[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 34084-34091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16454]



[[Page 34083]]

_______________________________________________________________________

Part IV





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Part 101



Food Labeling: Health Claims; Interim Final Rules

Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 / Rules 
and Regulations

[[Page 34084]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N-0426]


Food Labeling: Health Claims; Antioxidant Vitamins C and E and 
the Risk in Adults of Atherosclerosis, Coronary Heart Disease, Certain 
Cancers, and Cataracts

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an interim 
final rule to prohibit the use on foods of a claim relating to the 
relationship between antioxidant vitamins C and E and the risk in 
adults of atherosclerosis, coronary heart disease, certain cancers, and 
cataracts. This rule is in response to a notification of a health claim 
submitted under section 303 of the FDA Modernization Act of 1997 
(FDAMA). FDA has reviewed statements that the petitioner submitted in 
that notification, and, in conformity with the requirements of FDAMA, 
the agency is prohibiting the claim because the statements submitted as 
the basis of the claim are not ``authoritative statements'' of a 
scientific body, as required by FDAMA; therefore, section 303 of FDAMA 
does not authorize use of this claim. As provided for in section 301 of 
FDAMA, this rule is effective immediately upon publication.

DATES: The interim final rule is effective June 22, 1998; comments by 
September 8, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christine J. Lewis, Center for Food 
Safety and Applied Nutrition (HFS-451), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4168.

SUPPLEMENTARY INFORMATION:

I. The FDA Modernization Act of 1997

    On November 21, 1997, the President signed FDAMA into law (Pub. L. 
105-115), which amended the Federal Food, Drug, and Cosmetic Act (the 
act). Sections 303 and 304 of FDAMA amended section 403(r)(2) and 
(r)(3) of the act by adding new paragraphs (r)(2)(G), (r)(2)(H), 
(r)(3)(C), and (r)(3)(D) to section 403 of the act (21 U.S.C. 
343(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D), respectively), which 
provide for the use in food labeling of nutrient content claims and 
health claims, respectively, based on authoritative statements. These 
provisions of FDAMA supplement the petition process for nutrient 
content and health claims provided by section 403(r)(4) (21 U.S.C. 
343(r)(4)) and Secs. 101.69 and 101.70 (21 CFR 101.69 and 101.70, 
respectively) by providing an alternative for establishing the 
scientific basis for such claims by reliance on authoritative 
statements.
    FDAMA requires that a notification of the prospective nutrient 
content claim or the prospective health claim be submitted to FDA at 
least 120 days before a food bearing the claim may be introduced into 
interstate commerce. The notification must contain specific information 
including: (1) The exact wording of the prospective nutrient content 
claim or health claim; (2) a concise description of the basis upon 
which the petitioner relied for determining that the requirements of 
section 403(r)(2)(G)(i) of the act for nutrient content claims or 
section 403(r)(3)(C)(i) for health claims have been satisfied; (3) a 
copy of the authoritative statement that serves as the basis for the 
claim; and (4) a balanced representation of the scientific literature 
relating to the nutrient level for a prospective nutrient content claim 
or relating to the relationship between the nutrient and the disease or 
health-related condition for a prospective health claim. For a 
prospective nutrient content claim, the authoritative statement must 
identify the nutrient level to which the claim refers. For a 
prospective health claim, the authoritative statement must be a 
statement about the relationship between a nutrient and a disease or 
health-related condition to which the claim refers. For both types of 
claims, the authoritative statement must be currently in effect and it 
must have been published either by a scientific body of the U.S. 
Government that has official responsibility for public health 
protection or research directly relating to human nutrition (e.g., the 
National Institutes of Health (NIH) or the Centers for Disease Control 
and Prevention (CDC)) or by the National Academy of Sciences (NAS) or 
any of its subdivisions (hereinafter referred to as a ``scientific 
body'').
    Under new section 403(r)(2)(H) and (r)(3)(D) of the act, such a 
claim may be made beginning 120 days after submission of the 
notification until: (1) FDA has issued an effective regulation that 
prohibits or modifies the claim; (2) the agency has issued a regulation 
finding that the requirements under section 403(r)(2)(G) for a 
prospective nutrient content claim or under section 403(r)(3)(C) for a 
prospective health claim have not been met; or (3) a district court of 
the United States in an enforcement proceeding under chapter III of the 
act has determined that the requirements under section 403(r)(2)(G) for 
a prospective nutrient content claim or under section 403(r)(3)(C) for 
a prospective health claim have not been met. During the 120 days 
following submission of a notification and before the claim may appear 
on a food, the agency may also notify any person who is making the 
claim that the notification did not include all of the required 
information.
    Section 304 of FDAMA permits nutrient content claims based on 
authoritative statements for both conventional foods and for dietary 
supplements because section 304 amended section 403(r)(2) of the act, 
which provides for nutrient content claims on both conventional foods 
and dietary supplements. Section 303 of FDAMA does not include 
provisions for health claims for dietary supplements based on 
authoritative statements, however. In particular, section 403(r)(5)(D) 
of the act (21 U.S.C. 343(r)(5)(D)) specifies that health claims for 
dietary supplements shall not be subject to section 403(r)(3) of the 
act, but rather to a procedure and standard that FDA establishes by 
regulation. In section 303 of FDAMA, Congress amended section 403(r)(3) 
of the act, which provides for procedures and standards for health 
claims for conventional foods, to allow for health claims based on 
authoritative statements for conventional foods, but Congress did not 
amend section 403(r)(5)(D) of the act.
    Therefore, FDA believes that section 403(r)(3)(C) of the act 
authorizes use of a health claim based on an authoritative statement 
only on any conventional food that provides an appropriate level of the 
nutrient that is the subject of the health claim, that does not exceed 
the disqualifying levels identified in Sec. 101.14(a)(5) (21 CFR 
101.14(a)(5)), and that otherwise complies with section 403(r)(3)(C) 
and all other provisions of the act. Nevertheless, FDA has tentatively 
concluded that, for health claims authorized via the authoritative 
statement procedure provided by FDAMA, conventional foods and dietary 
supplements should be subject to the same standards and procedures. 
This position is consistent with the agency's final rule that made 
dietary supplements subject to the same general

[[Page 34085]]

requirements as apply to conventional foods with respect to health 
claims (59 FR 395, January 4, 1994). This approach is also consistent 
with the guidance of the Commission on Dietary Supplement Labels, which 
stated in its 1997 report (Ref. 1) that the process for the approval of 
health claims should remain the same for dietary supplements and 
conventional foods. Therefore, FDA intends to issue a proposed rule to 
provide for health claims based on authoritative statements for dietary 
supplements.

A. Authoritative Statements

     Sections 303 and 304 of FDAMA authorize the use of a health or 
nutrient content claim based, in part, on an ``authoritative 
statement.'' In particular, new section 403(r)(3)(C)(i) and 
(r)(2)(G)(i) of the act states that such claims are authorized and may 
be made when ``a scientific body * * * has published an authoritative 
statement, which is currently in effect.'' For a health claim, section 
403(r)(3)(C)(i) of the act requires that the statement must be ``about 
the relationship between a nutrient and a disease or health-related 
condition to which the claim refers.'' For a nutrient content claim, 
section 403(r)(2)(G)(i) of the act requires that the statement must be 
one ``that identifies the nutrient level to which the claim refers.''
    Section 403(r)(3)(C) and (r)(2)(G) of the act further requires 
that:
    * * * [a] statement shall be regarded as an authoritative 
statement of a scientific body described in subclause (i) only if 
the statement is published by the scientific body and shall not 
include the statement of an employee of the scientific body made in 
the individual capacity of the employee.
    Although Congress did not explicitly define the term 
``authoritative statement,'' section 403(r)(3)(C) and (r)(2)(G) of the 
act and the legislative history clarify several characteristics that 
Congress intended an ``authoritative statement'' to have. Most 
significantly, to be the basis for a health or nutrient content claim, 
a statement must: (1) Address certain subjects, namely, for a health 
claim, it must be about the relationship between a nutrient and a 
disease or health-related condition to which the claim refers, or, for 
a nutrient content claim, it must identify the nutrient level to which 
the claim refers; (2) be published by an appropriate scientific body 
and represent its official position, and may not be, for example, a 
statement of individual employees of the scientific body made in the 
individual capacities of the employees; (3) be based on a deliberative 
review of the scientific evidence on the subject of the statement and 
not indicate that the scientific evidence about the subject of the 
statement is preliminary or inconclusive; and (4) be currently in 
effect. The aspects of these requirements relevant to this rulemaking, 
and its companion rulemakings publishing elsewhere in this issue of the 
Federal Register, are discussed in greater detail in section I.A.1 of 
this document.
 1. To Be the Basis for a Health or Nutrient Content Claim, a Statement 
Must Address One of Two Subjects
    For a statement to be eligible for consideration as an 
``authoritative statement,'' it must address certain subjects. Section 
403(r)(3)(C) of the act provides that, for a health claim, it must be 
``about the relationship between a nutrient and a disease or health-
related condition to which the claim refers.'' Section 403(r)(2)(G) of 
the act provides that, for a nutrient content claim, it must ``identify 
the nutrient level to which the claim refers.''
    There are several aspects to these requirements. First, a statement 
cannot be an ``authoritative statement'' under section 403(r)(2)(G) or 
(r)(3)(C) of the act if it identifies no nutrient level or if it is not 
about the relationship between a nutrient and a disease or health-
related condition. For example, if a statement refers to no nutrient, 
to no disease or health-related condition, or to neither a nutrient nor 
a disease or health-related condition, it cannot be an authoritative 
statement under section 403(r)(3)(C) of the act. Second, if a statement 
is ``about the relationship between a nutrient and a disease or health-
related condition,'' or if it ``identif[ies] the nutrient level,'' it 
must be about the relationship or nutrient ``to which the claim 
refers.'' Moreover, the statement must be about the relationship 
between a nutrient and a disease or health-related condition in humans 
or it must identify a nutrient level for total daily consumption by 
humans.
    When evaluating what relationship a statement is about, or what 
nutrient level a statement identifies, it may be necessary to consider 
the context in which the statement appears. It is likely that a 
submitter will identify excerpted sentences as an ``authoritative 
statement.'' The context in which these excerpted sentences appears can 
be relevant when determining the subject of the statement. For example, 
sentences immediately adjoining the excerpted sentences or in a summary 
statement in the document may clarify the disease that is the subject 
of the excerpted sentences.
    Accordingly, the statutory requirement in section 
403(r)(3)(C)(ii)(II) and (r)(2)(G)(ii)(II) of the act that a 
notification include ``a copy of the statement referred to in subclause 
(i) upon which [the] person [who submitted the notification] relied in 
making the claim,'' means that the entire document from which the 
statement is excerpted should be included in a notification. The agency 
notes that submission of the entire document is also relevant to other 
determinations under section 403(r)(3)(C) and (r)(2)(G), such as 
whether the scientific evidence about the relationship or nutrient 
level at issue is preliminary or inconclusive, as discussed in section 
I.A.3 of this document, and whether a health or nutrient content claim 
is ``stated in a manner so that the claim is an accurate representation 
of the authoritative statement referred to in subclause (i),'' as 
required by section 403(r)(3)(C)(iv) and (r)(2)(G)(iv) of the act.
 2. To Be the Basis for a Health or Nutrient Content Claim, a Statement 
Must Be Published by an Appropriate Scientific Body and Represent the 
Official Policy of That Body.
     Section 403(r)(3)(C) and (r)(2)(G) of the act requires that an 
``authoritative statement'' be ``published.'' The agency understands 
the use of ``published'' in section 403(r)(3)(C)(i) and (r)(2)(G)(i) to 
mean that the statement must be publicly available in print form (paper 
or electronic).
    The identical last sentence of section 403(r)(3)(C) and (r)(2)(G) 
of the act states that:
     * * * [a] statement shall be regarded as an authoritative 
statement of a scientific body described in subclause (i) only if 
the statement is published by the scientific body and shall not 
include the statement of an employee of the scientific body made in 
the individual capacity of the employee.
 ``Published'' as used in this sentence means that the scientific body 
can be considered to be the author of the statement, in that the 
statement represents the official policy of the scientific body. Of 
course, the statements of scientific bodies--indeed, of organizations 
generally--are authored by individuals. Yet statements that are merely 
those of individual employees made in the individual capacities of the 
employees are not statements that have been authored by, and so 
represent the official policy of, the scientific body. Similarly, in 
the case of Federal scientific bodies with subdivisions, such as NIH 
and CDC, section 403(r)(3)(C) and (r)(2)(G) indicates that the 
scientific body, and not merely the subdivision, can be considered to 
have ``published'' a statement within the

[[Page 34086]]

meaning of those sections only if, as the legislative history 
indicates, ``statements issued by entities such as NIH and CDC reflect 
consensus within those institutions'' (H. Conf. Rept. 105-399, at 98 
(1997)). Accordingly, to be considered an ``authoritative statement'' 
under section 403(r)(3)(C) and (r)(2)(G), a statement must represent 
the official policy of a scientific body.
 3. To Be the Basis for a Health or Nutrient Content Claim, a Statement 
Must Be Based on a Deliberative Review of the Scientific Evidence on 
the Subject of the Statement, and It Should Not Indicate That the 
Scientific Evidence Is Preliminary or Inconclusive
     In section 403(r)(3)(C)(i) and (r)(2)(G)(i) of the act, Congress 
required that claims may be authorized only when ``a scientific body * 
* * has published an authoritative statement,'' not merely when a 
scientific body has published a statement (emphasis added). The use of 
``authoritative'' here indicates that a statement may not be the basis 
for a health or nutrient content claim merely because its source is a 
scientific body, an authority on the subject of the statement. A review 
of the legislative history of sections 303 and 304 of FDAMA indicates 
that, to be ``authoritative,'' Congress intended that a statement must 
be the product of a deliberative review of the scientific evidence on 
the subject of the statement. In addition, the statement should not 
indicate that the scientific evidence about the subject of the 
statement is preliminary or inconclusive.
     Congress intended both that claims based on authoritative 
statements should have ``a presumption of validity'' (H. Rept. 105-306, 
at 16 and 17 (1997)) and that ``more scientifically sound nutrition 
information * * * be provided to consumers through health and nutrient 
content claims'' based on authoritative statements (H. Conf. Rept. 105-
399, at 98 (1997) (emphasis added); see also H. Rept. 105-306, at 16 
(1997) and S. Rept. 105-43, at 49 (1997)).
    When FDA authorizes a health claim by regulation under section 
403(r)(3)(B) of the act or establishes a Daily Value that can serve as 
the basis for a nutrient content claim, it conducts a deliberative 
review of the scientific evidence about the relationship between a 
nutrient and a disease or health-related condition or about the 
nutrient level at issue and concludes that there is significant 
scientific agreement about the relationship or appropriate scientific 
consensus about the nutrient level. Congress intended that an 
``authoritative statement'' published by a scientific body could be the 
basis for health and nutrient content claims because the 
``authoritative statement'' is to serve as a presumptive surrogate for 
FDA's deliberative review of the scientific evidence.
    Congress therefore intended that an ``authoritative statement'' 
must be the product of a deliberative review of the scientific evidence 
on the subject of the statement. For example, the House Report states 
that:
     [a]uthoritative scientific bodies, as part of their official 
responsibilities for public health protection, regularly undertake 
deliberative reviews of the scientific evidence to evaluate 
potential diet/disease relationships, and issue authoritative 
statements concerning such relationships.
 (H. Rept. 105-306, at 16 (1997)). The Senate Report repeats this idea, 
noting that scientific bodies engage in:
    * * * deliberative processes * * * in issuing statements on 
matters of public health. Important Federal public health 
organizations, as part of their official responsibilities, routinely 
review the scientific evidence pertinent to diet and disease 
relationships, and publish statements developed through such 
reviews.
(S. Rept. 105-43, at 49 (1997)).
    Moreover, only a statement that a relationship between a nutrient 
and a disease or health-related condition exists or that identifies a 
level of a nutrient--and not merely statements about a possible 
relationship or level--can serve as the basis for claims that will 
provide consumers with scientifically sound information. Only a claim 
based on such a statement can be accorded a presumption of validity.
    Accordingly, a statement that indicates, for example, that research 
about a nutrient level or a relationship between a nutrient and a 
disease or health-related condition is preliminary or inconclusive, 
that indicates that such a relationship or a nutrient level is or 
should be the subject of ongoing scientific study, or that indicates 
the direction for future research about such a relationship or a 
nutrient level is not ``authoritative.'' When evaluating whether a 
statement about a relationship or nutrient level indicates that the 
scientific evidence is preliminary or inconclusive, the agency intends 
to consider the context in which the statement appears, as discussed in 
section I.A.1 of this document. For example, a statement of excerpted 
sentences might not indicate that research is preliminary or that there 
are unresolved questions that require additional study, but such 
qualifiers could be found elsewhere in the document.
     The agency notes that, even if a statement meets the criteria to 
be an ``authoritative statement,'' Congress also provided under new 
section 403(r)(3)(D)(i) of the act that FDA have the authority to 
prohibit a health claim based on an authoritative statement when there 
is not significant scientific agreement that there is a relationship 
between the nutrient and the disease or health-related condition in 
question. As the Senate Report on the provision explains, in an agency 
rulemaking to prohibit or modify a health claim based on an 
authoritative statement, ``the standards and criteria for health claims 
prescribed by section 403(r)(3) and implementing regulations, including 
the significan[t] scientific agreement standard, would be fully 
applicable'' (S. Rept. 105-43, at 51 (1997); see also H. Rept. 105-306, 
at 15 (1997)).
    With respect to nutrient content claims, Congress indicated that 
the agency is to determine ``whether the authoritative statement upon 
which the notification is based is supported by scientific consensus to 
the extent * * * appropriate to allow the claim'' (H. Rept. 105-306, at 
17-18 (1997)), an evaluation that FDA would make under section 
403(r)(2)(H) of the act, after the Federal scientific body that is the 
source of a statement determines that the statement reflects consensus 
within it, as discussed in section I.A.2 of this document.

B. Review Process

    As allowed by sections 303 and 304 of FDAMA, health claims and 
nutrient content claims based on authoritative statements from Federal 
scientific bodies or NAS may be made on foods in interstate commerce as 
soon as 120 days after submission of a notification of the claim to 
FDA. Upon receipt of a notification, FDA intends to review the 
notification to determine whether the components specified in section 
403(r)(2)(G) and (r)(3)(C) are present within the submission packet. 
When such components are missing, FDA intends to notify the submitter 
by letter identifying one or more of these components that is absent 
from the notification packet.
    If the necessary components are present, FDA intends to determine, 
for a health claim, what relationship between a nutrient and disease or 
health-related condition is at issue, or, for a nutrient content claim, 
what nutrient is at issue. If, by regulation under section 403(r)(3)(B) 
of the act, the agency has already authorized a health claim about the 
relationship at issue, then the notification provisions of section 
403(r)(3)(C) of the act may not be used to modify the existing health 
claim or to authorize the prospective health claim. Similarly, if by 
rulemaking the

[[Page 34087]]

agency has already established a Daily Value for the nutrient at issue, 
then the notification provisions of section 403(r)(2)(G) of the act may 
not be used to modify the existing Daily Value. Instead, a health claim 
about the relationship at issue or a nutrient content claim referring 
to the nutrient at issue may be made when the claim is consistent with 
the existing health claim regulation or with the established Daily 
Value and the authorized terms for nutrient content claims. 
Furthermore, if the prospective claim refers to a relationship or a 
nutrient that is not addressed by the statement that is identified as 
the ``authoritative statement'' on which the claim is based, then 
section 403(r)(3)(C) and (r)(2)(G) of the act does not authorize the 
health or nutrient content claim at issue. In each case, FDA intends to 
notify the submitter by letter that use of the claim is not authorized 
under section 403(r)(3)(C) or (r)(2)(G) of the act, as appropriate.
    If, however, a prospective claim could be authorized based on an 
appropriate authoritative statement, and if the prospective claim 
refers to a relationship or nutrient that is addressed by the statement 
that is identified in the notification as the ``authoritative 
statement,'' FDA then intends to evaluate further whether the statement 
is an ``authoritative statement.'' In particular, FDA intends to 
determine for a statement, as a threshold matter, whether: (1) It may 
be attributable to a scientific body or to one or more of its 
employees; (2) it is publicly available in print form (paper or 
electronic); and (3) the statement indicates that the scientific 
evidence about the relationship between a nutrient and a disease or 
health-related condition or a nutrient level is preliminary or 
inconclusive. With respect to the first of these issues, FDA notes that 
it can determine that a statement from a non-Federal body or agency--
such as a state university school of public health--is not an 
``authoritative statement,'' or that a statement from a scientist who 
was not an employee of an appropriate scientific body is not an 
``authoritative statement.'' As a general matter, however, only a 
scientific body can state whether a statement that is attributable to 
it or to one or more of its employees actually represents the official 
policy of the scientific body or not, and FDA would therefore consult 
with the scientific body if necessary.
    If a statement fails to meet any of these criteria, FDA would 
normally conclude that the statement is not an authoritative statement. 
In any case the agency may, and, when a statement meets these three 
criteria, the agency would normally, consult with the scientific body 
to which the statement is attributed. FDA would request that the 
scientific body determine, for example, whether the statement is 
currently in effect; whether the statement represents the official 
policy of the scientific body, for example, by reflecting consensus 
within that body, as opposed to being the statement of individual 
employees made in the individual capacities of those employees; and 
whether the statement is based on a deliberative review of the 
scientific evidence.
    If the statement is found to be issued by an appropriate scientific 
body and determined to be an ``authoritative statement'' under section 
403(r)(2)(G) or (r)(3)(C) of the act, the agency intends to review the 
wording of the claim to determine if it is in accordance with section 
403(r)(3)(C)(iv) or (r)(2)(G)(iv) of the act. These provisions of the 
act require that the claim be stated in a manner so that it is an 
accurate representation of the authoritative statement and so that the 
claim enables the public to comprehend the information provided in the 
claim and to understand the relative significance of such information 
in the context of a total daily diet.
    For health claims, FDA also intends to consider the requirement of 
section 403(r)(3)(C)(iii) of the act that there be compliance with, for 
example, sections 403(a) and 201(n) of the act (21 U.S.C. 321(n)), 
which require that the claim be truthful and not misleading, including 
compliance as appropriate with existing Sec. 101.14. FDA would also 
determine whether there is significant scientific agreement concerning 
the authoritative statement, as provided for under new section 
403(r)(3)(D)(i) of the act. For nutrient content claims, FDA intends to 
consider the requirements of section 403(r)(2)(G)(iii) of the act that 
there be compliance with, for example, section 403(r)(2)(A)(i) of the 
act, which requires that nutrient content claims use the terms defined 
in FDA's regulations, and sections 403(a) and 201(n) of the act, 
including compliance as appropriate with existing Sec. 101.13 (21 CFR 
101.13). If, after this review, FDA has no objections to the claim, 
then the statute provides that the claim may be used on food labels 120 
days after submission of a complete notification.
    By contrast, if the statement is not from an appropriate scientific 
body or is found not to be an ``authoritative statement'' from a 
Federal scientific body or NAS (or any of its subdivisions), the agency 
intends to determine that the notification does not meet the 
requirements of section 403(r)(3)(C) or (r)(2)(G) of the act in that 
the submitter has not submitted a statement from a Federal scientific 
body or NAS, or an authoritative statement from such a body. The agency 
may notify the submitter of this determination, and its basis, by 
letter. Alternatively, the agency may issue an interim final rule to 
prohibit the claim.
    Generally, the agency would notify the submitter by letter when, 
for example, the notification is deficient on its face, and the agency 
would use the rulemaking process when substantial scientific or legal 
questions are presented by the notification. The agency intends to 
elaborate further on these issues in implementing regulations. The 
agency has chosen to respond with nine interim rules publishing in this 
issue of the Federal Register to a notification for nine claims to 
specify the approach used by the agency to review this notification in 
the absence of implementing regulations, and to provide opportunity for 
public comment. In the future, the agency anticipates that it may 
respond to similar notifications by letter. Whether FDA sends a letter 
or acts by rulemaking to prohibit a claim, the agency may begin an 
enforcement action under the act in a U. S. district court if such a 
claim is used in food labeling.
    The agency notes that, when it sends such a letter or acts by 
regulation to prohibit the use of a claim, a person nonetheless may 
submit in the future a notification that bases the claim on a statement 
that meets the requirements of section 403(r)(3)(C) or (r)(2)(G) of the 
act. If there is no authoritative statement that may serve as a basis 
for the claim, an interested person may petition the agency under 
section 403(r)(4) of the act and Sec. 101.70 to authorize the health 
claim by regulation under section 403(r)(3)(B) of the act. For a 
nutrient content claim, an interested person may submit a citizen 
petition under 21 CFR 10.30 that requests the agency to establish the 
Daily Value to which the claim would refer.

II. The Notification

    Section 403(r)(2)(G) and (r)(3)(C) of the act became effective on 
February 19, 1998. On February 23, 1998, the agency received a 
notification from Weider Nutrition International, Inc., containing nine 
prospective claims that were identified in the text of the notification 
as health claims (Ref. 2). The notification included statements that 
the submitter described as authoritative statements and a scientific 
literature review for each claim. FDA has created nine separate 
dockets, one for each of

[[Page 34088]]

the nine claims and is issuing a separate interim final rule responding 
to each claim.
    This interim final rule addresses the first claim in the 
notification. The notification included six statements that the 
petitioner identified as authoritative statements on which the 
following claim is based: ``Antioxidant vitamins C and E may reduce the 
risk in adults of atherosclerosis, coronary heart disease, certain 
cancers, and cataracts. Sources of Vitamin C and E include fruits, 
vegetables, and dietary supplements.''
    The first sentence of this claim will be discussed in greater 
detail in section III of this document. FDA notes that this claim 
describes the relationship between vitamins C and E and a number of 
different diseases and, thus, in point of fact, reflects several 
prospective health claims. The second sentence, ``Sources of Vitamin C 
and E include fruits, vegetables, and dietary supplements,'' is not a 
health claim. Given that the notification indicated that it was 
intended to be a notification for health claims, this statement was not 
reviewed by FDA. The submitter did not separately identify this 
statement as any particular type of claim.
    Nonetheless, as a point of information, the agency wishes to 
highlight that statements that appropriately constitute nutrient 
content claims are allowed on labels and in the labeling of foods and 
dietary supplements. Moreover, statements that constitute dietary 
guidance are also allowed provided the information is truthful and not 
misleading as required by sections 403(a) and 201(n) of the act.
    With respect to nutrient content claims, FDA concluded in comment 
152 of its final rule for nutrient content claims (58 FR 2302 at 2345, 
January 6, 1993) that the term ``source'' alone merely connotes that a 
nutrient is present and does not provide consumers with meaningful 
information about the level of the nutrient. Therefore, FDA did not 
define the term ``source,'' although it did define several other terms 
that include the word ``source.'' For example, a food is defined as a 
``good source'' of a nutrient if it contains 10 to 19 percent of the 
Reference Daily Intake (RDI) for that nutrient per reference amount 
customarily consumed (Sec. 101.54(c) (21 CFR 101.54(c))), or as an 
``excellent source'' if it contains 20 percent or more of a nutrient's 
RDI per reference amount customarily consumed (Sec. 101.54(b)). In 
addition, ``trivial source'' is defined as a synonym for ``free'' and 
``low source'' as a synonym for ``low'' (see, for example, 21 CFR 
101.61(b)(1) and (b)(4)).
    Information regarding the agency's position on nutrient content 
claims is included in the preamble to the proposed and final rules for 
nutrient content claims (56 FR 60421, November 27, 1991, and 58 FR 
2302, January 6, 1993) and in the agency guidance document, ``Food 
Labeling--Questions and Answers--Volume I--For Guidance to Facilitate 
the Process of Developing or Revising Labels for Foods Other than 
Dietary Supplements'' (Ref. 3).
    As for statements that constitute dietary guidance, such label 
information must be truthful and not misleading as discussed in section 
II.D.6 of the preamble to the final rule for general requirements for 
health claims (58 FR 2478 at 2487, January 6, 1993) and in the agency 
guidance document, ``Food Labeling--Questions and Answers--Volume II--A 
Guide for Restaurants and Other Retail Establishments'' (Ref. 4). The 
agency notes that in the case of the subject sentence, not all fruits, 
vegetables, and dietary supplements contain significant amounts of 
vitamins C and E, and therefore if the statement were intended to 
reflect dietary guidance it cannot be considered to be truthful and not 
misleading. In addition, to be truthful and not misleading when used on 
a particular food's labeling, that food must contain significant 
amounts of vitamins C and E.

III. Basis for the Action

    FDA has reviewed the notification submitted in support of the 
prospective claim: ``Antioxidant vitamins C and E may reduce the risk 
in adults of atherosclerosis, coronary heart disease, certain cancers, 
and cataracts.'' The agency has determined that none of the six 
statements submitted as the basis for this claim meets the requirements 
in section 403(r)(3)(C) of the act to be an ``authoritative 
statement.'' Because the prospective claim is not based on an 
authoritative statement, it is not appropriate for the claim to appear 
on food labels and labeling. Consequently, FDA is issuing this interim 
final rule to prohibit the use of this claim. A discussion of the basis 
for the agency's action on the notification follows.
    First, FDA determined that the components required by section 
403(r)(3)(C) of the act were present in the notification submitted to 
support this claim. Second, FDA determined that, as a threshold matter, 
each of the six statements cited in support of the claim may be 
attributable either to an appropriate Federal scientific body or to an 
employee or employees of such a body.
    The notification in support of the claim that is the subject of 
this document cites statements from: (1) A published article authored 
by two employees of CDC; (2) public information provided on the 
Internet by an institute of NIH; (3) an electronic version provided on 
the Internet of ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' (Home and Garden Bulletin No. 232, Fourth Edition, 1995) 
(hereinafter, referred to as ``the dietary guidelines'') 
recommendations developed by a group of Federal agencies and issued 
jointly by the Department of Health and Human Services (DHHS) and the 
United States Department of Agriculture (USDA); (4) public information 
provided on the Internet by CDC's Office of Women's Health; (5) a NIH 
press release provided on the Internet; and (6) an electronic version 
provided on the Internet of a quarterly report from USDA's Agricultural 
Research Service (ARS). Thus, the statements in the notification are 
attributable to NIH, CDC, and USDA/ARS, as well as a group of Federal 
agencies that included NIH, CDC, and USDA/ARS. Two of the scientific 
bodies identified, NIH and CDC, are highlighted in the statute as 
Federal scientific bodies. FDA believes that USDA/ARS is also a 
scientific body of the U.S. Government with official responsibility for 
public health protection or research directly relating to human 
nutrition for the purposes of section 403(r)(2)(G) and (r)(3)(C) of the 
act. The group that developed the dietary guidelines included Federal 
agencies that are such scientific bodies. Accordingly, the statements 
provided in the notification in support of the claim may be 
attributable to appropriate Federal scientific bodies or to their 
employees.
    Finally, however, none of the six statements discussed in A. 
through F. of this section of this document was found to be an 
authoritative statement.

A. Statement 1

    Statement 1 reads: ``Antioxidant micronutrients, especially 
carotenes, vitamin C, and vitamin E, appear to play many important 
roles in protecting the body against cancer. They block the formation 
of chemical carcinogens in the stomach, protect DNA and lipid membranes 
from oxidative damage, and enhance immune function.'' The notification 
identified Statement 1 as an ``authoritative statement'' for purposes 
of making the claim that is the subject of this rulemaking. The 
statement is found in the conclusion section of an article published in 
The Annual Review of Nutrition (12:139-59:1992), entitled: ``Dietary 
Carotenes, Vitamin C, and Vitamin E as Protective Antioxidants in

[[Page 34089]]

Human Cancers,'' and authored by two persons, T. Byers and G. Perry, 
who are identified in the article as employees of CDC at the time of 
publication of the article. The Annual Review of Nutrition is published 
periodically by Annual Reviews, Inc., in Palo Alto, CA. Editors for 
each volume serve as reviewers for the various articles included in the 
volume and contributors are asked to submit articles for consideration 
for publication. The subject article is 20 pages of a review of the 
literature that includes a section on the theoretical roles of dietary 
oxidants in cancer prevention and focuses on the outcomes of laboratory 
animal research and epidemiologic studies conducted since 1987. The 
subject statement appears in the conclusion section of the paper. The 
agency notes that the next sentence in the conclusion section states: 
``Nevertheless, many important questions need to be answered before 
either micronutrient supplements or food fortification can be 
recommended as a cancer prevention strategy to the general 
population.''
    The noted qualifying sentence, as well as the wording of the 
statement itself (i.e., ``appear to play''), suggests that the 
scientific evidence about the relationship in question is preliminary 
or inconclusive, as discussed in section I.A.3 of this document.
    FDA asked CDC whether the statement is an ``authoritative 
statement'' under FDAMA. CDC responded to FDA that the statement is not 
an authoritative statement of CDC because it does not reflect consensus 
within CDC and was not published by CDC (Ref. 5). CDC indicated that 
the article was authored by individual employees made in the individual 
capacity of those employees. Therefore, FDA has concluded that the 
statement is not an ``authoritative statement'' under section 
403(r)(3)(C) of the act because the statement was not published by CDC 
and is instead the statement of individual employees of CDC made in 
their individual capacities, as discussed in section I.A.2 of this 
document.

B. Statement 2

    Statement 2 reads: ``[Antioxidants] may help prevent disease. 
Antioxidants fight harmful molecules called oxygen free radicals, which 
are created by the body as cells go about their normal business of 
producing energy * * * [Some] studies show that antioxidants may help 
prevent heart disease, some cancers, cataracts, that are more common as 
people get older.'' The notification identified Statement 2 as an 
``authoritative statement'' for purposes of making the claim that is 
the subject of this rulemaking. The statement is found within an 
information piece entitled ``Life Extension: Science or Fiction?'' that 
is provided on the Internet by the Administration on Aging and which 
includes statements from the ``Age Page'' of the National Institute on 
Aging (an Institute of NIH) (``<a href="http://www.aoa.dhhs.gov/aoa/pages/
agepages/lifextsn.html">http://www.aoa.dhhs.gov/aoa/pages/
agepages/lifextsn.html</a>'' accessed on 12/2/97). This electronically 
available information (submitted to the agency as a hardcopy reprint 
from the Internet information) is dated 1994, is approximately two 
standard printed pages in length, and is described as being intended to 
inform the reader about chemicals being studied that may play a role in 
aging and what scientists have learned about them so far. Topics 
covered include antioxidants, deoxyribonucleic acid (DNA), 
dehydroepiandrosterone (DHEA), and other hormones. Ten tips for healthy 
aging are also included. The section on antioxidants is 14 sentences in 
length and includes the three sentences identified as the subject 
statement. The agency notes that the last sentence of the antioxidant 
section is: ``More research is needed before specific recommendations 
can be made.''
    FDA asked NIH whether the statement is an ``authoritative 
statement'' under FDAMA. NIH responded to FDA that the statement is not 
an authoritative statement of NIH because it was prepared by an 
individual from the National Institute on Aging and is not based on a 
deliberative review of the scientific evidence regarding the nutrient-
disease relationship in question (Ref. 6). Therefore, FDA has concluded 
that the statement is not an ``authoritative statement'' under section 
403(r)(3)(C) of the act because it is not based on a deliberative 
review of the scientific evidence, as described in section I.A.3 of 
this document.

C. Statement 3

     Statement 3 reads: ``The antioxidant nutrients found in plant 
foods (e.g., vitamin C, carotenoids, vitamin E, and certain minerals) 
are presently of great interest to scientists and the public because of 
their potentially beneficial role in reducing the risk of cancer and 
certain other chronic diseases.'' The notification identified Statement 
3 as an ``authoritative statement'' for purposes of making the claim 
that is the subject of this rulemaking. The statement is from an 
electronic version of the dietary guidelines issued jointly by DHHS and 
USDA and provided on the Internet (``http:<a href="http://www.usda.gov/fcs/library/
0102-1.txt">www.usda.gov/fcs/library/
0102-1.txt</a>'' accessed on 12/5/97). The submitted material consists of 
selected pages reprinted from the Internet information, which 
identifies the seven dietary guidelines and gives background 
information on the use of, and reasons for, the guidelines. The dietary 
guidelines reflect the findings of a panel of scientists concerning the 
dietary recommendations to be made to the U.S. population, and the 
guidelines are based on a deliberative review of the scientific 
evidence about the nutrient/disease relationships that the guidelines 
address. The subject statement is found within the discussion that 
accompanies the recommendation to ``Choose a diet with plenty of grain 
products, vegetables, and fruits.''
    The statement indicates that a relationship between antioxidant 
nutrients and cancer and other chronic disease is ``of great interest'' 
because of a ``potentially beneficial role.'' The statement points to 
the need for future research and suggests that whether a relationship 
exists should be the subject of scientific study, but does not indicate 
that there exists a scientifically sound relationship that should be 
accorded a presumption of validity. This assessment is further 
supported by the fact that the subject of the dietary guidelines 
recommendation that the text is intended to clarify is the dietary 
importance of grain products, vegetables, and fruits, not the specific 
impact of antioxidant nutrients, vitamins C and E, per se. FDA notes 
that, consistent with the dietary guidelines, the agency has authorized 
a health claim for the relationship between cancer and fruits and 
vegetables that contain vitamin C (as well as vitamin A (as beta-
carotene) and dietary fiber) (21 CFR 101.78).
    On this basis, FDA has concluded that the statement is not an 
``authoritative statement'' under section 403(r)(3)(C) of the act 
because the statement indicates that the scientific evidence about the 
relationship in question is preliminary or inconclusive, as discussed 
in section I.A.3 of this document.
    The dietary guidelines is the product of a periodic review by a 
group of Federal agencies, the most recent review having been completed 
in 1995. FDA did not attempt to reconvene this group of Federal 
agencies to consult with it about whether the statement is an 
authoritative statement because, as discussed previously, the wording 
and context of the statement show that it is not an authoritative 
statement under section 403(r)(3)(C) of the act.

D. Statement 4

    Statement 4 reads: ``A diet high in fiber, high in antioxidants, 
and low in fat may play an important role in

[[Page 34090]]

preventing the development of atherosclerosis, coronary heart disease, 
and some cancers.'' The notification identified Statement 4 as an 
``authoritative statement'' for purposes of making the claim that is 
the subject of this rulemaking. The statement is found in information 
on ``Health in Later Years'' provided on the Internet by CDC's Office 
of Women's Health in a section entitled: ``Health Problems among Older 
Women,'' and is included in the subsection ``Improving Health and 
Quality of Life'' (``http://www.cdc.gov/od/owh/whily.htm'' accessed on 
11/26/97). This electronically available information (submitted to the 
agency as a hardcopy reprint from the Internet information) is not 
dated, is approximately three standard printed pages in length, and 
covers the topics of coronary heart disease, cancer, stroke, and other 
diseases.
    FDA asked CDC whether this statement is an ``authoritative 
statement'' under FDAMA. CDC responded that the statement is not an 
authoritative statement of CDC because, although it is a statement from 
CDC, it is not based upon a deliberative review of the scientific 
evidence regarding the nutrient-disease relationship in question; 
rather, it is a statement from an educational fact sheet developed by 
CDC's Office of Women's Health to convey information to the public 
(Ref. 5). Therefore, FDA has concluded that the statement is not an 
``authoritative statement'' under section 403(r)(3)(C) of the act 
because the statement is not based on a deliberative review of the 
scientific evidence.

 E. Statement 5

    Statement 5 reads: ``[It] is likely that certain antioxidants, such 
as vitamins C and E, may destroy the oxygen radicals, retard molecular 
damage, and perhaps slow the rate of aging.'' The notification 
identified Statement 5 as an ``authoritative statement'' for purposes 
of making the claim that is the subject of this rulemaking. The 
statement is contained in an undated press release from the National 
Institute on Aging at NIH, which was provided on the Internet (``http:/
/www.nih.gov/nia/new/press/agingcau.htm'' accessed on 12/1/97). The 
press release (submitted to the agency as a hardcopy reprint from the 
Internet) states that it is a synopsis of a recent publication 
entitled: ``Aging--Causes and Defenses,'' which had been authored by R. 
Martin, D. Danger, and N. Holbrook and published in The Annual Review 
of Medicine (44:419,429:1993). The press release indicates that it is 
providing a synopsis of the publication but does not clarify if the 
authors are associated with, or are staff of, NIH. The Annual Review of 
Medicine is published periodically by Annual Reviews, Inc., in Palo 
Alto, CA. Editors for each volume serve as reviewers for the various 
articles included in the volume and contributors are asked to submit 
articles to be considered for publication.
    The statement is not ``about the relationship between a nutrient 
and a disease or health-related condition'' because aging, the absence 
of oxygen radicals, and the presence of molecular damage are not 
diseases or health-related conditions. FDA has therefore concluded that 
the statement does not address a disease or health-related condition 
and therefore, as discussed in section I.A.1 of this document, is not 
an ``authoritative statement'' under section 403(r)(3)(C) of the act.

 F. Statement 6

    Statement 6 reads: ``Antioxidants are thought to help prevent heart 
attack, stroke and cancer.'' The notification identified Statement 6 as 
an ``authoritative statement'' for purposes of making the claim that is 
the subject of this rulemaking. The statement is found in Human 
Nutrition (quarterly reports of selected research projects, 4th quarter 
1996) issued by the USDA's ARS and provided on the Internet (``<a href="http://
www.ars.usda.gov/is/qtr/q496/hn496.htm">http://
www.ars.usda.gov/is/qtr/q496/hn496.htm</a>'' accessed on 12/3/97). Human 
Nutrition is a periodic compilation of brief (one paragraph) 
descriptions of ongoing research being conducted within the various ARS 
facilities. The subject statement (submitted to the agency as a 
hardcopy reprint from the Internet) appears in a description of 
research entitled: ``Do carotenoids--the bright red, yellow and orange 
pigments in fruits and vegetables--warrant a Recommended Dietary 
Allowance?'' The paragraph describes the nature and outcome of two ARS 
studies and is attributed to Betty J. Burr at the USDA Western Human 
Nutrition Research Center in San Francisco. The agency notes that the 
last sentence of the paragraph is: ``Further ARS studies will try to 
shed more light on whether a specific minimum daily intake of 
carotenoids is important for good health.''
    The context of the paragraph, as well as the wording of the 
statement (i.e., ``are thought''), suggests that the scientific 
evidence about the relationship in question is preliminary or 
inconclusive.
    The agency asked USDA whether the statement is an ``authoritative 
statement'' under FDAMA. USDA responded to FDA that the statement is 
not an authoritative statement of USDA because it was not based upon a 
deliberative review of the scientific evidence regarding a relationship 
between the nutrient and the disease in question (Ref. 7). USDA 
explained that the ARS quarterly reports describe progress on 
individual projects without a deliberative review of all relevant 
scientific evidence. Therefore, FDA has concluded that the statement is 
not an ``authoritative statement'' under section 403(r)(3)(C) of the 
act because it is not based on a deliberative review of the scientific 
evidence.
    In summary, FDA has concluded that the notification does not 
include any authoritative statement published by a scientific body as 
required by section 403(r)(3)(C) of the act. Accordingly, the subject 
claim relating to the relationship between antioxidant vitamins C and E 
and the risk in adults of atherosclerosis, coronary heart disease, 
certain cancers, and cataracts is not authorized under section 
403(r)(3)(C) of the act and is, therefore, prohibited. The agency notes 
that, at any future time, a notification may be submitted to the agency 
that bases such a claim or claims on a statement that meets the 
requirements of section 403(r)(3)(C) of the act. If there is no 
authoritative statement that may serve as a basis for such claims, an 
interested person may petition the agency under section 403(r)(4) of 
the act and Sec. 101.70 to authorize the health claim or claims by 
regulation under section 403(r)(3)(B) of the act.

IV. Issuance of an Interim Final Rule, Immediate Effective Date, 
and Opportunity for Public Comment

    For the reasons described in this section of this document, FDA is 
issuing this rule as an interim final rule, effective immediately, with 
an opportunity for public comment. New section 403(r)(7)(B) of the act 
(21 U.S.C. 343(r)(7)(B)), added by section 301 of FDAMA, provides that 
FDA ``may make proposed regulations issued under [section 403(r)] 
effective upon publication pending consideration of public comment and 
publication of a final regulation'' if the agency ``determines that 
such action is necessary * * * to enable [FDA] to act promptly to ban 
or modify a claim'' under section 403(r) of the act. For purposes of 
judicial review, ``[s]uch proposed regulations shall be deemed final 
agency action.'' The legislative history indicates that the agency 
should issue rules under this authority as interim final rules (H. 
Conf. Rept. 105-399, at 98 (1997)).

[[Page 34091]]

    As described in section III of this document, FDA has determined 
that the statements submitted in support of the prospective health 
claim do not meet the requirements for authoritative statements in 
section 403(r)(3)(C) of the act. FDA has determined that it is 
necessary to act promptly to prohibit the claim's use under section 
403(r)(3)(C) of the act, and accordingly, is issuing this interim final 
rule to ban its use under section 403(r)(3)(C).
    FDA invites public comment on this interim final rule. The agency 
will consider modifications to this interim final rule based on 
comments made during the comment period. Interested persons may, on or 
before September 8, 1998, submit to the Dockets Management Branch 
(address above) written comments regarding this interim final rule. 
Comments must be received by that date. 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.

V. Environmental Impact

    The agency has determined under 21 CFR 25.30(k) 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 Economic Impacts

A. Benefit-Cost Analysis

    FDA has examined the impacts of this interim final rule under 
Executive Order 12866. Executive Order 12866 directs Federal agencies 
to assess the 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). According to Executive Order 12866, a regulatory action is 
``significant'' if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million; adversely affecting in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. FDA 
finds that this interim final rule is not a significant regulatory 
action as defined by Executive Order 12866. In addition, it has been 
determined that this interim final rule is not a major rule for the 
purpose of congressional review.
    If in the future FDA authorizes health claims relating to the 
relationship between antioxidant vitamins C and E and the risk in 
adults of atherosclerosis, coronary heart disease, certain cancers, and 
cataracts after finding that there is significant scientific agreement 
about these relationships, the cost to consumers of prohibiting this 
claim at this time would be the cost of having kept, in the interim, 
information from appearing in food labeling that would ultimately be 
shown to be scientifically valid, truthful, and not misleading. At this 
time, the benefit to consumers of prohibiting this claim is that a 
claim that has not been shown to be scientifically valid will not 
appear in food labeling. Accordingly, consumers will be able generally 
to have confidence when they read food labeling that any diet-disease 
relationship information in that labeling has been shown to be 
scientifically valid.
    A health claim relating to the relationship between antioxidant 
vitamins C and E and the risk in adults of atherosclerosis, coronary 
heart disease, certain cancers, and cataracts has not been authorized 
under existing regulations. The prohibition of this claim in this 
interim final rule results in no regulatory changes for firms, and 
therefore no costs to firms are attributable to this interim final 
rule.

B. Small Entity Analysis

    FDA has examined the impacts of this interim final rule under the 
Regulatory Flexibility Act. The Regulatory Flexibility Act (5 U.S.C. 
601-612) requires Federal# agencies to consider alternatives that would 
minimize the economic impact of their regulations on small businesses 
and other small entities. In compliance with the Regulatory Flexibility 
Act, FDA finds that this interim final rule will not have a significant 
impact on a substantial number of small entities.
    A health claim relating to the relationship between antioxidant 
vitamins C and E and the risk in adults of atherosclerosis, coronary 
heart disease, certain cancers, and cataracts has not been authorized 
under existing regulations. The prohibition of this claim in this 
interim final rule results in no regulatory changes for firms, and 
therefore this rule will not result in a significant increase in costs 
to any small entity. Therefore, this rule will not have a significant 
economic impact on a substantial number of small entities. Accordingly, 
under the Regulatory Flexibility Act (5 U.S.C. 601-612), the agency 
certifies that this interim final rule will not have a significant 
economic impact on a substantial number of small entities.

C. Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of this interim final rule under the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This 
interim final rule does not trigger the requirement for a written 
statement under section 202(a) of UMRA because it does not impose a 
mandate that results in an expenditure of $100 million or more by 
State, local, and tribal governments in the aggregate, or by the 
private sector, in any 1 year.

VII. The Paperwork Reduction Act of 1995

    This interim final rule contains no collections of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VIII. 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. Commission on Dietary Supplement Labels, ``Report of the 
Commission on Dietary Supplement Labels,'' November 1997, p. vii.
    2. Notification to Donna E. Shalala, DHHS, from Jonathan W. 
Emord et al., Emord & Associates, P.C., Counsel for Weider Nutrition 
International, Inc., February 23, 1998.
    3. ``Food Labeling--Questions and Answers--Volume I--For 
Guidance to Facilitate the Process of Developing or Revising Labels 
for Foods Other than Dietary Supplements,'' August 1993, Questions 
C1-C54.
    4. ``Food Labeling--Questions and Answers--Volume II--A Guide 
for Restaurants and Other Retail Establishments,'' August 1995, 
Questions R117-R127.
    5. Letter to Christine J. Lewis, CFSAN, FDA, from Dixie E. 
Snider, CDC, April 21, 1998.
    6. Letter to Christine Lewis, CFSAN, FDA, from William R. 
Harlan, NIH, April 30, 1998.
    7. Letter to Christine Lewis, CFSAN, FDA, from Eileen Kennedy, 
USDA, May 7, 1998.

    Dated: June 16, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-16454 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F