[Federal Register Volume 60, Number 245 (Thursday, December 21, 1995)]
[Proposed Rules]
[Pages 66205-66227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31008]



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[[Page 66206]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 94P-0390 and 95P-0241]


Food Labeling: Nutrient Content Claims, General Principles; 
Health Claims, General Requirements and Other Specific Requirements for 
Individual Health Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations on nutrient content claims and health claims to provide 
additional flexibility in the use of these claims on food products. 
These changes are intended to benefit public health by encouraging 
manufacturers to use health claims and nutrient content claims that 
will assist consumers in maintaining a healthy diet. The agency's 
current regulations were issued in January of 1993 to implement the 
Nutrition Labeling and Education Act of 1990. This document proposes 
refinements to those regulations to allow additional synonyms for 
nutrient content claims without specific preclearance by the agency, 
permit health claims on certain foods that do not currently qualify 
because they do not contain 10 percent of certain required nutrients, 
permit the use of shortened versions of authorized health claims under 
certain circumstances, eliminate some of the required elements for 
health claims, and provide additional guidance for petitioners seeking 
exemption from the disqualification of some foods from bearing a health 
claim because they contain high levels of certain nutrients. FDA is 
proposing these amendments in response to petitions submitted by the 
National Food Processors Association (NFPA) and the American Bakers 
Association (ABA).

DATES: Written comments by March 20, 1996. The agency is proposing that 
any final rules that may issue based upon this proposal become 
effective on the date of publication.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857, 301-443-1751.

FOR FURTHER INFORMATION CONTACT: F. Edward Scarbrough, Center for Food 
Safety and Applied Nutrition (HFS-2), Food and Drug Administration, 200 
C St. SW., Washington, DC 20204, 202-205-4561.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Nutrition Labeling and Education Act of 1990

    On November 8, 1990, the President signed into law the Nutrition 
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). This new law amended the Federal Food, Drug, and Cosmetic Act 
(the act) in a number of important ways. Among the more notable aspects 
of the 1990 amendments were that they confirmed FDA's authority to 
regulate nutrient content and health claims on food labels and in food 
labeling.
    Section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)), which was 
added by the 1990 amendments, provides that a product is misbranded if 
it bears a claim that characterizes the level of a nutrient of the type 
required to be included in nutrition labeling unless the claim uses 
terms that are defined and designated in regulations adopted by FDA and 
is made in accordance with all other regulatory requirements. 
Similarly, section 403(r)(1)(B) of the act provides that a product is 
misbranded if it bears a claim that characterizes the relationship of a 
nutrient to a disease or health-related condition unless the claim is 
made in accordance with the requirements of the act.
    The 1990 amendments instruct the Secretary of Health and Human 
Services (the Secretary) (and, by delegation, FDA) to issue regulations 
defining nutrient content claims that characterize levels of nutrients 
in food. The 1990 amendments also instruct the Secretary (and, by 
delegation, FDA) to issue regulations authorizing health claims only if 
he or she determines,

    ``based on the totality of publicly available scientific 
evidence (including evidence from well-designed studies conducted in 
a manner which is consistent with generally recognized scientific 
procedures and principles), that there is significant scientific 
agreement, among experts qualified by scientific training and 
experience to evaluate such claims, that the claim is supported by 
such evidence'' (section 403(r)(3)(B)(i) of the act).

    Section 403(r)(3)(B)(ii) and (r)(3)(B)(iii) of the act describe the 
information that must be included in any health claim authorized under 
the act. The act provides that the claim shall be an accurate 
representation of the significance of the substance in affecting the 
disease or health-related condition, and that it shall enable the 
public to comprehend the information and understand its significance in 
the context of the total daily diet. Section 403(r)(4)(A)(i) of the act 
also provides that any person may petition FDA to issue a regulation 
authorizing a nutrient content or health claim.
    In addition, the 1990 amendments directed FDA to consider 10 
disease-nutrient relationships as possible subjects for health claims.

B. FDA's Implementation of the 1990 Amendments

    In the Federal Register of January 6, 1993 (58 FR 2066-2941), FDA 
adopted final rules that implemented the 1990 amendments to the act. 
Among those final rules, Sec. 101.13 sets out general principles for 
nutrient content claims and provides for their use on food labels. 
Other regulations in subpart D of part 101 (21 CFR part 101) establish 
specific requirements for nutrient content claims. These regulations 
define specific terms such as ``free,'' ``low,'' ``good source,'' 
``high,'' ``reduced,'' ``less (or fewer),'' ``more,'' and ``light'' or 
``lite,'' and establish values for these terms for various nutrients. 
They also designate certain synonyms that can be used in place of these 
defined terms (58 FR 2302). In addition, Sec. 101.69 establishes 
procedures for petitioning the agency to authorize additional nutrient 
content claims and provide for additional synonyms which, if 
authorized, will be listed in the relevant regulations (Sec. 101.69) 
(e.g., ``extra'' as a synonym for ``more'').
    FDA also adopted final rules that implemented the health claims 
provisions of the act (58 FR 2478). Section 101.14 establishes general 
principles for health claims. This regulation prescribes the 
circumstances in which a substance is eligible to be the subject of a 
health claim (Sec. 101.14(b)), sets forth the standard in section 
403(r)(3)(B)(i) of the act as the standard that the agency will apply 
in deciding whether to authorize a claim about a substance-disease 
relationship (101.14(c)), sets forth general rules on how authorized 
claims are to be made in food labeling (Sec. 101.14(d)), and 
establishes limitations on the circumstances in which claims can be 
made (Sec. 101.14(e)). The agency also adopted Sec. 101.70, which 
established a process for petitioning the agency to authorize health 
claims about a substance-disease relationship (Sec. 101.70(a)) and sets 
out the types of information that any such petition must include 
(Sec. 101.70(f)).
    At the same time, the agency announced its decisions regarding 
health claims on the 10 disease-nutrient 

[[Page 66207]]
relationships specified in the 1990 amendments. Of the 10, FDA 
authorized health claims for calcium and osteoporosis (58 FR 2665); 
dietary lipids and cancer (58 FR 2787); sodium and hypertension (58 FR 
2820); dietary saturated fat and cholesterol and risk of coronary heart 
disease (58 FR 2739); fiber-containing grain products, fruits, and 
vegetables and cancer (58 FR 2537); fruits, vegetables, and grain 
products that contain fiber, particularly soluble fiber, and risk of 
coronary heart disease (58 FR 2552); and fruits and vegetables and 
cancer (58 FR 2622). The regulations on general requirements for health 
claims and on the claims specified above became effective May 8, 1993.
    In the Federal Register of January 6, 1993 (58 FR 2066), FDA also 
issued ``Food Labeling Regulations Implementing the Nutrition Labeling 
and Education Act of 1990; Opportunity for Comments,'' (the 
implementation final rule). The implementation final rule provided 30 
days for interested persons to comment on technical issues arising in 
any of the final rules implementing the 1990 amendments. In the Federal 
Register of August 18, 1993 (58 FR 44020 to 44096), FDA published 
technical amendments to the final rules in response to the comments it 
received.
    In the Federal Register of October 14, 1993 (58 FR 53254), FDA 
proposed to authorize the use of a health claim about the relationship 
between folate and the risk of neural tube defects on the labels or in 
labeling of foods in conventional food form and dietary supplements. 
This action was in response to provisions of the 1990 amendments and 
the Dietary Supplement Act of 1992 (Pub. L. 102-571). In the Federal 
Register of January 4, 1994 (59 FR 395), FDA announced that the 
proposed regulation to authorize use of the health claim about the 
association between folate and neural tube defects in food labeling was 
considered a final regulation for dietary supplements of vitamins, 
minerals, herbs, and other similar nutritional substances.

II. The Petition of the National Food Processors Association

    The National Food Processors Association (NFPA) submitted a citizen 
petition dated October 25, 1994, requesting initiation of rulemaking 
for the adoption of amendments to the regulations governing nutrient 
content and health claims. This petition was assigned FDA Docket No. 
94P-0390.
    For nutrient content claims, NFPA requested specific amendments to 
Secs. 101.13 and 101.65 allowing use of synonyms and implied nutrient 
content claims, without FDA preclearance, that are understood by 
consumers to have the same meaning as a defined term, where such claims 
are made in accordance with the requirements for the defined term, and 
the defined term also appears in the product's labeling.
    NFPA also requested several amendments to the health claim 
regulations. Among other changes, NFPA requested that FDA permit the 
use of an abbreviated or implied health claim with a referral statement 
directing consumers to the complete claim elsewhere in labeling. 
Currently, all required information must appear in one place without 
other intervening material.
    It also requested that health claims be permitted for foods with 
levels of nutrients that FDA had determined increase the risk of other 
diseases to the general population. Among the general requirements for 
health claims, FDA established in Sec. 101.14(a)(5) levels of total 
fat, saturated fat, cholesterol, and sodium in a food above which the 
food is disqualified from making a health claim. These are identified 
as ``disqualifying nutrient levels.'' In its petition, NFPA suggested 
that FDA amend the regulation so that a food with a nutrient at a 
disqualifying level would be prohibited from making a health claim only 
if the nutrient is directly and adversely associated with the disease 
to which the claim refers. Absent such an association, NFPA requested 
that the presence of a nutrient above a threshold level not disqualify 
a product from bearing a health claim but instead require disclosure of 
that fact in labeling.
    Finally, NFPA requested an amendment to Sec. 101.14(e)(6), which 
prohibits a food in conventional food form from bearing a health claim 
unless the food contains 10 percent or more of the Reference Daily 
Intake or Daily Reference Value for vitamin A, vitamin C, iron, 
calcium, protein, or fiber per reference amount customarily consumed 
before any nutrient addition (the ``10 percent nutrient contribution 
requirement''). NFPA requested that this prohibition be replaced by a 
requirement that any food bearing a health claim that refers to an 
added nutrient disclose the fact of that nutrient addition in labeling.
    FDA issued a letter on May 11, 1995, granting most of the requests 
to initiate rulemaking on the foregoing aspects of the petition 
(hereinafter referred to as the May 11, 1995, letter). However, the 
agency denied certain aspects of NFPA's petition, including NFPA's 
request that FDA change the levels in Sec. 101.14(a)(5) from 
disqualification levels to disclosure levels. Although the agency 
recognized that it has the authority under section 403(r)(3)(A)(ii) of 
the act to exempt any claim from the disqualifying nutrient levels if 
it finds that the claim would ``assist consumers in maintaining healthy 
dietary practices,'' the agency concluded that a generic change in its 
regulations would not be consistent with the underlying goals of the 
NLEA.
    FDA acknowledged, however, that disclosure rather than 
disqualification may be appropriate under certain circumstances. The 
agency said it will seek more limited criteria to define the conditions 
under which disclosure rather than disqualification could be permitted.

III. The Petition of the American Bakers Association

    A citizen petition, dated July 27, 1995, was submitted to FDA by 
the ABA (Docket No. 95P-0241/CP 1), requesting that FDA amend, among 
other things, the regulatory provision in Sec. 101.14(e)(6) to permit 
enriched cereal-grain products that conform to the standards of 
identity in part 136, 137, or 139 (21 CFR part 136, 137, or 139), and 
bread that conforms to the standard of identity for enriched bread in 
Sec. 136.115, except that it contains whole wheat or other grain 
products not permitted under that standard, to bear health claims. The 
petition specifically requested that FDA amend Sec. 101.14(e)(6) to 
read:

    Except for dietary supplements, enriched grain products that 
conform to a standard of identity in part 136, 137, or 139, and 
bread that conforms to the standard of identity for enriched bread 
in Sec. 136.115, except that it contains whole wheat or other grain 
products not permitted under that standard, or where provided for in 
other regulations in part 101, subpart E.

In the alternative, ABA suggested that the agency expand the list of 
qualifying nutrients to include complex carbohydrates, niacin, or 
thiamin or allow the 10 percent nutrient contribution requirement to 
apply to all foods for which the summation of the Daily Value of the 
applicable nutrients is 10 percent rather than requiring that the 10 
percent be based on a single serving.
    Because of the similarities in the NFPA and ABA petitions regarding 
the 10 percent nutrient contribution and health claims, FDA is 
responding to part of the ABA petition in this document, which 
implements FDA's May 11, 1995, letter response to the NFPA petition. 
Other issues raised in the ABA petition will be handled separately.

[[Page 66208]]


IV. The Proposals

    As the petitioners have requested, the agency is reconsidering its 
position on several of the issues raised in the NFPA and ABA petitions. 
The agency is well within its legal authority to reconsider the issues 
in the NFPA petition and propose changes to the current food labeling 
regulations. ``An agency may always change its mind and alter its 
policies.'' (See Conference of State Bank Examiners v. Office of Thrift 
Supervision, 792 F. Supp. 837, 845 (D.D.C. 1992)). While the burden is 
on the agency to justify the change from the status quo, that 
justification need not consist of an affirmative demonstration that the 
status quo is wrong. The agency need only supply ``a reasoned analysis 
for the change.'' (See Center for Auto Safety v. Peck, 751 F.2d 1336, 
1349 (D.C. Cir 1985) (citing Motor Vehicle Mfrs. Ass'n v. State Farm 
Mutual, 463 U.S. 29, 41, 103 S.Ct. 2856, 2865-2866 (1983))). The agency 
can justify its departure from past policy ``with reference to the 
objectives underlying statutory scheme it purports to construe.'' (See 
Simmons v. I.C.C., 829 F.2d 150, 156 (D.C. 1987)).
    One of the primary purposes of the 1990 amendments was to educate 
consumers about healthful dietary practices. The legislative history 
states, ``Health claims supported by significant scientific agreement 
can reinforce the Surgeon General's recommendations and help Americans 
to maintain a balanced and healthful diet'' (Ref. 1).
    If the current regulations hinder food companies who want to use 
one of the FDA-authorized claims, as NFPA has alleged, this public 
health objective will be frustrated. As the agency has stated, if valid 
health claims are not being used, ``there is a cost imposed on society 
in that some valuable information may not be conveyed to consumers'' 
(58 FR 2927 at 2940). Consumers cannot change their dietary practices 
if they do not have the necessary information.
    The agency is pleased that many food companies are using the health 
claims on the labels of their products. While the agency has not done 
an extensive survey, FDA notes that dozens of health claims have 
appeared on products such as cereal, cookies, frozen dessert bars, egg 
products, and frozen vegetables. Nonetheless, the agency is concerned 
that health claims are not being used as extensively as they could be, 
despite the fact that many foods qualify for such claims.
    FDA also notes that food companies are submitting petitions seeking 
approval of new claims. Since the final regulations have been 
published, the agency has received two such petitions, one regarding 
sugar alcohols and dental caries and one regarding oat products and 
coronary heart disease. A proposed regulation to authorize a health 
claim regarding sugar alcohols and dental caries was published in the 
Federal Register on July 20, 1995 (60 FR 37502) (hereinafter referred 
to as the sugar alcohols proposal). The agency expects to complete in 
the very near future its evaluation of the petition regarding oat 
products and coronary heart disease.
    Accordingly, the agency is proposing changes to the regulations 
regarding the use of synonyms for nutrient content claims, the 10 
percent nutrient contribution requirement for health claims, the use of 
abbreviated health claims, the specific requirements for individual 
health claims, and disqualifying levels for health claims to facilitate 
additional use of these claims.

A. Synonyms in Nutrient Content Claims

    Section 403(r)(1)(A) and (r)(2) of the act state that claims that 
either expressly or by implication characterize the level of a nutrient 
(nutrient content claims) 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 agency. Based on these 
provisions, the agency has 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 has 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'') (Sec. 101.13(b)(2)(i)) or 
that suggests 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)(ii)).
    The agency has specifically defined a number of expressed nutrient 
content claims (``free,'' ``low,'' ``reduced,'' ``light,'' ``good 
source,'' ``high,'' and ``more'') and provided for their synonyms, 
e.g., ``no,'' ``little,'' ``contains,'' and ``rich in.'' The agency 
also provided for certain implied nutrient content claims 
(Sec. 101.65(c) and (d)). Finally, the agency has defined the implied 
nutrient content claim ``healthy'' (Sec. 101.65(d)(2)).
    The agency considered the use of additional synonyms for the 
defined terms in the 1993 nutrient content claims final rule (58 FR 
2302 at 2320). At that time the agency provided for a limited number of 
specific synonyms and declined to provide for either long lists of 
synonyms or conditions for use of unevaluated terms. The agency 
concluded that permitting additional synonyms to be used in conjunction 
with either a defined claim or a disclosure statement explaining the 
synonym's intended meaning would not assist consumers in maintaining 
healthy dietary practices (58 FR 2302 at 2320). The agency stated that 
there is no provision in the act that allows for the use of undefined 
synonyms in the absence of action by the agency. Because of time 
constraints, in developing the final regulations FDA was unable to 
fully study the suggested schemes for use of terms without preclearance 
to determine whether a scheme could be devised that would constitute 
approval by the agency without preclearance of each term.
    The agency also considered but rejected (58 FR 2302 at 2373) the 
suggestion that implied claims that are defined on the label be 
permitted. The agency did provide for certain implied claims on 
products that meet the definition for certain expressed claims and gave 
specific examples of some of these claims in the preamble (58 FR 2302 
at 2374) and in the regulations (Sec. 101.65(c)(3)) (e.g., ``high in 
oat bran'' for foods that are a good source of fiber; ``no oil'' for 
fat free foods).
    In the October 25, 1994, petition, as stated above, NFPA requested 
that the agency reconsider allowing synonyms and implied nutrient 
content claims to be used without FDA preclearance under certain 
circumstances. NFPA maintained that FDA's strict interpretation and 
application of the 1990 amendments totally frustrated the achievement 
of the various statutory goals of improving consumer education about 
diet and health and thereby reducing the incidence of diet-related 
diseases.
    NFPA argued that, because the regulations sharply limit the 
terminology that can be used to make nutrient content claims for food 
products and require ``premarket clearance'' of terminology that FDA 
has not specifically authorized by regulation, the regulations ban a 
host of truthful and nonmisleading labeling statements. The petitioner 
requested that FDA propose amendments that would permit nonmisleading 
terms or statements that are reasonably understood by consumers to be 
synonyms of a term defined in subpart D of part 101 to be used in 
product labeling when the defined term also is used in the labeling. 
Requesting similar amendments for implied claims, NFPA 

[[Page 66209]]
stated that such amendments would ensure that claims characterizing the 
level of a nutrient in a food are truthful and nonmisleading but would 
give manufacturers greater freedom to construct such labeling messages 
creatively.
    In its May 11, 1995, response, FDA recognized that there may 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 would 
provide the food industry with an increased incentive to develop more 
healthful products. Permitting synonyms for defined terms to be used on 
product labels without specific authorization for the particular 
synonyms has the potential to provide the industry with a greater 
variety of ways to convey nutrient information to the consumer because 
the nutrient content claims on the label would not be restricted to a 
finite list of terms that can only be expanded by filing an appropriate 
petition. This approach could facilitate the industry's efforts to 
arrive at terms that not only appropriately describe the nutrient level 
in a food but also effectively catch the attention of the consumer.
    In its May 11, 1995, letter, 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. The agency 
stated that it was granting NFPA's petition to initiate rulemaking on 
the use of additional synonyms anchored to specifically authorized 
terms.
    Consequently, the agency is proposing to add new paragraph (r) to 
Sec. 101.13, which provides that synonyms may be used in labeling in 
accordance with one of two 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 in one of the regulations listing authorized nutrient 
content claims in subpart D of part 101 (``listed synonym''). FDA 
included a number of synonyms in the regulation that it adopted as part 
of the 1993 nutrient content claims final rule. It has also adopted 
synonyms as a result of a petition filed in accordance with 
Sec. 101.69(n). Additional synonyms may be added to FDA's regulations 
following this procedure. Second, FDA is proposing in Sec. 101.13(r)(2) 
to authorize the use of synonyms that are not specifically listed by 
name in the regulations in subpart D of part 101, part 105, or part 107 
(21 CFR part 105 or part 107) (``unlisted synonyms'') but are used in 
labeling in accordance with the labeling requirements set out in this 
provision.
    Specifically, in Sec. 101.13(r)(2), the agency is proposing a 
number of requirements to ensure that the use of unlisted synonyms will 
not confuse or mislead consumers. In particular, FDA is proposing in 
Sec. 101.13(r)(2)(i) to require that an unlisted term be reasonably 
understood by consumers to be a synonym of a term defined in subpart D 
of part 101, part 105, or part 107. Such an understanding is necessary 
because the agency has, for example, defined the terms ``high'' and 
``good source'' to represent two different levels of a nutrient.
    Consumers can reasonably be expected to understand that ``without 
any [nutrient]'' is the same as ``free of [nutrient],'' and that ``not 
much'' of a nutrient is, in common usage, synonymous with ``low'' for 
that nutrient since ``not much'' implies that some but not a lot of the 
nutrient is present. Other ``synonyms'' however, may not be so clear. 
It is important, therefore, that the use of unlisted synonyms that FDA 
is proposing to authorize under Sec. 101.13(r)(2) be clear and 
unambiguous to consumers regarding the levels to which they apply. 
Without such clarity, consumers may be confused as to the nutrient 
content of the food bearing the claim. Thus, regardless of the 
prominent use of a listed term or other explanatory information 
discussed below, terms that are not clearly understood by consumers to 
be synonymous with specific listed terms may still be misleading and 
misbrand the food under both section 403(a) and section 403(r)(1)(A) of 
the act.
    Further, the agency is concerned that different manufacturers might 
use the same term but anchor it to different nutrient content claims. 
For example ``plenty of fiber'' might be anchored to ``good source'' on 
one product label and ``high'' on another. In this event, the agency 
reserves the right to call for petitions to define the term by 
regulation or to define the term on its own initiative.
    The agency agrees with NFPA that, in addition to considering the 
words of the individual claim, it is important to consider the meaning 
of the unlisted synonym in the context of the entire product label. It 
is possible, for instance, that other statements such as other nutrient 
content claims on the label or in labeling could establish a context in 
which the unlisted synonym would be misleading. Section 403(a) of the 
act states that a food is misbranded if it bears any labeling statement 
that is false or misleading in any particular. Therefore, proposed 
Sec. 101.13(r)(2)(i) requires that the unlisted synonym not be 
misleading in the context of the entire label.
    The agency seeks comments as to whether further requirements should 
be imposed to ensure that an unlisted term is truly synonymous with a 
listed term. For example, FDA seeks comments as to whether it should 
require companies to have data in their files demonstrating that 
consumers understand the unlisted term to be synonymous with the listed 
term in question as a condition for the use of the unlisted terms. In 
addition, the agency seeks comments on why, if it includes such a 
requirement, it should not also require that such data be available for 
review by regulatory officials.
    As stated above, for any term used as a synonym authorized under 
proposed Sec. 101.13(r)(2) not to be misleading, the defined term for 
which it purports to be a synonym would have to be clear to the 
consumer. Proposed Sec. 101.13(r)(2)(ii)(A) will require that the 
listed term appear prominently and conspicuously on the label.
    Proposed Sec. 101.13(r)(2)(ii)(A)(1) requires the listed term 
appear immediately adjacent to (with no intervening material) the most 
prominent (as defined in Sec. 101.13(j)(2)(iii)) use of the unlisted 
synonym. The agency tentatively concludes that having a listed term 
immediately adjacent to the most prominent use of each such unlisted 
synonym will help to ensure that consumers understand the claim that is 
being made and thus to ascertain the level of the nutrient that the 
food purports to contain.
    The agency tentatively concludes that it is not sufficient for the 
listed term to appear anywhere on the label, as suggested in the NFPA 
petition. Such a scheme would not guarantee that the unlisted synonym 
is read in conjunction with a listed term and would hinder the consumer 
from ascertaining the level of the nutrient that the food purports to 
have. For example, with such a provision, the unlisted synonym 
authorized under Sec. 101.13(r)(2) could be very large and prominent, 
and the listed term could be a part of the fine print (i.e., in small 
print that is in sentence or paragraph form elsewhere on the label). 
Although such defining information may be read by consumers at some 
point, it would be unlikely to be fully read and comprehended at the 
same 

[[Page 66210]]
time as the unlisted term and thus would not make clear to the consumer 
that the two statements are synonymous.
    The agency's proposal is consistent with section 403(f) of the act 
which deems a food to be misbranded if any word, statement, or other 
information required by the act to appear on the label or labeling is 
not prominently placed with such conspicuousness (as compared with 
other words, statements, designs, or devices, in the labeling) and in 
such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. 
Section 403(f) of the act necessitates placement of the listed term on 
the label so that it is likely to be read and understood, and thereby 
to eliminate any ambiguity as to the meaning of the unlisted synonym. 
Allowing the listed term to be anywhere on the label that the 
manufacturer chooses would not ensure that this requirement is met.
    There are a number of precedents for requiring clarifying 
information in labeling to be adjacent to the text that it clarifies. 
For example, Sec. 101.3(e) requires that the word ``imitation'' precede 
the name of the food imitated; the term ``artificial'' is required by 
Sec. 101.22(i)(1)(i), (i)(1)(ii), and (i)(3) to be adjacent to the name 
of the flavor; and Sec. 102.5(b)(2) (21 CFR 102.5(b)(2)) requires that 
if the percentage of a characterizing ingredient is required to be 
included in the common or usual name of the food, it must be adjacent 
to the name of the food. Further, several aspects of the nutrient 
content claims regulations require that clarifying statements such as 
the referral statement, ``See [side] panel for nutrition information'' 
(Sec. 101.13(g)); the disclosure statement, ``See [side] panel for 
information about [sodium] and other nutrients'' (Sec. 101.13(h)); the 
percentage reduction and identity of the reference food for a relative 
claim (Sec. 101.14(j)(2)(ii)); and other clarifying information about 
the food in relation to the claim, e.g., Sec. 101.13(i)(2) and (p)(2), 
be immediately adjacent to the claim to which the statement pertains.
    As with accompanying information for relative claims (i.e., percent 
reduction in the nutrient and identity of the reference food 
(Sec. 101.13(j)(2)(i) through (j)(2)(iii)), the agency considers the 
presence of a listed term to be necessary to ensure that the claim is 
understood by, and is not misleading to, consumers. However, as with 
accompanying information, it recognizes that to require that this 
information be included each time an unlisted synonym is used may 
overburden the label. Consequently, as with relative claims, the agency 
is proposing to require only that the defined term or listed synonym be 
placed immediately adjacent to the most prominent declaration of each 
unlisted synonym. Because of the similar purposes of the two 
requirements, the agency believes that the provisions in 
Sec. 101.1(j)(2)(iii) for determining the order of prominence of 
relative claims are also appropriate for determining the order of 
prominence of presentations of an unlisted synonym. The order of 
prominence for relative claims is: (1) A claim on the principal display 
panel adjacent to the statement of identity, (2) a claim elsewhere on 
the principal display panel, (3) a claim on the information panel, or 
(4) a claim elsewhere on the label or labeling.
    The agency is proposing in Sec. 101.13(r)(2)(ii)(A)(2) that the 
listed term be at least half as prominent as the unlisted synonym. If 
it adopts these changes, FDA will evaluate prominence using type size, 
style, and color. In the past, FDA has required certain clarifying 
information to be in type at least half the size of that of the 
statement it is clarifying. For example, when the term ``light'' is 
used to describe a physical or organoleptic property of a food (e.g., 
``light in color''), the clarifying information ``in color'' is 
required to be at least half the type size as the word ``light'' 
(Sec. 101.56(e)(2)). Similarly, when the term ``light'' is used on a 
meal type product to describe a nutrient reduction, a clarifying 
statement as to whether the food is ``low in calories'' or ``low in 
fat'' is required and must be at least half the size of the term 
``light'' (Sec. 101.56(d)(1)(ii)). Further, Sec. 102.5 requires that 
the percentage declaration of a characterizing ingredient or component 
be no less than half the height of the largest type appearing in the 
common or usual name when it has a material bearing on the nature of 
the product. Further, this information must appear in bold-faced type. 
As a final example, Sec. 101.13(f) requires that any nutrient content 
claim not be more than two times larger than, and not unduly prominent 
in type style compared to, the statement of identity. All of these 
provisions are examples of requirements where clarifying information 
must be at least half as large or prominent as the statement that it is 
clarifying.
    FDA is proposing section 101.13(r)(2)(ii)(A)(1) and 
(r)(2)(ii)(A)(2) to ensure that the combination of unlisted and listed 
terms that appear on a food label are understood by consumers to be 
making a single claim. This understanding is crucial because the act 
requires that a nutrient content claim be made ``only if the 
characterization of the level made in the claim uses terms which are 
defined in regulations * * *.'' (Section 403(r)(2)(A)(i) of the act 
(emphasis added).) In its petition, NFPA argues that there is nothing 
in the act that defines a claim to mean individual label statements--as 
opposed to the overall message conveyed by labeling for a product. The 
petition stated that, in NFPA's view, a ``claim'' is properly viewed 
under the statute as referring to the message about the level of a 
particular nutrient in the food conveyed in the context of the entire 
product labeling. NFPA maintained that, while the labeling should 
include terms defined by FDA, other synonyms or implied statements 
concerning the nutrient should be viewed as components of the single 
labeling claim. FDA tentatively concludes that the use of unlisted 
synonyms in the manner proposed will ensure that consumers understand 
them to be part of a single nutrient content claim that uses terms 
defined by regulation. As stated in its May 11, 1995, letter to NFPA, 
however, the agency cannot finalize this rule unless it receives 
evidence demonstrating that consumers understand the terms used in this 
way.
    FDA also recognizes that there may be some labels on which the 
listed term is significantly more prominent than an unlisted synonym. 
This would be the case, for example, if the listed term was made in a 
``burst'' or in the statement of identity and the unlisted synonym was 
used in a paragraph in smaller sized type. Such usage might occur if a 
manufacturer wanted to use a variety of ways to express the level of a 
nutrient in a discussion about the food. The agency tentatively finds 
that, in this case, the level of the nutrient described by the listed 
term would be clearly understood, and additional clarification next to 
the smaller print on the same label would not be necessary. Therefore, 
FDA is proposing in Sec. 101.13(r)(2)(ii)(B) that if the listed term is 
more than twice as prominent on a label as the listed synonym, such 
that the claimed nutrient level is clearly understood, e.g., a bold 
faced listed term versus an unlisted synonym used only in a paragraph 
in smaller sized type, the listed need not be placed adjacent to the 
unlisted synonym. The agency requests comment on whether this approach 
is consistent with a nonmisleading label.
    The agency is also providing in proposed Sec. 101.13(r)(2)(iv) that 
a listed term may not be used with an unlisted synonym to form a new 
term, e.g., extra low, extra high, especially good source, or great 
source. In its review of food 

[[Page 66211]]
labels before the passage of the 1990 amendments, the Institute of 
Medicine (IOM) stated that consumers were confused by the plethora of 
terms on food labels and recommended that definitions of nutrient 
levels for label claims be severely restricted (Ref. 2). The IOM 
recommended that four levels be defined for explicit claims: Low, very 
low, high and very high or their equivalents. The agency has 
essentially done just that in defining, ``low,'' ``free,'' ``good 
source'' and ``high.'' With the use of unlisted synonyms, the agency is 
concerned that there may be instances when the use of unapproved 
modifiers for these terms (e.g., ``extra low,'' ``extra high,'' 
``especially good source,'' ``great source'') would confuse consumers 
by unjustifiably suggesting that there is a distinction between the 
listed term with and without the modifier. To avoid this confusion, the 
agency tentatively concludes that it is necessary to prohibit the use 
of claims that consist of a term that modifies an existing listed term.
    In the course of developing the definitions and other requirements 
for the use of nutrient content claims, the agency made a diligent 
effort to determine the various meanings and requirements of the 
nutrient content claims it defined. In some cases the agency determined 
that, in order for the label not to be misleading, it was necessary for 
certain additional information to be conveyed to consumers along with 
the claim. This information included referral or disclosure statements 
(required by the statute), additional label statements such as 
accompanying information for foods bearing relative claims 
(Sec. 101.13(j)(2)), and other statements such as ``not a sodium free 
food'' on a food bearing an ``unsalted'' claim that was not ``sodium 
free'' (Sec. 101.61(c)(2)(iii)). Just as this information is necessary 
for a listed term not to be misleading and for a label bearing such a 
claim to provide full and relevant information to the consumer, the 
agency tentatively concludes that such additional information is 
equally important and necessary when unlisted synonyms are used. 
Consequently, the agency is proposing in Sec. 101.13(r)(2)(iii) to 
require that unlisted synonyms be used in conformance with all of the 
requirements for the use of the listed terms.
    The petitioners also requested that the agency permit the use of 
unlisted synonyms with implied claims such as terms, statements, or 
symbols. As with unlisted synonyms, FDA tentatively finds that this 
concept may have some merit. However, the agency points out that 
implied claims that are consistent with a listed term may currently be 
used on a label. Therefore, the agency is not proposing further 
provisions for the use of implied nutrient content claims.

B. Section 101.14(e)(6): The 10 Percent Nutrient Contribution 
Requirement

    In the Federal Register of January 6, 1993, FDA published a final 
rule entitled ``Food Labeling: General Requirements for Health Claims 
for Food'' (58 FR 2478) (hereinafter referred to as the 1993 health 
claims final rule). Among other things, this 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, before any nutrient 
addition (Sec. 101.14(e)(6)). As explained in that document, FDA 
concluded that such a requirement was necessary to assure that the 
value of health claims would not be trivialized or compromised by their 
use on foods of little or no nutritional value. Furthermore, such a 
requirement responded to Congress's intent that health claim provisions 
consider the role of the nutrients in food in a way that will enhance 
the chances of consumers constructing total daily diets that meet 
dietary guidelines. Thus, foods bearing health claims should be 
consistent with current dietary guidelines. Furthermore, the agency 
concluded that fortification of foods of little or no nutritional value 
for the sole purpose of qualifying that food for a health claim is 
misleading, especially if foods such as confections, soda, and sweet 
desserts are fortified to qualify for a health claim, because such 
foods have been cited in dietary guidance as those that should be used 
sparingly.
    In the Federal Register of August 18, 1993 (58 FR 44036), FDA 
published technical amendments to the health claim regulations in 
response to comments that the agency received on the implementation 
final rule (hereinafter referred to as the 1993 health claims technical 
amendment). One of the comments stated that if a health claim petition 
were submitted for the claim ``useful only in not promoting tooth 
decay,'' virtually none of the sugar-free products on the market would 
be eligible to bear the claim because of the 10 percent nutrient 
contribution requirement.
    In the 1993 health claims technical amendments, FDA acknowledged 
that certain food products of limited nutritional value that have been 
specially formulated relative to a specific disease condition, such as 
dental caries, may be determined to be appropriate foods to bear a 
health claim. The agency commented that its intention was to deal with 
such situations within the regulations authorizing specific health 
claims. Therefore, FDA amended Sec. 101.14(e)(6) to state that:

    Except for dietary supplements not in conventional food form or 
where provided for in other regulations in part 101, subpart E, the 
food contains 10 percent or more of the Reference Daily Intake or 
Daily Reference Value for vitamin A, vitamin C, iron, calcium, 
protein, or fiber per reference amount customarily consumed prior to 
any nutrient addition.

The terminology ``not in conventional food form'' was subsequently 
deleted in the final rules pertaining to health claims for dietary 
supplements published in the Federal Register on January 4, 1994 (59 FR 
395).
    The sugar alcohols proposal proposes such an exemption from the 10 
percent nutrient contribution requirement.
    Following publication of the health claims final rule, two trade 
associations--NFPA and the ABA--submitted petitions to FDA requesting 
that the agency revise the general requirements for health claims and 
reconsider its decision regarding the 10 percent nutrient contribution 
requirement. The NFPA petition argued that the 10 percent nutrient 
contribution requirement precludes truthful, nonmisleading health 
claims because it sets an arbitrary nutritional contribution a food 
must make to the diet to qualify for any claim. Consequently, NFPA 
argued, the 10 percent nutrient contribution requirement prohibits some 
common fruits, vegetables, and other wholesome and nutritious foods 
from making health claims. While NFPA agreed that a food bearing a 
health claim should contain levels of the nutrient consistent with the 
health claim, it contended that the lack of significant levels of other 
nutrients should not prevent a food from bearing a health claim. NFPA 
argued that if other nutrient levels are deemed to be material with 
respect to consumers' understanding of a health claim, then such levels 
should be disclosed in the Nutrition Facts panel.
    Furthermore, NFPA contended that the 1993 health claims final rule 
precludes truthful, nonmisleading claims because it prohibits a food 
from satisfying the 10 percent nutrient contribution requirement 
through fortification. NFPA stressed that even though fortification of 
a food to support a health claim is material information that should be 
disclosed in labeling, added and indigenous nutrients are equally 
nutritious, and, therefore, 

[[Page 66212]]
prohibiting fortified foods from bearing a health claim is not 
justified.
    NFPA requested that FDA amend Sec. 101.14(e) by revoking the 
requirement that foods bearing a health claim contain 10 percent of the 
DV of vitamin A, vitamin C, calcium, protein, iron, or fiber before any 
nutrient addition, so that fruits, vegetables, and other nutritious 
foods could bear health claims.
    The ABA petition did not request that the agency revoke the 10 
percent nutrient contribution requirement. Rather, it requested that 
FDA modify the 10 percent nutrient contribution requirement to permit 
health claims on certain enriched grain products. ABA contended that 
while some enriched breads might meet the 10 percent nutrient 
contribution requirement for fiber, most enriched grain products cannot 
meet the 10 percent nutrient contribution requirement for any of the 
six listed nutrients because they are precluded by the standards of 
identity from containing 10 percent of the six listed nutrients. ABA 
also stated that the standards of identity require specific nutrient 
addition at levels that were established by FDA as optimal for reducing 
the risk of certain diet-related diseases. These foods, in fact, have 
been used for many years to improve the nutrition of U.S. consumers and 
to reduce the risk of diet-related diseases. Therefore, ABA contended 
that these foods are precisely the kinds of foods that should be 
permitted to bear health claims.
    ABA argued that the 10 percent nutrient contribution requirement 
was obviously not intended to apply to foods that conform to the 
standards of identity for enriched grain products because it precludes 
virtually all enriched grain products from bearing health claims. It 
contended that this exclusion is inconsistent with the basis of the 
health claims because these foods are not only beneficial in reducing 
the risk of diet-related diseases but, more importantly, are also 
recommended in current dietary guidelines as foods whose consumption 
should be increased to maintain a balanced and healthful diet. The 
petition noted that the Food Guide Pyramid recommends that 6 to 11 
servings of grain products be consumed per day. ABA contended that this 
recommendation demonstrates the importance of including these foods in 
the diet. ABA argued that the 10 percent nutrient contribution 
requirement has had the unintended effect of precluding foods that FDA 
concluded could appropriately bear a health claim from bearing the 
claim. Thus, ABA requested that the agency amend Sec. 101.14(e) to 
exempt from the 10 percent nutrient contribution requirement enriched 
grain products that conform to a standard of identity in part 136, 137, 
or 139, and bread that conforms to the standard of identity for 
enriched bread in Sec. 136.115, except that it contains whole wheat or 
other grain products not permitted under that standard.
    In the alternative, ABA suggested that the agency expand the list 
of nutrients that must be present at 10 percent to include complex 
carbohydrates, niacin, or thiamin. Such action, the petition explained, 
would permit enriched grain products to bear health claims because 
these products are a significant source of such nutrients.
    As a second alternative, ABA suggested that FDA amend the 10 
percent nutrient contribution requirement to allow it to apply to a 
daily consumption of grain products rather than to the nutrient profile 
of a specific food.
    FDA has fully evaluated and considered the arguments raised in both 
petitions. FDA recognizes that the 10 percent nutrient contribution 
requirement may have had the unintended effect of prohibiting health 
claims on certain foods that could be beneficial for consumers and help 
them to maintain a balanced and healthful diet. The agency is 
concerned, however, that eliminating the 10 percent nutrient 
contribution requirement will permit misleading health claims on foods 
with little or no nutritional value such as candies and soft drinks or 
will encourage overfortification of the food supply (e.g., vitamin or 
mineral addition to soft drinks). The appearance of health claims on 
such foods would be inconsistent with Congress's intent when it enacted 
the health claims provisions. As discussed in the 1993 health claims 
final rule, Congress enacted the health claims provisions of the 1990 
amendments to not only protect consumers from health claims that are 
not scientifically valid but also to help consumers maintain healthy 
dietary practices by providing information that would be useful in 
constructing total daily diets that meet current dietary guidelines. 
Thus, an important part of the significance and benefit of health 
claims is that they appear on foods that are compatible with current 
dietary recommendations. (See H. Rept. 101-538, 101st Cong., 2d sess. 
pp. 9-10 (1990).)
    During the development of the health claims final rule, FDA 
considered other alternatives that would ensure that health claims are 
not trivialized or rendered meaningless by appearing on foods of little 
or no nutritional value. For example, the agency considered prohibiting 
health claims on specific foods, such as confections, soda, and snack 
foods, based on the foods' categorization or characteristic use. 
However, as fully discussed in the 1993 health claims final rule (58 FR 
2478 at 2521), the agency was not persuaded that such action was in 
keeping with the intent of the statute. The agency concluded that 
Congress did not intend that specific foods that could be in general 
use be prohibited from bearing a health claim. Thus, the agency 
concluded that a prohibition on health claims for specific categories 
of foods was not a viable option.
    However, given the requirement in section 403(r)(3)(B)(iii) of the 
act that a claim should enable the public to comprehend the information 
in a claim and understand the relative significance of that information 
in the context of a total daily diet, FDA concluded (as discussed in 
the 1993 health claims final rule (58 FR 2478 at 2521-2522)) that it is 
appropriate to provide a basis for health claims that takes into 
account the nutritional contribution of the food beyond its role as a 
source of calories. The agency noted that ``Congress intended that FDA 
establish provisions of health claims regulations by considering the 
role of the nutrients in food in a way that will enhance the chances of 
consumers constructing total daily diets that meet dietary guidelines'' 
(Id. at 2521). Without such provisions, foods that are not compatible 
with dietary guidelines could bear health claims. In addition to being 
inconsistent with Congress's intent when it established the health 
claim provisions, and section 403(r) of the act, claims intended to 
promote the consumption of a food that is incompatible with dietary 
guidelines would be misleading to consumers and, therefore, would be in 
violation of section 403(a) (id.). Such claims would be misleading 
because consumers would be purchasing the food, in part, to achieve a 
more healthful diet, when, in fact, such foods are inconsistent with 
dietary guidelines. Further, such claims could be damaging if consumers 
are encouraged to replace wholesome and nutritious foods that are 
recommended in dietary guidelines with these foods.
    Thus, the agency concluded then, and reiterates now, that the 10 
percent nutrient contribution requirement is 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. If the agency were to revoke this requirement, 
it would have to establish 

[[Page 66213]]
an alternative mechanism to ensure that health claims are not made on 
inappropriate foods. The NFPA petition did not suggest any alternatives 
to the 10 percent nutrient contribution requirement to preclude 
misleading health claims on inappropriate foods.
    The agency also tentatively concludes 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. Relying 
on either of the two alternatives suggested in the ABA petition would 
not adequately assist consumers in placing foods that bear health 
claims in their proper dietary context.
    The ABA's suggestion that the nutrients required to be present at 
10 percent be expanded to include thiamin, niacin, or carbohydrates 
would not encourage consumers to increase their intake of vitamins and 
minerals that have been identified as those of continuing public health 
significance. Public health concerns for deficient intakes of thiamin, 
niacin, or carbohydrates have lessened considerably in the last 20 
years, whereas the inadequate intakes of vitamin A, vitamin C, calcium, 
and iron remain a public health concern especially because of the 
possible association between several of these nutrients and the risk of 
chronic disease. Furthermore, expanding the list of nutrients required 
to be at 10 percent to include thiamin, niacin, or carbohydrates would 
permit only certain foods to bear health claims, such as enriched 
cereal grain products. Certain fruit and vegetable products that are 
promoted in dietary guidelines but that are currently prohibited from 
bearing health claims would still not be able to bear a health claim. 
Consequently, the agency tentatively concludes that expanding the list 
of nutrients would not sufficiently address the concern that the 
current regulation precludes certain foods that contribute to a 
healthful diet, and whose consumption is encouraged by the dietary 
guidelines, from bearing health claims.
    Likewise, permitting the 10 percent nutrient contribution 
requirement to be based on the daily consumption of a food group would 
not enhance the likelihood of consumers achieving dietary goals. In 
fact, such a requirement would be contrary to dietary goals because it 
would reduce the likelihood that a consumer would reach 100 percent of 
the DV if daily consumption of an entire food group only supplies 10 
percent of one of the listed nutrients. One reason for requiring that a 
serving of the food provide 10 percent of one or more of the listed 
nutrients is to assist the consumer in achieving daily intakes 
recommended in current dietary guidelines. Permitting a food that does 
not meet the 10 percent nutrient requirement to bear a claim on the 
basis that the total daily consumption of foods from that category 
would provide 10 percent of the nutrient would be inconsistent with one 
of the basic principles of the requirement. Accordingly, the agency has 
not been persuaded by the arguments raised in the petitions to propose 
to eliminate the 10 percent nutrient contribution requirement, to 
expand the list of nutrients that will qualify a food to bear a health 
claim, or to allow the 10 percent nutrient requirement to apply to a 
daily consumption of grain products rather than to the nutrient profile 
of a specific food.
    Regarding the request that FDA permit fortification to meet the 10 
percent nutrient contribution requirement, the agency is concerned that 
fortification of foods solely to bear a health claim could result in 
deceptive or misleading labeling and, thereby, be in violation of 
section 403(a) of the act. As fully addressed in the 1993 health claims 
final rule (58 FR 2478 at 2522), fortification of a food of little or 
no nutritional value for the purpose of bearing a health claim has the 
great potential of misleading and confusing consumers if foods like 
confections, soda, and sweet desserts are fortified to qualify for a 
health claim when, at the same time, dietary guidance as contained in 
the Food Guide Pyramid, for example, states that ``[T]hese foods 
provide calories and little else nutritionally. Most people should use 
them sparingly'' (Ref. 3). Indiscriminate fortification of such foods 
with one nutrient would not make such foods consistent with dietary 
guidelines. Consequently, FDA has not been persuaded that foods should 
be permitted to be fortified to qualify to bear a health claim. 
Accordingly, FDA is denying NFPA's request to permit fortification to 
specifically qualify a food to bear a health claim.
    The agency notes, as discussed in the 1993 health claims technical 
amendments (58 FR 44036 at 44037), that some foods either have been 
traditionally formulated in accordance with the fortification policy or 
to meet standards of identity that include fortification and, in that 
form, contain 10 percent or more of one of the six nutrients listed. In 
such cases, the agency notes that the food would not be precluded by 
Sec. 101.14(e)(6) from being fortified to qualify for a health claim.
    Although the agency has not been persuaded that elimination of the 
10 percent nutrient contribution requirement is in order, or that it 
should permit fortification so that a food could qualify to bear a 
health claim, the agency has been persuaded by the arguments raised in 
the petitions that it should act to modify the 10 percent nutrient 
contribution requirement. As stated above, the agency acknowledges that 
the 10 percent nutrient contribution requirement has had the unintended 
effect of precluding some foods that contribute to a healthful diet, 
and whose consumption is encouraged by the dietary guidelines, from 
bearing health claims. As discussed above, the agency's primary goals 
in establishing the 10 percent nutrient contribution requirement were 
to preclude foods of little or no nutritional value from bearing health 
claims and, at the same time, to enhance the likelihood of consumers 
constructing overall daily diets that conform to current dietary 
guidelines.
    FDA recognizes that precluding certain fruits, vegetables, and 
grain products from bearing health claims because of the 10 percent 
nutrient contribution requirement is contrary to that goal. The agency 
agrees with the arguments raised in the petitions that certain fruits, 
vegetables, and grain products that otherwise meet the requirements of 
the specific health claim should be able to bear the claim even though 
they do not contain 10 percent of one of the six listed nutrients 
because these foods comprise a major part of a balanced and healthful 
diet, and because current dietary guidance promotes consumption of 
these foods. Moreover, diets high in fruits, vegetables, and grain 
products have been associated with various specific health benefits, 
including lower occurrence of coronary heart disease and of some 
cancers (Refs. 4 and 5) and therefore, are exactly the types of foods 
that should be included in the diet to reduce the risk of specific 
diet-related diseases. Precluding such foods from bearing health claims 
could confuse consumers and undermine the utility of health claims.
    Furthermore, the foods described in the petitions are not the types 
of foods FDA intended to preclude from bearing health claims when it 
established the 10 percent nutrient contribution requirement. In fact, 
these foods can contribute significantly to a balanced and healthful 
diet and to achieving compliance with dietary guidelines even though 
they do not meet the 10 percent nutrient contribution requirement. 
Consequently, the agency 

[[Page 66214]]
tentatively concludes that 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, that do not 
meet the 10 percent nutrient contribution requirement but that meet all 
other aspects of the health claim should be permitted to bear a health 
claim. Accordingly, the agency is proposing to amend Sec. 101.14(e)(6) 
to exempt these products from the 10 percent nutrient contribution 
requirement.
    The agency is proposing to limit the exemption for fruit and 
vegetable products to those products comprised solely of fruits and 
vegetables because it is concerned that permitting health claims on 
fruit and vegetable products that do not contain 10 percent of one of 
the six listed nutrients, but that contain ingredients that may raise 
the level of certain other nutrients, such as fat, cholesterol, and 
sodium, would be inconsistent with the purpose of the health claim and 
incompatible with current dietary guidelines. While the agency 
recognizes that fruit and vegetable products with added syrups, sauces, 
and other ingredients that have increased levels of fat, cholesterol, 
or sodium have an appropriate place in the diet, the agency tentatively 
concludes that to exempt these products from the 10 percent nutrient 
contribution requirement would be to promote the consumption of foods 
that do not fall within the recommendations in dietary guidelines. 
Accordingly, the agency is not prepared to extend the exemption to 
these products. However, FDA requests comment on whether the exemption 
proposed in this document should be extended to include fruit and 
vegetable products with added oils, sodium, sauces, syrups, or other 
ingredients.
    The agency also requests comment on whether other foods, for 
example, other types of grain products such as breakfast cereals, 
should be exempt from the 10 percent nutrient contribution requirement. 
The agency advises that comments submitted in support of extending this 
exemption to other foods should provide valid data and sound 
justification for exempting such foods from the 10 percent nutrient 
contribution requirement. If the comments persuade the agency that such 
foods are being unfairly precluded from bearing health claims, and that 
the foods are consistent with the intent of the health claims, the 
agency will consider including such foods in the exemption provided in 
any final regulation based on this proposal.

C. Abbreviated Health Claims

    Current Sec. 101.14(d)(2)(iv) mandates that all information 
required to be included in the claim appear in one place without other 
intervening material. The current rule, however, does permit 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 elsewhere on 
the other labeling. The current rule also permits the use of graphic 
material, such as a symbol that constitutes an expressed or implied 
health claim, to be used on the label or labeling of the product 
provided that it is accompanied by the complete claim, an abbreviated 
claim, or a referral statement (Sec. 101.14(d)(2)(iv)).
    In the preamble to its 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). 
The agency was concerned that an abbreviated claim did 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. The agency was concerned that such confusion is possible 
``whenever the full health claim information appears in a location 
different from that of the reference statement and is especially likely 
to occur when a multiplicity of labeling is associated with a product'' 
(Id.). The agency then described the situation where the grocer 
displays an abbreviated claim on a display (labeling) near the product 
but only puts the full claim on a billboard in a far corner of the 
store (labeling) (id.).
    In its petition, NFPA requested that the agency reconsider this 
position and permit greater latitude in constructing and presenting 
health claims. More specifically, the petition requested that FDA 
permit abbreviated health claims that are accompanied by a referral 
statement directing the consumer to the label panel where the complete 
health claim appears.
    The agency has no desire for its regulations to unnecessarily stand 
in the way of the use of health claims and the presentation of the 
important information contained therein. While health claims are 
currently being used on the label and in labeling, the agency would 
like to see them used more extensively. Consequently, the agency agreed 
to initiate rulemaking in this area. The agency stated, however, that 
it must have assurance that the claims will be presented in a 
scientifically valid, truthful, and nonmisleading manner.
    FDA notes that in this document the agency is proposing to provide 
the basis for shorter health claims by making optional some of the 
elements that it has required to be included in claims. If those 
changes are finalized, many of the complete claims will be brief enough 
to permit their use on the principal display panel. For example, a 
claim for sodium and hypertension could be made in 12 words: ``Diets 
low in sodium may reduce the risk of high blood pressure.'' Most other 
claims would be of a similar length. The agency believes that these 
shortened claims will, for the most part make this issue moot. 
Nevertheless, the agency recognized that some claims may still remain 
somewhat complex.
    In those cases where the complete health claim remains long and 
somewhat complex, the agency recognizes that there may be a need to 
permit a shortened version of the claim on the principal display panel. 
Although the entire health claim contains important information 
necessary for consumers to fully understand the subject substance-
disease relationship, the agency recognizes that a short message that 
captures the consumer's attention will facilitate use of the claim. As 
a result, the communication of formation will assist consumers in 
achieving healthful dietary practices.
    The agency tentatively concludes that the use of an abbreviated 
health claim on the principal display panel is consistent with the act. 
The full health claim includes information required under section 
403(a) and 403(r)(3)(B)(iii) of the act. Section 403(r)(3)(B)(iii) 
requires that the complete health claim ``enable[] 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.'' Section 403(a) of the act requires only that a claim not 
be false and misleading. FDA has long required that all information 
that is necessary to make the claim truthful and not misleading appear 
in one place, without any intervening material. (See, e.g., United 
States v. An Article of Food * * * ``Manischewitz * * * Diet Thins'', 
377 F. Supp. 746 (E.D. New York 1974)). However, there is nothing in 
the act that would require that information required under section 
403(r)(3)(B)(iii) appear as 

[[Page 66215]]
part of the claim each time it is presented on the label.
    Thus, an abbreviated health claim that is a scientifically valid 
representation of the relationship between a substance and a diet-
related disease may be permissible under section 403(a) of the act if 
it is truthful and not misleading. If such an abbreviated claim 
includes a prominent and immediately adjacent reference to the full 
claim elsewhere on the label, the requirements of section 403(a) and 
(r)(3)(B)(iii) of the act would be fulfilled. Consequently, the agency 
is proposing to amend Sec. 101.14(d)(2)(iv). In addition to permitting 
the current reference statement to the full claim 
(Sec. 101.14(d)(2)(iv)(A)), the agency is proposing to permit an 
abbreviated health claim to be used on the principal display panel of 
the label provided that it is accompanied by a reference statement to 
the complete health claim on the same label or in the same labeling 
(proposed Sec. 101.14(d)(2)(iv)(B)).
    It is vital to compliance with the act that the complete claim 
appear elsewhere on the same label or in the same labeling as the 
abbreviated claim. For example, as discussed below for the calcium and 
osteoporosis health claim, the agency is concerned that consumers might 
be less likely to read the full health claim if an abbreviated claim 
appears on the principal display panel of a label, and the full health 
claim appears in a separate brochure that accompanies the product.
    The agency is also proposing to require that the reference 
statement be prominent and in immediate proximity to the abbreviated 
claim. The agency notes, of course, that if the proposed provision is 
adopted, an abbreviated claim could not be used unless the food meets 
the criteria necessary to make the complete health claim.
    As stated above, in the section D.IV. of this document, the agency 
is proposing to amend the regulations in subpart E of part 101, where 
appropriate, to set forth the elements that are required to ensure that 
an abbreviated health claim complies with section 403(a) of the act. As 
stated above, provision for an abbreviated claim will not be needed for 
most of the nutrient-disease relationships about which FDA has 
authorized claims if the revisions proposed in this document are 
adopted. Consumers may benefit, however, from abbreviated claims for a 
few of the longer, more complicated claims, such as those for calcium/
osteoporosis and folic acid/neural tube defects.
    The agency strongly emphasizes that the diet-disease relationship 
may not be overstated. Even with a prominent referral to the full 
claim, the abbreviated claim must not overemphasize the importance of 
the substance in the diet-disease relationship or in the total daily 
diet. The concept of risk reduction must be accurately conveyed.
    The agency notes that some of the diet-disease relationships may 
already be well-known by consumers. Therefore, nutrient content claims 
such as ``low sodium'' and ``reduced cholesterol'' on the principal 
display panel and elsewhere on the label may serve as a reminder of the 
diet-disease relationship and provide a way to market a product for its 
contribution to a healthy diet.
    FDA encourages the use of all authorized claims by the food 
industry in order to educate consumers about the importance of a 
healthy diet. The agency believes that the proposed changes to 
Sec. 101.14(d)(2)(iv) will result in increased use of the authorized 
health claims and, consequently, will fulfill the legislative intent to 
educate the public about diet-disease relationships.

D. Specific Requirements for Health Claims

    To date, FDA has authorized eight health claims that are codified 
in the Code of Federal Regulations, Title 21, subpart E of part 101 
(Secs. 101.72 to 101.79). Among the actions requested by NFPA in its 
petition is one to ``* * * modify the regulations in subpart E of part 
101 prescribing the content of authorized health claims so that they 
constitute `safe harbors' rather than requirements for claims; * * *.'' 
To accomplish this request, NFPA requested that the health claims 
regulations be modified to permit simplified, nondeceptive claims that 
are likely to be more easily understood. NFPA contended that the 
specific health claims regulations contained in subpart E of part 101 
include several provisions that prescribe the content and form of 
health claims to an extent that far exceeds that necessary to ensure 
that claims are truthful and not misleading. Mentioned as an example 
was that some regulations require claims to include references to 
specific nondietary factors even though, in NFPA's view, this 
information is unnecessary to ensure a claim is stated in a truthful, 
nonmisleading manner. Cited as illustrative of the nature of the 
problem was the model claim from the calcium/osteoporosis regulation 
(Sec. 101.72(e)) containing all required elements:

    Regular exercise and a healthy diet with enough calcium helps 
teen and young adult white and Asian women maintain good bone health 
and may reduce their high risk of osteoporosis later in life.

Each of the other regulations authorizing claims in subpart E of part 
101 was identified as requiring similar information.
    NFPA requested that the regulations in subpart E of part 101 
governing the specific information that must appear in a health claim, 
and the circumstances in which a claim could be used, be amended. 
Where, for example, Sec. 101.14(d)(2)(i) requires that labeling 
statements about a health claim be based on, and consistent with, the 
conclusions set forth in the regulations in subpart E of part 101, NFPA 
recommended amending Sec. 101.14(d)(2)(i), along with Sec. 101.14(d)(1) 
and the rest of (d)(2), so that such statements are objective and 
either consistent with applicable guidelines set forth in subpart E of 
part 101, or a reasonable basis for the claim is otherwise 
substantiated. The petitioner contended that such changes would operate 
to allow truthful, nonmisleading health claims that either omit 
information currently required under the regulations (e.g., nondietary 
information) or that include other useful information not expressly 
authorized by the regulations.
    Responding to NFPA in the May 11, 1995, letter, FDA acknowledged 
that, although use of health claims in food labeling has increased over 
the period of time that they have been in effect, the number of 
products bearing such claims is not as great as the agency had 
anticipated. Because of the importance of the information conveyed to 
consumers by health claims, the agency stated that it would review the 
authorizing regulations to determine whether they contain any 
unnecessary barriers to the use of the claims and, if so, take steps to 
remove those barriers. FDA stated that, as part of this assessment, it 
would conduct a review of what are referred to as ``required elements'' 
in each of the eight authorized health claims to determine whether any 
of them are unnecessary or can be made optional and initiate rulemaking 
to propose any changes identified in its internal review.
    The eight authorized health claims in subpart E of part 101 are 
codified following the same format. Thus the ``required elements'' for 
each claim are contained in paragraph (c) of the respective regulation 
under the heading ``Requirements.'' For example, specific requirements 
that apply to the calcium/osteoporosis health claim are contained in 
Sec. 101.72(c)(2)(i)(A) through (c)(2)(i)(E).

[[Page 66216]]

    The agency has reviewed all of the required elements in the eight 
authorized claims codified in subpart E of part 101. This document 
presents the results of this review for the following seven claims: 
Sec. 101.72 on calcium and osteoporosis; Sec. 101.73 on dietary lipids 
and cancer; Sec. 101.74 on sodium and hypertension; Sec. 101.75 on 
dietary saturated fat and cholesterol and risk of coronary heart 
disease; Sec. 101.76 on fiber-containing grain products, fruits, and 
vegetables and cancer; Sec. 101.77 on fruits, vegetables, and grain 
products that contain fiber, particularly soluble fiber, and risk of 
coronary heart disease; and Sec. 101.78 on fruits and vegetables and 
cancer. The health claim on folate and neural tube defects 
(Sec. 101.79) will be dealt with separately but in a manner consistent 
with the review of the other health claims.
    Since the final rules on the seven claims addressed in this 
document were published on January 6, 1993 (58 FR 2537 to 2849), new 
data have become available allowing FDA to reconsider the need for some 
information that, at the time the specific health claim regulations 
were issued, was considered necessary to preclude a claim from being 
misleading. Most notable among these data are two documents, one a 
National Institutes of Health (NIH) consensus statement on optimal 
calcium intake (hereinafter referred to as the 1994 consensus 
statement) and the other an FDA report on consumer understanding of 
health claims (hereinafter referred to as the 1995 consumer report) 
(Refs. 6 and 7, respectively).
1. The Calcium/Osteoporosis Health Claim
    The 1994 consensus statement is the result of the Consensus 
Development Conference on Optimal Calcium Intake convened by NIH on 
June 6 through 8, 1994, which brought together experts in public 
education and different biomedical sciences dealing with osteoporosis 
and bone and dental health. Directly relevant to the calcium/
osteoporosis health claim, this conference addressed questions and 
provided recommendations on optimal calcium intake for various 
population segments, on important cofactors for achieving optimal 
intake, on the risks associated with increased intake, on the best ways 
to attain optimal intake, and on the public health strategies that are 
available or are needed to implement optimal calcium intake 
recommendations.
    The 1995 consumer report is part of FDA's ongoing review of its 
regulations governing health claims. The report evaluated consumer 
understanding of four health claims (dietary lipids and cancer, fruits 
and vegetables and cancer, calcium and osteoporosis, and folate and 
neural tube defects) and consumer reaction to possible variations on 
the messages. The report describes the content, the manner of 
presentation, and the results of a consumer survey of knowledge about 
the four health claims mentioned above among consumer groups at 
eastern, central, and western locations in the United States.
    For the calcium/osteoporosis health claim, the first required 
element is contained in Sec. 101.72(c)(2)(i)(A) and provides that:

    The claim makes clear that adequate calcium intake throughout 
life is not the only recognized risk factor in this multifactorial 
bone disease by listing specific factors, including sex, race, and 
age that place persons at risk of developing osteoporosis and 
stating that an adequate level of exercise and a healthful diet are 
also needed.

The effect of presenting the information required by this element is to 
convey the message that, for any individual, several factors define the 
disease risk.
    The focus of the 1994 consensus statement is, as stated in its 
title, optimal calcium intake for promotion of public health. The first 
of several significant conclusions in the report is that a large 
percentage of Americans fail to meet currently recommended guidelines 
for optimal calcium intake. Because of the need to correct this public 
health shortfall and to improve bone health in the United States, 
thereby reducing the risk of osteoporosis, FDA tentatively concludes 
that a singular focus on achieving and maintaining adequate calcium 
intake as a required element in the calcium/osteoporosis health claim 
is important.
    Accordingly, FDA is proposing to simplify Sec. 101.72(c)(2)(i)(A) 
by limiting the requirement to a balanced statement that reflects the 
importance of the essential nutrient calcium over a lifetime in a 
healthful diet to reduce osteoporosis risk, but that does not imply 
that calcium is the only risk factor for the development of 
osteoporosis. To this end, proposed Sec. 101.72(c)(2)(i)(A) states that 
the claim must make clear that adequate calcium intake as part of a 
healthful diet throughout life is essential to reduce the risk of 
osteoporosis.
    FDA has included the reference to a ``healthful diet'' in proposed 
Sec. 101.72(c)(2)(i)(A) for consistency with the general requirement in 
Sec. 101.14(d)(2)(v) that ``the claim enable[ ] the public * * * to 
understand the relative significance of such information [in this case, 
the relationship between calcium and osteoporosis] in the context of a 
total daily diet.'' The effect of adequate calcium intake can only be 
realized if the calcium is a part of a healthy diet that provides all 
essential and other nutrients to optimize nutritional health status.
    The proposed revision of Sec. 101.72(c)(2)(i)(A) emphasizes the 
most important risk factor in the development of osteoporosis on the 
label of a food product, i.e., adequacy of dietary calcium intake. 
Nevertheless, the agency is concerned that such a claim could lead 
consumers to believe that adequacy of dietary calcium intake is the 
only risk factor for the disease. In the proposal to authorize the 
calcium/osteoporosis health claim, the following was stated:

    Calcium intake is not the only recognized risk factor in the 
development of osteoporosis. Other factors include a person's sex, 
race, hormonal status, family history, body stature, level of 
exercise, general diet, and specific life style choices, such as 
smoking and excess alcohol consumption.

(56 FR 60689 at 60698, November 27, 1991). Based on that information in 
part, Sec. 101.72(c)(2)(i)(A) requires a listing of several specific 
risk factors, in addition to dietary calcium intake, in the calcium/
osteoporosis health claim.
    As stated above, however, FDA acknowledges that the number of food 
products bearing health claims is not as great as the agency had 
anticipated. FDA is concerned that manufacturers have been disinclined 
to use lengthy health claims on food labels, and that too many words 
will detract from the central consumer message of the claim. As a 
result, FDA is concerned that health claims like the calcium/
osteoporosis claim will continue to be infrequently used, and that the 
benefits of communicating information on diet-disease relationships 
through such claims will not be realized.
    Because of these concerns, the agency has reevaluated the 
requirement in Sec. 101.72(c)(2)(i)(A) that a calcium/osteoporosis 
health claim ``* * * list[ ] specific factors, including sex, race, and 
age that place persons at risk of developing osteoporosis and stat[e] 
that an adequate level of exercise * * * [is] also needed.'' Given the 
consensus statement's central focus on optimal calcium intake and the 
agency's desire to make health claims as useful and useable as 
possible, FDA is proposing to replace the requirement in 
Sec. 101.72(c)(2)(i)(A) that specific risk factors and the need for an 
adequate level of exercise be stated in any claim with the more simple 
requirement that the claim not imply that adequate dietary calcium 
intake is the only recognized risk factor for a reduced risk 

[[Page 66217]]
of osteoporosis. This revision will ensure that the scientific validity 
of claims about osteoporosis is preserved by recognizing the 
multifactorial nature of this disease without adding words to the 
claim.
    In concert with the proposed change in Sec. 101.72(c)(2), the 
agency is proposing to redesignate Sec. 101.72(d)(2) as paragraph 
(d)(5) and to add a new paragraph (d)(2) that provides for the 
provision of the following information from current 
Sec. 101.72(c)(2)(i)(A) as optional information:

    The claim may list specific risk factors for osteoporosis, 
identifying them among the multifactorial risks for the disease. 
Such factors include a person's sex, age, and race. The claim may 
state that an adequate amount of exercise is also needed to reduce 
risk for the disease.

    The 1995 consumer report identified the calcium/osteoporosis model 
health claim as the one most actively disliked (Ref. 7). This dislike 
most likely arises primarily from a misunderstanding one of the 
concepts required in Sec. 101.72(c)(2)(i)(B), specific identification 
of the populations at particular risk for the disease. The current 
regulation states:

    The claim does not state or imply that the risk of osteoporosis 
is equally applicable to the general United States population. The 
claim shall identify the populations at particular risk for the 
development of osteoporosis. These populations include white (or the 
term ``Caucasian'') women and Asian women in their bone forming 
years (approximately 11 to 35 years of age or the phrase ``during 
teen or early adult years'' may be used). The claim may also 
identify menopausal (or the term ``middle-aged'') women, persons 
with a family history of the disease, and elderly (or ``older'') men 
and women as being at risk.

    The 1995 consumer report states that minority women were unanimous 
in objecting to the inference that black American women do not need 
calcium. Accordingly, minority participants questioned the accuracy of 
the information. All of the survey participants recognized that calcium 
is essential for everyone. Although there was some recognition based on 
prior knowledge that younger women need to be concerned about 
osteoporosis, no participant thought the model claim communicated that 
concept very well. For these and other reasons, older women tended to 
dismiss the model claim as incorrect.
    The agency did not intend that the calcium/osteoporosis health 
claim imply that calcium is not needed by any individual or specific 
population. Given that calcium is essential for every person, the 
agency attempted to craft requirements for presenting this disease 
claim in a truthful, nonmisleading, and scientifically valid manner. In 
reviewing the scientific data supporting the claim, including the 
incidence of low-trauma bone fracture in the elderly, FDA stated in the 
preambles to the calcium/osteoporosis proposed and final rules (56 FR 
60689 and 58 FR 2665, respectively) that those individuals in the 
general population at greatest risk of developing osteoporosis, and for 
whom the health claim would have greatest benefit, include Caucasian 
and possibly Asian women and adolescent girls and young adult women 
between 11 and 35 years of age. For this and other reasons, a 
requirement for identifying these high risk groups was included in 
Sec. 101.72(c)(2)(i)(B). In identifying those at highest risk, there 
was no intent by the agency to imply that other consumers are risk 
free.
    The 1994 consensus statement is silent in ascribing relative risk 
for osteoporosis on the basis of race or ethnicity of population 
groups. For adolescents and young adults of both sexes, 11 through 24 
years of age, the optimal calcium requirement is given as a range of 
1,200 to 1,500 milligrams (mg) of calcium daily. The report says the 
following about a subset of this population, 12 to 19 year old females:

    Importantly, population surveys of girls and young women 12-19 
years of age show their average calcium intake to be less than 900 
mg/day, which is well below the calcium intake threshold. The 
consequences of low calcium intake during this crucial period of 
rapid skeletal accrual raise concerns that achievement of optimal 
peak adult peak bone mass may be seriously compromised. Special 
education and public measures aimed at improving dietary calcium 
intake in this age group are essential.

(Ref. 6.)
    FDA tentatively concludes that greater use in food labeling of the 
calcium/osteoporosis health claim, articulated in a manner that will be 
accepted and followed by consumers, can help support significant 
strides in improving calcium intake in all segments of the U.S. 
population. Accordingly, the agency is proposing to revise 
Sec. 101.72(c)(2)(i)(B) in several ways.
    First, it is proposing to revise Sec. 101.72(c)(2)(i)(B) by 
removing the requirement to identify by race those populations at 
particular risk for the development of osteoporosis. In neither the 
statement cited above nor elsewhere in the 1994 consensus statement is 
any racial or ethnic segment among girls and young women 12 to 19 years 
of age identified as being more at risk for the consequences of a less 
than optimal calcium intake. The 1994 NIH consensus statement found 
that the recommendation for optimal nutrient requirements for any 
particular age/sex population segment to forestall the impact of a 
degenerative disease applies to all members of that segment, although 
not necessarily to the same degree for everyone. Thus, the agency is 
proposing not to require mention of race or ethnicity as a required 
element but to permit such information as an option since it is useful 
and important to those to whom it applies.
    Nevertheless, retention of teen and young adult women, irrespective 
of race or ethnicity, as the focus of the claim is important because, 
as stated succinctly in the 1994 consensus statement:

    Two important factors that influence the occurrence of 
osteoporosis are optimal bone mass attained in the first two or 
three decades of life and the rate at which bone is lost in later 
years.

    Failure to attain optimal bone mass during the bone-forming years 
of adolescence and early adulthood is a loss that cannot be recovered 
during middle age or later in life (Ref. 6). Once peak adult bone mass 
is reached at about age 25, bone turnover is stable in men and women 
such that bone formation and bone resorption (breakdown) are balanced. 
In women, resorption rates increase, and bone mass declines, beginning 
with the fall in estrogen production that is associated with the onset 
of menopause. Unlike hormone replacement therapy, supplemental calcium 
during this initial phase will not slow the decline in bone mass 
attributable to estrogen deficiency. The effects of calcium in reducing 
the rate of bone loss can be shown more clearly in postmenopausal women 
after the period when the effects of estrogen deficiency are no longer 
dominant (i.e., about 10 years after menopause).
    Osteoporosis affects more than 25 million people in the United 
States and is the major underlying cause of bone fractures in 
postmenopausal women and the elderly (Ref. 6). Given this tremendous 
cost to public health, it is essential that the health claim on calcium 
and osteoporosis inform consumers, particularly those at great risk for 
the disease, of the importance of adequate calcium intake throughout 
life for attaining peak adult bone mass and for reducing the rate of 
bone resorption or loss, two processes that occur at different periods 
over a lifetime.
    Thus, FDA is proposing to retain the requirement in 
Sec. 101.72(c)(2)(i)(B) that the claim not suggest that the risk of 
osteoporosis applies equally to the general U.S. population. However, 
it is proposing to remove the required 

[[Page 66218]]
reference to any racial or ethnic group in identifying the at-risk 
population. The agency is proposing to identify this population in the 
following way:

    * * * The claim shall identify the population at particular risk 
for the development of osteoporosis as women in their bone forming 
years from approximately 11 to 35 years of age. An optional 
statement that further characterizes this and other populations at 
risk for developing osteoporosis may be made in accordance with 
paragraph (d)(3) of this section.

    FDA is proposing to permit identification of Caucasian women and 
Asian women as among those at particular risk for the disease as 
optional information, along with other information from 
Sec. 101.72(c)(2)(i)(B), in new Sec. 101.72(d)(3). While the 1995 
consumer report (Ref. 7) found evidence that some consumers could be 
misled by references in the calcium/osteoporosis health claim to 
Caucasian and Asian women, FDA tentatively concludes that, if properly 
qualified, this information could be helpful in informing such women 
who may be unaware of their risk of developing this disease. By 
providing for this information as an optional element in 
Sec. 101.72(d), the agency is attempting to encourage manufacturers to 
use this information in formats where the message can be phrased in 
enough detail to clarify its meaning. For example, ``while all women 
may be at risk of osteoporosis, Caucasian and Asian women are 
particularly at risk,'' may be understood and not rejected by 
consumers. While this statement provides more detail than seems to be 
necessary in the basic health claim, this information could be useful 
in a longer discussion of calcium and osteoporosis, for example in a 
paragraph format on a large label or in a pamphlet. The agency requests 
comment, and is particularly interested in data, on whether its 
tentative view that consumer understanding would be helped is correct.
    Section 101.72(c)(2)(i)(C) established a requirement for 
identifying the mechanism whereby adequate dietary calcium over a 
lifetime should reduce the risk of osteoporosis:

    The claim states that adequate calcium intake throughout life is 
linked to reduced risk of osteoporosis through the mechanism of 
optimizing peak bone mass during adolescence and early adulthood. 
The phrase ``build and maintain good bone health'' may be used to 
convey the concept of optimizing peak bone mass. When reference is 
made to persons with a family history of the disease, menopausal 
women, and elderly men and women, the claim may also state that 
adequate calcium intake is linked to reduced risk of osteoporosis 
through the mechanism of slowing the rate of bone loss.

    The agency concluded in developing this requirement that it is 
important for consumers to have a basic understanding of the biological 
and physiological mechanisms by which adequate dietary intake of 
calcium achieves a reduced risk of osteoporosis. However, information 
developed since the regulation was published indicates that a health 
claim may not be the best way to provide this information. The 1995 
consumer survey (Ref. 7) found that, because participants had learned 
elsewhere that calcium intake is related to general bone health, they 
thought the food label was not the right means for conveying this 
information. In addition, this awareness by consumers that calcium's 
ability to ``build and maintain good bone health'' is the mechanism 
whereby risk of osteoporosis is reduced, raises a question as to 
whether there is a need to state that fact in a health claim. In the 
interest of streamlining the claim, therefore, FDA is proposing to make 
the statement of the mechanism by which calcium intake affects the risk 
of osteoporosis optional information. The agency is proposing to move 
Sec. 101.72(c)(2)(i)(C) to Sec. 101.72(d)(4), changing only the word 
``shall'' to ``may''.
    Section 101.72(c)(2)(i)(D) requires that:

    The claim does not attribute any degree of reduction in risk of 
osteoporosis to maintaining an adequate calcium intake throughout 
life;

This paragraph is consistent with requirements in regulations for all 
other authorized claims that no attribution to degree of risk reduction 
for the respective disease or health-related condition be made in 
reference to the nutrient or substance that is the subject of the claim 
(see, for example: Secs. 101.73(c)(2)(i)(E), 101.74(c)(2)(i)(D), 
101.75(c)(2)(i)(D), 101.76(c)(2)(i)(E), 101.77(c)(2)(i)(G), 
101.78(c)(2)(i)(E), and 101.79(c)(2)(i)(F).
    Unlike these other regulations, Sec. 101.72 does not contain an 
express requirement that the claim state that adequate calcium intake 
throughout life ``may'' or ``might'' reduce the risk of osteoporosis 
(see, for example, paragraphs (c)(2)(i)(A) in Secs. 101.73 through 
101.79). However, it is clear that FDA also intended that this 
requirement apply to the calcium/osteoporosis health claim. This 
intention may be inferred from the two model health claims that use the 
term ``may'' in relating calcium intake with a reduction in risk of 
osteoporosis. Accordingly, the agency is proposing to revise 
Sec. 101.72(c)(2)(i)(D) and redesignate it as Sec. 101.72(c)(2)(i)(C) 
to read as follows:

    The claim does not attribute any degree to which maintaining 
adequate calcium intake throughout life may reduce the risk of 
osteoporosis;

This proposed revision retains the prohibition against attributing the 
degree to which adequate calcium intake is associated with a reduced 
risk for osteoporosis while introducing the concept that, because of 
the multifactorial nature of the disease, maintenance of an adequate 
calcium intake throughout life may reduce risk of developing the 
disease.
    Section 101.72(c)(2)(i)(E) contains the conditional requirement 
that a calcium/osteoporosis health claim include a statement that 
reflects the limit on the benefit derived from dietary calcium intake 
as follows:

    The claim states that a total dietary intake greater than 200 
percent of the recommended daily intake (2,000 milligrams (mg) of 
calcium) has no further known benefit to bone health. This 
requirement does not apply to foods that contain less than 40 
percent of the recommended daily intake of 1,000 mg of calcium per 
day or 400 mg of calcium per reference amount customarily consumed 
as defined in Sec. 101.12(b) or per total daily recommended 
supplement intake.

    Most conventional foods and many calcium-fortified foods do not 
exceed the threshold of 40 percent of the DV for calcium for adults and 
children 4 or more years of age and, therefore, do not trigger the 
required use of the statement in Sec. 101.72(c)(2)(i)(E). Dietary 
supplements containing calcium, particularly single nutrient 
supplements containing 500 or 600 mg of calcium per tablet, exceed the 
threshold and are therefore required to bear the statement as part of a 
health claim. The Dietary Supplement Health and Education Act of 1994 
(the DSHEA) (Pub. L. 103-417) was enacted on October 25, 1994, and 
amends the act (Ref. 8). Among the findings of Congress for this new 
law regarding the benefits of dietary supplements to health promotion 
and disease prevention is one that identifies a link between ingestion 
of certain nutrients or dietary supplements and reduced risk for 
several chronic diseases including osteoporosis. Another finding states 
that the Federal Government should not take any actions to impose 
unreasonable regulatory barriers limiting or slowing the flow of safe 
products and accurate information to consumers.
    Among the issues addressed in the 1994 consensus statement is the 
question of the ways by which optimal calcium intake may be attained. 
The 

[[Page 66219]]
document draws the following conclusion:

    The preferred source of calcium is through calcium-rich foods 
such as dairy products. Calcium-fortified foods and calcium 
supplements are other means by which optimal calcium intake can be 
reached in those who cannot meet this need by ingesting conventional 
foods.

    The agency has taken into consideration the expressed intent of the 
DSHEA and this finding from the 1994 consensus statement and 
tentatively concludes that revision of Sec. 101.72(c)(2)(i)(E) is in 
order. The agency is proposing to raise the threshold for the required 
statement from 400 to 1,500 mg of calcium, along with other changes.
    With regard to adverse effects and the risks associated with 
increased levels of calcium intake, the 1994 consensus statement states 
the following:

    Even at intake levels of less than 4 g/day, certain otherwise 
healthy persons may be more susceptible to developing hypercalcemia 
or hypercalciuria. Likewise, subjects with mild or subclinical 
illnesses marked by dysregulation of 1,25-dihydroxyvitamin D 
synthesis (e.g., primary hyperparathyroidism, sarcoidosis) may be at 
increased risk from higher calcium intakes. Nevertheless, in 
intervention studies (albeit of relatively short duration--less than 
4 years), no adverse effects of moderate supplementation up to 1500 
mg/day have been reported.

(Ref. 6.)
    The same document concludes that daily calcium intake, up to a 
total of 2,000 mg, appears to be safe in most individuals (Ref. 6). For 
major segments of the U.S. population the 1994 consensus statement 
identifies an optimal calcium requirement of either 1,500 mg or a range 
of 1,200 to 1,500 mg of calcium per day. These population groups 
include adolescents and young adults 11 to 24 years of age, pregnant 
and lactating women, women over 50 (postmenopausal) who are not on 
estrogens, and men over 65 years of age (Ref. 6). Therefore, the agency 
tentatively finds that a level of 1,500 mg of calcium as the proposed 
threshold for the statement in Sec. 101.72(c)(2)(i)(E) is not only 
consistent with current recommendations for dietary calcium intake but 
is also well within a range that is not known to cause adverse effects.
    The agency is consequently proposing to require that the statement 
of limited benefit appear only on foods that provide more than 1,500 mg 
of calcium per day. FDA has expressed this proposed threshold level as 
a percentage of the Daily Values (DV's) for adults and children 4 or 
more years of age and for pregnant or lactating women. The agency notes 
that the calcium DV's for adults and children 4 or more years of age 
and for pregnant or lactating women have not changed and are 1,000 and 
1,300 mg, respectively. (See Sec. 101.9(c)(8)(iv) and 58 FR 2206 at 
2213.) The agency intends to redesignate this requirement as 
Sec. 101.72(c)(2)(i)(D).
    A common form of a calcium dietary supplement in the marketplace is 
as a tablet containing either 500 or 600 mg of calcium as the sole 
nutrient with directions for use in labeling that recommend an intake 
of one or two tablets per day. A health claim in the labeling of such a 
product would not require the additional statement in proposed 
Sec. 101.72(c)(2)(i)(D). FDA tentatively concludes that this proposed 
change is consistent with the recommendation from the 1994 consensus 
statement on dietary sources for this nutrient.
    For consistency with the proposed revisions in Sec. 101.72(c) and 
(d), FDA has revised the model health claims in proposed 
Sec. 101.72(e). FDA has used the phrase ``Especially for teen and young 
adult women'' in example 1, which sets out how a claim that conforms 
with Sec. 101.72(c) might look to reflect the effects on the risk of 
developing osteoporosis that may be realized by this population segment 
without implying that adequate calcium intake is without benefit for 
others.
    The agency solicits comment on the proposed revisions to the 
calcium/osteoporosis health claim and is particularly interested in 
data on consumer understanding of this claim, and how such 
understanding can be improved.
2. Other Health Claims
    A common requirement in the authorized claims for dietary fat and 
cancer (Sec. 101.73); sodium and hypertension (Sec. 101.74); dietary 
saturated fat and cholesterol and risk of coronary heart disease 
(Sec. 101.75); fiber-containing grain products, fruits, and vegetables 
and cancer (Sec. 101.76); fruits, vegetables, and grain products that 
contain fiber, particularly soluble fiber, and risk of coronary heart 
disease (Sec. 101.77); and fruits and vegetables and cancer 
(Sec. 101.78) is a statement that development of the particular disease 
depends on many factors.
    It is well documented over the past 10 years that consumers are 
generally aware that development of major chronic diseases, such as 
cancer and coronary heart disease, is dependent on a number of 
different factors such as smoking, excess body weight, family history 
of the disease, exposure to environmental chemicals, and dietary and 
other factors (Refs. 9 and 10). Additionally, the requirement that 
authorized claims use the term ``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. In responding to comments on the scientific 
standard for health claims as to whether or not a claim based on 
preliminary scientific data would be consistent with that standard, the 
agency said:

    * * * Further, absolute claims about diseases affected by diet 
are generally not possible because such diseases are almost always 
multifactorial. Diet is only one factor that influences whether a 
person will get such a disease. For example, in the case of calcium 
and osteoporosis, genetic predisposition (e.g., where there is a 
family history of fragile bones with aging) can play a major role in 
whether an individual will develop the disease. Because of factors 
other than diet, some individuals may develop the disease regardless 
of how they change their dietary patterns to avoid the disease. For 
those individuals, a claim that changes in dietary patterns will 
reduce the risk of disease would be false. Thus, health claims must 
be free to use the term ``may'' with respect to the potential to 
reduce the risk of disease. However, use of this term would not be 
appropriate for health claims on food labeling where significant 
scientific agreement does not exist that there is a high probability 
that a reduction in disease risk will occur.

(58 FR 2478 at 2505.)
    Given these facts, as part of its review of required elements for 
all health claims the agency has reconsidered the need to remind 
consumers of the multifactorial nature of hypertension, heart disease, 
and cancer. Based on its review, FDA tentatively concludes that the 
statement of that fact in each claim can be made optional. In place of 
the requirement for stating the multifactorial nature of the disease, 
the agency proposes to substitute a requirement that the claim not 
imply that the substance that is the subject of the health claim is the 
only recognized risk factor for the corresponding disease or health-
related condition. Thus, the agency tentatively concludes that the 
concept of the multifactorial nature of the disease or health-related 
condition for each health claim will be preserved without adding 
additional words to the claim. The agency requests comment on whether 
consumers will be misled to believe reduction of risk will be achieved 
if the multifactorial nature of 

[[Page 66220]]
the disease or health-related condition is not stated in the claim.
    Accordingly, the agency is proposing to revise 
Secs. 101.73(c)(2)(i)(F), 101.74(c)(2)(i)(E), 101.75(c)(2)(i)(E), 
101.76(c)(2)(i)(D), 101.77(c)(2)(i)(F), and 101.78(c)(2)(i)(I) in 
similar fashion to ensure that the health claim not imply that there is 
only one recognized risk factor for the development of the 
corresponding disease or health-related condition. The agency is also 
proposing to revise Secs. 101.73(d)(1), 101.74(d)(1), 101.75(d)(1), 
101.76(d)(2), 101.77(d)(1), and 101.78(d)(2) to state that development 
of the disease in question depends on many factors and to list the 
relevant factors for each disease. For consistency, the agency is also 
proposing to revise the model claims to reflect the proposed revisions 
to Secs. 101.73, 101.74, 101.75, 101.76, 101.77, and 101.78.
    In addition, the agency is proposing to correct Sec. 101.77(e) by 
adding the phrase ``and the risk of coronary heart disease'' which was 
inadvertently omitted in the final rule.
    The health claim for fruits and vegetables and cancer (Sec. 101.78) 
contains one additional element that FDA tentatively concludes could be 
optional instead of a mandatory part of the claim. In 
Sec. 101.78(c)(2)(i)(D) the regulation states:

    The claim characterizes the food bearing the claim as containing 
one or more of the following, for which the food is a good source 
under Sec. 101.54: dietary fiber, vitamin A, or vitamin C.

This required statement is very similar to the one required by 
Sec. 101.78(c)(2)(i)(C):

    The claim characterizes fruits and vegetables as foods that are 
low in fat and may contain vitamin A, vitamin C, and dietary fiber.

    The agency believes that the statement required by 
Sec. 101.78(c)(2)(i)(C) is necessary to describe the relationship 
between the food and the disease. In the 1993 health claims final rule, 
FDA stated that by requiring that all characterizing nutrients be 
identified as characteristic of dietary patterns rich in fruits and 
vegetables without specifically attributing reduced cancer risk to a 
single nutrient, the claim is consistent with current scientific 
knowledge. However, the requirement in Sec. 101.78(c)(2)(i)(D) 
identifies for the consumer which of the characterizing nutrients is 
contributed by the labeled food. FDA tentatively concludes that this 
information need not be a required element of the claim because it is 
available as part of the nutrition label.
    Therefore, the agency has tentatively concluded that the 
information in Sec. 101.78(c)(2)(i)(D) can be made optional. 
Accordingly, the agency is proposing to remove Sec. 101.78(c)(2)(i)(D); 
redesignate Sec. 101.78(d)(3) through (d)(5) as Sec. 101.78(d)(4) 
through (d)(6), and add new Sec. 101.78(d)(3) which reads:

    The claim may characterize fruits and vegetables that meet the 
requirements described in paragraph (c)(2)(ii) of this section as 
foods that are low in fat and that contain (or are a good source of) 
one or more of vitamin A, vitamin C, or dietary fiber.

    FDA is also proposing to revise the model health claims in 
Sec. 101.78(e) to reflect these changes.
3. Abbreviated Health Claims
    In addition to eliminating some of the requirements for a full 
health claim, as stated above, NFPA requested that FDA permit the use 
of abbreviated health claims in labeling, such as on the principal 
display panel. FDA has reviewed the health claims as it is proposing to 
revise them to determine whether the required elements can be 
reorganized in accordance with proposed Sec. 101.14(d)(2)(iv) to 
facilitate their use on the food label.
    With the revisions to Secs. 101.73, 101.74, 101.75, 101.76, 101.77, 
and 101.78 proposed in this document, the agency tentatively finds that 
all of the required elements for each of the claims are required under 
section 403(a) of the act to ensure that the claims are truthful and 
not misleading as well as under section 403(r) to ensure that they are 
scientifically valid. Accordingly, the agency tentatively concludes 
that there is no basis upon which it can propose to permit the 
splitting of these required elements between the principal display 
panel and another part of the food label.
    Using the health claim for dietary fat and cancer as an example, 
the agency is proposing to remove the requirement that the claim state 
that cancer is a multifactorial disease. The remaining specific 
requirements in Sec. 101.73(c)(2)(i)(A) through (c)(2)(i)(E) are 
necessary so that claims on the relationship between dietary fat and 
cancer are truthful, not misleading, and scientifically valid. A claim 
consistent with these requirements can be expressed in 11 or fewer 
words (e.g., ``A low fat diet may reduce the risk of some cancers''). 
These requirements also ensure that consumers will be able to 
understand the relative significance of the information presented in 
the claim in the context of a total daily diet. Accordingly, the agency 
tentatively finds that there is no need to divide the required elements 
of Sec. 101.73 into those that must be included whenever the claim is 
presented and those that need only be included as part of the full 
claim. Based on the same reasoning, FDA has reached the same judgment 
about the elements of the claims authorized by Secs. 101.74 through 
101.78.
    The agency tentatively concludes, however, that such a split is 
appropriate among the required elements of health claims on calcium and 
osteoporosis (Sec. 101.72). The various proposed revisions for the 
specific requirements in Sec. 101.72(c)(2)(i) would produce a claim 
that is shorter than is provided for in the current regulation. 
Nonetheless, even with the proposed revisions, the length of the claim 
that would be required under Sec. 101.72 is such that, to facilitate 
use of the claim, FDA is proposing to distinguish between those 
elements necessary to ensure that the claim is truthful and not 
misleading, and those elements that are necessary to understand the 
significance of the claim in the context of the total daily diet.
    Section 101.72(c)(2)(i)(A), which the agency is proposing to 
revise, sets forth the most important requirement. It establishes the 
essence of the calcium/osteoporosis claim in that it requires clarity 
in a statement that associates adequacy of dietary calcium intake over 
a lifetime with a reduced risk of osteoporosis, a degenerative disease 
that affects more than 25 million Americans, particularly 
postmenopausal women and the elderly, and that is manifested by an 
incidence of 1.5 million bone fractures annually (Ref. 6). This 
provision sets out information that is fundamental if a claim 
associating calcium and osteoporosis is to be truthful and not 
misleading.
    Section 101.72(c)(2)(i)(C), which requires that the claim not 
attribute any particular degree of risk reduction to adequate calcium 
intake is also necessary to ensure that claims are truthful, not 
misleading, and scientifically valid. Compliance with this requirement, 
however, does not add any words to the claim.
    For the remaining requirements, Sec. 101.72(c)(2)(i)(B) prohibits 
the implication that risk for the disease applies equally across the 
U.S. population. Instead, it requires identification of that segment of 
the population that is most at risk for developing the disease later in 
life, women in their bone forming years. The agency requires this 
information in response to section 403(r)(3)(b)(iii) of the act, which 
as stated above, requires that the claim accurately represent the 
relationship between calcium and osteoporosis in a manner that is 
comprehensible to the public. It is also under section 
403(r)(3)(b)(iii) of the act 

[[Page 66221]]
that FDA is requiring in Sec. 101.72(c)(2)(i)(D) that the claim 
disclose that further benefit does not derive from a daily dietary 
intake of calcium that exceeds 2,000 mg.
    Given these bases for the calcium/osteoporosis claim, an 
abbreviated claim consistent with the principles proposed earlier in 
this document may be developed that sets out the information required 
under Sec. 101.72(c)(2)(i)(A) and (c)(2)(i)(C). To reflect this fact, 
the agency is proposing to renumber current Sec. 101.72(c)(2)(ii), 
which deals with the nature of a food bearing a calcium/osteoporosis 
health claim, as Sec. 101.72(c)(2)(iii), and it is proposing a new 
Sec. 101.72(c)(2)(ii) that describes how the health claim is to be 
presented on the label or in labeling. This proposed new paragraph 
states that all of the elements listed in Sec. 101.72(c)(2)(i) must be 
included in one presentation of the claim on the label or labeling. 
However, it also provides that a short, simple statement of the claim 
that includes the elements in Sec. 101.72(c)(2)(i)(A) and (c)(2)(i)(C), 
and thus that is truthful, not misleading, and scientifically valid, 
may be used on the principal display panel as long as the full claim 
appears on the label or in the labeling, and, there is a referral 
statement to the full claim in immediate proximity to the abbreviated 
statement.
    The referral statement that FDA is proposing accompany the 
abbreviated claim is consistent with that provided for in the general 
requirements for nutrient content claims (Sec. 101.13) and health 
claims (Sec. 101.14(d)(2)(iv)). Because this referral statement is 
short, it is also consistent with the use of an abbreviated claim.
    In 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). The agency was concerned that 
an abbreviated claim did 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. The agency was concerned 
that such confusion is possible whenever the full health claim 
information is in a location different from that of the reference 
statement, and that such confusion is especially likely to occur when a 
multiplicity of labeling is associated with a product. If these 
concerns can be addressed, however, the use of an abbreviated claim on 
the principal display panel would facilitate use of the claim and, as a 
result, the communication of information that will assist consumers in 
achieving healthful dietary practices.
    The agency has tentatively concluded that this proposed rule 
addresses these concerns. It is providing for an abbreviated statement 
that reflects the facts that are material under section 201(n) of the 
act (21 U.S.C. 321(n)) and that are necessary to ensure that the claim 
is scientifically valid. It is also providing for an accompanying 
referral statement to additional information that is necessary for a 
full understanding of the claim. The agency is concerned, however, 
about the possibility that consumers may not read the complete claim, 
and thus that they will not have all the facts necessary to fully 
understand the significance of the claim being made and to comprehend 
the claim in the context of the daily diet. For this reason, the agency 
is asking for data to demonstrate that permitting an abbreviated claim 
in the manner that FDA has proposed will not significantly decrease the 
likelihood that consumers will read the full claim.
    In Sec. 101.72(c)(2)(ii)(A) and (c)(2)(ii)(B), the agency is 
proposing requirements for the type size and location of the referral 
statement that are consistent with those for nutrient content claims in 
Sec. 101.13(g)(1) and (g)(2).
    FDA has long held that accompanying information should be in a size 
reasonably related to that of the information that it modifies. Section 
403(f) of the act requires that information required under the act be 
placed on the label with such conspicuousness as to render it likely to 
be read. Section 403(r)(2)(B) of the act requires that a referral 
statement for nutrient content claims appear prominently, although it 
does not specify requirements such as to type size or style.
    For nutrient content claims, FDA established type size requirements 
for referral and disclosure statements that are related to the area of 
the surface bearing the principal display panel rather than to the type 
size used for the nutrient content claim. The proportionality between 
size of the referral statement and the size of the label panel ensures 
that the referral statement is presented with appropriate prominence. 
However, when the claim is less than twice what the minimum size of the 
referral statement would be, given the size of the label and 
Sec. 101.105(i), the type size of the referral statement may be less 
than that required under Sec. 101.105 for net quantity of contents. In 
such circumstances, the referral statement is of appropriate prominence 
if it is at least one-half the size of the claim and not less than one-
sixteenth of an inch. This approach to the type size requirement for 
the referral statement provides additional flexibility to firms in 
utilizing label space but still ensures adequate prominence for this 
statement.
    Because, under this proposal, health claim referral statements are 
to be used in a manner that is similar to how nutrient content claim 
referral statements are used, and because they are likely to appear on 
the principal display panel, the agency tentatively concludes that a 
health claim referral statement should be subject to the same type size 
requirements as those for nutrient content claims. Therefore, the 
agency tentatively concludes that the requirements for the referral 
statement set forth in Sec. 101.72(c)(2)(ii)(A) and (c)(2)(ii)(B) are 
appropriate when an abbreviated health claim is used, and it is 
including them in this proposed rule.
    In concert with the proposed requirements for an abbreviated health 
claim, the agency is including an abbreviated health claim among the 
examples of other model claims in proposed Sec. 101.72(e).

E. 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 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.'' This section helps to ensure 
that consumers who rely on health claims will be consuming foods that 
will assist them in structuring a healthful diet that meets dietary 
guidelines.
    As discussed more fully in the preamble to the 1993 health claims 
final rule, the agency implemented this provision by considering a 
food's role in the total daily diet and calculating levels of total 
fat, saturated fat, cholesterol, and sodium that would increase the 
risk of disease or health-related conditions in the general population. 
FDA calculated these levels by considering the number of foods consumed 
each day, as well as the number of foods that are likely to contain 
significant levels of these nutrients.
    The agency has established different disqualifying levels for 
different types of foods, depending on the role that they play in the 
daily diet. Section 101.14(a)(5) defines the disqualifying level for 
individual foods as 20 percent of the DV's for total fat, saturated 
fat, cholesterol, and sodium. These levels 

[[Page 66222]]
translate to 13.0 grams (g) of total fat, 4.0 g of saturated fat, 60 mg 
of cholesterol, and 480 mg of sodium per reference amount customarily 
consumed, per label serving size, and for foods with reference amounts 
customarily consumed of 30 g or less or 2 tablespoons or less, per 50 
g. The regulations make additional allowances for main dish products 
and meal-type products. The disqualifying levels for main dish and meal 
products are 30 percent and 40 percent of the DV, respectively. These 
different levels are consistent with the legislative history, which 
states, ``a particular level of fat in a frozen dinner might not 
trigger the provision, whereas the same amount of fat in a snack food 
might trigger it.''
    A food that exceeds the disqualifying level for any of the four 
disqualifying nutrients may not bear a health claim unless the agency 
has granted an exemption ``based on a finding that such a claim would 
assist consumers in maintaining healthy dietary practices.'' (Section 
403(r)(3)(A)(ii) of the act.) To date, the agency has received no 
petitions for an exemption from this provision.
    The NFPA petition requested that the defined disqualification 
levels be converted to disclosure levels under certain circumstances. 
More specifically, 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 and adversely related to the disease mentioned in the claim.'' 
The petition went on to state 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.''
    As stated in the May 11, 1995, letter to NFPA, FDA concludes that a 
generic change in its regulations would not be consistent with the 
underlying goals of the NLEA. The current disqualifying levels assist 
consumers in constructing total daily diets that meet dietary 
guidelines. The agency considered the role a food plays in the daily 
diet when it calculated the disqualifying levels. Health claims on 
foods with levels of fat, saturated fat, cholesterol, or sodium that 
exceed the disqualifying levels would encourage increased intake of 
these foods and would make it difficult for consumers to follow the 
Surgeon General's recommendations and to construct a healthful diet. 
Even with the current disqualification levels, consumers could reach 
the DV's for total fat, saturated fat, cholesterol, or sodium by eating 
as few as five foods that bear health claims.
    The agency considers the current disqualification rules to be 
consistent with congressional intent. Congress contemplated that health 
claims would be reserved for those foods that can contribute to a 
healthful diet. As the House Report states, ``Health claims supported 
by a significant scientific agreement can reinforce the Surgeon 
General's recommendations and help Americans to maintain a balanced and 
healthful diet.'' (See H. Rept. 101-538, 101st Cong., 2d sess. pp. 9-10 
(1990).)
    Nevertheless, the agency tentatively finds that there may be some 
instances where disclosure rather than disqualification is appropriate. 
While FDA continues to believe that exceptions should be granted on a 
case-by-case basis, using a petition process, the agency recognizes 
that further guidance on the criteria that it will use to evaluate 
petitions for exceptions would be useful. FDA is, therefore, proposing 
to amend its regulations to give such guidance.
    Proposed Sec. 101.70(f) provides guidance for petitioners 
requesting an exception to the prohibition in Sec. 101.14(e)(3) against 
health claims for foods exceeding the disqualifying levels identified 
in Sec. 101.14(a)(5). This proposed amendment to the petition 
procedures sets out some of the factors that the agency will consider 
when evaluating a petition.
    The first factor that FDA is proposing to list is whether the risk 
of the disease or health-related condition is of such public health 
significance, and the role of the diet so critical, that 
disqualification is not appropriate (proposed Sec. 101.70(f)(1)). The 
agency recognizes that there may be instances where extraordinary 
efforts are needed to address a particular public health problem. In 
such cases, the agency would consider providing for disclosure rather 
than disqualification levels.
    The second factor is whether the availability of foods that qualify 
for a health claim is adequate to address the public health concern 
that is the subject of the health claim (proposed Sec. 101.70(f)(2)). 
The agency intends to consider whether the application of the claim is 
so limited because of the disqualification levels that it will not be 
possible to meet the public health goal of the health claim. If only a 
limited number of food products qualify to bear the claim because of 
the disqualifying levels, the agency would consider providing for 
disclosure rather than disqualification levels.
    The third factor that FDA intends to consider is whether there is 
some evidence that the population to which the health claim is targeted 
is not at risk for the disease or health-related condition associated 
with the disqualifying nutrient (proposed Sec. 101.70(f)(3)). Although 
the current disqualifying nutrients are associated with diseases or 
health-related conditions that pose risks to the general population, 
there may be some categories of foods that are targeted to specific 
subpopulations that are not at particular risk for the disease or 
health-related condition associated with the disqualifying nutrient 
(toddlers, for example). The agency would be willing to look at data 
and to consider whether an exception to the disqualifying levels should 
be made for foods intended for such subgroups.
    Related to this criterion, is the question of whether there is 
evidence that consumers can identify themselves as being at risk for a 
particular disease or health-related condition associated with the 
disqualifying levels. For instance, some individuals can already 
identify themselves as being sensitive to sodium and, therefore, would 
recognize the risk of a high sodium food if it were disclosed. If the 
ability to self-identify for these risks becomes widespread, disclosure 
might be sufficient to reduce the risk from the disqualifying nutrient. 
FDA would expect to receive data that demonstrate that this ability 
exists, however, before it would be willing to grant an exemption on 
this basis.
    Finally, the agency intends to consider whether there are any other 
public health reasons for providing for disclosure rather than 
disqualification (proposed Sec. 101.70(f)(4)). The agency does not 
consider the above list of criteria exhaustive. There may be other 
criteria that would be useful in determining whether the agency should 
provide for disclosure rather that disqualification levels for health 
claims, and the agency is open to considering such factors.
    The agency requests comments on the appropriateness of these 
criteria.
    The agency notes that there are ways to convey important health 
information other than through health claims. A food may still be able 
to bear a nutrient content claim or a structure/function claim in order 
to highlight a particular attribute even if it exceeds the 
disqualification level for a health claim. For example, while whole 
milk may not be able to bear a calcium and osteoporosis health claim, 
it can still bear a ``high calcium'' nutrient content claim, so long as 
the levels of fat and saturated fat are disclosed. Similarly, 

[[Page 66223]]
cooking oils that are lower in saturated fat may not be able to bear a 
``healthy heart'' claim but can still bear a ``low'' or ``less'' 
saturated fat nutrient content claim.
    In addition, some products can make other truthful and not 
misleading claims. For example, the label of whole milk can state 
``Calcium builds strong bones.'' While such a claim is not considered a 
health claim under the 1990 amendments, it still conveys important 
dietary advice useful to consumers in constructing a healthful diet.

V. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    FDA is proposing to: (1) Specify circumstances under which synonyms 
may be used, authorizing the use of unlisted synonyms provided that 
they are properly anchored to a listed term; (2) exempt certain types 
of products from the 10 percent nutrient contribution requirement; (3) 
provide the basis for shorter health claims by eliminating some of the 
required elements; and (4) permit an abbreviated health claim to be 
used on the principal display panel. FDA is also providing guidance for 
petitioners requesting an exception to the prohibition against health 
claims for foods exceeding FDA's defined disqualifying levels. The 
agency anticipates that the costs of this proposed rule will be 
minimal. If this rule is finalized as proposed, it will not require any 
manufacturers currently making claims to change their labels or 
labeling. Also, this rule may reduce the costs of making future claims 
by reducing the uncertainty and relaxing the requirements of the 
petition process for claims.
    Although many health claims have appeared on a variety of products, 
the agency is concerned that health claims are not being used as 
extensively as they could be. To the extent that valid claims are not 
being used, a cost is imposed on society in that some valuable 
information may not be conveyed to consumers. This proposed rule will 
reduce the cost of lost beneficial information by making it easier for 
firms to make nutrient content and health claims. The agency is aware 
that the food label or labeling is a major means of providing 
information on foods at the point-of-purchase. By adopting a less 
restrictive approach to claims, the agency is providing industry with a 
method by which the label can be used to inform consumers of the health 
benefits of foods in such a way that will catch the attention of 
consumers. As long as the claims are truthful, not misleading, and 
scientifically valid, the additional information will benefit consumers 
by reinforcing the Surgeon General's recommendations and helping 
consumers maintain healthful dietary practices. In addition, the 
greater flexibility provided to industry will increase the incentive to 
develop more healthful products.
    The Regulatory Flexibility Act requires analyzing options for 
regulatory relief for small businesses. The current claims regulations 
may have discouraged small businesses from making valid nutrient 
content claims and health claims. To the extent that this rule relaxes 
the restrictions on the ability of firms to use claims on the labels or 
in the labeling of their products, this rule will benefit small firms. 
In accordance with the Regulatory Flexibility Act, the agency certifies 
that the proposed rule will not have a significant economic impact on a 
substantial number of small businesses.

VII. Paperwork Reduction Act

    FDA tentatively concludes that this proposed rule contains no 
reporting, recordkeeping, labeling, or other third party disclosure 
requirements; thus there is not ``information collection'' 
necessitating clearance by the Office of Management and Budget. 
However, to ensure the accuracy of this tentative conclusion, FDA is 
seeking comment on whether this proposed rule to permit additional 
flexibility in the use of health claims and synonyms for nutrient 
content claims on food labels imposes any paperwork burden.

VIII. Comments

    Interested persons may, on or before March 20, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

IX. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. House Committee on Energy and Commerce, ``Nutrition Labeling 
and Education Act of 1990,'' 101st Congress, 2d sess., Report 101-
538, pp. 9-10, June 13, 1990.
    2. Committee on the Nutrition Components of Food Labeling, Food 
and Nutrition Board, IOM, National Academy of Science, ``Nutrition 
Labeling, Issues and Directions for the 1990's,'' Washington, DC, 
National Academy Press, 1990.
    3. United States Department of Agriculture, Human Nutrition 
Information Services, ``USDA's Food Guide Pyramid,'' Home and Garden 
Bulletin No. 249, April, 1992.
    4. ``The Surgeon General's Report on Nutrition and Health,'' 
DHHS, Public Health Service Publication No. 88-50210 (Government 
Printing Office Stock No. 017-001-00465-1), U.S. Government Printing 
Office, Washington, DC, 1988.
    5. Committee on Diet and Health, Food and Nutrition Board, 
Commission on Life Sciences, National Research Council, National 
Academy of Science, ``Diet and Health: Implications for Reducing 
Chronic Disease Risk,'' National Academy Press, Washington, DC, 
1989.
    6. National Institutes of Health, Office of the Director, ``NIH 
Consensus Statement, Optimal Calcium Intake,'' vol. 12, No. 4, June 
6-8, 1994. Available from: NIH Consensus Program Information 
Service, P.O. Box 2577, Kensington, MD 20891, 1-800-644-6627.
    7. Levy, A., Food and Drug Administration, Center for Food 
Safety and Applied Nutrition, Division of Market Studies, ``Summary 
Report on Health Claims Focus Groups,'' June 15, 1995.
    8. Dietary Supplement Health and Education Act of 1994 (Pub. L. 
103-417), October 25, 1994.
    9. Technical Report--Cancer Prevention Awareness Survey--Wave 
II, Office of Cancer Communications, National Cancer Institute, 
National Institutes of Health, Bethesda, MD, November 1986.
    10. Brenda Derby, Memorandum to Victor Frattali, ``Consumer 
Understanding of 

[[Page 66224]]
Multifactoriality of Disease,'' October 25, 1995.-

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

    2. Section 101.13 is amended by revising the introductory text of 
paragraph (b) and adding new paragraph (r) to read as follows:

Sec. 101.13  Nutrient content claims--general principles.

* * * * *
    (b) A claim that expressly or implicitly characterizes the level of 
a nutrient (nutrient content claim) of the type required in nutrition 
labeling under Sec. 101.9 with the exception of such claims on 
restaurant menus and except as noted in paragraph (r) of this section 
for unlisted synonyms, may not be made on the label or in labeling of 
foods unless the claim is made in accordance with this regulation and 
with the applicable regulations in subpart D of this part or in part 
105 or part 107 of this chapter.
* * * * *
    (r) Expressed synonyms for nutrient content claims may be used, 
provided:
    (1) The term is listed as a synonym of a defined term in the 
regulations in subpart D of this part or in part 105 or part 107 of 
this chapter; or
    (2) The term is used in a manner that complies with the following 
requirements:
    (i) Such term is not misleading and, in the context of the entire 
label, is reasonably understood by consumers to be a synonym of a term 
listed in subpart D of this part or in part 105 or part 107 of this 
chapter;
    (ii)(A) The term that is listed in subpart D of this part or in 
part 105 or part 107 of this chapter, and for which the unlisted term 
is being used as a synonym, appears prominently and conspicuously on 
the label, such that it is:
    (1) Immediately adjacent (with no intervening material) to the most 
prominent use of the unlisted synonym (as determined in accordance with 
Sec. 101.13(j)(2)(iii)); and
    (2) At least half as prominent (including type size, style, and 
color) as the unlisted synonym authorized under this paragraph.
    (B) If the term listed in subpart D of this part or in part 105 or 
part 107 of this chapter is more than twice as prominent on a label as 
the synonym authorized under this paragraph such that the claimed 
nutrient level is clearly understood (e.g., a claim in the statement of 
identity versus an unlisted synonym used only in a paragraph in small 
sized type), the term listed in subpart D of this part or in part 105 
or part 107 of this chapter need not be placed adjacent to the unlisted 
synonym authorized under this paragraph.
    (iii) The unlisted synonym is used in conformance with all the 
requirements for the use of the defined term, i.e., the referral 
statement required in Sec. 101.13(g) and any other required label 
statements appear in the prescribed manner; and
    (iv) This paragraph does not authorize a term listed in subpart D 
of this part or in part 105 or part 107 of this chapter to be used in 
conjunction with an unlisted qualifying term (e.g., ``extra low,'' 
``extra high,'' ``especially good source,'' or ``great source'').
    3. Section 101.14 is amended by revising paragraphs (d)(2)(iv) and 
(e)(6) to read as follows:

Sec. 101.14  Health claims: general requirements.

* * * * *
    (d) * * *
    (2) * * *
    (iv) All information required to be included in the claim appears 
in one place without other intervening material, except that the 
principal display panel of the label or labeling may bear:
    (A) The 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 name of the disease or 
health-related condition (e.g., ``See attached pamphlet for information 
about calcium and osteoporosis''), with the entire claim appearing 
elsewhere on the other labeling, Provided that, where any graphic 
material (e.g., a heart symbol) constituting an explicit or implied 
health claim appears on the label or labeling, the reference statement 
or the complete claim shall appear in immediate proximity to such 
graphic material; or
    (B) As authorized under subpart E of this part, an abbreviated 
claim consisting only of a truthful, nonmisleading, and scientifically 
valid description of the relationship between the substance and the 
disease or health-related condition, Provided that:
    (1) Such an abbreviated claim is accompanied by a reference 
statement to the complete health claim;
    (2) The reference statement is prominent and in immediate proximity 
to the abbreviated claim; and
    (3) The complete health claim appears on the same label, or in the 
same labeling, in which the abbreviated claim appears.
* * * * *
    (e) * * *
    (6) Except for dietary supplements, fruit or vegetable products 
composed solely of fruits and vegetables, enriched grain products that 
conform to a standard of identity in part 136, 137, or 139 of this 
chapter, and bread which conforms to the standard of identity for 
enriched bread in Sec. 136.115 of this chapter except that it contains 
whole wheat or other grain products not permitted under that standard, 
or where provided for in other regulations in part 101, subpart E, the 
food contains 10 percent or more of the Reference Daily Intake or Daily 
Reference Value for vitamin A, vitamin C, iron, calcium, protein, or 
fiber per reference amount customarily consumed prior to any nutrient 
addition.
* * * * *
    4. Section 101.70 is amended in paragraph (f) by adding in the 
model petition new text immediately preceding the last undesignated 
paragraph of section B to read as follows:

Sec. 101.70  Petitions for health claims.

* * * * *
    (f) * * *
    B. * * *
    In deciding the merits of a petition filed for an exception to the 
prohibition in Sec. 101.14(e)(3) against health claims for foods 
exceeding the disqualifying levels identified in Sec. 101.14(a)(5), the 
agency will consider the following factors:
    1. The public health significance of the risk of the disease or 
health-related condition that is the subject of the claim and the role 
that the diet plays in decreasing that risk;
    2. The availability of foods that qualify for a claim to address 
the underlying public health concerns;
    3. Evidence demonstrating the population to which the health claim 
is targeted is not at risk for the disease or health-related condition 
associated with the disqualifying nutrient, including, 

[[Page 66225]]
but not limited to, the ability of individuals to identify themselves 
as being at risk for the disease or health-related condition associated 
with the disqualifying nutrient; and
    4. All other evidence demonstrating the public health need for 
waiving the disqualification requirements.
* * * * *
    5. Section 101.72 is amended by revising paragraph (c)(2)(i); by 
redesignating paragraphs (c)(2)(ii) and (d)(2) as (c)(2)(iii) and 
(d)(5), respectively; by adding new paragraphs (c)(2)(ii), (d)(2), 
(d)(3), and (d)(4); and by revising paragraph (e) to read as follows:

Sec. 101.72  Health claims: calcium and osteoporosis.

* * * * *
    (c)(2) Specific requirements. (i) Nature of the claim. A health 
claim associating calcium with a reduced risk of osteoporosis may be 
made on the label or labeling of a food described in paragraph 
(c)(2)(iii) of this section, provided that:
    (A) The claim makes clear that adequate calcium intake as part of a 
healthful diet throughout life is essential to reduce the risk of 
osteoporosis. The claim does not imply that adequate dietary calcium 
intake is the only recognized risk factor for the development of 
osteoporosis;
    (B) The claim does not state or imply that the risk of osteoporosis 
is equally applicable to the general United States population. The 
claim shall identify the population at particular risk for the 
development of osteoporosis as women in their bone forming years from 
approximately 11 to 35 years of age. An optional statement that further 
characterizes this and other populations at risk for developing 
osteoporosis may be made in accordance with paragraph (d)(3) of this 
section;
    (C) The claim does not attribute any degree to which maintaining 
adequate calcium intake throughout life may reduce the risk of 
osteoporosis; and
    (D) The claim states that total dietary intake of calcium greater 
than 2,000 milligrams (mg) per day (200 percent of the DV for calcium 
for adults and children 4 or more years of age or 154 percent of the 
daily value (DV) for pregnant or lactating women) provides no further 
benefit to bone health in reducing the risk of osteoporosis. This 
requirement does not apply to a food that provides 1,500 mg or less of 
calcium per day (150 percent or less of the DV for calcium for adults 
and children 4 or more years of age or 115 percent or less of the DV 
for pregnant or lactating women) when used as directed in labeling.
    (ii) Presentation of the claim. All of the elements listed in 
paragraph (c)(2)(i) of this section must be included in one 
presentation of the claim displayed prominently on the label or 
labeling on which the claim appears. Other presentations of the claim 
on that label or labeling, including on the principal display panel, 
need not include the information in paragraphs (c)(2)(i)(B) and 
(c)(2)(i)(D) of this section provided that, displayed prominently and 
in immediate proximity to such claim, the following referral statement 
is used: ``See -------- for more information'' with the blank filled in 
with the identity of the panel on which is presented the statement of 
the claim that includes all of the elements in paragraph (c)(2)(i) of 
this section.
    (A)-The referral statement ``See [appropriate panel] for more 
information'' shall be in easily legible boldface print or type, in 
distinct contrast to other printed or graphic matter, that is no less 
than that required by Sec. 101.105(i) for net quantity of contents, 
except where the size of the claim is less than two times the required 
size of the net quantity of contents statement, in which case the 
referral statement shall be no less than one-half the size of the claim 
but no smaller than one-sixteenth of an inch.
    (B) The referral statement shall be immediately adjacent to any 
presentation of the health claim that does not include all of the 
elements of paragraph (c)(2)(i) of this section, and there may be no 
intervening material between the claim and the referral statement. If 
the abbreviated health claim appears on more than one panel of the 
label, the referral statement shall be adjacent to the claim on each 
panel except for the panel that bears the full health claim where it 
may be omitted.
-* * * * *
    (d) * * *
    (2) The claim may list specific risk factors for osteoporosis, 
identifying them among the multifactorial risks for the disease. Such 
factors include a person's sex, age, and race. The claim may state that 
an adequate amount of exercise is also needed to reduce risk for the 
disease.
    (3) The claim may further identify the population at particular 
risk for the development of osteoporosis as including white (or 
``Caucasian'') women and Asian women in their bone forming years 
(approximately 11 to 35 years of age). The claim may also identify 
menopausal (or the term ``middle-aged'') women, persons with a family 
history of the disease, and elderly (or ``older'') men and women as 
being at risk.
    (4) The claim may state that adequate calcium intake throughout 
life is linked to reduced risk of osteoporosis through the mechanism of 
optimizing peak bone mass during adolescence and early adulthood. The 
phrase ``build and maintain good bone health'' may be used to convey 
the concept of optimizing peak bone mass. When reference is made to 
persons with a family history of the disease, menopausal women, and 
elderly men and women, the claim may also state that adequate calcium 
intake is linked to reduced risk of osteoporosis through the mechanism 
of slowing the rate of bone loss.
-* * * * *
    (e) Model health claims. The following are examples of model health 
claims that may be used in food labeling to describe the relationship 
between calcium and osteoporosis:
    (1) Examples 1 and 2. Model health claims for a food that does not 
require the statement specified in paragraph (c)(2)(i)(D) of this 
section:

    Especially for teen and young adult women, adequate calcium in a 
healthful diet may reduce the risk of osteoporosis later in life.
    A healthful diet with adequate calcium and regular exercise help 
teen and young adult white and Asian women maintain good bone health 
and may reduce their high risk of osteoporosis later in life.

    (2) Example 3. Model health claims for a food labeled for use by 
adults and children 4 or more years of age that requires the statement 
specified in paragraph (c)(2)(i)(D) of this section:

    Exercise and a healthful diet with enough calcium may help teen 
and young adult women reduce their high risk of osteoporosis later 
in life. Adequate calcium is important for everyone (women and men 
at all ages) but daily intakes above 2,000 mg (200 percent of the 
DV) may not provide added benefit.

    (3) Example 4. Abbreviated model health claim for use with a full 
health claim and that conforms with the requirements of paragraph 
(c)(2)(ii) of this section:

    Adequate calcium in a healthful diet may reduce the risk of 
osteoporosis. See [appropriate panel] for more information.

    6. Section 101.73 is amended by revising paragraphs (c)(2)(i)(F), 
(d)(1), and (e)(1) to read as follows:

Sec. 101.73  Health claims: dietary lipids and cancer.

* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (F) The claim does not imply that dietary fat consumption is the 
only 

[[Page 66226]]
recognized risk factor for the development of cancer.
* * * * *
    (d) Optional information. (1) The claim may indicate that 
development of cancer depends on many factors and identify one or more 
of the following as risk factors for the disease: Family history of a 
specific type of cancer, cigarette smoking, alcohol consumption, 
overweight and obesity, ultraviolet or ionizing radiation, exposure to 
cancer-causing chemicals, and dietary factors.
* * * * *
    (e) * * *
    (1) A low fat diet may reduce the risk of some cancers.
-* * * * *
    7. Section 101.74 is amended by revising paragraphs (c)(2)(i)(E), 
(d)(1), (e)(1), and (e)(2) to read as follows:

Sec. 101.74  Health claims: sodium and hypertension.

-* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (E) The claim does not imply that dietary sodium consumption is the 
only recognized risk factor for the development of high blood pressure.
-* * * * *
    (d) Optional information. (1) The claim may indicate that 
development of high blood pressure depends on many factors and identify 
one or more of the following as risk factors for the disease in 
addition to dietary sodium consumption: Family history of high blood 
pressure, growing older, alcohol consumption, and excess weight.
-* * * * *
    (e) * * *
    (1) A low sodium diet may reduce the risk of high blood pressure.
    (2) [This product] can be part of a low sodium, low salt diet that 
might reduce the risk of hypertension or high blood pressure.
    8. Section 101.75 is amended by revising paragraphs (c)(2)(i)(E), 
(d)(1), (e)(1), and (e)(2) to read as follows:

Sec. 101.75  Health claims: dietary saturated fat and cholesterol and 
risk of coronary heart disease.

-* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (E) The claim does not imply that consumption of dietary saturated 
fat and cholesterol is the only recognized risk factor for the 
development of coronary heart disease.
-* * * * *
    (d) Optional information. (1) The claim may indicate that coronary 
heart disease risk depends on many factors and identify one or more of 
the following in addition to saturated fat and cholesterol about which 
there is general scientific agreement that they are major risk factors 
for this disease: A family history of coronary heart disease, elevated 
blood total and LDL-cholesterol, excess body weight, high blood 
pressure, cigarette smoking, diabetes, and physical inactivity.
-* * * * *
    (e) * * *
    (1) Diets low in saturated fat and cholesterol may reduce the risk 
of heart disease;
    (2) Your risk of heart disease might be reduced by a diet low in 
saturated fat and cholesterol and a healthy lifestyle;
-* * * * *
    9. Section 101.76 is amended by revising paragraphs (c)(2)(i)(D), 
(d)(2), (e)(1), and (e)(2) to read as follows:

Sec. 101.76  Health claims: fiber-containing grain products, fruits, 
and vegetables and cancer.

-* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (D) The claim does not imply that consumption of diets low in fat 
and high in fiber-containing grain products, fruits, and vegetables is 
the only recognized risk factor for a reduced risk of developing 
cancer.
-* * * * *
    (d) * * *
    (2) The claim may indicate that development of cancer depends on 
many factors and identify one or more of the following as risk factors 
for the disease: Family history of a specific type of cancer, cigarette 
smoking, alcohol consumption, overweight and obesity, ultraviolet or 
ionizing radiation, exposure to cancer-causing chemicals, and dietary 
factors.
-* * * * *
    (e) * * *
    (1) Low fat diets rich in fiber-containing grain products, fruits, 
and vegetables may reduce the risk of some types of cancer.
    (2) A diet low in fat and high in grain products, fruits, and 
vegetables that contain fiber may reduce your risk of some cancers.
-* * * * *
    10. Section 101.77 is amended by revising paragraphs (c)(2)(i)(F), 
(d)(1), and (e) to read as follows:

Sec. 101.77  Health claims: fruits, vegetables, and grain products -
that contain fiber, particularly soluble fiber, and risk of -coronary 
heart disease.

    (c) * * *
    (2) * * *
    (i) * * *
    (F) The claim does not imply that consumption of diets low in 
saturated fat and cholesterol and high in fruits, vegetables, and grain 
products that contain fiber, particularly soluble fiber, is the only 
recognized risk factor for a reduced risk of developing coronary heart 
disease.
-* * * * *
    (d) Optional information. (1) The claim may indicate that 
development of coronary heart disease depends on many factors and 
identify one or more of the following as risk factors for the disease: 
A family history of coronary heart disease, elevated blood-, total- and 
LDL-cholesterol, excess body weight, high blood pressure, cigarette 
smoking, diabetes, and physical inactivity.
-* * * * *
    (e) Model health claims. The following model health claims may be 
used in food labeling to characterize the relationship between diets 
low in saturated fat and cholesterol and high in fruits, vegetables, 
and grain products that contain soluble fiber and the risk of coronary 
heart disease:
    (1) Diets low in saturated fat and cholesterol and rich in fiber-
containing fruits, vegetables, and grain products may reduce the risk 
of heart disease.
    (2) A diet low in saturated fat and cholesterol and high in fruits, 
vegetables, and grain products that contain fiber may lower blood 
cholesterol levels and reduce your risk of heart disease.
    11. Section 101.78 is amended by removing paragraph (c)(2)(i)(D); 
by redesignating paragraphs (c)(2)(i)(E) through (c)(2)(i)(J) and 
(d)(3) through (d)(5) as (c)(2)(i)(D) through (c)(2)(i)(I) and (d)(4) 
through (d)(6), respectively; by revising newly redesignated paragraph 
(c)(2)(i)(I), paragraphs (d)(2), (e)(1), and (e)(2); and by adding new 
paragraph (d)(3) to read as follows:

Sec. 101.78  Health claims: fruits and vegetables and cancer.

 -* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (I) The claim does not imply that consumption of diets low in fat 
and high in fruits and vegetables is the only recognized risk factor 
for a reduced risk of developing cancer.
-* * * * * 

[[Page 66227]]

    (d) * * *
    (2) The claim may indicate that development of cancer depends on 
many factors and identify one or more of the following as risk factors 
for the disease: Family history of a specific type of cancer, cigarette 
smoking, alcohol consumption, overweight and obesity, ultraviolet or 
ionizing radiation, exposure to cancer-causing chemicals, and dietary 
factors.
    (3) The claim may characterize fruits and vegetables that meet the 
requirements described in paragraph (c)(2)(ii) of this section as foods 
that are low in fat and that contain (or are a good source of) one or 
more of vitamin A, vitamin C, or dietary fiber.
-* * * * *
    (e) * * *
    (1) Low fat diets rich in fruits and vegetables (foods that are low 
in fat and may contain dietary fiber, vitamin A and vitamin C), may 
reduce the risk of some types of cancer.
    (2) A diet low in fat and high in certain fruits and vegetables, 
foods that are low in fat and that may contain vitamin A and vitamin C, 
may reduce your risk of some cancer.

    Dated: December 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31008 Filed 12-20-95; 8:45 am]
BILLING CODE 4160-01-F