs are prevented only by the 
nutrient itself or a specific precursor of it. (Ref. 3 Carpenter and 
Harper, Modern Nutrition in Health and Disease).
    \4\The IOM Final Report also establishes Acceptable 
Macronutrient Distribution Ranges (AMDRs) for some nutrients. AMDRs 
are ranges of macronutrient intakes that are associated with reduced 
risk of chronic disease, while providing recommended intakes of 
other essential nutrients. AMDRs are not considered to be a type of 
DRI.
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    An RDA is an estimate of the minimum daily average dietary intake 
level that meets the nutrient requirements of nearly all (97 to 98 
percent) healthy individuals in a particular life stage and gender 
group. The setting of an RDA is contingent on there being sufficient 
scientific evidence to establish an EAR, which is the average daily 
nutrient intake level estimated to meet the requirement of half the 
healthy individuals in a particular life stage and gender group.
    If there is insufficient scientific evidence to establish an EAR, 
then an AI is established instead of an RDA (assuming there is 
sufficient data to support establishment of an AI). An AI is the 
recommended average daily intake level that is assumed to be adequate 
based on observed or experimentally determined approximations or 
estimates of nutrient intake by a group (or groups) of apparently 
healthy people.
    Among other nutrients, the IOM Final Report addresses omega-3 fatty 
acids, including ALA, EPA, and DHA. These fatty acids are also called 
n-3 fatty acids because the first double bond is located at the third 
carbon from the methyl end of the molecule (Ref. 4). For ALA, the IOM 
Final Report does not establish a DRI in the form of an RDA because 
there is insufficient scientific evidence to establish an EAR. As 
noted, if there is insufficient scientific evidence to establish an 
EAR, then no RDA is established. Instead, the IOM Final Report 
establishes AIs for different life stage groups (e.g., girls ages 9 
through 13, boys ages 14 through 18). Those AIs are based on median 
intakes in the United States, where an omega-3 fatty acid deficiency is 
nonexistent in healthy individuals. The IOM Final Report does not 
establish a DRI in any form for either EPA or DHA.

II. The Three Notifications Submitted to FDA

A. The Seafood Processors Notification

    On January 16, 2004, FDA received a nutrient content claim 
notification for foods, including conventional foods and dietary 
supplements, containing ALA, EPA, and DHA omega-3 fatty acids submitted 
jointly in the seafood processors notification under section 
403(r)(2)(G) of the act (Ref. 5). The notification stated that the 
nutrient content claims it proposed were based upon authoritative 
statements made in the IOM Prepublication Report (Ref. 2). As of May 
16, 2004, it has been permissible to make the nutrient content claims 
set forth in the notification.

[[Page 66106]]

    The notification proposed ``high,'' ``good source,'' and ``more'' 
claims for ALA, and ``high'' claims for DHA and EPA. With respect to 
specific authoritative statements that identify a nutrient level for 
ALA, the seafood processors notification referenced the following age-
gender group specific AIs identified in the IOM Prepublication Report: 
0.9 grams/day (g/day) for males and females age 4 to 8 years; 1.2 g/day 
for males age 9 to 13 years; 1.0 g/day for females age 9 to 13 years; 
1.6 g/day for males 14 and more years of age; and 1.1 g/day for females 
14 and more years of age. Also, the notification quoted the following 
as authoritative statements that identify a nutrient level for ALA, 
EPA, and DHA: ``Because of a lack of evidence for determining the 
requirement for n-3 fatty acids, an AI [for ALA] is set based on the 
highest median intake of [ALA] by adults in the United States where a 
deficiency is basically nonexistent in free-living populations * * * 
and rounding. Small amounts of EPA and DHA can contribute towards 
reversing an n-3 fatty acid deficiency * * * EPA and DHA can contribute 
up to 10 percent of the total n-3 fatty acid intake and therefore up to 
this percent can contribute toward the AI for [ALA] * * *'' (Ref. 2, p. 
8 to 38).
    In calculating a qualifying level for the basis of the ``high,'' 
``good source,'' and ``more'' claims for ALA, the seafood processors 
notification set 1.3 g as a daily value for ALA and applied the 
specific percentages of this value as qualifying levels for the three 
ALA nutrient content claims as outlined in 21 CFR 101.54.\5\ The value 
of 1.3 g was a result of computing a population-weighted average of age 
and gender-specific AIs for ALA, using 2005 projected U.S. census data. 
The notification acknowledged that there is currently in effect a 
nutrient content claim for choline that is based on the highest age and 
gender-specific AI for that nutrient (Refs. 6 and 7). Nonetheless, the 
notification set a daily value for ALA using a population-weighted 
average because a recent report from the IOM, titled ``Dietary 
Reference Intakes: Guiding Principles for Nutrition Labeling and 
Fortification'' (IOM Guiding Principles Report, Ref. 8), recommended 
setting new DVs based on this method, rather than on the highest age 
and gender-specific AI.
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    \5\For a ``high'' claim, the food must contain 20 percent or 
more of the reference value per reference amount customarily 
consumed. For a ``good source'' claim, the food must contain 10 to 
19 percent of the reference value per reference amount customarily 
consumed. For a ``more'' claim, the food must contain at least 10 
percent more of the reference value per reference amount customarily 
consumed than an appropriate reference food.
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    In setting a qualifying level for the ``high'' claim for EPA or 
DHA, the seafood processors notification set 130 milligrams (mg) as the 
daily value for EPA or DHA (i.e., 10 percent of the daily value for 
ALA) and set 130 mg (i.e., equal to the daily value) as the qualifying 
level for the ``high'' claim. The notification did not request ``good 
source'' or ``more'' claims for EPA or DHA.
    Also, the seafood processors notification specified accompanying 
statements for the above claims. The ``high'' and ``good source'' 
claims would include one of the following statements:
    (1) ``Contains ------ mg of [DHA/EPA/ALA] per serving, which is --
---- % of the Daily Value for [DHA/EPA (130 mg) or {ALA (1.3 
g){time} ].''
    (2) ``Contains ------ % of the Daily Value for [DHA/EPA/ALA] per 
serving. The Daily Value for [{DHA/EPA is 130 mg{time}  or [ALA is 1.3 
g]].''
    For ``more'' claims, the notification specified that the claims 
would be accompanied by statements such as: ``------ % [10 % or 
greater] more of the Daily Value for ALA per serving than [reference 
food]. This product contains ------ mg ALA omega-3 per serving, which 
is ------ % of the Daily Value for ALA omega-3 (1.3 g). [Reference 
food] contains ------ mg ALA omega-3 per serving.''
    To qualify for ``high'' claims for ALA, the product would need to 
contain at least 260 mg of ALA per reference amount customarily 
consumed (RACC). To qualify for ``good source'' claims for ALA, the 
product would need to contain at least 130 mg of ALA per RACC. To 
qualify for ``more'' claims for ALA, the product would need to contain 
at least 130 mg or more of ALA per RACC than the reference food. To 
qualify for ``high'' claims for EPA or DHA, the product would need to 
contain at least 130 mg of EPA or DHA per RACC.

B. The Martek Notification

    On January 21, 2005, FDA received a notification of nutrient 
content claims for foods, including conventional foods and dietary 
supplements, containing ALA and DHA omega-3 fatty acids in the Martek 
Notification, under section 403(r)(2)(G) of the act (Ref. 9). The 
notification stated that the nutrient content claims were based upon 
authoritative statements made in the IOM Prepublication Report (Ref. 
2). As of May 22, 2005, it has been permissible to make the nutrient 
content claims set forth in the notification.
    The notification proposed ``high,'' ``good source,'' and ``more'' 
claims for ALA, and ``high'' claims for DHA. With respect to specific 
authoritative statements that identify a nutrient level for ALA, the 
Martek notification cited AIs for ALA identified in the IOM 
Prepublication Report (i.e., 1.6 grams per (g)/ day for adult men and 
1.1 g/day for adult women, specifically) and cited the following 
sentence: ``While intake levels much lower than the AI occur in the 
United States without the presence of a deficiency, the AI can provide 
the beneficial health effects associated with the consumption of n-3 
fatty acids'' (Ref. 2, p. 8-2). As authoritative statements that 
identify a nutrient level for DHA, the notification cited the following 
statements from the IOM Prepublication Report the following: (1) ``EPA 
and DHA can contribute up to 10 percent of the total n-3 fatty acid 
intake and therefore up to this percent can contribute towards the AI 
for alpha-linolenic acid;'' (2) ``The AMDR for [ALA] is set at 0.6 to 
1.2 percent of energy. Up to 10 percent of this range can be consumed 
as [EPA] and/or [DHA];'' and (3) ``A growing body of literature 
suggests that higher intakes of [ALA], [EPA] and [DHA] may afford some 
degree of protection against CHD. Because the physiological potency of 
EPA and DHA is much greater than that for [ALA] acid, it is not 
possible to estimate one AMDR for all n-3 fatty acids. Up to 10 percent 
of the AMDR can be consumed as EPA and/or DHA.''
    In determining nutrient qualifying levels for the proposed 
``excellent,'' ``good source,'' and ``more'' claims for ALA, the Martek 
notification set 1.6 g as the daily value for ALA and applied specific 
percentages of this value as qualifying levels for these claims as 
outlined in Sec.  101.54. The Martek notification based the daily value 
for ALA on the AI of 1.6 g identified for adult males in the IOM 
Prepublication Report, making no adjustments for intakes based on 
population-weighted averages. The Martek notification took issue with 
the seafood processors notification because that notification set a 
daily value for ALA based on a population-weighted method rather than 
the historically used highest age and gender-specific reference value.
    In determining a qualifying level of nutrient for the proposed 
``excellent'' claim for DHA, the Martek notification set 160 mg as the 
daily value for DHA (i.e., 10 percent of the daily value for ALA) and 
applied 32 mg or more (i.e., 20 percent of the daily value for DHA) as 
a qualifying level for the claim. The Martek notification proposed the 
following exact words for the claims:
    (1) `` `Excellent source of ALA.' (`High in ALA,' `Rich in ALA') 
Contains ------ mg

[[Page 66107]]

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.]
    (2) `` `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.]
    (3) `` `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).]
    (4) `` `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.]

C. The Ocean Nutrition Notification

    On December 9, 2005, FDA received a notification of nutrient 
content claims for foods, including conventional foods and dietary 
supplements, containing both EPA and DHA omega-3 fatty acids in the 
Ocean Nutrition notification, under section 403(r)(2)(G) of the act 
(Ref. 10). The notification stated that the nutrient content claims 
were based upon authoritative statements made in the IOM prepublication 
report (Ref. 2). As of April 9, 2006, it has been permissible to make 
the nutrient content claims set forth in the notification.
    The Ocean Nutrition notification proposed ``high'' claims for EPA 
and DHA combined. With respect to specific authoritative statements 
that identify the nutrient level for EPA and DHA combined, the Ocean 
Nutrition notification referenced the AI for adult males of 1.6 g per 
day of ALA identified in the IOM Prepublication Report (Ref. 2). In 
addition, the notification referenced the following statements from the 
IOM Prepublication Report (Ref. 2): (1) ``EPA and DHA can contribute up 
to 10 percent of the total n-3 fatty acid intake and therefore up to 
this percent can contribute towards the AI for [ALA],'' and (2) ``The 
AMDR for [ALA] is set at 0.6 to 1.2 percent of energy. Up to 10 percent 
of this range can be consumed as [EPA] and/or [DHA].'' The notification 
contended that a combination of EPA and DHA is the most appropriate 
basis for establishing nutrient content claims derived from the IOM 
Prepublication Report.
    In calculating a nutrient qualifying level for the proposed 
``excellent source'' claim for the combination of EPA and DHA, the 
Ocean Nutrition notification set 1.6 g as a daily value for ALA and 160 
mg as a daily value for the combination of EPA and DHA (i.e., 10 
percent of the daily value for ALA), and used 32 mg or more (i.e., 20 
percent of the daily value for the combination of EPA and DHA) as a 
qualifying level for the ``excellent source'' claim.
    The Ocean Nutrition notification proposed the following exact words 
for the 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 EPA and DHA 
combined per serving, which is ------% of the 160 mg Daily Value for a 
combination of EPA and DHA.''

III. Basis for the Proposed Action

    FDA has reviewed the three notifications submitted in support of 
the claims for ALA, EPA, and DHA. With respect to the claims for ALA in 
the Martek notification, FDA proposes to take no regulatory action at 
this time. FDA expresses no opinion as to whether those claims are 
supported by a statement that satisfies the requirements of section 
403(r)(2)(G) of the act for authoritative statements. In the November 
2, 2007, Federal Register (72 FR 62149), we have published an Advance 
Notice of Proposed Rulemaking (ANPRM) soliciting comment on how daily 
values for nutrients should be calculated, including the 
appropriateness of using an AI to set a DV.\6\
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    \6\In one other instance, FDA has taken no regulatory action 
with respect to a notification that proposed a nutrient content 
claim based on an AI. The nutrient content claim for choline (Ref. 
7) was based upon a reference value that the notifier set using the 
AIs established by the IOM in 1998 for that nutrient (Ref. 8). 
Choline is essential in the human diet and the AIs for that nutrient 
were established based upon experimental data demonstrating 
prevention of alanine aminotransferase abnormalities in healthy men.
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    With respect to the claims for ALA in the seafood processors 
notification, FDA proposes to prohibit those claims because they are 
based on a population-weighted average of the AIs for ALA. The 
population-weighted average approach to determining DVs for nutrients 
is different from the ``population coverage'' approach that FDA has 
used to date and continues to use, pending any possible rulemaking 
based on the issuance of the agency's ANPRM on DV issues.\7\ The 
concurrent use of two different methods to set daily values on which 
nutrient content claims in food labeling are based creates an 
inconsistency that could lead to consumer confusion about such claims, 
as discussed more fully below. Therefore, FDA proposes to conclude that 
the ALA claims set forth in the seafood processors notification do not 
enable the public to comprehend the information provided and to 
understand the relative significance of such information in the context 
of the daily diet, as required by section 403(r)(2)(G)(iv) of the act. 
A claim that does not meet the requirements of section 403(r)(2)(G) of 
the act may not be made on the label or labeling of food.
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    \7\FDA seeks comment in the ANPRM on whether the agency should 
continue to use the population-coverage approach or switch to the 
population-weighted average approach to setting DVs. The agency's 
reasons for adopting the population-coverage approach to set DVs in 
1993 are discussed in the final rule entitled ``Reference Daily 
Intakes and Daily Reference Values'' (see 58 FR 2206 at 2211, 
January 6, 1993).
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    With respect to claims for EPA and DHA, whether singly or in 
combination, FDA proposes to conclude that the IOM statements submitted 
as the basis of the claims do not meet the requirements of section 
403(r)(2)(G) of the act in two respects. First, none of the statements 
identify the nutrient level to which the claims refer (i.e., daily 
values for EPA and DHA that can serve as the basis for the requested 
nutrient content claims) (see section 403(r)(2)(G)(i) of the act). 
Second, in the absence of a nutrient level for EPA and DHA derived from 
the authoritative statement of a scientific body defined in 
403(r)(2)(G)(i) of the act, the requested claims do not convey 
meaningful information about EPA and DHA content because they lack an 
adequate scientific basis. Thus, the claims do not enable the public to 
comprehend the information provided and to understand the relative 
significance of such information in the context of the daily diet, as 
required by section 403(r)(2)(G)(iv) of the act.
    In this regard, FDA notes that the setting of daily values and 
qualifying levels for claims in food labeling on the basis of 
statements that do not identify the nutrient level to which the claims 
refer can result in inconsistent and conflicting claims that confuse 
consumers. The requirement in section 403(r)(2)(G) of the act that an 
authoritative statement identify the nutrient level to which the claim 
refers helps to ensure consistency in the use of a particular nutrient 
content claim

[[Page 66108]]

among different products from different manufacturers.
    The notification process in section 403(r)(2)(G) of the act 
provides a mechanism for authorizing a new nutrient content claim based 
on an authoritative statement by a scientific body of the United States 
government with official responsibility for public health protection or 
research directly relating to human nutrition, or by the National 
Academy of Sciences or any of its subdivisions. Under this expedited 
process, the scientific basis for a nutrient content claim is 
established through reliance on an authoritative statement of one of 
the scientific bodies designated in section 403(r)(2)(G), which has 
already reviewed the relevant scientific evidence. Therefore, when FDA 
is reviewing a notification under section 403(r)(2)(G) , the agency 
does not conduct an independent review of the body of scientific 
evidence associated with the proposed nutrient content claim. Rather, 
FDA's review is limited to considering whether the authoritative 
statement and the proposed nutrient content claim meet the requirements 
of section 403(r)(2)(G) of the act. (In contrast, the agency will 
conduct its own review of the scientific evidence for the proposed 
claim when a nutrient content claim petition is submitted under section 
403(r)(4) of the act (see 21 CFR 101.69).)
    FDA notes that all of the notifications at issue in this rulemaking 
relied on statements made in the IOM Prepublication Report. For 
purposes of this proposed rule, FDA has evaluated the claims in the 
notifications in light of relevant statements made in the IOM Final 
Report. Unless stated otherwise, those statements may be presumed to be 
identical to statements made in the IOM Prepublication Report.

A. ALA

    The following statement in the IOM Final Report is pertinent to 
this proposed rule and is identical to a statement made in the IOM 
Prepublication Report that was cited by all three of the notifications: 
``The AI for [ALA] is 1.6 and 1.1 g/day for men and women, 
respectively.'' (Ref. 1, Summary, p. 9). ALA is essential in the human 
diet. The IOM established AIs for ALA based upon the median intake of 
ALA by different gender and life stage groups in the United States, 
where a deficiency is basically nonexistent in free-living populations 
(see pages 427, 469 to 472, 1051 to 1051) (Ref. 1).
    At this time, FDA proposes to take no regulatory action with 
respect to the nutrient content claims for ALA in the Martek 
notification. FDA notes that those claims are based on a daily value 
that the notifier set using the highest gender and life-stage AI (i.e., 
1.6 g/day of ALA for men ages 19 years and older). Assuming, without 
deciding the issue, that it is appropriate to use an AI to set a DV, 
the population-coverage approach used by Martek in this notification 
ensures that the nutritional needs of almost all segments of the 
population are covered. This approach is consistent with the method 
that FDA has used in determining DVs to date (see 58 FR 2206 at 2211, 
January 6, 1993).
    In contrast, FDA proposes to prohibit the claims for ALA in the 
seafood processors notification because those claims are based on a 
daily value that the notifier set using a population-weighted average 
of AI reference values (1.3 g/day).\8\ A daily intake level based on a 
population-weighted average of AI values may not be adequate for some 
segments of the population (e.g., men ages 19 and over). Use of the 
population-weighted average approach in the seafood processors 
notification also results in a daily value for ALA that is inconsistent 
with the daily value for ALA claims based on the population-coverage 
approach used in the Martek ALA notification. As discussed in the 
preceding paragraph, FDA is proposing no regulatory action concerning 
nutrient content claims for ALA based on the Martek ALA notification, 
which means that such claims will continue to be permitted on food 
labels if this rule is finalized as proposed.
---------------------------------------------------------------------------

    \8\FDA's proposal to prohibit the claims for ALA in the seafood 
processors notification should not be read as an endorsement of the 
use of an AI to set a DV. As previously noted, FDA has published an 
ANPRM to seek comment on the appropriateness of using an AI to set a 
DV, among other issues.
---------------------------------------------------------------------------

    The inconsistency between the population-weighted average method 
used to set the daily value for ALA in the seafood processors 
notification and the population coverage method used for that purpose 
in the Martek notification is likely to result in inconsistent and 
conflicting nutrient content claims on food labels.. For example, a 
food labeled as a ``good source'' of ALA must contain at least 160 mg 
of ALA per RACC under the criteria in the Martek notification, while 
another food containing only 130 mg ALA per RACC would also be able to 
bear the same ``good source'' claim under the criteria in the seafood 
processors notification. Such inconsistencies make meaningful product-
to-product comparisons of ALA content based on label claims impossible. 
To enable the public to comprehend the information provided in nutrient 
content claims and 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 act, qualifying ALA levels for nutrient content 
claims in food labeling must be based on a single daily value 
determined using the same method as the DVs for other nutrients.
    FDA recognizes that the IOM Guiding Principles Report recommends 
setting new DVs based on a population-weighted average of reference 
values. However, that report disclaims any intent to make regulatory 
recommendations; rather, the guiding principles it provides are 
recommendations that FDA may accept or reject as appropriate to its 
activities. As previously noted, in the November 2, 2007, Federal 
Register (72 FR 62149), we have published an ANPRM that seeks comment 
on the appropriateness of using a population-weighted average, as 
opposed to a population-coverage approach, to set a DV. In the interim, 
FDA's position continues to be that the population-coverage approach 
should be used, for the reasons discussed in the 1993 final rule on DVs 
(58 FR 2206 at 2211) and for consistency with the manner in which FDA 
has determined DVs for nutrients to date.
    Therefore, FDA is proposing to find that the nutrient content 
claims for ALA set forth in the seafood processors notification do not 
meet the requirements of the act.

B. EPA and DHA

    The following statements about EPA and DHA in the IOM Final Report 
are pertinent to this proposed rule and are essentially similar to 
statements made in the IOM Prepublication Report that were cited by one 
or more of the notifications:
    ``[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 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

[[Page 66109]]

consumed as EPA and/or DHA (0.06 to 0.12 percent of energy).''\9\
---------------------------------------------------------------------------

    \9\Generally, in place of ``approximately 10 percent'' and 
``this percent,'' the IOM Prepublication Report stated ``up to 10 
percent'' and ``up to this percent.''
---------------------------------------------------------------------------

    FDA proposes to conclude that these statements do not identify a 
nutrient level, or reference value, for EPA and/or DHA that FDA could 
use to establish by regulation a label reference value for use in 
nutrition labeling. As noted, the IOM Final Report establishes 
reference values in the form of DRIs for a number of nutrients. DRIs 
include the EAR, RDA, AI, and UL. The IOM Final Report does not 
establish an EAR, RDA, AI, or UL for EPA or DHA. The ``approximately 10 
percent'' statements in the IOM Final Report are not reference values. 
They do not reflect a recommended or defined intake level of EPA and/or 
DHA that could serve as a basis for setting a DV that could be used to 
characterize a given level of EPA and/or DHA for purposes of nutrition 
labeling.
    In summary, FDA proposes to conclude that the statements cited by 
the three notifications and the essentially similar statements in the 
IOM Final Report do not identify a nutrient level to which the EPA and 
DHA claims refer, and therefore do not meet the requirements of section 
403(r)(2)(G) of the act for authoritative statements. In the absence of 
an authoritative statement that identifies the nutrient level to which 
a claim refers, the requirements of section 403(r)(2)(G) of the act are 
not met. Therefore, FDA proposes to find that any nutrient content 
claim pertaining to EPA or DHA that is made on the label or labeling of 
a food renders that food misbranded under section 403(r) of the act.
    FDA recognizes that consumption of EPA and/or DHA may provide 
health benefits and that industry may wish to alert consumers to those 
benefits. There are numerous lawful means of doing so. Under 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 
in any way 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 
``Contains x mg of EPA and DHA omega-3 fatty acids per serving.'' Also, 
under 21 CFR 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)''). In addition, the potential health benefits of consuming 
EPA and DHA can be communicated to consumers by using the qualified 
health claim about the relationship between EPA and DHA and reduced 
risk of CHD (Refs. 11 and 12).

IV. Environmental Impact

    We have carefully considered the potential environmental effects of 
this action. FDA has determined under 21 CFR 25.30(k) that this action 
is of a type that does not have a significant effect on the human 
environment. Therefore, neither an environmental assessment nor an 
environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 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). FDA has determined that 
this proposed rule is not a significant regulatory action as defined by 
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. Based on FDA's review of the labels in the 
marketplace, FDA does not believe that a substantial number of small 
entities will be significantly affected. The agency requests comment on 
whether this rule will 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 $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.
Benefit-Cost Analysis
1. The Need for This Regulation
    We discussed the legal and regulatory need for this proposed rule 
in section III of this document.
2. Options
    We analyzed two regulatory options: (1) Take no new regulatory 
action; and (2) prohibit the EPA and DHA claims and the ALA claims 
based on a daily value of 1.3 grams, but allow the ALA claims based on 
a daily value of 1.6 grams.
    Option 1: Take No New Regulatory Action
    This option would result in no change to the current situation, and 
so would result in no costs or benefits. This is not a viable option 
under FDA's current statutory and regulatory framework, as we discussed 
earlier in this preamble. However, we use this option as the basis for 
comparing the costs and benefits of other regulatory options.
    Option 2: Take the Regulatory Actions as Described in the Proposed 
Rule
    FDA received the first notification from the seafood processors on 
January 16, 2004. Because FDA did not issue a regulation prohibiting 
the use of these nutrient content claims within 120 days, ``high'' 
claims for ALA, EPA, and DHA, as well as ``good source'' and ``more'' 
claims for ALA have been permissible since May 16, 2004. A second 
notification, from Martek, received on January 21, 2005, notified FDA 
of ``high'' claims for ALA and DHA, as well ``good source'', and 
``more'' claims for ALA. A third notification, from Ocean Nutrition, 
received on December 9, 2005, notified FDA of a ``high'' claim and an 
``excellent source'' claim for EPA and DHA combined. All of these 
claims became permissible 120 days after the FDA received the 
respective notifications because the agency did not issue a regulation 
prohibiting them. A cost of this rule will be label changes for 
products bearing claims that are prohibited. These costs may be lower 
if producers can schedule regulatory label changes to coincide with 
their scheduled label changes.
    Number of Labels Affected
    FDA does not have data on the number of products bearing an ALA, 
EPA, DHA, or EPA plus DHA nutrient content claim on the label. 
Therefore, we attempt to estimate a range for the number of products 
that may bear an affected nutrient content claim.

[[Page 66110]]

Products whose eligibility will be affected by this rule:
     Have levels of DHA greater than 32 mg.;
     Have levels of EPA greater than 130 mg.;
     Have levels of EPA and DHA combined of greater than 32 
mg.;
     Have levels of ALA greater than 130 mg and less than 160 
mg for ``good source'' or ``more'' claim; and
     Have levels of ALA greater than 260 mg and less than 320 
mg for ``high'' claim.
    In this analysis, we distinguish between levels of DHA greater than 
32 mg and less than 130 mg and levels greater than 130 mg, because FDA 
received the notification for ``high'' claims for foods with more than 
32 mg of DHA in January of 2005 and the notification for ``high'' 
claims for foods with more than 130 mg of DHA in January of 2004. The 
longer a claim has been in effect, the more likely that it is in use by 
manufacturers. More time allows manufacturers to integrate the label 
change with other packaging changes. Also, if a food is reformulated to 
meet claim requirements, it may take more time to test the new 
formulation and put it into the marketplace. In addition to label 
changes due to loss of claims, products that refer to the ALA daily 
value of 1.3 g have to alter their packaging to refer to the revised 
daily value of 1.6 g. FDA was not able to undertake a comprehensive 
review of labels in the marketplace to determine how many products 
currently have labels with an affected nutrient content claim. Instead, 
FDA went through a multi-step process to estimate the likely number of 
claims in the marketplace.
    1. We determined which products are eligible to make a nutrient 
content claim.
    2. We conducted an informal review of these products in local 
groceries and online groceries to determine if any were making an 
affected nutrient content claim.
    3. We determined how many labels there were in the marketplace for 
each of the products eligible to make an affected nutrient content 
claim.
    4. We estimated the number of products likely to make an affected 
claim based on the number of products in the marketplace, the results 
of the informal review, and the length of time the claim had been in 
effect.
    EPA and DHA occur naturally in some fish, with higher levels in 
fattier fish. Many dietary supplements, particularly fish oils, contain 
EPA and DHA. ALA is present in some nuts and nut oils, flaxseeds and 
flaxseed oil, vegetable oils, and in many prepared foods that include 
flaxseeds, nuts, or oils as an ingredient. We searched an online grocer 
for all packaged fish and seafood products and expanded this list by a 
review of all canned, frozen, and refrigerated fish and seafood 
products in the 1999 Infoscan supermarket scanner data collected by 
Information Resources, Inc. (IRI) (Ref. 13). The IRI Infoscan 
supermarket scanner data provide very specific information on 
individual food items. Infoscan store tracking is based primarily on 
all-store, census scanner data, which are collected weekly from more 
than 32,000 supermarket, drug, and mass merchandiser outlets across the 
United States. For these products, we determined the average serving 
size for each product type, for example, 2 ounces (oz) for canned tuna. 
We then used the United States Department of Agriculture (USDA) 
National Nutrient Database for Standard Reference (Ref. 14) to 
determine the levels of EPA and/or DHA in a serving size of that food. 
USDA updates this database frequently. We used the most current version 
available when we calculated these numbers. However, we have not 
recalculated the numbers with each subsequent update because we do not 
expect that doing so would affect our estimates to any significant 
degree. Therefore, the benefit of recalculating the numbers would 
probably not justify the time and cost of doing so. We classified all 
products whose levels of EPA and/or DHA exceeded the threshold for a 
nutrient content claim as potential claim losers. Tables 1 and 2 of 
this document show the products and their levels of EPA and/or DHA. 
Table 2 reflects a 3-oz serving size for cooked fish.

                           Table 1.--DHA and/or EPA Levels of Canned Seafood and Fish
----------------------------------------------------------------------------------------------------------------
                                                                  EPA or DHA                       EPA plus DHA
   Canned Foods       Serving Size     DHA (mg)     EPA (mg)   Eligible >= 130    DHA Eligible    Eligible >= 32
                                                                      mg            >= 32 mg            mg
----------------------------------------------------------------------------------------------------------------
Herring                        2 oz          668          550  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Mackerel                       2 oz          452          246  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Caviar                        .5 oz          539          389  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Salmon                         2 oz          459          481  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
White Tuna in                  2 oz          358          133  Yes              Yes              Yes
 water
----------------------------------------------------------------------------------------------------------------
Sardines                       2 oz          288          268  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Anchovies                     .5 oz          123           73  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
Shrimp, mixed                  2 oz          126          146  Yes              Yes              Yes
 species
----------------------------------------------------------------------------------------------------------------
Oyster                         2 oz          130          120  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Canned shrimp                  3 oz          249          214  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Light Tuna in                  2 oz          127           27  No               Yes              Yes
 water
----------------------------------------------------------------------------------------------------------------
Crabmeat                       2 oz           71           81  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
White Tuna in oil              2 oz          101           38  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
Light Tuna in oil              2 oz           58           15  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------

[[Page 66111]]

 
Gefiltefish                  1.5 oz           19           32  No               No               Yes
----------------------------------------------------------------------------------------------------------------


                   Table 2.--DHA and/or EPA Levels of Frozen and Refrigerated Seafood and Fish
----------------------------------------------------------------------------------------------------------------
                                                                   EPA or DHA                      EPA plus DHA
     Frozen and        Serving Size     DHA (mg)     EPA (mg)   Eligible >= 130    DHA Eligible   Eligible >= 32
    Refrigerated                                                       mg            >= 32 mg           mg
----------------------------------------------------------------------------------------------------------------
Salmon                          3 oz         1099          525  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Mackerel                        3 oz         1016          555  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Tuna                            3 oz          757          241  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Herring                         3 oz          733          603  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Albacore Tuna                   3 oz          535          198  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Trout                           3 oz          449          172  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Sardines                        3 oz          433          402  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Mussels                         3 oz          430          235  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Pollock                         3 oz          383           77  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Squid                           3 oz          323          138  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Other (fish sticks)         6 sticks          216          144  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Halibut                         3 oz          248           60  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Oyster                          3 oz          245          225  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Sole/Flounder                   3 oz          219          207  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Whiting                         3 oz          200          241  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Shrimp                          3 oz          189          219  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Grouper                         3 oz          187           23  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Perch                           3 oz          179           68  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Yellowfin Tuna                  3 oz          154           31  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Haddock                         3 oz          138           65  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Cod                             3 oz          131            3  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Clams                           3 oz          124          117  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
Lobster                         3 oz          118          290  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Catfish                         3 oz          109           42  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
Crab                            3 oz           96          239  Yes              Yes              Yes
----------------------------------------------------------------------------------------------------------------
Scallop                         3 oz           92           76  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
Octopus                         3 oz           69           65  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
Snapper                         3 oz           43            3  No               Yes              Yes
----------------------------------------------------------------------------------------------------------------
Gefiltefish/                    3 oz           38           63  No               Yes              Yes
 Whitefish/ Pike
----------------------------------------------------------------------------------------------------------------
Crawfish                        3 oz           23           99  No               No               Yes
----------------------------------------------------------------------------------------------------------------
Orange Roughy                   3 oz            2            2  No               No               No
----------------------------------------------------------------------------------------------------------------


[[Page 66112]]

    FDA was not able to carry out a similar systematic review of foods 
for ALA claims, because a much wider range of foods may meet the ALA 
claim. However, only a small proportion of foods have ALA levels 
between 130 and 160 mg (for ``good source'' and ``more'' claims) and 
ALA levels between 260 and 320 mg (for ``high'' claim), and therefore 
will lose their eligibility. In addition to foods that naturally 
contain these fatty acids, some manufacturers have been increasing the 
levels of ALA, EPA, or DHA in their products. Foods, such as eggs and 
milk, can be enriched with ALA, EPA, or DHA by manipulating the diet of 
chickens and cows, respectively. Also, manufacturers can add ALA to 
their products by including ingredients like flaxseed oil or ground 
flaxseed. To find ALA-, EPA-, or DHA-enriched foods, we searched the 
Internet using keyword searches and in local grocery stores.
    FDA searched three local grocery stores for products bearing claims 
involving ALA, EPA, or DHA. FDA found one new line of products making 
an ALA claim: pasta with ground flaxseeds to increase the ALA content. 
This product meets the level of ALA needed to make a ``good source'' 
ALA claim under both the 130 and 160 mg levels. FDA did not find any 
products making a ``high'' claim. However, the labels refer to an ALA 
daily value of 1.3 g, so they will have to be changed to reflect the 
1.6 g daily value. FDA also searched the Internet to find food products 
that are likely to include a nutrient content claim. FDA found several 
brands of eggs, one with added DHA and many with added ALA. FDA 
reviewed 12 Web sites for ALA- or DHA-enriched eggs. In many cases the 
Web sites provided a picture of the egg carton, but did not give the 
full label information. For the ALA eggs, nutrition information on the 
Web site always emphasized the omega-3 content (which is appropriate on 
the label or in the labeling of the product as long as the statement 
does not in any way implicitly characterize the level of the nutrient 
in the food and it is not false or misleading in any respect (e.g., 
``100 mg omega-3 fatty acids per serving'') (21 CFR 101.13(i)(3)), not 
the specific ALA content. However, the Web site for the DHA-enriched 
eggs emphasized the DHA content and the DHA daily value established 
under the seafood processors notification. Based on the Internet 
review, FDA thinks it unlikely that any of the ALA-enriched eggs would 
be making an affected claim and likely that the DHA-enriched egg would 
make an affected claim. The DHA-enriched eggs included processed and 
shell eggs and were sold in six different packages. FDA also searched a 
major online drugstore that compiles dietary supplements sold by many 
other online retailers. This Web site also provided all the labeling 
information in the dietary supplement package. FDA searched for dietary 
supplements using the keywords EPA, DHA, fish oil, and ALA. The 
searches resulted in 53 hits for EPA, 49 hits for DHA, 55 hits for fish 
oil, and 48 hits for ALA. Many of the products in the searches 
overlapped. In reviewing these products, FDA found two dietary 
supplements making affected claims. Overall, these searches were 
limited and ad hoc and do not constitute a representative sample of the 
marketplace. Table 3 of this document presents the affected stock 
keeping units (SKUs). Every product and package size combination 
represents an SKU. Therefore, the number of SKUs corresponds to the 
number of product labels.

                Table 3.--Claims Found in the Marketplace
------------------------------------------------------------------------
          Product            Number of  Manufacturers   Number  of SKUs
------------------------------------------------------------------------
Dietary supplements          2                         2
------------------------------------------------------------------------
Eggs                         1                         6
------------------------------------------------------------------------
Pasta                        1                         6
------------------------------------------------------------------------

    Because FDA is unsure about whether the egg product that we 
identified actually makes a claim, the actual number of SKUs may be 
slightly lower than FDA indicates in Table 3 of this document. However, 
because our searches were not representative and we did not perform a 
comprehensive review of food labels, there are likely to be more claims 
in the marketplace than we were able to identify using the ad-hoc 
search procedure we discussed above. For the categories of food FDA was 
able to identify as containing more than the qualifying levels of EPA 
and/or DHA, FDA counted the number of SKUs in the 1999 IRI database by 
downloading all canned, frozen, and refrigerated seafood and fish from 
the database, then further breaking down these categories into types of 
seafood and fish using the information provided in each record. FDA 
only counted branded products, because private label brands make claims 
infrequently. In the IRI data, the type of fish is usually represented 
by an abbreviation in the product name, like ``abtn'' for albacore 
tuna. So, we counted the number of each type of fish using the 
abbreviations in the name provided by IRI. For some products, we were 
not able to identify the fish or we could not find data on the EPA and/
or DHA contents. Most of the foods in the IRI data that did not specify 
the type of fish were breaded fish fillets or fish sticks. Therefore, 
for the ``other'' category of fish we assigned the usual serving size 
and EPA and DHA levels for fish sticks. Some fish and seafood had 
multiple levels of EPA and DHA in the USDA Nutrient Laboratory 
database, depending on the specific variety. If we were not able to 
determine the relevant type of fish or seafood, we used the median 
value in the database for the type of fish or seafood. Because 1999 is 
the most recent IRI data available to us, we needed to correct for 
changes in the marketplace since 1999. To do so, we used the USDA food 
disappearance data to estimate changes in the availability of seafood 
on the market between 1999 and 2003 (the most recent year for which 
data is available) (Ref. 15). FDA then adjusted the 1999 IRI data by 
the growth in the relevant seafood category. FDA made an additional 
adjustment to the count of potentially affected products based on the 
usual frequency of scheduled label changes. Table 4 of this document 
presents the proportion of branded SKUs that are typically redesigned 
within a given period of time. Therefore, FDA estimates that 67 percent 
of labels would have been redesigned in the timeframe since the seafood 
processors notification went into effect, 33 percent of the labels 
would have been redesigned since the Martek notification went into 
effect, and 5 percent of the labels would have been redesigned since 
the Ocean Nutrition notification went into effect. In tables 5 and 6 of 
this document, FDA presents an estimate of the number of labels (SKUs) 
in the market currently eligible to make an EPA and/or DHA claim. 
Because foods eligible to make ALA claims include nuts and nut oils and 
flaxseed and flaxseed oils, as well as foods that include one of these 
sources as an ingredient, FDA was not able to estimate the number of 
foods eligible to make an ALA claim. However, only foods with between 
130 mg and 160 mg of ALA or foods with between 260 mg and 320 mg of ALA 
will have a change in their eligibility status, which should be a 
relatively small number of the total number of eligible foods. Also, we 
do not count the number of packages of enriched foods because we did 
not have a comprehensive, up-to-date database of foods enriched with 
ALA, EPA, or DHA.

[[Page 66113]]



                 Table 4.--Frequency of Label Redesigns
------------------------------------------------------------------------
            Time period                       Proportion of SKUs
------------------------------------------------------------------------
6-month                              5 percent
------------------------------------------------------------------------
12-month                             33 percent
------------------------------------------------------------------------
24-month                             67 percent
------------------------------------------------------------------------
36-month                             100 percent
------------------------------------------------------------------------


                                        Table 5.--Number of Canned Foods Eligible to Make an EPA and/or DHA Claim
--------------------------------------------------------------------------------------------------------------------------------------------------------
                 Canned Foods                   EPA or DHA Eligible at 130 mg  DHA Eligible at 32 mg    EPA plus DHA Eligible at 32 mg    Adjusted SKUs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salmon                                                                    Yes                    Yes                                Yes              335
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sardines                                                                  Yes                    Yes                                Yes              282
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gefiltefish                                                                No                     No                                Yes              161
--------------------------------------------------------------------------------------------------------------------------------------------------------
Light Tuna in water                                                        No                    Yes                                Yes              130
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shrimp, mixed species                                                     Yes                    Yes                                Yes              146
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anchovies                                                                  No                    Yes                                Yes              116
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oyster                                                                    Yes                    Yes                                Yes              111
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shrimp                                                                    Yes                    Yes                                Yes              104
--------------------------------------------------------------------------------------------------------------------------------------------------------
Crabmeat                                                                   No                    Yes                                Yes               93
--------------------------------------------------------------------------------------------------------------------------------------------------------
Herring                                                                   Yes                    Yes                                Yes               93
--------------------------------------------------------------------------------------------------------------------------------------------------------
Light Tuna in oil                                                          No                    Yes                                Yes               76
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mackerel                                                                  Yes                    Yes                                Yes               84
--------------------------------------------------------------------------------------------------------------------------------------------------------
White Tuna in water                                                       Yes                    Yes                                Yes               58
--------------------------------------------------------------------------------------------------------------------------------------------------------
Caviar                                                                    Yes                    Yes                                Yes               33
--------------------------------------------------------------------------------------------------------------------------------------------------------
White Tuna in oil                                                          No                    Yes                                Yes                9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of SKUs eligible                                                 1,246                  1,540                              1,701  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted for time since eligibility                                       835                    508                                 85  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------


                          Table 6.--Number of Frozen and Refrigerated Seafood and Fish Eligible to Make an EPA and/or DHA Claim
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Frozen and Refrigerated             EPA or DHA Eligible at 130 mg  DHA Eligible at 32 mg    EPA plus DHA Eligible at 32 mg    Adjusted SKUs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shrimp                                                                    Yes                    Yes                                Yes            1,272
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salmon                                                                    Yes                    Yes                                Yes              329
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other                                                                     Yes                    Yes                                Yes              116
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tuna                                                                      Yes                    Yes                                Yes              249
--------------------------------------------------------------------------------------------------------------------------------------------------------
Herring                                                                   Yes                    Yes                                Yes              242
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oyster                                                                    Yes                    Yes                                Yes              228
--------------------------------------------------------------------------------------------------------------------------------------------------------
Crab                                                                      Yes                    Yes                                Yes              155
--------------------------------------------------------------------------------------------------------------------------------------------------------
Octopus                                                                    No                    Yes                                Yes              160
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cod                                                                       Yes                    Yes                                Yes               95
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lobster                                                                   Yes                    Yes                                Yes              126
--------------------------------------------------------------------------------------------------------------------------------------------------------
Scallop                                                                    No                    Yes                                Yes              101
--------------------------------------------------------------------------------------------------------------------------------------------------------
Whiting                                                                   Yes                    Yes                                Yes               82
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 66114]]

 
Clams                                                                      No                    Yes                                Yes               75
--------------------------------------------------------------------------------------------------------------------------------------------------------
Crawfish                                                                   No                     No                                Yes               80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Albacore Tuna                                                             Yes                    Yes                                Yes               78
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sole/Flounder                                                             Yes                    Yes                                Yes               61
--------------------------------------------------------------------------------------------------------------------------------------------------------
Catfish                                                                    No                    Yes                                Yes               55
--------------------------------------------------------------------------------------------------------------------------------------------------------
Haddock                                                                   Yes                    Yes                                Yes               37
--------------------------------------------------------------------------------------------------------------------------------------------------------
Squid                                                                     Yes                    Yes                                Yes               43
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pollock                                                                   Yes                    Yes                                Yes               31
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mussels                                                                   Yes                    Yes                                Yes               39
--------------------------------------------------------------------------------------------------------------------------------------------------------
Orange Roughy                                                              No                     No                                 No               30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gefiltefish/ Whitefish/ Pike                                               No                    Yes                                Yes               19
--------------------------------------------------------------------------------------------------------------------------------------------------------
Halibut                                                                   Yes                    Yes                                Yes               17
--------------------------------------------------------------------------------------------------------------------------------------------------------
Trout                                                                     Yes                    Yes                                Yes               19
--------------------------------------------------------------------------------------------------------------------------------------------------------
Perch                                                                     Yes                    Yes                                Yes               18
--------------------------------------------------------------------------------------------------------------------------------------------------------
Yellowfin Tuna                                                            Yes                    Yes                                Yes                7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mackerel                                                                  Yes                    Yes                                Yes                9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Snapper                                                                    No                    Yes                                Yes                7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grouper                                                                   Yes                    Yes                                Yes                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sardines                                                                  Yes                    Yes                                Yes                4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of SKUs eligible                                                 3,335                  3,677                              3,757  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted for time since eligibility                                     2,234                  1,213                                188  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Cost of Label Changes
    Producers who will be affected by this rule are likely to go 
through several steps to modify their labels to come into compliance 
with the proposed requirements. The producers will do the following: 
(1) Conduct administrative activities, (2) alter the graphic design, 
(3) conduct prepress activities, engrave plates or cylinders, and (4) 
print and manufacture labels. Producers incur costs associated with 
each step of the process. The first step requires that producers read 
and develop a strategy to comply with the proposed requirements. 
Second, they will develop a new graphic design for the label that 
complies with the proposed requirements. Third, a prepress operator 
will convert the new design into printing plates or cylinders. Fourth, 
the new labels will be printed. The costs associated with label changes 
will also vary depending on whether the label change can be coordinated 
with a scheduled label change. There may be an additional inventory 
cost to producers if they have to dispose of already printed labels.
    FDA contracted with RTI International to estimate the costs of 
label changes to producers (Ref. 16). RTI estimated the costs 
associated with each of these steps, as well as the cost of discarded 
inventory of unused labels. Manufacturers regularly redesign their 
labels, so RTI only estimated a cost associated with the label change 
if the regulatory label change could not be done with a regularly 
scheduled label change. The estimated schedule for label changes is 
presented in table 4 of this table. Tables 7 and 8 present estimates of 
per SKU cost of a label change.

                                    Table 7.--Cost of Label Change (per SKU) for Seafood and Pasta (in 2005 Dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Canned Seafood             Frozen Seafood        Refrigerated Seafood            Pasta
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative                                                           $200                     $200                     $400                     $500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Graphic                                                                  $800                     $900                   $1,400                   $1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 66115]]

 
Prepress                                                               $1,200                     $500                     $800                     $900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Engraving                                                              $2,900                     $700                   $1,100                   $1,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inventory                                                                  $0                       $0                       $0                       $0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                  $5,100                   $2,300                   $3,700                   $4,300
--------------------------------------------------------------------------------------------------------------------------------------------------------


                               Table 8.--Cost of Label Change (per SKU) for Dietary Supplements and Eggs (in 2005 Dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Dietary Supplement
                                                   Dietary Supplement Liquid            Pills                Processed Eggs             Shell Eggs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative                                                           $900                     $900                     $500                     $500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Graphic                                                                $3,300                   $2,200                   $1,600                   $1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prepress                                                               $2,100                   $2,100                   $1,100                   $1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Engraving                                                              $2,100                   $2,100                     $900                     $900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inventory                                                                  $0                     $100                       $0                     $500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                  $8,400                   $7,400                   $4,100                   $4,600
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Based on our ad hoc searching, it is clear that not all products 
eligible to make an affected claim are making a claim. Overall, we 
estimate that at least 14 product labels will have to be changed as a 
result of this rule. Table 9 of this document presents an estimate of 
the cost associated with known label changes. This is probably an 
underestimate of the labeling cost because FDA has not conducted a 
comprehensive review of food labels to identify the number of products 
bearing these claims and we have probably underestimated the number of 
such claims. However, we are uncertain about the true number of 
existing claims.

                       Table 9.--Lower Bound Estimate of Total Costs from Labeling Changes
----------------------------------------------------------------------------------------------------------------
                    Product                          Number of SKUs              Cost of Label Change\*\
----------------------------------------------------------------------------------------------------------------
Dietary supplements                                                   2                                   $5,200
----------------------------------------------------------------------------------------------------------------
Eggs                                                                  6                                   $8,600
----------------------------------------------------------------------------------------------------------------
Pasta                                                                 6                                   $8,500
----------------------------------------------------------------------------------------------------------------
Total                                                                14                                  $22,300
----------------------------------------------------------------------------------------------------------------
\*\Assumes 67 percent of label changes can be made with regularly scheduled label changes.

    To determine the number of dietary supplements that qualify for a 
nutrient content claim, FDA counted the number of dietary supplements 
that have fish oil, ALA, EPA, or DHA as an ingredient in the Dietary 
Supplement Sales Information database (Ref. 17). The Dietary Supplement 
Sales Information database is a survey of the ingredients in 3,000 
dietary supplements. Based on a total count of 113 qualifying dietary 
supplements in the database, FDA estimates that the Internet review of 
dietary supplements covered approximately half of the qualifying 
dietary supplements, and so a likely estimate is that four dietary 
supplements would have to change their labels. In the search of local 
grocery stores, we reviewed approximately 200 fish and seafood 
packages. None of the labels we reviewed included an affected claim. 
However, it seems likely that each of the five companies that 
participated in notifications to FDA may make some nutrient content 
claim. Therefore, FDA estimates that it is likely that a label change 
would be required for six SKUs for each of the five manufacturers. FDA 
estimated 6 SKUs per manufacturer because the product lines identified 
for eggs and pasta that were making an affected nutrient content claim 
both included 6 SKUS. Finally, for the other two types of products we 
found that made a label claim, we estimate that, similar to dietary 
supplements, there are twice as many affected claims in the market. 
Table 10 of this document presents an estimate of the likely total cost 
of label changes.

                         Table 10.--Likely Estimate of Total Costs From Labeling Changes
----------------------------------------------------------------------------------------------------------------
           Product                       Number of SKUs                       Cost of Label Change\*\
----------------------------------------------------------------------------------------------------------------
Dietary supplements                                             4                                        $10,400
----------------------------------------------------------------------------------------------------------------

[[Page 66116]]

 
Notifiers                                                      30                                        $39,200
----------------------------------------------------------------------------------------------------------------
Eggs                                                           12                                        $17,200
----------------------------------------------------------------------------------------------------------------
Pasta                                                          12                                        $17,000
----------------------------------------------------------------------------------------------------------------
Total                                                          58                                        $83,800
----------------------------------------------------------------------------------------------------------------
\*\Assumes 67 percent of label changes can be made with regularly scheduled label changes

    Health Effects
    Benefits from a labeling rule typically arise from changes in 
consumption of nutrients, either increases in consumption of beneficial 
nutrients or decreases in consumption of detrimental nutrients. 
Consumption changes because the behavior of producers or consumers 
changes. Product reformulation, in which producers alter the 
composition of their product to qualify for a positive label claim or 
avoid a negative label statement, may lead to substantial changes in 
the consumption of certain beneficial nutrients. There may also be 
direct changes in consumer choices, if consumers purchase healthier 
food based on information they see on the label. Several studies have 
linked label use to improved diet (Refs. 18 and 19).
    The removal of nutrient content claims for EPA and/or DHA may 
result in reduced consumption of EPA and DHA under two scenarios. 
First, consumption of these nutrients may be reduced if consumers 
choose not to purchase and consume products because they do not have 
the prohibited nutrient content claims on the label. Second, producers 
might face reduced incentives to increase levels of EPA and DHA in 
products, which might lead some producers to a decision not to 
reformulate. A review of the literature on product reformulation in a 
report on modeling manufacturers' decision to reformulate finds 
evidence that increased provision of nutrition information on labels 
leads manufacturers to reformulate to make healthier products or to 
attempt to market new healthier products (Ref. 20). If the continued 
availability of nutrient content claims for EPA and/or DHA would have 
encouraged producers to increase levels of EPA and/or DHA, there may be 
additional reductions in consumption of EPA and/or DHA due to lower 
levels in the food supply. However, because the agency has 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.
    Furthermore, FDA wishes to emphasize that this ruling does not 
affect the continuing availability of a qualified health claim that 
states, ``Supportive but not conclusive research shows that consumption 
of EPA and DHA omega-3 fatty acids may reduce the risk of CHD. One 
serving of [Name of the food] provides [ ] gram of EPA and DHA omega-3 
fatty acids. [See nutrition information for total fat, saturated fat, 
and cholesterol content.].'' To make the qualified health claim, the 
product must contain EPA and DHA, and meet limits for cholesterol, 
saturated fat, total fat, and sodium and meet the 10 percent nutrient 
content requirement for vitamin C, vitamin A, iron, calcium, protein, 
or fiber (Ref. 21). Producers may opt to reformulate their products to 
use the qualified health claim.
    Therefore, FDA estimates the quantitative costs of this rule to be 
$83,800 due entirely to projected labeling changes, and potential non-
quantified costs associated with a potential forgone decrease in risk 
of CHD resulting from a possible decrease in the consumption of EPA 
and/or DHA.
    Benefits
    This option would prevent consumers from mistakenly interpreting 
``high,'' ``good source,'' and ``more'' claims relating to the level of 
EPA and/or DHA in food to imply that an authoritative scientific body 
has determined that consumers should consume a particular level of EPA 
and/or DHA per day. This, in turn, might prevent some consumers from 
forming an incorrect assessment of the relationship of the levels of 
EPA and/or DHA in particular foods to such recommended levels. This 
could generate a health benefit because if consumers base their 
consumption patterns on an incorrect assessment of the significance of 
the amount of EPA and/or DHA in particular foods, then they might 
change their consumption patterns in ways that could be detrimental to 
their health. For example, some consumers might believe they would not 
receive any additional benefit from consuming additional food 
containing EPA and/or DHA after eating a food that is labeled as being 
``high'' in those nutrients even though they might actually benefit 
significantly from additional amounts of those nutrients. 
Alternatively, some consumers might believe that it is worthwhile to 
forgo a certain level of other nutrients in order to consume a food 
that is ``high'' level of EPA and/or DHA when, in fact, they could 
obtain nearly the same benefit from a food with less EPA and/or DHA. 
FDA does not have sufficient information to quantify this potential 
benefit.

VI. The Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore clearance by OMB under the 
Paperwork Reduction Act of 1995 is not required.

VII. Federalism Analysis

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized as proposed, would 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, there 
is some other clear evidence that the Congress intended preemption of 
State law, or where the exercise of State authority conflicts with the 
exercise of Federal authority under the Federal statute.'' Section 403A 
of the act (21 U.S.C. 343-1) is an express preemption provision. In 
relevant part, section 403A(a)(5) of the act (21 U.S.C. 343-1(a)(5)) 
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-- * * * (5) any 
requirement respecting any claim of the type described in section 
403(r)(1) made

[[Page 66117]]

in the label or labeling of food that is not identical to the 
requirement of section 403(r) * * *''.
    Currently, this provision operates to preempt States from imposing 
nutrient content claim labeling requirements concerning ALA, EPA, DHA, 
and EPA and DHA combined because no such requirements have been imposed 
by FDA under section 403(r) of the act. Under FDA's authority under 
section 403(r)(2)(H) of the act, the agency proposes to find that the 
requirements of section 403(r)(2)(G) have not been met with respect to 
the nutrient content claims for EPA and DHA in the seafood processors 
notification, the nutrient content claim for DHA in the Martek 
notification, and the nutrient content claim for EPA and DHA in the 
Ocean Nutrition notification. FDA also proposes to prohibit the 
nutrient content claims for ALA in the seafood processors notification.
    Although this proposed rule, if finalized as proposed, would have 
preemptive effect in that it would preclude States from promulgating 
any nutrient content claim labeling requirements for ALA, EPA, DHA, and 
EPA and DHA combined that are not identical to those required by this 
proposed rule, this preemptive effect would be consistent with what 
Congress set forth in section 403A of the act. Section 403A(a)(5) of 
the act displaces both state legislative requirements and state common 
law duties. Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., 
concurring in part and concurring in judgment); id. at 510 (O'Connor, 
J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring 
in part and dissenting in part); Cipollone v. Liggett Group, Inc., 505 
U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., 
joined by Thomas, J., concurring in judgment in part and dissenting in 
part).
    FDA believes that the preemptive effect of the proposed rule, if 
finalized as a proposed, would be consistent with Executive Order 
13132. Section 4(e) of the Executive order provides that ``when an 
agency proposes to act through adjudication or rulemaking to preempt 
State law, the agency shall provide all affected State and local 
officials notice and an opportunity for appropriate participation in 
the proceedings.'' FDA's Division of Federal and State Relations is 
inviting the States' participation in this rulemaking by providing 
notice via fax and e-mail transmission to State health commissioners, 
State agriculture commissioners, food program directors, and drug 
program directors as well as FDA field personnel of FDA's publication 
of the proposed rule prohibiting the nutrient content claims for ALA, 
EPA, DHA, and EPA and DHA combined set forth in the three FDAMA 
notifications received by FDA. The notice provides the States with 
further opportunity for input on the rule. It advises the States of 
FDA's publication of the proposed rule and encourages the States and 
local governments to review the notice of proposed rulemaking and to 
provide any comments to the docket (Docket No. 2004N-0217, 2005P-0189, 
or 2006P-0137).
    In conclusion, FDA has determined that the preemptive effects of 
this proposed rule, if finalized as proposed, are consistent with 
Executive Order 13132.

VIII. Effective Date

    FDA is proposing to make this regulation effective on the uniform 
compliance date for food labeling regulations established by the agency 
that is applicable to the publication date of the final rule.

IX. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen between 
9 a.m. and 4 p.m., Monday through Friday, except on Federal Government 
holidays. (FDA has verified the Web site addresses, but is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    1. Institute of Medicine of the National Academies, ``Dietary 
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, 
Cholesterol, Protein, and Amino Acids,'' Summary, Chapter 8, and 
Chapter 11, the National Academies Press, Washington, DC, 2005.
    2. Institute of Medicine of the National Academies, 
Prepublication Copy, ``Dietary Reference Intakes for Energy, 
Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and 
Amino Acids,'' Summary, Chapter 8, and Chapter 11, the National 
Academies Press, Washington, DC, 2002.
    3. Carpenter, K.J. and A.E. Harper, ``Evolution of Knowledge of 
Essential Nutrients,'' in Modern Nutrition in Health and Disease, 
Eds. M.E. Shils, M. Shike, A.C. Ross, B. Caballero, and R.J. 
Cousins, Philadelphia, P.A.: Lippincott Williams & Wilkins, p. 7, 
2006.
    4. Stryer, L., Biochemistry, Fourth Edition, New York: W.H. 
Freeman and Co., p. 604, 1995.
    5. Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and 
Trans-Ocean Products, Inc. ``Notification for a Nutrient Content 
Claim Based on an Authoritative Statement,'' Item CP1, Docket No. 
2004N-0217, Division of Dockets Management, May 15, 2004.
    6. U.S. Food and Drug Administration, ``Nutrient Content Claims 
Notification for Choline Containing Foods,'' (http://
www.cfsan.fda.gov/~dms/flcholin.html) August 30, 2001.
    7. Institute of Medicine of the National Academies, ``Dietary 
Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, 
Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline,'' the 
National Academies Press, Washington, DC, pp. 390 to 422, 1998.
    8. Institute of Medicine of the National Academies, ``Dietary 
Reference Intakes: Guiding Principles for Nutrition Labeling and 
Fortification,'' the National Academies Press, Washington, DC, pp. 
82 to 95, 2003.
    9. Martek Biosciences Corporation, ``Notification for a Nutrient 
Content Claim Based on an Authoritative Statement,'' Item CP1, 
Docket 2005P-0189, Division of Dockets Management, May 23, 2005.
    10. Ocean Nutrition Canada, ``Notification for a Nutrient 
Content Claim Based on an Authoritative Statement,'' Item CP1, 
Docket No. 2006P-0137, Division of Dockets Management, December 9, 
2005.
    11. A letter from William K. Hubbard, FDA to Jonathan W. Emord, 
Esq., Emord & Associates, P.C., (http://www.cfsan.fda.gov/~dms/ds-
ltr38.html), September 8, 2004.
    12. A letter from William K. Hubbard, FDA to Martin J. Hahn, 
Esq., Hogan & Hartson, L.L.P., (http://www.cfsan.fda.gov/~dms/ds-
ltr37.html), September 8, 2004.
    13. Information Resources, Inc., (IRI), download, (http://www.infores.com/public/us/content/infoscan/fooddrugmass.htm), 1999.
    14. U.S. Department of Agriculture, Agricultural Research 
Service, USDA National Nutrient Database for Standard Reference, 
Release 17, Nutrient Data Laboratory Home Page (http://www.nal.usda.gov/fnic/foodcomp), 2004.
    15. U.S. Department of Agriculture Economic Research Service, 
Food Consumption Data System (http://www.ers.usda.gov/data/foodconsumption/Index.htm), 2005.

[[Page 66118]]

    16. RTI International, ``FDA Labeling Cost Model,'' Prepared for 
FDA, January, 2003.
    17. RTI International, ``Dietary Supplement Sales Information,'' 
Prepared for FDA, October 1999.
    18. Neuhouser, M.L., A.R. Kristal, and R.E. Patterson, ``Use of 
Food Nutrition Labels Associated with Lower Fat Intake,'' Journal of 
the American Dietetic Association, vol. 53, pp. 45 to 50, 53, 1999.
    19. Kim, S., R.M. Nayga, Jr., and O. Capps, Jr., ``The Effect of 
Food Label Use on Nutrient Intakes: An Endogenous Switching 
Regression Analysis,'' Journal of Agricultural and Resource 
Economics, vol. 25, pp. 215 to 231, 2000.
    20. RTI International, ``Modeling the Decision to Reformulate 
Food and Cosmetics,'' Prepared for FDA, October 2003.
    21. U.S. Food and Drug Administration, ``Summary of Qualified 
Health Claims Permitted,'' Accessed at http://www.cfsan.fda.gov/
~dms/qhc-sum.html#omega3 on September 26, 2005.

    Dated: November 19, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22991 Filed 11-26-07; 8:45 am]
BILLING CODE 4160-01-S