[Federal Register: May 4, 2004 (Volume 69, Number 86)]
[Proposed Rules]
[Page 24541-24547]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04my04-12]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 1994P-0390 and 1995P-0241]
Food Labeling: Nutrient Content Claims, General Principles;
Health Claims, General Requirements and Other Specific Requirements for
Individual Health Claims; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or the agency) is
reopening for 60 days the comment period for the proposed rule entitled
``Food Labeling: Nutrient Content Claims, General Principles; Health
Claims, General Requirements and Other Specific Requirements for
Individual Health Claims'' (the 1995 proposal). In that document, FDA
proposed to amend its existing nutrient content claims and health
claims regulations to provide additional flexibility in the use of
these claims on food products. Since the publication of the 1995
proposal, FDA established a task force for the Consumer Health
Information for Better Nutrition Initiative, which recommended that FDA
seek public comment on several topics related to qualified health
claims and unqualified health claims (i.e., health claims that are
supported by significant scientific agreement (SSA) and authorized by
FDA by regulation). Some of these topics on unqualified health claims
were specifically addressed in the 1995 proposal and, therefore, FDA is
reopening the comment period on the 1995 proposal to seek comment on
the proposed amendments to permit unqualified health claims on certain
foods that do not contain 10 percent or more of one of certain required
nutrients, the proposed amendments to provide criteria that FDA would
consider in determining whether to grant an exemption from
disqualifying nutrient levels related to unqualified health claims of
certain nutrients, and the proposed amendments to retain the word
``may'' or ``might'' in unqualified health claims. In addition, FDA is
seeking comment on the proposed use of unlisted synonyms and
abbreviated health claims. Specifically, for unlisted synonyms (i.e.,
terms not defined by regulation), FDA repeats its request for data or
other information demonstrating that unlisted synonyms that are
anchored to defined terms in nutrient content claims are reasonably
understood by consumers to be synonyms of the defined terms. For
abbreviated health claims, FDA seeks comments and requests data or
other information regarding whether abbreviated health claims would
mislead consumers.
DATES: Submit written or electronic comments by July 6, 2004.
ADDRESSES: You may submit comments, identified by Docket Nos. 1994P-
0390 and 1995P-0241, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the
instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket Nos. 1994P-0390 and
1995P-0241 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://www.fda.gov/dockets/ecomments, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, 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/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.
SUPPLEMENTARY INFORMATION:
I. Reopening of Comment Period
In the Federal Register of December 21, 1995 (60 FR 66206), FDA
proposed to amend its regulations on nutrient content claims and health
claims to provide additional flexibility in the use of these claims on
food products. In the 1995 proposal, FDA proposed the following: (1) To
allow additional synonyms for nutrient content claims without specific
preclearance by the agency (i.e., unlisted synonyms), (2) to permit
health claims on certain foods that do not currently qualify to bear a
claim because they do not contain 10 percent of one or more of certain
required nutrients, (3) to permit the use of shortened versions of
authorized health claims (i.e., abbreviated health claims) under
certain circumstances, (4) to eliminate and/or make optional some of
the specific health claim elements required by regulation, and (5) to
provide criteria that FDA would consider in determining whether to
grant an exemption from disqualifying nutrient levels to permit some
foods to bear an unqualified health claim even though they contain high
levels of one or more of certain nutrients. FDA proposed these
amendments in response
[[Page 24542]]
to petitions submitted by the National Food Processors Association
(NFPA) (docket number 1994P-0390) and the American Bakers Association
(ABA) (docket number 1995P-0241).
FDA requested comments on the 1995 proposal by March 20, 1996. On
March 22, 1996 (61 FR 11793), FDA extended the comment period for 120
days, until July 18, 1996. On January 24, 1997 (62 FR 3635), FDA
reopened the comment period for the 1995 proposal until March 10, 1997,
to provide interested persons an opportunity to obtain and comment on
an FDA study, entitled ``Consumer Impacts of Health Claims: An
Experimental Study'' that is relevant to issues in the 1995 proposal.
The agency also sought comment on two consumer research studies
submitted by The Quaker Oats Co. pertaining to the use of abbreviated
health claim statements (62 FR 3635 at 3636). Finally, on March 11,
1997 (62 FR 11129), FDA extended the comment period for the 1995
proposal until April 24, 1997, in response to requests to allow
interested persons more time to review the studies and submit comments.
Due to competing priorities, including evolving food safety issues, the
agency has not yet published a final rule on the 1995 proposal.
In December 2002, FDA announced a major new initiative, the
Consumer Health Information for Better Nutrition Initiative, to make
available more and better information about conventional foods and
dietary supplements to help American consumers improve their health and
decrease their risk of contracting diseases by making sound dietary
decisions. Under this initiative, the agency established a task force
on Consumer Health Information for Better Nutrition (the task force).
The task force was charged with the following: (1) Reporting on how the
agency can improve consumer understanding of the health consequences of
their dietary choices and increase competition by product developers in
support of healthier diets, including how the agency should apply the
``weight of the evidence'' standard established under the initiative
for qualified health claims in order to achieve these goals; (2)
developing a framework of regulations that will give these principles
the force and the effect of law; (3) identifying procedures for
implementing the initiative, as well as determining the organizational
staffing needs necessary for the timely review of qualified health
claim petitions; and (4) developing a consumer studies research agenda
designed to identify the most effective ways to best present
scientifically based, truthful and nonmisleading information to
consumers and to identify the kinds of information known to be
misleading to consumers.
On July 11, 2003, FDA published a notice in the Federal Register
(68 FR 41387) announcing the availability of the ``Consumer Health
Information for Better Nutrition Initiative--Task Force Final Report''
(the task force report), which includes nine attachments. Attachment A
(``Possible Regulatory Frameworks for Qualified Health Claims in the
Labeling of Conventional Human Food and Human Dietary Supplements'') of
the task force report describes options or alternatives for regulating
qualified health claims (i.e., claims that do not meet the SSA standard
of evidence required by section 403(r)(3)(B)(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i)) and Sec.
101.14(c) (21 CFR 101.14(c)) to evaluate the scientific validity of
health claims). The task force recommended that FDA solicit comment on
these regulatory alternatives as well as several additional topics,
including topics related to unqualified claims (i.e., claims that meet
the SSA standard of evidence and are authorized by FDA by regulation).
Accordingly, in an advance notice of proposed rulemaking published in
the Federal Register of November 25, 2003 (68 FR 66040) (the qualified
health claim ANPRM), FDA requested public comment on the regulatory
alternatives and all except two of the additional topics identified in
attachment A of the task force report. These two topics are as follows:
(1) The minimum nutrient contribution requirement\1\ and (2)
disqualifying nutrient levels. The task force recommended that FDA seek
comments on these two topics, in particular, in the interest of
increasing flexibility in regulating the use of health claims. The task
force believed that such flexibility would further advance the use of
reliable diet and health information to consumers via food labels.
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\1\ Although the task force report and qualified health claim
ANPRM refer to ``minimum nutrient content requirements,'' in order
to be consistent with the 1995 proposal, we refer to the requirement
in this document as the ``minimum nutrient contribution
requirement.'' The terms refer to the same requirement in Sec.
101.14(e)(6) and may be used interchangeably.
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Although FDA identified the minimum nutrient contribution
requirement and disqualifying nutrient levels in the qualified health
claim ANPRM, FDA stated that because these two topics were raised in
the 1995 proposal, the agency intends to seek comments on them by
reopening the comment period for the 1995 proposal (68 FR 66040 at
66045). Thus, FDA did not request comments on the minimum nutrient
contribution requirement and disqualifying nutrient levels for health
claims in the qualified health claim ANPRM, but is doing so today by
reopening the comment period for the 1995 proposal.
In addition, one of the topics on which FDA requested comments in
the qualified health claim ANPRM, and on which the agency is also
reopening the comment period for the 1995 proposal, is the use of the
word ``may'' in unqualified health claims to describe the relationship
between a substance and a disease or health-related condition.
Information on FDA's Consumer Health Information for Better Nutrition
Initiative and a copy of the task force report can be found at http://www.fda.gov/oc/mcclellan/chbn.html
.
Finally, FDA is also seeking comment on the proposed use of
unlisted synonyms and abbreviated health claims. For unlisted synonyms
(i.e., terms not defined by regulation), FDA repeats its request for
data or other information demonstrating that unlisted synonyms that are
anchored to defined terms in nutrient content claims are reasonably
understood by consumers to be synonyms of the defined terms. FDA also
seeks comments on the current petition process in Sec. 101.69(n) (21
CFR 101.69(n)) for synonyms and examples of synonyms that industry may
be seeking to use. For abbreviated health claims, FDA seeks comments
and requests data or other information regarding whether abbreviated
health claims would mislead consumers.
II. Request for Comments
Because of the length of time that has elapsed since publication of
the 1995 proposal, and the recent availability of the task force
report, FDA is interested in updating the administrative record for the
1995 proposal by seeking comments on certain topics before issuing a
final rule. Comments previously submitted to the Division of Dockets
Management (formerly the Dockets Management Branch) do not need to be
resubmitted because all comments submitted to the previously listed
docket numbers will be considered in any final rule to the 1995
proposal. As noted in section I of this document, FDA is seeking
comments on three topics within the scope of the 1995 proposal and
identified in the task force report and qualified health claim ANPRM:
(1) The minimum nutrient contribution requirement, (2) disqualifying
nutrient levels, and (3) use of the word ``may'' in unqualified health
claims to describe the relationship between a substance and a disease
or
[[Page 24543]]
health-related condition. Further, FDA is also seeking comment on the
proposed use of unlisted synonyms (i.e., terms not defined by
regulation) and abbreviated health claims.
A. Section 101.14(e)(6): The Minimum Nutrient Contribution Requirement
As explained in the 1995 proposal, FDA published a final rule
entitled ``Food Labeling: General Requirements for Health Claims for
Food'' (the 1993 health claims final rule) in the Federal Register of
January 6, 1993 (58 FR 2478). Among other things, this final rule
requires that, to be eligible to bear a health claim, a food other than
a dietary supplement contain 10 percent or more of the daily value (DV)
for vitamin A, vitamin C, iron, calcium, protein, or fiber, per
reference amount customarily consumed (RACC) before any nutrient
addition (Sec. 101.14(e)(6)). Following publication of the 1993 health
claims final rule, NFPA and ABA submitted petitions to FDA requesting,
among other things, that the agency reconsider its decision regarding
the 10 percent nutrient contribution requirement.
In the preamble of the 1995 proposal, FDA recognized that the 10
percent nutrient contribution requirement may have had the unintended
effect of prohibiting health claims on certain foods that could be
beneficial to consumers and help them maintain a balanced and healthful
diet (60 FR 66206 at 66212). The agency was concerned, however, that
eliminating the requirement will permit misleading health claims on
foods with little or no nutritional value, such as candies or soft
drinks, or will encourage overfortification of the food supply (e.g.,
vitamins or minerals added to soft drinks) (id.). FDA stated that the
appearance of health claims on such foods would be inconsistent with
Congress' intent when it enacted the health claims provisions in the
Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 101-
535) (id.). Accordingly, the agency reiterated its position that a
minimum nutrient contribution requirement was a necessary component of
the health claims provisions to ensure that such claims appear on foods
that make a nutritional contribution to the diet and are consistent
with dietary guidelines (id.). FDA further explained that if the agency
were to consider revoking the 10 percent nutrient contribution
requirement, it would have to establish an alternative mechanism to
ensure that health claims are not made on foods with little or no
nutritional value (60 FR 66206 at 66212 through 66213). The NFPA
petition did not suggest any alternatives to the requirement to
preclude misleading health claims on such foods. In addition, the
agency tentatively concluded that the alternatives suggested in the ABA
petition would not ensure that health claims were made only on foods
that are consistent with dietary guidelines (60 FR 66206 at 66213).
In response to the petitioners' request, FDA proposed to maintain
the 10 percent nutrient contribution requirement, but amend Sec.
101.14(e)(6) to exempt certain fruit, vegetable, and grain products
from the requirement. These products included fruit and vegetable
products comprised solely of fruits and vegetables, enriched grain
products that conform to a standard of identity, and bread that
conforms to the standard of identity for enriched bread except that it
contains whole wheat or other grain products not permitted under that
standard (60 FR 66206 at 66214). FDA specifically requested comment on
whether the proposed exemption should be extended to include the
following items: (1) Fruit and vegetable products with added oils,
sodium, sauces, syrups, or other ingredients; and (2) other foods, for
example, other types of grain products such as breakfast cereals (id.).
In light of the task force report's recommendation, FDA is
requesting comments on the proposed amendments to Sec. 101.14(e)(6) in
the 1995 proposal and on whether and how FDA could provide additional
flexibility with respect to the 10 percent nutrient contribution
requirement for foods bearing a health claim.
In addition, FDA requests comments on a specific alternative
approach to the 10 percent nutrient contribution requirement that was
suggested by two comments submitted on the 1995 proposal. In response
to the 1995 proposal, FDA received several comments on the need for the
10 percent nutrient contribution requirement, the proposed exemptions
to this requirement, and alternative approaches. With respect to
alternative approaches, two of the comments proposed a nutrient density
approach as an alternative to the 10 percent nutrient contribution
requirement. Under this approach, if the percent of the reference daily
intake (RDI) or daily reference value (DRV) of vitamin A, vitamin C,
calcium, iron, protein, or fiber per RACC is the same as, or more than,
the percent caloric contribution of the food per RACC (calculated on
the basis of a 2,000 calorie diet), then the food would be eligible to
bear a health claim. FDA is specifically seeking comments on the use of
a nutrient density approach as an alternative to the current 10 percent
nutrient contribution requirement. Any comments related to this
alternative approach should include a rationale explaining why it is
appropriate or inappropriate, and include data or other information
explaining how this approach will or will not ensure that foods with
little or no nutritional value do not bear health claims.
B. Disclosure Versus Disqualifying Nutrient Levels for Health Claims
Section 403(r)(3)(A)(ii) of the act provides that a health claim
may only be made for a food that
* * * does not contain, as determined by the Secretary [of
Health and Human Services] by regulation, any nutrient in an amount
which increases to persons in the general population the risk of a
disease or health-related condition which is diet related, taking
into account the significance of the food in the total daily diet,
except that the Secretary may by regulation permit such a claim
based on a finding that such a claim would assist consumers in
maintaining healthy dietary practices and based on a requirement
that the label contain a disclosure [statement] * * *.
This section helps to ensure that consumers who rely on health claims
will be consuming foods that assist them in structuring a healthful
diet that meets dietary guidelines (60 FR 66206 at 66221).
In Sec. 101.14, FDA established disqualifying nutrient levels for
foods, with additional allowances for main dish products and meal
products. A food that exceeds its established disqualifying level for
any of the four disqualifying nutrients (i.e., fat, saturated fat,
cholesterol, and sodium) may not bear a health claim. The general
requirements for health claims allow exceptions to the disqualifying
nutrient level requirement (Sec. 101.14(a)(4) and (e)(3)).
Specifically, consistent with section 403(r)(3)(A)(ii) of the act,
Sec. 101.14(e)(3) provides that FDA may permit a health claim despite
the fact that a disqualifying level of one of the four listed nutrients
is present in the food, if FDA finds that such a claim will assist
consumers in maintaining healthy dietary practices. If FDA makes such a
determination, the health claim must be made in accordance with the
regulation that makes such a finding and the label must bear a
disclosure statement that complies with Sec. 101.13(h) (21 CFR
101.13(h)) highlighting the nutrient that exceeds the disqualifying
level. This disclosure statement identifies the disqualifying nutrient
and refers the consumer to more information about the nutrient as
follows: ``See nutrition information for ------------content.''
[[Page 24544]]
The NFPA petition requested that the disqualification levels in
Sec. 101.14(a)(4) be converted to disclosure levels under certain
circumstances. The petition suggested that ``the presence of one of
these nutrients at the prescribed level would require disqualification
only if the nutrient was found in another health claim regulation to be
directly or adversely related to the disease mentioned in the claim.''
The petition also stated that ``[i]f the nutrient is not so directly
related to the disease to which the claim refers, the regulations would
require only disclosure by an appropriate referral statement in
conjunction with the health claim on the label, as the regulations now
require for nutrient content claims.''
In the 1995 proposal, FDA explained that a generic change in its
regulations would not be consistent with the underlying goals of the
NLEA (60 FR 66206 at 66222). The disqualifying nutrient levels assist
consumers in constructing total daily diets that meet dietary
guidelines (id.). Nevertheless, the agency tentatively found that there
may be some instances where disclosure rather than disqualification is
appropriate (id.). FDA proposed to continue to decide on a case-by-case
basis through the petition process whether to convert disqualifying
levels for health claims to disclosure levels in regulations
authorizing specific health claims. However, FDA also proposed criteria
that it would use to evaluate petitions requesting an exception to the
prohibition in Sec. 101.14(e)(3) against health claims for foods
exceeding the disqualifying nutrient levels in Sec. 101.14(a)(4)
(id.).
Consistent with the task force report's recommendation, FDA is
requesting comment on the proposed amendments to 21 CFR 101.70(f) in
the 1995 proposal and on whether and how FDA could provide additional
flexibility with respect to exceptions to the disqualifying nutrient
levels requirement. FDA continues to believe that the current
disqualifying nutrient levels assist consumers in constructing total
daily diets that meet dietary guidelines (60 FR 66206 at 66222). FDA
seeks comments, including scientific and consumer research that
address, among other things, the effectiveness of disclosure through
appropriate referral statements in lieu of the current disqualifying
levels in assisting consumers to construct healthful diets. FDA is
interested in research data or other information that is relevant to
this issue that has become available since the publication of the 1995
proposal, as well as any ongoing research in this area.
FDA has also asked for comment on the use of disclosure and
disqualifying criteria in the context of cholesterol-raising lipids in
the ANPRM published in the Federal Register of July 11, 2003 (68 FR
41507), entitled ``Trans Fatty Acids in Nutrition Labeling; Consumer
Research to Consider Nutrient Content and Health Claims and Possible
Footnote or Disclosure Statements'' (the trans fat ANPRM). In the trans
fat ANPRM, FDA solicited comment on scientific information and data,
including consumer research data, that would support the usefulness and
need for a disclosure statement, in conjunction with nutrient content
or health claims, concerning the levels of saturated fat, trans fat, or
cholesterol in a food or in the diet (68 FR 41507 at 41509). The agency
intends to consider comments received in response to the trans fat
ANPRM that are relevant to the use of disclosure statements in lieu of
disqualifying levels in any final rule on the 1995 proposal.
C. Use of ``May'' in Health Claims
In the 1995 proposal, the agency explained that a common
requirement in authorized health claims is a statement that development
of the particular disease that is the subject of the claim depends on
many factors (60 FR 66206 at 66219). FDA then tentatively concluded
that this statement reminding consumers about the multifactorial nature
of the disease was not necessary and could be made optional (id.). The
agency based its decision upon the following considerations: (1)
Information showing that consumers are generally aware that the
development of major chronic diseases is dependent upon a number of
different factors and (2) consideration of the requirement that
authorized health claims use the term ``may'' or ``might'' (e.g.,
``calcium may reduce the risk of osteoporosis''). As explained in the
1995 proposal,
* * * the requirement that authorized health claims use ``may''
or ``might'' to relate the ability of the substance that is the
subject of the claim to reduce the risk of the corresponding disease
or health-related condition is an indication to consumers of the
multifactorial nature of the disease or health-related condition. *
* *
(id.). Therefore, in the 1995 proposal, FDA made optional the statement
in unqualified health claims that development of a particular disease
depends on many factors, but retained the word ``may'' or ``might'' to
describe the ability of a substance to reduce the risk of a disease or
health-related condition and to reflect the multifactorial nature of
the disease or health-related condition.
In the qualified health claim ANPRM, FDA again explained that it
considered the use of the word ``may'' to reflect that diseases are
almost always multifactorial, and that diet is only one factor that
influences a person's risk for disease (68 FR 66040 at 66043). However,
the agency acknowledged that, although the word ``may'' is intended to
alert consumers that there is no certainty that any one dietary
practice will, in fact, reduce an individual's risk of disease, the
word ``may'' could instead be interpreted as a reflection of the
science supporting the claim (id.). Accordingly, in the qualified
health claim ANPRM, FDA requested comment on whether the agency should
remove the requirement for the word ``may'' from unqualified health
claims to eliminate the uncertainty about the science underlying claims
that meet SSA (id.). The agency questioned whether there are
alternatives to this change, and whether such a change would assist
consumers in identifying the level of science supporting such health
claims (id.).
Any comments received in response to this topic in the qualified
health claim ANPRM will also be considered as comments to the 1995
proposal. If the agency determines that the word ``may'' or ``might''
should be removed from unqualified health claims to eliminate the
uncertainty about the science underlying a claim that meets SSA, would
a separate statement be necessary (and not be made optional as proposed
in the 1995 proposal) to convey to consumers the multifactorial nature
of the disease in a health claim? Would consumers be misled by a health
claim stating that a substance ``will'' reduce the risk of a disease or
health-related condition? Would consumers think that the product
bearing such a health claim will benefit them without understanding
that other nondietary factors may contribute equally, if not greater,
to the disease risk?
In the 1995 proposal, the agency stated that it reviewed the
``required elements'' in each of the eight unqualified health claims
that were authorized at the time of publication of the 1995 proposal to
determine whether any of the required elements are unnecessary or could
be made optional (60 FR 66206 at 66216). Since the publication of the
1995 proposal, the agency has authorized four additional unqualified
health claims: (1) Dietary noncariogenic carbohydrate sweeteners and
dental caries (Sec. 101.80 (21 CFR 101.80)), (2) soluble fiber from
certain foods and risk of coronary heart disease (Sec. 101.81 (21 CFR
101.81)), (3) soy protein and risk of coronary heart
[[Page 24545]]
disease (Sec. 101.82 (21 CFR 101.82)), and (4) plant sterol/stanol
esters and risk of coronary heart disease (Sec. 101.83 (21 CFR
101.83)). Notably, none of these more recent health claims requires a
statement, commonly required in the other health claims, that
development of a disease or health-related condition depends on many
factors. Instead, the following health claims include a requirement
identical to the one proposed in the 1995 proposal that the claim does
not imply that consumption of the particular substance is the only
recognized means of achieving a reduced risk of the disease (see
Sec. Sec. 101.80(c)(2)(i)(F), 101.81(c)(2)(i)(F), 101.82(c)(2)(i)(F),
and 101.83(c)(2)(i)(F)), and that the claim includes the use of ``may''
or ``might'' to describe the ability of the substance to reduce the
risk of the disease or health-related condition and to reflect the
multifactorial nature of the disease or health-related condition (see
Sec. Sec. 101.80(c)(2)(i)(B), 101.81(c)(2)(i)(A), 101.82(c)(2)(i)(A),
and 101.83(c)(2)(i)(B)).\2\ The agency now solicits comments on whether
these four health claims contain any of the ``elements'' that are
unnecessary or could be made optional.
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\2\ In addition, in the final rules for the soy protein and
coronary heart disease (CHD) health claim and the oats and CHD
health claim, FDA expressly deferred its decision regarding the use
of abbreviated claims for these health claims, pending consideration
of the issue in the 1995 proposal (64 FR 57700 at 57720, October 26,
1999 (soy protein and CHD), 62 FR 3584 at 3594, January 23, 1997
(oats and CHD)).
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D. Synonyms in Nutrient Content Claims
Section 403(r)(1)(A) and (r)(2)(A)(i) of the act provide that a
claim that either expressly or by implication characterizes the level
of a nutrient (nutrient content claim) may be made in the label or
labeling of a food only if the characterization of the level made in
the claim uses terms that are defined in regulations of the Secretary
(and by delegation, FDA). Based on these provisions, the agency defined
expressed claims as any direct statement about the level (or range) of
a nutrient in the food (Sec. 101.13(b)(1)). In addition, it defined
implied claims as nutrient content claims that describe the food or an
ingredient therein in a manner that suggests that a nutrient is absent
or present in a certain amount (e.g., ``high in oat bran'' suggests
that the food is high in fiber) or that suggest that the food, because
of its nutrient content, may be useful in maintaining healthy dietary
practices and is made in association with an expressed claim or
statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'')
(Sec. 101.13(b)(2)(i) through (b)(2)(ii)).
The agency has specifically defined a number of expressed nutrient
content claims (e.g., ``free,'' ``low,'' ``reduced,'' ``light,'' ``good
source,'' ``high,'' and ``more'') and provided for their synonyms
(e.g., ``no,'' ``little,'' ``contains,'' and ``rich in''). (See e.g.,
21 CFR 101.54 and 101.56.) These synonyms may be used in place of the
defined term but their use must comply with all of the requirements
applicable to the relevant defined term. The agency also provided for
certain implied nutrient content claims in Sec. 101.65(c) and (d).
Section 403(r)(4)(A)(ii) of the act provides that any person may
petition the agency for permission to use terms in a nutrient content
claim that are consistent with the terms defined by the agency by
regulation. Within 90 days of the submission of such a petition, FDA
shall issue a final decision denying the petition or granting such
permission. In addition, Sec. 101.69(n) sets forth the specific
procedures and requirements for a petition for a synonymous term.
In its petition, NFPA requested that FDA reconsider allowing
synonyms and implied nutrient content claims to be used without FDA
preclearance under certain circumstances. NFPA argued that, because the
regulations sharply limit the terminology that can be used to describe
the level of a nutrient in a food and require ``premarket clearance''
of such terms, the regulations ban a host of truthful and nonmisleading
labeling statements. The petition requested that FDA propose an
amendment that would permit nonmisleading terms or statements that are
reasonably understood by consumers to be synonyms of terms defined in
subpart D of part 101 (21 CFR part 101, subpart D) to be used in
product labeling when the corresponding defined term is also used in
the labeling. Requesting similar amendments for implied claims, NFPA
stated that such amendments would ensure that claims characterizing the
level of a nutrient in a food are truthful and nonmisleading, while
giving manufacturers greater freedom to construct such labeling
messages creatively.
In the 1995 proposal, the agency recognized that there might be
some merit to the argument that more latitude in the use of truthful,
nonmisleading nutrient content claims may assist consumers in
maintaining healthy dietary practices because greater flexibility in
the use of these terms would provide the food industry with an
increased incentive to develop more healthful products (60 FR 66206 at
66209). The agency noted that, while a plethora of uncontrolled terms
would confuse consumers by diminishing the usefulness of clearly
defined and limited terms, NFPA's ``anchoring'' concept, if properly
implemented, could offer the possibility of increasing the available
terms without confusing consumers (id.). The agency stated that it was
granting NFPA's petition to initiate rulemaking on the use of
additional synonyms anchored to authorized terms. It noted, however,
that before the agency could finalize the 1995 proposal for the use of
such synonyms, it would need data demonstrating that consumers will
understand synonyms that are used in this manner\3\ (60 FR 66206 at
66210).
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\3\ The NFPA petition also requested that FDA permit the use of
synonyms with implied claims such as terms, statements, or symbols.
In the 1995 proposal, FDA tentatively found that this concept may
have some merit. However, FDA pointed out that implied claims that
are consistent with a defined term may currently be used in
labeling. Therefore, the agency did not propose amendments for the
use of synonyms with implied nutrient content claims (60 FR 66206 at
66211).
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In the 1995 proposal, the agency proposed to add Sec. 101.13(r) to
permit the use of synonyms in labeling when they are used in accordance
with one of two proposed provisions. First, proposed Sec. 101.13(r)(1)
reflects the fact that a term may be used as a synonym when the agency
has specifically listed it as a synonym for a defined term by
regulation (``listed synonym'' or ``defined term'') (60 FR 66206 at
66209). Second, FDA proposed in Sec. 101.13(r)(2) to authorize the use
of synonyms that are not specifically listed by regulation (``unlisted
synonyms'' or ``anchored synonyms''), provided that they are anchored
to defined terms, not misleading in the context of the entire label,
reasonably understood by consumers to be a synonym of the defined term,
and the defined term appears prominently and conspicuously on the label
(60 FR 66206 at 66209 through 66210). However, the agency reiterated
its concerns about consumers' ability to understand synonyms used in
this manner and said that it would not be able to finalize this
proposed change unless it received evidence demonstrating that
consumers would be able to understand the synonyms (60 FR 66206 at
66210).
In response to the 1995 proposal, FDA received several comments
that specifically addressed the use of anchored synonyms. These
comments encompassed a wide variety of views regarding FDA's authority
to provide for anchored synonyms and the propriety of those synonyms.
None of these comments, however, provided any data,
[[Page 24546]]
as requested by the agency, to demonstrate that consumers would
understand that unlisted terms that are anchored to defined terms are
synonyms of those terms. Therefore, FDA is repeating its request for
data or information establishing whether consumers would be able to
understand and not be misled by unlisted synonyms that are tied to
defined terms.
FDA is considering whether, as an alternative to the proposed use
of unlisted synonyms, to modify the existing requirements in Sec.
101.69(n) to facilitate the agency's review of a petition for a
synonymous term, if the current petition process is too burdensome. The
agency requests comments on whether the current petition process in
Sec. 101.69(n) for synonyms is too burdensome, and if so, why. In
addition, the agency seeks comments on how it can streamline the
information currently required under Sec. 101.69(n) to better enable
the agency to determine that the use of a synonymous term is consistent
with the defined term and would not be misleading. Can FDA provide more
flexibility regarding the nature and amount of information or data that
is currently required in a petition for approval of synonyms? Further,
FDA is interested in any examples of unlisted synonyms that industry
believes are limited by the current regulations, truthful and
nonmisleading, and for which no premarket clearance should be required.
E. Abbreviated Health Claims
Current Sec. 101.14(d)(2)(iv) requires that all information
required to be in a health claim appear together in one place without
other intervening material. This regulation also permits a reference
statement: ``See -------------- for information about the relationship
between ---------------- and --------------,'' with the blanks filled
in with the location of the labeling containing the health claim, the
name of the substance, and the disease or health-related condition
(e.g., ``See attached pamphlet for information about calcium and
osteoporosis''), with the complete health claim appearing at the
location referenced in the statement.
In its petition, NFPA requested that FDA amend Sec.
101.14(d)(2)(iv) to permit abbreviated health claims that are
accompanied by a referral statement directing the consumer to the label
panel where the complete health claim appears. In the preamble to the
1993 health claims final rule, the agency stated that it did not
believe that it is appropriate to use abbreviated health claims as
referral statements (58 FR 2478 at 2512). FDA explained that an
abbreviated health claim still constitutes a health claim because it
clearly characterizes the relationship between a substance and a
disease or health-related condition (id.). Further, such claims are
misleading because they do not include facts that are material in light
of the representation that is made and that are necessary to understand
the claim in the context of the daily diet (id.). Moreover, FDA stated
that the referral statement in Sec. 101.14(d)(2)(iv) does not
constitute a health claim because it does not characterize the
relationship between a substance and disease or health-related
condition (id.). Such a referral statement simply refers the consumer
to a location where the complete health claim appears (id.). In its
petition, NFPA requested that the agency reconsider this position.
In the 1995 proposal, the agency explained that a complete health
claim must comply with section 403(a) and (r)(3)(B)(iii) of the act (60
FR 66206 at 66214). Section 403(a) of the act requires that all claims
on a food label and in food labeling be truthful and not misleading.
Section 403(r)(3)(B)(iii) of the act requires, in part, that a health
claim be stated in a manner that enables the public to comprehend the
information provided in the claim and to understand the relative
significance of such information in the context of a total daily diet.
FDA stated that, although it has long required that all information
that is necessary to make a claim truthful and not misleading appear in
one place, there is nothing in the act that would require that
information that is required under section 403(r)(3)(B)(iii) of the act
appear as part of the claim each time that it is presented on the label
(60 FR 66206 at 66214 through 66215). Thus, FDA tentatively concluded
that an abbreviated health claim that is a scientifically valid
representation of the relationship between a substance and a disease or
health-related condition may be permissible under section 403(a) of the
act if it is not false or misleading (60 FR 66206 at 66215). The agency
also tentatively concluded that if such an abbreviated claim included a
prominent and immediately adjacent reference statement to the complete
claim located elsewhere on the label, the requirements of section
403(a) and (r)(3)(B)(iii) of the act would be fulfilled (id.).
Accordingly, in the 1995 proposal, the agency proposed to amend
Sec. 101.14(d)(2)(iv) to provide for the use of an abbreviated health
claim when authorized in a specific health claim regulation in subpart
E of part 101 (21 CFR part 101, subpart E). Of the health claims
considered in the 1995 proposal, the agency proposed to authorize an
abbreviated claim for one (21 CFR 101.72), on the relationship between
calcium and osteoporosis (60 FR 66206 at 66220 through 66221). Based on
its review of the specific requirements of the remaining health claims,
however, FDA tentatively concluded that there was no basis upon which
it could propose to permit the splitting of the required elements on
the food label (60 FR 66206 at 66220). The agency noted that, in the
same rulemaking, it was proposing to provide the basis for shorter
health claims by making optional some of the elements that are required
by regulation to be included in claims (60 FR 66206 at 66214). FDA
explained that if those changes are finalized, many of the complete
claims will be brief enough to render consideration of abbreviated
claims moot (id.).
Following the 1995 proposal, FDA conducted a consumer research
study, entitled ``Consumer Impacts of Health Claims: An Experimental
Study,'' relevant to issues in the 1995 proposal, including abbreviated
health claims. In addition, the Quaker Oats Co. submitted reports of
two studies, ``Quaker Oatmeal On-Pack Health Claim Survey'' and
``Consumer Perception Study of a Statement Related to Heart Disease on
the Label of Quaker Oats,'' pertaining to the use of abbreviated health
claims. To allow interested persons an opportunity to obtain and
comment on these studies, FDA reopened the comment period on the 1995
proposal (62 FR 3635, January 24, 1997).
The agency is interested in additional comments on these studies
and the use of abbreviated health claims. FDA is particularly
interested in receiving consumer research data or other information
that is relevant to the issue of abbreviated health claims that has
become available since the 1995 proposal, as well as any ongoing
research on consumer understanding of abbreviated health claims. In
addition, FDA seeks comments on whether abbreviated health claims would
mislead consumers. The agency is also interested in comments on whether
abbreviated claims are needed given the agency's proposal to make
optional some of the ``specific elements'' that are currently required
to be included in health claims, thereby leading to shorter claims.
Finally, the agency seeks comments on whether and how the
discontinued use of the word ``may'' in health claims (see section II.C
of this document) would affect the use of or need for
[[Page 24547]]
abbreviated claims. As previously discussed, in the past, the agency
has considered the use of the word ``may'' or ``might'' in health
claims to communicate to consumers the multifactorial nature of the
disease or health-related condition (60 FR 66206 at 66219). That is,
these words are considered to indicate the ability of a substance to
reduce the risk of a disease or health-related condition (id.). In
section II.C of this document, FDA seeks comments on whether ``may''
should be removed from health claims because it could be interpreted as
a reflection of the science supporting the claim instead of the
multifactorial nature of the disease. Significantly, however, the
agency relied, in part, upon the use of ``may'' to justify making
optional the requirement that a health claim state that development of
a particular disease depends on many factors, and thereby provide for a
shorter health claim (60 FR 66206 at 66219). If the agency were to make
optional or discontinue the use of the word ``may'' or ``might'' in
unqualified health claims, would health claims be misleading to
consumers? Would FDA need to retain the requirement that a health claim
state that development of a particular disease depends on many factors
in order for the claim not to be misleading? If so, would such
information need to appear as part of the claim each time the claim is
presented on the label in order for the claim not to be misleading?
III. 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 numbers found in brackets
in the heading of this document. If you base your comments on
scientific evidence or data, please submit copies of the specific
information along with your comments. Received comments may be seen in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: April 26, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10126 Filed 5-3-04; 8:45 am]
BILLING CODE 4160-01-S
