[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Follow the 

instructions for submitting comments.
    Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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