[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.
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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) (``http://www.aoa.dhhs.gov/aoa/pages/
agepages/lifextsn.html'' 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:www.usda.gov/fcs/library/
0102-1.txt'' 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 (``http://
www.ars.usda.gov/is/qtr/q496/hn496.htm'' 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
