[Federal Register: November 27, 2007 (Volume 72, Number 227)]
[Proposed Rules]
[Page 66103-66118]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27no07-42]
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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:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> 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:
<bullet> FAX: 301-827-6870.
<bullet> 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:
<bullet> Have levels of DHA greater than 32 mg.;
<bullet> Have levels of EPA greater than 130 mg.;
<bullet> Have levels of EPA and DHA combined of greater than 32
mg.;
<bullet> Have levels of ALA greater than 130 mg and less than 160
mg for ``good source'' or ``more'' claim; and
<bullet> 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
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Cod Yes Yes Yes 95
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Lobster Yes Yes Yes 126
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Scallop No Yes Yes 101
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Whiting Yes Yes Yes 82
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[[Page 66114]]
Clams No Yes Yes 75
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Crawfish No No Yes 80
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Albacore Tuna Yes Yes Yes 78
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sole/Flounder Yes Yes Yes 61
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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