[Federal Register: November 25, 2003 (Volume 68, Number 227)]
[Proposed Rules]               
[Page 66040-66048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25no03-15]                         
 
=======================================================================
-----------------------------------------------------------------------
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
[Docket No. 2003N-0496]
RIN 0910-AF09
 
 
Food Labeling: Health Claims; Dietary Guidance
 
AGENCY:  Food and Drug Administration, HHS.
 
ACTION:  Advance notice of proposed rulemaking.
 
-----------------------------------------------------------------------
 
SUMMARY:  The Food and Drug Administration (FDA) is issuing this 
advance notice of proposed rulemaking (ANPRM) to request comments on 
alternatives for regulating qualified health claims in the labeling of 
conventional human foods and dietary supplements. FDA also is 
soliciting comments on various other issues related to health claims 
and on the appropriateness and nature of dietary guidance statements on 
conventional food and dietary supplement labels. Comments on the 
regulatory alternatives and the additional topics will inform FDA's 
rulemaking to establish regulations for qualified health claims, as 
well as any policy initiative(s) that FDA may undertake to provide 
information to consumers to help them make wise food choices.
 
DATES:  Submit written or electronic comments by January 26, 2004.
 
ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments
.
 
FOR FURTHER INFORMATION CONTACT:  Paulette Gaynor, Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-800), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 301-436-1450.
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
    The Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 
101-535)\1\ directed FDA to issue regulations authorizing health claims 
(i.e., labeling claims that characterize the relationship of a 
substance to a disease or health-related condition) only if the agency 
determines, based upon 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 (SSA), among experts qualified by scientific training and 
experience to evaluate such claims, that the claim is supported by such 
evidence (21 U.S.C. 343(r)(3)(B)(i)). Congress delegated to FDA the 
authority to establish the procedure and standard for health claims for 
dietary supplements (21 U.S.C. 343(r)(5)(D)). In accordance with the 
NLEA, FDA issued regulations establishing general requirements for 
health claims in labeling for conventional foods (58 FR 2478, January 
6, 1993). By regulation (59 FR 395, January 4, 1994), and under 
Congressional authority\2\, FDA adopted the same general requirements, 
including the procedure and standard, for health claims in dietary 
supplement labeling that Congress had prescribed in the NLEA for health 
claims in the labeling of conventional foods. (See 21 U.S.C. 343(r)(3) 
and (r)(4).)
---------------------------------------------------------------------------
 
    \1\ The NLEA authorized health claims in food labeling by 
amending the Federal Food, Drug, and Cosmetic Act (the act) to add 
section 403(r) to the act (21 U.S.C. 343(r)). This section 
specifies, in part, that a food is misbranded if it bears a claim 
that expressly or by implication characterizes the relationship of a 
nutrient to a disease or health-related condition unless the claim 
is made in accordance with section 403(r)(3) (for conventional 
foods) or 403(r)(5)(D) (for dietary supplements).
    \2\ FDA issued regulations establishing general requirements for 
health claims in dietary supplement labeling (59 FR 395) under the 
NLEA and the Dietary Supplement Act of 1992 (Public Law 102-571).
---------------------------------------------------------------------------
 
    The procedure requires the evidence supporting a health claim to be 
presented to FDA for review before the claim may appear in labeling 
(Sec.  101.14(d) and (e) and 101.70) (21 CFR 101.14(d) and (e), 
101.70)). The standard requires a finding of ``significant scientific 
agreement'' (SSA) before FDA may authorize a health claim by regulation 
(Sec.  101.14(c)). FDA's current regulations, which mirror the 
statutory language in 21 U.S.C. 343(r)(3)(B)(i), provide that this 
standard is met only if FDA determines that there is SSA, among experts 
qualified by scientific training and experience to evaluate such 
claims, that the claim is supported by the totality of publicly 
available scientific evidence, including evidence from well-designed 
studies conducted in a manner that is consistent with generally 
recognized scientific procedures and principles (Sec. Sec.  101.14(c) 
and 101.70(f)).
    Among its provisions regulating claims, the NLEA required FDA to 
determine whether claims respecting 10 specific substance/disease 
relationships met the requirements for a health claim (NLEA section 
3(b)(1)(A)(vi) and (x), Pub. L. 101-535). FDA conducted these 
statutorily required analyses. Not all relationships that Congress 
required the agency to consider were found to meet the standard of SSA, 
and, so, not all were authorized by FDA. Some of the substance/disease 
relationships that were found to lack SSA became the subject of a 
lawsuit, Pearson v. Shalala (Pearson), brought by dietary supplement 
marketers and health advocacy organizations.
    In Pearson, the plaintiffs challenged FDA's general health claims 
regulations for dietary supplements and FDA's decision not to authorize 
health claims for four specific substance/disease relationships. 
Although the U.S. District Court for the District of Columbia initially 
ruled in favor of FDA (14 F. Supp. 2d 10 (D.D.C. 1998)), the U.S. Court 
of Appeals for the D.C. Circuit reversed the lower court's decision 
(Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)).\3\ The appeals 
court held
 
[[Page 66041]]
 
that, on the administrative record compiled in the challenged 
rulemakings, the first amendment does not permit FDA to reject health 
claims that the agency determines to be potentially misleading unless 
the agency also reasonably concludes that a disclaimer would not 
eliminate the potential deception.
---------------------------------------------------------------------------
 
    \3\ The appellate court decided the case on January 15, 1999. On 
March 1, 1999, the Government filed a petition for rehearing en 
banc. The U.S. Court of Appeals for the D.C. Circuit denied the 
petition for rehearing on April 2, 1999 (172 F.3d 72 (D.C. Cir. 
1999)).
---------------------------------------------------------------------------
 
    The Appeals Court further stated that it did not ``rule out the 
possibility that where evidence in support of a claim is outweighed by 
evidence against the claim, the FDA could deem it incurable by a 
disclaimer and ban it outright.'' (164 F. 3d at 659.) Also, the court 
saw ``no problem with the FDA imposing an outright ban on a claim where 
evidence in support of the claim is qualitatively weaker than the 
evidence against the claim.'' Id. at 659 n.10. This language was the 
genesis of the ``weight of the evidence'' criterion discussed in this 
ANPRM.
    In the Federal Register of October 6, 2000 (65 FR 59855), following 
the Appeals Court ruling in Pearson, FDA published a notice announcing 
its intention to exercise its enforcement discretion with regard to 
certain categories of dietary supplement health claims that may not 
meet the SSA standard currently endorsed in Sec.  101.14(c).\4\ The 
October 6, 2000, notice identified circumstances in which the agency 
intended to consider exercising enforcement discretion for a qualified 
health claim in dietary supplement labeling. Included in the agency's 
consideration was whether the scientific evidence in support of a given 
health claim outweighed the scientific evidence against it. In the 
Federal Register of December 20, 2002 (67 FR 78002), FDA published a 
notice of availability announcing that the agency was identifying 
qualified health claim enforcement discretion factors in the form of 
guidance and expanding its consideration of enforcement discretion to 
include health claims in the labeling of conventional foods as well as 
dietary supplements.\5\
---------------------------------------------------------------------------
 
    \4\ In the Federal Register of December 1, 1999 (64 FR 67289), 
FDA published a notice to inform the public of the steps FDA planned 
to follow to carry out the Pearson decision. In the Federal Register 
of December 22, 1999 (64 FR 71794), FDA published a notice of 
availability of guidance clarifying the SSA standard in light of 
Pearson. The October 2000 notice announced FDA's revisions to the 
1999 implementation strategy.
    \5\ FDA decided to apply the enforcement discretion factors to 
conventional foods to promote consistency in health messages, to 
enable consumers to learn about important health information even if 
it may not necessarily meet the current SSA standard, and to avoid 
further litigation over the constitutionality of the health claims 
provisions of the NLEA applicable to conventional food labeling to 
the extent that these provisions do not permit qualified claims (68 
FR 41387 at 41389).
---------------------------------------------------------------------------
 
    Six days after publication of the December 20, 2002, notice and the 
guidance, the U.S. District Court for the District of Columbia issued 
its decision in Whitaker v. Thompson, 248 F. Supp. 2d 1 (D.D.C. 2002) 
(Whitaker). In Whitaker, the district court, interpreting Pearson, 
found that ``credible evidence,'' rather than ``weight of the 
evidence,'' is the appropriate standard for FDA to apply in evaluating 
qualified health claims. Whitaker, 248 F.Supp. 2d at 10. In light of 
Whitaker, FDA believes that the weight of the evidence standard in the 
October 6, 2000, Federal Register notice and the December 20, 2002, 
guidance must be tempered by the test of credible evidence (68 FR 41387 
at 41388-41389).
    Also in December 2002, FDA announced a major new initiative, the 
Consumer Health Information for Better Nutrition Initiative, to make 
available more and better information about conventional foods and 
dietary supplements to help consumers improve their health and decrease 
the risk of contracting diseases by making sound dietary decisions. 
Under this initiative, the agency established the Task Force on 
Consumer Health Information for Better Nutrition (the Task Force). The 
Task Force was charged with, among other things, reporting on how the 
agency can improve consumer understanding of the health consequences of 
dietary choices and increase competition by product developers in 
support of healthier diets. This charge includes how the agency should 
evaluate scientific evidence for qualified health claims, as well as 
developing a framework for regulations that will give these principles 
the force and effect of law.
    FDA announced the availability of the Task Force report (Ref. 1), 
in a notice published in the Federal Register of July 11, 2003 (68 FR 
41387). The notice also announced the availability of two guidances 
entitled ``Guidance for Industry and FDA: Interim Evidence-Based 
Ranking System for Scientific Data'' (Ref. 2) and ``Guidance for 
Industry and FDA: Interim Procedures for Qualified Health Claims in the 
Labeling of Conventional Human Food and Human Dietary Supplements'' 
(Ref. 3) that further updated the agency's approach on how it intends 
to implement the Pearson decision. Further, the notice stated that FDA 
intended to publish an ANPRM to solicit comments on the regulatory 
approaches and topics addressed in the Task Force report. This ANPRM is 
that document.
    As of September 1, 2003, the agency has implemented the evidence-
based ranking system and the procedures for qualified health claims\6\ 
on an interim basis. However, FDA recognizes the need for transparent, 
long-term procedures that have the force and effect of law.\7\ Such 
procedures would benefit both the industry and the consumer, provided 
they result in well-reasoned, science-based decisions that facilitate 
the communication of truthful and non-misleading information to the 
consumer. To this end, the agency is issuing this ANPRM to solicit 
comment on various approaches the agency might adopt to regulate 
qualified health claims in the labeling of conventional foods and 
dietary supplements.\8\
---------------------------------------------------------------------------
 
    \6\ FDA is using the term ``qualified health claim'' to refer to 
health claims that do not meet the current SSA standard. This is in 
contrast to FDA's use of the term ``unqualified health claim'' to 
refer to health claims that meet the current SSA standard and are or 
could be authorized under the NLEA and regulations issued under the 
act, including 21 CFR 101.70.
    \7\ Since the October 2000 Federal Register notice and under the 
December 2002 guidance, when FDA decides to exercise its enforcement 
discretion with respect to a qualified health claim, it so notifies 
the petitioner by letter. This process was developed as a short-term 
response to the court decisions described above and does not provide 
for public participation.
    \8\ In accordance with the recommendation of the Task Force, FDA 
is also conducting consumer research to determine whether 
potentially misleading health claims can be cured by disclaimers in 
at least some cases. The agency does not have such data for 
conventional foods or dietary supplements. Within the next year, the 
agency will be completing research in this area. FDA's rulemaking 
will be informed by the results of this research, as well as the 
agency's evaluation and consideration of the regulatory alternatives 
and public comment.
---------------------------------------------------------------------------
 
    Although the Task Force focused primarily on the issue of qualified 
health claims, its discussions were enriched by considerations related 
to promoting partnerships with sister public health agencies and 
others, with the goal of increasing the quantity and improving the 
impact of health messages\9\ on conventional human foods
 
[[Page 66042]]
 
and human dietary supplements.\10\ In light of the need for improved 
health messages and science-based competition among food (including 
dietary supplement) producers to promote better health, and given the 
broader goals of the Consumer Health Information for Better Nutrition 
Initiative, FDA believes that it would be prudent to expand the scope 
of this ANPRM to request comments on the appropriateness and nature of 
dietary guidance statements on food labels.
---------------------------------------------------------------------------
 
    \9\ In the Federal Register of November 27, 1991 (56 FR 60537 at 
60538), FDA stated that for consistency with the NLEA, the agency 
was using the term ``health claim'' in place of ``health message,'' 
which was used in pre-NLEA Federal Register documents (i.e., 
proposed rule of August 4, 1987 (52 FR 28843); ANPRM of August 8, 
1989 (54 FR 32610); and re-proposed rule of February 13, 1990 (55 FR 
5176)) that discussed disease-related information on food labeling. 
Thus, the use of the term ``health message'' in those previous 
documents was roughly equivalent to the use of the term ``health 
claim'' in post-NLEA Federal Register documents. In recent documents 
(e.g., the December 2002 guidance, the Task Force report), including 
this ANPRM, however, FDA is using the term ``health message''in a 
broader context than solely to refer to health claims. That is, FDA 
considers that the term ``health message'' includes the various 
forms of dietary statements (e.g., a health claim, a dietary 
guidance statement).
    \10\ Health messages on product labels can be divided into 
several categories, including health claims, dietary guidance 
statements, and ``structure/function'' claims. A structure/function 
claim describes the effect of a substance or product on the 
structure or function of the human body (see 21 U.S.C. 321(g)(1)(C) 
and 343(r)6)). An example of a structure/function claim is: Calcium 
helps build strong bones. Structure/function claims do not refer to 
a disease, and in this way often resemble one type of dietary 
guidance statement as described in section III.A of this document. 
Structure/function claims may appear on conventional foods as well 
as dietary supplements. Such claims are not pre-reviewed by FDA, but 
must be truthful and not misleading as required under sections 
201(n) and 403(a)(1) of the act (21 U.S.C. 321(n), and 343(a)(1)). 
Additional requirements apply when a structure/function claim is 
used in the labeling of a dietary supplement. For example, firms 
must notify FDA of a structure/function claim within 30 days after 
first marketing the product with the statement, and a disclaimer 
must accompany the statement (see 21 U.S.C. 343(r)(6) and 21 CFR 
101.93).
---------------------------------------------------------------------------
 
II. Health Claims
 
A. Regulatory Alternatives for Qualified Health Claims
 
    FDA is considering three alternatives (i.e., options) identified in 
the Task Force report (Ref. 4) for regulating health claims that do not 
meet the SSA standard of evidence (i.e., qualified health claims) 
required in 21 U.S.C. 343(r)(3)(B)(i) and Sec.  101.14(c) to evaluate 
the scientific validity of health claims. The options identified by the 
Task Force are: Option 1--incorporate the interim procedures and 
evidence-based ranking system into a regulation under notice-and-
comment rulemaking; option 2--reinterpret the SSA standard to apply to 
the accuracy of the characterization of the evidence supporting the 
claim, instead of the underlying substance-disease relationship, and 
subject qualified health claims to notice-and-comment rulemaking; and 
option 3--treat qualified health claims as wholly outside the NLEA and 
regulate them solely on a postmarket basis, if they are false or 
misleading. FDA is seeking comment on each of the options described, 
including comments about the strengths and weaknesses of each option 
from the perspective of public health, policy, law, and practicality; 
and which is the best option and why. The agency also is requesting 
comments that suggest additional options for regulating qualified 
health claims, together with an analysis of the strengths and 
weaknesses of each suggested alternative from the perspective of public 
health, policy, law, and practicality.
1. Option 1
    The first option would be to codify the current interim procedures 
and evidence-based ranking system into a regulation, or codify a 
variation of these. This approach addresses both procedural and 
substantive concerns about qualified health claims, and also allows 
such claims to be made in labeling in a more timely manner than under 
option 2. With respect to the procedural issues, this approach is 
consistent with the spirit of the NLEA because it maintains the 
premarket clearance system that provides for FDA review of qualified 
health claims and the supporting data, and an opportunity for public 
participation. This option is similar in approach to the suggestions 
made in comments on the December 20, 2002, guidance on qualified health 
claims. Even though the process would not include notice-and-comment 
rulemaking for the agency's decision on a qualified health claim, the 
petition with the requested qualified health claim and the supporting 
data would be made available to the public for comment.
    Second, this approach responds to the first amendment concerns 
identified in Pearson by providing for the use of disclaimers to 
communicate to consumers the level of scientific evidence in support of 
health claims and to cure potentially misleading health claims. The 
addition of a clarifying disclaimer to a potentially misleading claim 
would provide consumers with truthful and nonmisleading information. 
(See Pearson, 164 F.3d at 658-59.)
    Finally, this approach allows for faster review and, if necessary, 
revision of qualified health claims. Under this option, the agency's 
review of a petition for a qualified health claim would usually be 
completed within 270 days after receipt of the petition. In addition, 
the agency's decision on a qualified health claim would remain in the 
form of an enforcement discretion letter and not, as some comments to 
the December 20, 2002, guidance requested, in the form of a regulation. 
Thus, FDA could more readily revise its decision about a qualified 
health claim if subsequent data were to indicate the need to do so. The 
data underlying qualified health claims are, by definition, preliminary 
and subject to change as more studies are conducted. If the qualified 
health claim were established in a regulation, FDA could amend it only 
through notice-and-comment rulemaking. Thus, a claim that becomes 
inaccurate or misleading because of new scientific developments would 
remain in labeling until the regulation was revised.
2. Option 2
    The second option would be to require each qualified health claim 
to undergo notice-and-comment rulemaking, which is the statutorily 
prescribed process for health claims for conventional foods. Requiring 
rulemaking before a qualified health claim is allowed on food labels is 
consistent with suggestions made in a comment on the December 20, 2002, 
guidance.
    This approach would require FDA to reinterpret the SSA standard to 
apply to the claim (including the disclaimer, if any) instead of the 
underlying substance-disease relationship. Thus, the agency's focus 
would be on whether the words of the claim accurately reflect the data 
supporting it (e.g., ``limited and preliminary scientific research 
suggests * * *.''), rather than whether there is SSA supporting the 
substance-disease relationship.
    Because the SSA requirement in FDA's health claim regulations 
(Sec.  101.14(c)) tracks the language of the statute (21 U.S.C. 
343(r)(3)(B)(i)), and both require FDA to evaluate whether there is SSA 
that the claim is supported by the totality of publicly available 
scientific evidence, it would not be necessary to amend Sec.  101.14(c) 
to implement this option. However, FDA would have to revoke its 
contrary interpretation of the statute and Sec.  101.14(c) in the 
preambles to the general health claim regulations. In those preambles, 
FDA stated that SSA was about the substance-disease relationship 
instead of the words of the claim.
    Mandatory rulemaking for each qualified health claim may not 
provide sufficient flexibility to implement changes in the claims 
necessitated by rapid developments in science. Moreover, this process 
could be quite burdensome without any apparent corresponding public 
health benefit if the claim is based on weak scientific evidence. In 
addition, the reinterpretation of the SSA standard to apply to the 
claim rather than the underlying substance-disease relationship could 
eliminate the value of the standard because claims about
 
[[Page 66043]]
 
any substance-disease relationship, no matter how weak or preliminary 
the evidence, would meet SSA as long as the claim accurately described 
the level of the evidence.
    This approach may be vulnerable to a first amendment challenge 
because it applies the statutorily prescribed process for reviewing 
unqualified health claims to qualified health claims. The statutory 
process requires notice-and-comment rulemaking and permits FDA up to 
540 days to complete its review of a health claim petition (see 21 
U.S.C. 343(r)(4)(A)(i)). Although the United States Court of Appeals 
for the Second Circuit has held that a period of 540 days is not an 
unconstitutional prior restraint for unqualified health claims (see 
Nutritional Health Alliance v. Shalala, 144 F.3d 220 (1998), cert. 
denied, 525 U.S. 1040 (1998)), it is unclear whether it is too long to 
restrain qualified health claims in which the SSA standard is applied 
to the claim itself rather than the substance/disease relationship. FDA 
is concerned that this approach may be found to be unconstitutional 
because the value of commercial speech often depends upon its 
timeliness.
3. Option 3
    A third option would be to treat qualified health claims as wholly 
outside the NLEA and regulate them on a postmarket basis under section 
403(a)(1) of the act, which provides that food is misbranded if its 
labeling is false or misleading. Consistent with FDA's past practice, 
``false or misleading'' would be defined to include lacking 
substantiation.
    Under this approach, FDA could only evaluate and, where necessary, 
prohibit a claim after it appears on a product label (or in other 
product labeling). This is similar to the Federal Trade Commission's 
(FTC) approach, but with one significant difference: FTC has 
administrative subpoena power, allowing FTC to obtain a company's 
substantiating data, evaluate the data, and, where appropriate, take 
enforcement action with relative speed. In contrast, while FDA holds 
administrative subpoena power in some circumstances, the agency is not 
vested with such power for the investigation and enforcement of health 
claims in the labeling of conventional foods and dietary supplements.
    As a result, the agency would have to build enforcement cases by 
first searching the literature and consulting with experts. Depending 
on the nature of the matter, FDA might also have to test how consumers 
would interpret the claim (where, for example, there was a serious 
question about the existence of an implied claim). There is also a 
concern that this option would not afford FDA any role in reviewing or 
clearing claims before they appeared in labeling and would not provide 
any opportunity for public participation. Finally, this option could be 
inefficient and too resource intensive for FDA to be able to protect 
consumers from misleading claims that would already be in the labeling 
of products in the marketplace.
 
B. Issues Raised in the Task Force Report
 
    In its report, the Task Force recommended that FDA seek comment on 
several additional topics: (1) Data and research on a substance/disease 
relationship, including incentives for SSA; (2) revised claim language 
for unqualified health claims; (3) interim final rules for unqualified 
health claims; (4) use of phrases such as ``FDA authorized'' in 
qualified and unqualified health claims; (5) consumer education; (6) 
evaluations of outside groups; and (7) competent and reliable evidence.
1. Data and Research on a Substance/Disease Relationship, Including 
Incentives for SSA
    Although FDA intends to provide for the use of qualified health 
claims, the agency remains interested in authorizing unqualified health 
claims by regulation under the SSA standard. Based on the July 2003 
interim evidence-based ranking guidance (Ref. 2), the level of 
scientific evidence to support the substance/disease relationship for 
an unqualified health claim would continue to be based on relevant, 
high quality studies, such as randomized, controlled intervention 
trials and prospective observational cohort studies, which minimize 
bias. FDA is requesting comments on how to provide incentives for 
manufacturers to develop the data needed to obtain SSA for an 
unqualified health claim. In addition, FDA is requesting comments on 
how to more effectively develop public-sponsored research on substance/
disease relationships.
2. Revised Claim Language for Unqualified Health Claims
    The health claim regulations require unqualified health claims to 
state that the substance ``may'' reduce the risk of the specified 
disease (e.g., ``calcium may reduce the risk of osteoporosis'') (Sec.  
101.14(d)(2)(ii)). In the final rule on general requirements for health 
claims for conventional foods (58 FR 2478 at 2505), FDA explained that 
the agency's use of the term ``may'' relates to the potential to reduce 
the risk of disease. The agency intended the use of the word ``may'' to 
convey to consumers that there is no guarantee that any one dietary 
practice will, in fact, reduce an individual's risk of a disease. FDA 
noted that absolute claims about diseases affected by diet generally 
are not possible because such diseases are almost always 
multifactorial, and that diet is only one factor that influences 
whether a person will get such a disease (58 FR 2478 at 2505). 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. Id. Because of factors other than diet, some individuals 
may develop the disease regardless of how they change their dietary 
patterns to avoid the disease. Id. Thus, FDA intended the word ``may'' 
to alert consumers that there is no certainty that risk of disease will 
be reduced for each individual. However, it seems to the agency that in 
common practice the word ``may'' could be, and perhaps often is, 
interpreted as a reflection of the science supporting the claim rather 
than the certainty about the ability of a dietary practice to affect 
any one consumer. Thus, the word ``may'' leads to uncertainty about the 
science behind the claim, which was not FDA's intention.
    The Task Force suggested that FDA consider removing the requirement 
for the word ``may'' from unqualified health claims to eliminate the 
uncertainty about the science underlying claims that meet SSA. FDA is 
requesting comments on whether the agency should make this change, 
whether there are alternatives to this change, and whether such a 
change would assist consumers in identifying the level of science 
supporting such health claims.
3. Interim Final Rules for Unqualified Health Claims
    The Task Force recommended that FDA solicit comment on whether FDA 
should authorize unqualified health claims through interim final rules 
(IFRs) to expedite the availability of the health claim in food 
labeling. Before Pearson, the agency's general practice was to provide 
for the unqualified health claim through full notice-and-comment 
rulemaking, i.e., by issuing a proposed rule with a comment period, 
followed by a final rule authorizing the health claim (see section 
403(r)(4)(A)(i) and Sec.  101.70(j)). Although this practice has made 
for a relatively slow process, the comments received have proved useful 
to the agency (e.g., to more accurately
 
[[Page 66044]]
 
articulate the science and to better define the substance that is the 
subject of the claim). However, as a general matter, comments have not 
persuaded the agency that any particular proposed health claim should 
not be allowed.
    In light of this consideration, after Pearson, FDA began using 
authority given to the agency by the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amendments to the 
act to authorize some unqualified health claims faster (see 65 FR 59855 
at 59856). FDA has authorized three health claims, based on a finding 
of SSA, through the IFR process under section 403(r)(7) of the act.\11\ 
First, in the Federal Register of September 8, 2000 (65 FR 54686), FDA 
issued an IFR that authorized a health claim for plant sterol/stanol 
esters and reduced risk of coronary heart disease (CHD) ((Sec.  101.83) 
(21 CFR 101.83)). The agency intends to issue a final rule on this 
claim, that includes consideration of public comment. Second, in the 
Federal Register of October 2, 2002 (67 FR 61773), FDA issued an IFR 
that amended the health claim regulation in 21 CFR 101.81 authorizing a 
health claim about the relationship between beta-glucan soluble fiber 
from whole oat sources and reduced risk of CHD to include an additional 
eligible source of whole oat beta-glucan soluble fiber (the oatrim 
IFR). After consideration of comments, the agency adopted as a final 
rule, without change, the provisions of the oatrim IFR (68 FR 44207, 
July 28, 2003). Third, in the Federal Register of December 2, 2002 (67 
FR 71461), FDA issued an IFR that amended the health claim regulation 
in 21 CFR 101.80 authorizing a health claim about the relationship 
between dietary sugar alcohols and dental carries to include the sugar 
D-tagatose (the D-tagatose IFR). After consideration of comments, the 
agency adopted as a final rule, without change, the provisions of the 
D-tagatose IFR (68 FR 39831, July 3, 2003).
---------------------------------------------------------------------------
 
    \11\ Section 403(r)(7) of the act (21 U.S.C. 343(r)(7)) 
authorizes FDA (by delegation from the Secretary of Health and Human 
Services) to make regulations issued under section 403(r) of the act 
effective upon publication pending consideration of public comment 
and publication of a regulation that considers such comment, if the 
agency determines that such action is necessary for public health 
reasons. This authority enables FDA to act promptly on petitions 
that provide information that is necessary to: (1) Enable consumers 
to develop and maintain healthy dietary practices, (2) enable 
consumers to be informed promptly and effectively of important new 
knowledge regarding nutritional and health benefits of food, or (3) 
ensure that scientifically sound nutritional and health information 
is provided to consumers as soon as possible. Regulations made 
effective upon publication under this authority are deemed to be 
final agency action for purposes of judicial review. The legislative 
history indicates that such regulations should be issued as interim 
final rules (H.R. Rep. No. 105-399, at 98 (1997), reprinted in 1997 
U.S.C.C.A.N. 2880, 2888).
---------------------------------------------------------------------------
 
    FDA recognizes that the general rulemaking process (i.e., non-IFR 
process) for unqualified health claims may be lengthy; however, this 
process may help ensure the validity of the scientific evidence under 
the SSA standard before such a claim is authorized, and may help 
prevent the unfair market advantage that could arise if FDA were to 
inappropriately characterize a substance or misinterpret the publicly 
available scientific evidence. The agency is interested in comments on 
the balance between the priorities of timeliness and comprehensiveness 
in the agency's review of an unqualified health claim. FDA is 
requesting comments on whether the agency should continue to use the 
IFR process for some or all unqualified health claims as a means of 
expediting the agency's processing of these petitions. Are there 
specific circumstances when IFRs should or should not be considered 
appropriate for health claims that meet the SSA standard?
4. Use of Phrases Such as ``FDA authorized'' in Qualified and 
Unqualified Health Claims
    The agency has for decades discouraged or prohibited use of such 
phrases as ``FDA authorized'' or ``FDA approved'' in labeling. The 
agency's policy on such statements was generally based on one of two 
reasons: (1) All products of the type were FDA approved, so that a 
label statement regarding one product implied a difference that did not 
exist; or (2) ``approval'' terminology was not appropriate because FDA 
did not approve any individual (or specific) product. FDA is requesting 
data or other information on whether a phrase indicating FDA 
authorization (e.g., ``FDA says * * *'') would encourage consumers to 
have more confidence in a claim it accompanied than in a claim without 
the phrase. FDA is interested in receiving evidence of data concerning 
any confusion or potential confusion. Should such a phrase be 
encouraged at all, even if it were to give the consumer confidence in 
the claim? Would such a phrase, when used with claims supported by 
different levels of science, confuse or potentially confuse consumers?
5. Consumer Education
    The Task Force report noted growing evidence of a public health gap 
in knowledge and behavior with respect to substance/disease 
relationships. Even when the scientific evidence for substance/disease 
relationship does not meet the standard of SSA, there may be 
considerable evidence of a relationship between the substance and the 
disease, and consumers may find this information useful in planning 
their diets. FDA is requesting comments on how the agency could best 
educate consumers about the role of qualified health claims on food 
labeling, and how such claims may be used by consumers to advance their 
own understanding of diet and health matters.
6. Evaluations of Outside Scientific Groups
    FDA has been requested on several occasions to consider accepting 
the evaluations of outside scientific groups as representing scientific 
consensus that could justify health claims. Some wanted to be able to 
convene their own groups of experts. Others wanted FDA to rely on such 
organizations as the American Heart Association or the American 
Dietetic Association, which evaluate scientific information and provide 
advice to their constituents on diet and health. In its report, the 
Task Force asked FDA to consider the recommendations of such groups as 
evidence of the strength of the science underlying a health claim. 
However, to make such a system work fairly to the benefit of all, 
including consumers, FDA would need to have confidence in the 
scientific validity of the group's conclusions about the particular 
claim in question. Some groups would have more expertise than others, 
and FDA is not aware of a mechanism for evaluating them fairly and 
accurately. FDA is requesting comment on whether the evaluations of 
non-governmental groups should be given weight in evaluating the 
strength of the science supporting a health claim. If the agency should 
give weight to the evaluations of these groups, how should this weight 
be determined?
    FDA's Food Advisory Committee (FAC) is a body of experts chartered 
to advise the agency on scientific issues upon request; however, FDA 
does not believe that the FAC is an appropriate body to conduct the 
initial evaluation of the data supporting a proposed health claim. 
Because of the limited number of meetings in the FAC's charter and 
other issues that may be brought before the FAC, FDA does not believe 
that the FAC could conduct a timely evaluation of such data. On an 
interim basis, FDA has chosen to use experts identified by another 
Federal agency (i.e., Agency for Healthcare Research and Quality 
(AHRQ)) whose mission includes retaining large numbers of such experts
 
[[Page 66045]]
 
under contract. Both FDA and AHRQ are agencies within the Department of 
Health and Human Services. This process should provide the scientific 
expertise and additional resources that FDA needs to conduct its 
scientific reviews within acceptable timeframes.
7. Competent and Reliable Scientific Evidence
    FDA's July 2003 interim evidence-based ranking guidance (Ref. 2) 
describes a process for systematically evaluating the scientific 
evidence relevant to a substance/disease relationship that is the 
subject of a health claim petition. The scientific rating system 
provides a means by which the totality of the publicly available 
scientific evidence relevant to a substance/disease relationship can be 
assigned to one of four ranked levels.
    The interim evidence-based ranking system presupposes that FTC's 
requirement of ``competent and reliable scientific evidence'' to 
substantiate a claim related to health or safety has been met. For 
purposes of FDA's evaluation of qualified health claims based upon 
credible evidence under Pearson, the Task Force recommended that FDA 
consider scientific evidence only if it is competent and reliable. FTC 
defines ``competent and reliable scientific evidence'' as ``tests, 
analyses, research, studies, or other evidence'' based upon the 
expertise of professionals in the relevant area, that has been 
``conducted and evaluated in an objective manner by persons qualified 
to do so, using procedures generally accepted'' in the profession to 
``yield accurate and reliable results.'' In Re: Great Earth 
International, Inc., 110 F.T.C. 188 (1988).
    FDA is requesting comments on the meaning and/or relevance of 
``competent and reliable scientific evidence'' for the purposes of 
supporting a qualified health claim. FDA seeks these comments within 
the specific context of qualified health claims only. Any agency 
interpretation of ``credible evidence'' in the context of qualified 
health claims would not apply to the meaning of that term in other 
regulatory contexts within FDA's purview.
 
C. Issues for Future Consideration
 
    Although the regulatory alternatives discussed previously focus 
primarily on assessing scientific data as a basis for qualified health 
claims, the Task Force recognized that there may be merit in developing 
greater flexibility in other areas of health claim regulation. The Task 
Force believed that more flexibility in regulating the use of health 
claims would further advance the use of reliable diet and health 
information to consumers via food labels. With respect to increased 
flexibility, the Task Force recommended that FDA solicit comments on 
two issues, in particular: (1) Disqualifying nutrient levels, and (2) 
minimum nutrient content requirements (referred to in the Task Force 
report as ``minimal nutrient limits'').
    Disqualifying nutrient levels--Under existing regulations in Sec.  
101.14(a)(4), a health claim generally is not allowed on a food label 
or in food labeling when the food contains more than a specified level 
of total fat, saturated fat, cholesterol, or sodium.\12\ However, when 
there is a public health benefit, FDA has made exceptions to these 
disqualifying nutrient levels. For example, FDA authorized a health 
claim in Sec.  101.83 for plant sterol/stanol esters and reduced risk 
of CHD in labeling for dressings for salad and spreads even though 
these products exceed the disqualifying level for total fat because 
they contain more than 13 grams of fat per reference amount customarily 
consumed (RACC) (see Sec.  101.83(c)(1)).
---------------------------------------------------------------------------
 
    \12\ The disqualifying nutrient levels are 13.0 grams (g) of 
fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 
480 mg of sodium, per reference amount customarily consumed (RACC), 
per label serving size, and, only for foods with an RACC of 30 g or 
less or 2 tablespoons or less, per 50 g (Sec. 101.14(a)(4)).
---------------------------------------------------------------------------
 
    Minimum nutrient content requirement--Under Sec.  101.14(e)(6) of 
FDA's general health claim regulations, a food may not bear 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 RACC prior to any nutrient addition. FDA 
has provided for some flexibility in this requirement in that nutrients 
that traditionally have been added through fortification in accordance 
with FDA's fortification policy may be considered to meet the 10-
percent requirement (see, e.g., 58 FR 44036 at 44037; August 18, 1993). 
In addition, FDA has excepted some unqualified health claims from this 
general requirement (see, e.g., Sec.  101.83(c)(1) (health claim about 
plant sterol/stanol esters and reduced risk of CHD on dressings for 
salad)). Here again, additional flexibility may be appropriate for 
considering health claims for foods that may not meet the minimum 
nutrient content requirement.
    As the Task Force report noted, FDA received a petition from the 
National Food Processors Association (NFPA) on these two issues, among 
others. In response to the NFPA petition and a separate petition from 
the American Bakers Association, in the Federal Register of December 
21, 1995 (60 FR 66206 (the 1995 proposed rule)), FDA proposed to amend 
its regulations on nutrient content claims and health claims to provide 
additional flexibility in the use of these claims on food products. The 
1995 proposed rule proposed refinements to the agency's current 
regulations to allow additional synonyms for nutrient content claims 
without specific preclearance by the agency, to permit health claims on 
certain foods that do not currently qualify because they do not meet 
the minimum nutrient content requirement, to permit the use of 
shortened versions of authorized health claims under certain 
circumstances, to eliminate some of the required elements for health 
claims, and to specify the criteria that FDA will consider in 
evaluating petitions seeking exemption from the disqualifying nutrient 
levels.
    FDA is identifying these two issues (i.e., disqualifying nutrient 
levels and minimum nutrient content requirement) in this ANPRM to 
acknowledge the Task Force report's recommendation that FDA solicit 
comment on them. However, because these issues were raised in the 1995 
proposed rule, FDA intends, in the near future, to re-open the comment 
period on the 1995 proposed rule to solicit additional comments on 
these issues. Thus, to avoid duplication and confusion, FDA is not 
requesting comments on disqualifying nutrient levels and minimum 
nutrient content requirements for health claims in this ANPRM.
 
III. Dietary Guidance
 
    Through the years, the Federal Government has worked to provide 
consistent and scientifically sound recommendations to consumers about 
healthy eating patterns and wise food choices. Such advice originated 
with the ``Basic Four'' and has progressed through today's ``Dietary 
Guidelines for Americans'' (developed jointly by U.S. Department of 
Health and Human Services and U.S. Department of Agriculture (USDA)) 
and USDA's ``Food Guide Pyramid.'' The agency believes that encouraging 
the use of dietary guidance statements on food labels is an important 
component of the Consumer Health Information for Better Nutrition 
Initiative.
    The Task Force recommended that FDA not only seek opportunities to 
exercise flexibility in its evaluation of health claims in the areas 
discussed previously, but also to seek opportunities to promote the 
development and use of more dietary guidance statements on foods. The
 
[[Page 66046]]
 
purpose of such dietary guidance statements is to assist and encourage 
individuals in making better food choices and establishing healthier 
eating patterns. If FDA's mission is properly understood to include a 
role in assisting the public in making wise dietary choices that 
benefit long-term health, a number of possible strategies become 
evident. Those strategies include, for example, challenging industry to 
channel competitive energies into disseminating health information in 
food labeling and promoting food products on the basis of nutritional 
value, as well as taste, price, amount, and convenience. Importantly, 
as mentioned previously, there is also the possibility to pursue a 
range of consumer information options in collaboration with other 
Federal agencies, health researchers, and stakeholders as more 
information about diet/health relationships becomes available.
 
A. Regulatory Distinctions Between Dietary Guidance and Health Claims
 
    As previously stated, section 403(r) of the act contains statutory 
provisions for the regulation of health claims, among other types of 
label statements. Under Sec. Sec.  101.14 and 101.70, a ``health 
claim'' has a specific definition and is regulated differently from 
other types of statements on labels of conventional foods and dietary 
supplements. Health claims are specifically about the relationship 
between a substance and a disease; they are required to be reviewed and 
authorized by FDA prior to use. Health claims are limited to claims 
about disease risk reduction, and cannot be claims about the cure, 
mitigation, or treatment of disease. The latter claims are currently 
regarded as constituting drug claims under section 201(g) of the act 
(21 U.S.C. 321(g)) (see Whitaker v. Thompson, 239 F.Supp. 2d 43, 52-53 
(D.D.C. 2003)). The following is an example of a health claim about the 
relationship between calcium (a substance) and osteoporosis (a 
disease): ``Calcium may reduce the risk of osteoporosis.'' In 
comparison, the following is an example of a drug claim: ``Consumption 
of 320 mg daily of Saw Palmetto extract may cure cancer.''
    Unlike health claims, which target a specific substance and a 
specific disease or health-related condition, dietary guidance 
statements focus instead on general dietary patterns, practices, and 
recommendations that promote health. In addition, such statements can 
be made on conventional food and dietary supplement labels without FDA 
review or authorization before use. Like all statements in food 
labeling, dietary guidance statements must be truthful and 
nonmisleading as required under sections 201(n) and 403(a)(1) of the 
act. An example of a dietary guidance statement is: ``Diets rich in 
fruits and vegetables may reduce the risk of some types of cancer and 
other chronic diseases.'' As part of a cooperative effort with the 
National Cancer Institute (NCI), FDA recently encouraged the produce 
industry and food manufacturers to use this statement in the labeling 
of fruits, vegetables, and foods that meet the criteria for NCI's 5 A 
Day for Better Health Program (Ref. 5).
    FDA addressed the issue of dietary guidance during the development 
of health claim regulations (58 FR 2478, January 6, 1993 (for 
conventional foods); 59 FR 395; (for dietary supplements)). In the 
preambles to the final rules, the agency stated that a health claim 
contains two basic elements: A substance and a disease or health-
related condition. To clarify the difference between dietary guidance 
statements and health claims, FDA stated that it would use the term 
``dietary guidance'' to refer to statements that do not contain both 
basic elements of a health claim\13\ (58 FR 2478 at 2487 and 59 FR 395 
at 418). Thus, dietary guidance statements may make reference to a 
disease or substance, but not both. For example, dietary guidance 
statements might focus on general dietary patterns or practices and 
broad categories of foods, rather than a specific substance. 
Alternatively, they may link a specific substance to a nondisease 
endpoint such as building bones, a healthy lifestyle, or promoting 
health. In this case, the substance element is present in the statement 
but not the disease element.
---------------------------------------------------------------------------
 
    \13\ In this ANPRM, FDA is using the term ``statement(s)'' in 
place of the term ``claim(s)'' to emphasize the distinction between 
a health claim and dietary guidance when the discussion relates 
specifically to dietary guidance.
---------------------------------------------------------------------------
 
    A health claim expressly or by implication characterizes the 
relationship of certain substances to a disease or health-related 
condition (21 U.S.C. 343(r)(1)(B)). Hence, the elements (i.e., the 
substance element, and the disease or health-related condition element) 
of a health claim may be either express or implied.
    The term ``substance'' means a specific food or component of food, 
regardless of whether the food is in conventional food or dietary 
supplement form (Sec.  101.14(a)(2)). In discussing the definition of 
``substance'' in the preamble to the final rule on general requirements 
for health claims for conventional foods (58 FR 2478 at 2479-2480), FDA 
noted that it agreed with comments that its proposed definition for 
substance interpreted the NLEA too narrowly with respect to the 
regulation of health claims about foods, and that Congress intended 
that foods (in addition to food components) could be the subject of 
health claims regulated under section 403(r) of the act. (As proposed, 
Sec.  101.14(a)(2) stated: ``Substance means a component of a 
conventional food or of a dietary supplement of vitamins, minerals, 
herbs, or other nutritional substances'' (56 FR 60537 at 60563, 
November 27, 1991)). However, based upon the legislative history of the 
NLEA,\14\ the agency noted that to be a health claim, a claim about a 
food must be, at least by implication, a claim about a substance in the 
food (58 FR 2478 at 2480). FDA further explained that when a consumer 
could reasonably interpret a claim about the relationship of a food to 
a disease or health-related condition to be an implied claim about a 
substance in that food, that claim would satisfy the first element of a 
health claim (i.e., the substance element). Id.
---------------------------------------------------------------------------
 
    \14\ See H.R. Rep. No. 101-538, at 20 (1990), reprinted in 1990 
U.S.C.C.A.N. 3336, 3350.
---------------------------------------------------------------------------
 
    In addition, FDA concluded that a claim about the benefits of a 
broad class of foods (e.g., fruits or vegetables) that does not make an 
express or implied connection to a substance found in that class of 
foods would not constitute an implied claim, and that such a claim is 
not a health claim. Rather, such a statement would be dietary guidance 
because it is not expressly or impliedly about a substance. If a 
substance in a broad class of foods cannot be expressly identified, it 
may be possible to find that it is implied. For example, in the 
preamble to the final rule concerning a specific health claim about an 
association between antioxidant vitamins and cancer (58 FR 2622, 
January 6, 1993), FDA introduced the concept of a marker for the 
substance element of an implied health claim. In that final rule, FDA 
decided not to authorize a health claim about a relationship between 
antioxidant vitamins and cancer, and instead authorized a health claim 
relating substances in diets low in fat and high in fruits and 
vegetables to a reduced risk of cancer. In short, the agency authorized 
a health claim in which the subject was fruits and vegetables that were 
low in fat and were good sources of certain substances (e.g., fiber, 
vitamin A, or vitamin C). It was not clear whether the marker 
substances were actually the active substances or merely served as 
markers for other unidentified substances. The purpose of identifying
 
[[Page 66047]]
 
the marker substances was to distinguish certain fruits and vegetables 
that were characterized by compositions known to help reduce cancer 
risk from other fruits and vegetables that might not provide the same 
benefit.
 
B. Issues Relating to Dietary Guidance
 
    FDA recognizes the importance of dietary guidance in assisting and 
encouraging the U.S. population to make better food choices and 
establish healthier eating patterns. Although these types of statements 
are not health claims, consistent and scientifically sound dietary 
guidance statements can be useful to consumers when they are truthful 
and nonmisleading. As previously mentioned, FDA has no regulatory 
authority to review or authorize dietary guidance statements before 
use. When used in labeling for foods, however, such statements must be 
truthful and not misleading under sections 201(n) and 403(a)(1) of the 
act. The agency generally has viewed most dietary guidance for the 
general U.S. population as originating from Federal agencies with 
public health missions related to diet and disease. For example, major 
Federal documents such as the Dietary Guidelines for Americans issued 
by USDA and U.S. Department of Health and Human Services exemplify 
government consensus about dietary recommendations. Given the important 
role that information on food labels can play in affecting consumers' 
health and dietary decisions, FDA sees a need to foster enhanced 
federal cooperative efforts to identify and agree upon dietary guidance 
that is appropriate for food labels and how such guidance may be used.
1. Definitions
    Dietary guidance--FDA requests comments on an appropriate 
definition of ``dietary guidance'' for labeling purposes, as well as 
the current approach, outlined previously, to distinguish between 
health claims and dietary guidance statements.
    Substance--Since the distinction between dietary guidance 
statements and health claims often focuses on whether the ``substance'' 
element is present in the claim (whether express or implied), FDA 
requests comments on ways in which the definition of ``substance'' in 
Sec.  101.14(a)(2) can or should be clarified. Additionally, in regard 
to the appropriate definition of ``substance'' for purposes of a health 
claim, FDA is interested in comments on whether a specific authorized 
health claim about whole grain foods (described later) properly refers 
to a substance as compared to a broad category of food. This health 
claim is authorized based on a statement from an authoritative body 
under section 403(r)(3)(C) of the act.\15\
---------------------------------------------------------------------------
 
    \15\ Under the provisions of the FDAMA, a manufacturer may 
submit to FDA a notification of a health claim based on an 
authoritative statement published by an appropriate authoritative 
body (i.e., a scientific body of the United States Government with 
official responsibility for public health protection or research 
directly relating to human nutrition (such as the National 
Institutes of Health or the Centers for Disease Control and 
Prevention) or the National Academy of Sciences or any of its 
subdivisions) (21 U.S.C. 343(r)(3)(C)). If FDA does not act to 
prohibit or modify such a claim within 120 days of receipt of the 
notification, the claim may be used.
---------------------------------------------------------------------------
 
    On March 10, 1999, General Mills, Inc., submitted to the agency a 
notification containing a prospective claim about the relationship of 
whole grain foods and heart disease and certain cancers. The 
notification cited the following statement from the Executive Summary 
of the National Academy of Sciences report, ``Diet and Health: 
Implications for Reducing Chronic Disease Risk'' (page 8), as an 
authoritative statement: ``Diets high in plant foods--i.e., fruits, 
vegetables, legumes, and whole-grain cereals--are associated with a 
lower occurrence of coronary heart disease and cancers of the lung, 
colon, esophagus, and stomach.'' For purposes of eligibility to bear 
the prospective claim, the notification defined ``whole grain foods'' 
as foods that contain 51 percent or more whole grain ingredient(s) by 
weight per RACC. It suggested that compliance with this definition 
could be assessed by measuring the dietary fiber level of whole wheat, 
the predominant grain in the U.S. diet. The level of fiber was intended 
for compliance purposes only and was not defined as the substance that 
was the subject of the health claim or as a marker for that substance.
    FDA's decision not to prohibit or modify the claim means that, as 
of July 8, 1999, manufacturers may use the following claim on the label 
and in labeling of any product that meets the eligibility criteria 
described in the notification: ``Diets rich in whole grain foods and 
other plant foods and low in total fat, saturated fat, and cholesterol, 
may help reduce the risk of heart disease and certain cancers.'' FDA 
seeks comments on whether this claim properly refers to a substance as 
compared to a broad category of food. The notification and additional 
materials regarding the claim are publicly available from the Division 
of Dockets Management (Docket No. 99P-2209) (see ADDRESSES).
2. The Substance as the Subject of a Health Claim
    FDA's experience demonstrates that most substances that are the 
subject of an authorized health claim are substances that can be found 
in a number of foods (e.g., calcium) or spread throughout the food 
supply (e.g., saturated fat). FDA has provided for health claims that 
include reference to the common substance to assist consumers in their 
understanding of the nature of the diet/health relationship, and more 
importantly so that consumers recognize that they can construct healthy 
diets by using a variety of foods and nutrient sources rather than just 
one. For instance, in the example of the calcium/osteoporosis claim, 
FDA requires that the substance that is the basis of the claim (i.e., 
calcium) be included in the wording of the claim (21 CFR 101.72). FDA 
requests comments on the usefulness of statements that expressly 
include the substance that is the basis for the claim (e.g., ``Calcium-
rich foods, such as yogurt, may reduce the risk of osteoporosis'') 
versus ``food-specific'' claims such as: ``Yogurt may reduce the risk 
of osteoporosis.''
3. The Use of Food Category ``Substitutions'' or ``Replacements'' as a 
Form of Dietary Guidance
    FDA views food substitution/replacement recommendations as 
potentially helpful to consumers, but also potentially problematic 
because they might be misleading or confusing to consumers. For 
example, the message to substitute mono- and polyunsaturated fats for 
saturated fats to promote heart health is intended to help consumers 
reduce their intake of saturated fat and cholesterol within the dietary 
context of moderate fat intakes. A message to choose fish, shellfish, 
lean poultry and other lean meats, beans, or nuts daily while limiting 
intakes of high-fat processed meats has a similar intention. However, 
the likelihood that these messages will positively affect the ability 
of consumers to choose healthful diets depends on an understanding of 
the total dietary context of the message, which may prove confusing or 
difficult to effectively communicate to consumers. FDA is requesting 
comments on whether dietary guidance statements should include 
recommendations for making food or substance ``substitutions'' or 
``replacements.'' If these types of dietary guidance statements are 
encouraged, how can FDA ensure that they are made in clear and 
nonmisleading ways that will enhance and benefit public health?
 
[[Page 66048]]
 
    FDA notes that the agency has used certain criteria such as 
disqualifying or disclosure levels and minimum ``qualifying'' criteria 
to ensure that foods that bear a health claim fit within the context of 
a healthy diet and contain adequate amounts of the substance of 
interest. Given the absence of these types of criteria for dietary 
guidance statements, how can FDA ensure that recommendations for making 
food or substance ``substitutions'' or ``replacements'' are not 
misleading? FDA requests comments on how such statements can be 
provided for in a way that is based on sound science and is helpful and 
nonmisleading to consumers. Moreover, FDA requests comments on whether 
and how recommendations to make dietary substitutions or replacements 
can, or should, be differentiated from claims about the effects of 
biologically active substances for the purposes of food labeling and 
appropriate consumer communication.
4. Dietary Guidance on Food Labels
    FDA is seeking comment on dietary guidance statements on food 
labels generally and on approaches appropriate for FDA to consider 
under its statutory authorities. As part of this consideration, FDA is 
requesting comments on whether providing a list of dietary guidance 
statements that FDA recommends for inclusion on food labels would be 
desirable or useful to manufacturers. In addition, FDA is requesting 
comments on these topics: (1) Whether and how the agency should partner 
with other Federal agencies to identify and agree upon recommended 
dietary guidance statements for food labeling, (2) the appropriate 
criteria for evaluating the scientific validity of dietary guidance 
statements that appear on products in the marketplace, and (3) whether 
and how the agency should address dietary guidance statements from non-
federal sources (e.g., States, trade associations, professional 
associations, etc.).
 
IV. Future Analysis of Benefits and Costs
 
    For the agency's future analysis of benefits and costs of the 
regulatory options for qualified health claims, FDA requests comments, 
including available data, on the following questions:
    [sbull] What effects do health claims have on consumer purchases of 
foods and dietary supplements? What effects do health claims have on 
the total diet?
    [sbull] Is there a difference between consumers' willingness to buy 
products with qualified health claims and consumers' willingness to buy 
products with health claims based on SSA?
    [sbull] What effects would the different qualifying phrases 
described in the interim procedures for qualified health claims 
guidance\16\ (Ref. 3) and the Task Force report (Ref. 4) have on the 
willingness of consumers to buy the products containing the claims? Is 
there evidence that consumers would find the differences among 
qualifying phrases to be substantial?
---------------------------------------------------------------------------
 
    \16\ The guidance identifies three different qualifying phrases 
(or standardized qualifying language) for qualified health claims. 
These phrases are used according to a scientific ranking assigned to 
the claim (which is discussed in the interim evidence-based ranking 
system guidance (Ref. 2)). FDA has categorized these phrases as B, 
C, and D, as follows: Category B: ``Although there is scientific 
evidence supporting the claim, the evidence is not conclusive.''; 
Category C: ``Some scientific evidence suggests * * * however, FDA 
has determined that this evidence is limited and not conclusive.''; 
Category D: ``Very limited and preliminary scientific research 
suggests * * * FDA concludes that there is little scientific 
evidence supporting this claim.'' The Task Force report lists the 
same three qualifying phrases in its overview of the interim 
procedures for qualified health claims guidance.
---------------------------------------------------------------------------
 
    [sbull] What types of foods and dietary supplements are most likely 
to use qualified health claims in their labeling? What types of claims 
are most likely to be used by those products?
    [sbull] What types of existing products will manufacturers re-
formulate in order to be able to make qualified health claims? What 
types of claims are most likely to lead to re-formulation?
    [sbull] What new products might be developed in response to 
qualified health claims?
    [sbull] Would any of the regulatory options discussed in this ANPRM 
have a significant effect on small businesses or other small entities?
    [sbull] What additional research should FDA, other government 
agencies, or other organizations sponsor to answer these questions?
 
V. References
 
    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen between 
9 a.m. and 4 p.m., Monday through Friday, except on Federal Government 
holidays. FDA has verified the Web site address, but is not responsible 
for subsequent changes to the Web site after this document publishes in 
the Federal Register.
    1. Task Force Final Report, ``Consumer Health Information for 
Better Nutrition Initiative'' (July 10, 2003) (Internet addresses: 
http://www.fda.gov/oc/mcclellan/chbn.html or http://www.fda.gov/ohrms/dockets/default.htm).
    2. ``Guidance for Industry and FDA: Interim Evidence-Based 
Ranking System for Scientific Data'' (Internet addresses: http://www.cfsan.fda.gov/guidance.html or http://www.fda.gov/ohrms/dockets/default.htm).
 
    3. ``Guidance for Industry and FDA: Interim Procedures for 
Qualified Health Claims in the Labeling of Conventional Human Food 
and Human Dietary Supplements'' (Internet addresses: http://www.cfsan.fda.gov/guidance.html or http://www.fda.gov/ohrms/dockets/default.htm).
 
    4. Task Force Final Report, Attachment A: ``Possible Regulatory 
Frameworks for Qualified Health Claims'' (Internet addresses: http://www.fda.gov/oc/mcclellan/chbn.html or http://www.fda.gov/ohrms/dockets/default.htm).
 
    5. CFSAN, Office of Nutritional Products, Labeling and Dietary 
Supplements, ``Dietary Guidance Message About Fruits and 
Vegetables'' (July 29, 2003; revised August 28, 2003) (Internet 
address: http://www.cfsan.fda.gov/~dms/lab-dg.html).
 
VI. How to Submit Comments
 
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
 
    Dated: November 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29448 Filed 11-21-03; 8:45 am]
 
BILLING CODE 4160-01-S