[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Rules and Regulations]
[Pages 28230-28233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13380]
[[Page 28229]]
_______________________________________________________________________
Part VIII
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 101
Food Labeling; Timeframe for Final Rules Authorizing Use of Health
Claims; Final Rule and
Food Labeling; Health Claims; Soluble Fiber from Certain Foods and
Coronary Health Disease; Proposed Rule
Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 / Rules
and Regulations
[[Page 28230]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 97N-0075]
Food Labeling; Timeframe for Final Rules Authorizing Use of
Health Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to provide a timeframe in which it will issue, in
rulemakings on health claims, final rules announcing whether it will
authorize the use of the claim at issue. FDA is also providing for
extensions of that timeframe for cause. The agency is issuing this
final rule in response to a recent judicial decision.
DATES: This final rule will be effective June 23, 1997.
FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St., SW., Washington, DC 20204, 202-205-5483.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 17, 1997 (62 FR 12579), FDA
proposed to amend its health claim regulations (Sec. 101.70 (21 CFR
101.70)) to establish a timeframe in which it would issue final rules
in proceedings on whether to authorize claims on diet-disease
relationships. FDA issued this proposal in response to the decision in
Nutritional Health Alliance v. Shalala, 95 Civ. 4950 (RO) (S.D.N.Y.)
(NHA v. Shalala), which involved a First Amendment challenge to the
constitutionality of FDA's health claim regulations. As part of its
decision, the court ordered FDA to establish a reasonable timeframe for
the issuance of health claim final rules.
FDA proposed to amend Sec. 101.70 to state that within 270 days of
the date of publication of a proposal to authorize a health claim, the
agency will publish a final rule that either authorizes the use of a
health claim or explains why the agency has decided not to authorize
one (proposed Sec. 101.70(j)(4)(i)). FDA also proposed to provide that,
for cause, the agency may extend the period in which it will publish a
final rule. The proposal stated that FDA will publish a notice of any
such extension in the Federal Register, and that it will explain in
that notice the basis for the extension, the length of the extension,
and the date by which the final rule will be published (proposed
Sec. 101.70 (j)(4)(ii)).
In response to the proposal, FDA received four letters, each
containing one or more comments. Some of the comments addressed issues,
such as the burdensomeness of the health claim petition process,
disqualifying levels, and the legality of the court's decision in NHA
v. Shalala, that are outside the scope of this rulemaking, which
focuses only on the establishment of a timeframe for issuance of final
rules in health claim proceedings. Therefore, FDA will not address
these comments in this document. The relevant comments that FDA
received, and the agency's response to them, are set out in the
discussion that follows:
II. Response to Comments
A. Timeframe of 270 Days
1. As stated in section I of this document, FDA proposed to
establish a timeframe of 270 days from the date that it issues a
proposal to the date of publication of the final rule. FDA justified
providing a 270-day timeframe by describing the steps it had to take to
arrive at a final rule and by reviewing its experiences in three health
claim proceedings: Folate and neural tube defects (61 FR 8779, March 5,
1996), sugar alcohols and dental caries (61 FR 8752 at 43433, August
23, 1996), and whole oat products and coronary heart disease (62 FR
3584, January 23, 1997).
Although several of the comments found merit in FDA's proposal to
establish a timeframe, all asserted that the 270-day timeframe is too
long. One comment asserted that it would be unreasonable to allow this
much time to pass between the publication of the proposal and the final
rule. Two comments argued that the major issues raised by a health
claim petition are resolved in the 190-day period before the agency
issues a proposal. One of these comments argued that the 190-day period
conforms with other statutory time limits placed on the agency, such as
those for food additives, abbreviated new drug applications, and device
classification petitions, and, thus, that little additional time should
be allowed for publication of a final rule. These comments took issue
with FDA's reliance on the folate proceedings for support of the 270-
day proposal. One comment argued that the controversy in that
rulemaking concerned the development of FDA's fortification policy for
folic acid, not the health claim itself; and the other comment asserted
that FDA disregarded the recommendations of the Public Health Service
on folate and neural tube defects. One of these comments also took
issue with FDA's reliance on the whole oat product proceeding, arguing
that in the whole oat product proceeding FDA should first have issued
authorization for claims on oatmeal and oat bran and then considered
the comments that it received that suggested that the evidence before
the agency supported a claim for whole oat flour. Finally, one comment
asserted that the timeframe should require the agency to put a high
priority on completing the proceeding. The comment stated that
providing 180 to 210 days would better accomplish this goal, and that
if a longer period were justified in a particular proceeding, FDA could
grant itself an extension.
FDA has carefully considered these comments, but it does not agree
that 270 days is too long or unreasonable. The agency agrees with the
comment that stated that the timeframe should be one that puts a high
priority on completion of the rulemaking. This will be the effect of a
270-day timeframe.
The agency points out that claims that most of the issues raised by
a petition are resolved by the time FDA publishes a proposal simply do
not reflect the agency's experience. If a proposal for a health claim
were ever received by the public without controversy, FDA would act
rapidly to issue a final rule shortly after the comment period closed.
However, every health claim proposal that FDA has issued has been
controversial. The agency received numerous responses on each of the
proposals for folate, sugar alcohols, and whole oats products cited
previously in this section. The proposal for folate, sugar alcohols,
and whole oats products received approximately 100, 20, and 1,450
comments, respectively. These comments ranged from questioning the
basis for the claim, to the scope of the proposed claim, to the very
validity of the claim. The obligation to receive comments on the
agency's proposed resolution of the issues raised by a petition, and to
respond to those comments, is what sets health claims apart from the
proceedings cited in one of the comments.
Contrary to the comments, the whole oat product proceeding
illustrates the type of rethinking of the proposal that comments
engender. As stated in the proposal (62 FR 12579 at 12581), FDA's
proposal to authorize a claim for oatmeal and oat bran elicited
comments that it should also authorize the claim for whole oat flour.
It is true, as one comment stated, that FDA could have
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issued a final rule on oatmeal and oat bran and then proceeded to
consider the question of whole oat flour separately. However, doing so
would have required the creation of two Federal Register documents
rather than one. FDA's goal is to ensure that a health claim, providing
as much truthful, nonmisleading, and scientifically valid information
as possible, is authorized as soon as possible. FDA managers concluded,
based on their evaluation of agency resources that, on balance, having
to prepare one document would result in more information being
authorized faster than if the agency had to prepare two documents.
Thus, FDA followed the course that it did.
Moreover, contrary to the comments, FDA's reliance on the folic
acid proceeding, as illustrative of the intradepartmental input that
FDA tries to receive in arriving at a final rule (62 FR 12579 at 12580
and 12581) was appropriate and relevant. The controversy in the folic
acid rulemaking was not focused on FDA's fortification policy per se,
nor did FDA disregard the recommendations of the Public Health Service.
The question that FDA dealt with in that proceeding was whether
authorization of claims about the relationship between folate,
including folic acid, and neural tube defects would result in the
fortification of the food supply at a level that would present a risk
to those who suffer from vitamin B12 deficiency (see, e.g.,
58 FR 2606 at 2614 (January 6, 1993)). In recognizing the relationship
between folate and neural tube defects in 1992, the Public Health
Service recognized that this safety question was presented (see 58 FR
2606 at 2609), and that it needed to be addressed. As FDA tried to
resolve the question of what level of folate in the food supply would
be safe, it found that there was some disagreement within the Public
Health Service about this question. Although FDA resolved this
question, it took time for it to do so, and the fact that it did take
time was the reason that FDA referred to the folate rulemaking in the
proposal.
Moreover, there is reason to believe that FDA's need for time to
resolve issues within the Public Health Service in arriving at a final
rule will continue. Elsewhere in this issue of the Federal Register,
FDA is isssuing a proposal to authorize a health claim on the
relationship of soluble fiber from psyllium husk and the risk of
coronary heart disease. This proposal reveals that there are
reservations within the Public Health Service about whether the
available evidence establishes the scientific validity of this
substance-disease relationship. While FDA, because of its commitment to
authorize as much health claim information as possible as fast as
possible, is issuing the proposal based on its tentative conclusion
that the scientific standard is met, it is likely that discussions
within the Public Health Service will be necessary in arriving at a
final rule. This fact supports that 270 days from the publication of
the proposal may well be necessary to arrive at a satisfactory
resolution of the issues raised by a substance-disease relationship.
Thus, FDA's experience supports that a significant amount of time
is necessary after the close of a comment period in a health claim
proceeding for FDA to analyze the comments, evaluate the evidence that
bears on the issues raised by the comments, and arrive at a final rule.
FDA explained in the preamble to the proposal why it may take up to 195
days to do so (270 days minus the 75 day comment period). The comment
that asserted that this work could be done in 105 to 135 days (180 to
210 day timeframe) did not present any evidence to support its
assertion.
Therefore, FDA has concluded that 270 days from the publication of
a proposal represents a reasonable and appropriate timeframe for
publication of a final rule in a health claim proceeding.
2. Two comments complained that 270 days represented an unfair
burden on industry. One comment asserted that it would mean that a
company would have to wait 16 months from the time that it submitted
its petition to make a claim that it had documented was supported by
significant scientific agreement.
FDA recognizes that these comments raise a significant point. The
court in NHA v. Shalala expressed concern about the fact that speech
that FDA has tentatively determined is scientifically valid is
prohibited while FDA arrives at a final rule (see slip op. at 10).
Nonetheless, FDA points out that there are countervailing interests
here that must be balanced against those of a manufacturer in making
health claims. As the court recognized in NHA v. Shalala, the
Government has a substantial interest in ``preventing the spread of
unsubstantiated health claims on labels so that consumers may not be
deceived and follow unsound health practices; ensuring the reliability
of scientific information disseminated in connection with the sale of
dietary supplements; and protecting consumers from being induced to
purchase products by misleading information on labels.'' (Slip op. at
8.) Moreover, a system that requires premarket authorization of health
claims directly and materially advances these substantial interests
(id.).
The question that the comments thus raise is whether requiring that
firms wait 9 months from the time that their requested speech has been
determined to be presumptively valid (that is, from the date that FDA
proposes to authorize the claim they seek to make) imposes more of a
burden than is necessary to further the Government's legitimate
interests. (See Board of Trustees of the State University of New York
v. Fox, 492 U.S. 469, 478 (1989).) FDA concludes that it does not.
In the March 17, 1997, proposal, FDA carefully delineated why it
will require 270 days from the date of issuance of the proposal to
decide whether health claims about the substance-disease relationship
that it has proposed to authorize will in fact be scientifically valid.
While, as stated in section II.A.1 of this document, it may be possible
for FDA to issue a final rule in less time, and FDA will endeavor to do
so, 270 days represents a reasonable estimate of the amount of time
that it will require to ensure that the authorization it issues in the
final rule is consistent with the policies embodied in the Federal
Food, Drug, and Cosmetic Act and in the implementing regulations.
None of the comments have demonstrated that a 270-day period is
substantially excessive. (See Board of Trustees of the State of New
York v. Fox, supra, 492 U.S. at 479.) Thus, FDA is making no change in
the provision for a 270-day timeframe in response to these comments.
3. One comment argued that persons should be permitted to begin
using health claims when they are issued in proposed form by FDA. The
comment pointed out that the agency would not have issued the proposal
if it did not believe that there was significant scientific support for
the validity of the relationship that is the subject of the claim. One
comment said that the timeframe that FDA establishes should provide
predictability and certainty for the industry.
FDA has considered how to accommodate the concerns expressed by
these comments. The agency finds that it cannot authorize claims to be
made based on the proposal. The point of the health claim proceeding is
to ensure that claims are scientifically valid, truthful, and not
misleading. There is always the possibility that even though FDA has
tentatively concluded that a substance-disease relationship is
scientifically valid, it will receive comments that will challenge that
tentative conclusion. For example, FDA tentatively concluded that there
is a
[[Page 28232]]
relationship between sodium and hypertension, but the agency received
comments arguing that the available scientific evidence did not support
that sodium had an effect on hypertension (see 58 FR 2820 at 2822 to
2826, January 6, 1993). It would have been inappropriate for FDA to
allow claims on sodium and hypertension while it was still deciding
whether these claims are valid. To permit claims on the basis of a
proposal would be to permit preliminary claims. The health claim
provisions of the Nutrition Labeling and Education Act of 1990 (Pub. L.
101-535) were passed to protect consumers against such claims (see 59
FR 395 at 403, January 4, 1994). Therefore, FDA finds that it cannot
accommodate this comment.
As for providing predictability and certainty, FDA points out that
no predictability or certainty that a claim could ultimately be made
can derive from the filing of a petition. On several occasions, firms
have filed petitions that they thought demonstrated that there was
significant scientific agreement in support of a claim, but FDA has
found that it could not agree and denied the petition (e.g., see FDA
response to petition on calcium and hypertension (Docket No. 96P-0047).
As for predictability and certainty from the date of publication of
a proposal, FDA advises that, as explained previously, certainty is not
possible because new evidence may be submitted in comments that
establish that the substance-disease relationship is not scientifically
valid. Such a result is not likely, but the agency cannot rule it out.
Predictability also cannot be ensured. While FDA is committing
itself to issuing a final rule 270 days from the date of publication of
a proposal, it is FDA's firm desire to issue final rules in as little
time as possible. Moreover, occasionally, the agency may be compelled
to grant itself an extension.
Thus, FDA cannot provide predictability and certainty. However, a
firm that submits a well-supported petition can do so with some
confidence that, within 16 months from the date of submission, it will
likely be able to make claims about the substance-disease relationship
that is the subject of its petition.
B. Extensions
4. Several comments asserted that it was likely that FDA would not
complete rulemakings within the 270-day period. These comments argued
that, therefore, it was important that FDA not be able to grant itself
unlimited extensions. One comment stated that extensions should be
justified by a publicly available record, that they should be granted
for periods of 90 days, and that the total maximum extension should not
be for more than 270 days.
FDA does not agree that it is likely that it will not complete
health claim rulemakings in a timely manner. As stated previously, FDA
considers these proceedings to be a high priority, and it does not
anticipate failing to meet the timeframes. However, the agency
recognizes that, on occasion, cause may exist for extending the period
in which it arrives at a final rule. FDA agrees with the comment that
stated that any extensions should be justified with a publicly
available record. In fact, FDA stated in the proposal that it would
proceed in this manner (62 FR 12579 at 12581).
FDA also finds merit in the argument advanced by the comments that
the agency should not be able to grant itself unlimited extensions. If
the agency were to adopt a regulation that left it free to do so, FDA
would not have adequately addressed the concern expressed by the court
in NHA v. Shalala that the agency not prohibit presumptively valid,
nonmisleading health claims for an indefinite period (slip op. at 10).
FDA agrees with the comment that stated that extensions be granted
for 90 days. Consequently, the agency has modified proposed
Sec. 101.70(j)(4)(ii) to provide that FDA may extend the comment period
for a period of no more than 90 days.
FDA also agrees with the comment that suggested that the agency
limit the number of extensions that it grant itself. FDA has decided
that it should be able to grant itself two extensions rather than
three. After one extension, the agency will have had a year to finalize
the health claim proposal. The agency's experience has been that it has
been able to resolve all issues that have arisen in health claim
proceedings in that amount of time. If the agency is unable to resolve
any issue within a year, it will likely be because significant
scientific agreement with respect to that issue simply does not exist.
In such circumstances, the appropriate course of action may be to deny
authorization for claims about the substance-disease relationship, or
about some aspect of the substance-disease relationship, in question.
FDA has modified proposed Sec. 101.70(j)(4)(ii) to reflect the agency's
determination to limit itself to two 90-day extensions.
III. Analysis of Impacts
A. Economic Impact
In the proposal, FDA stated that it had examined the impacts of the
proposed rule under Executive Order 12866 and the Regulatory
Flexibility Act. The agency found that the proposed rule was not a
significant regulatory action under the Executive Order, and that it
would not have a significant economic impact on a substantial number of
small entities. FDA received no comments on these conclusions, and,
therefore, finds no basis or reason to modify them.
B. Environmental Impact
FDA determined under 21 CFR 25.24(a)(8) that the proposed rule was
of a type that did not individually or cumulatively have an effect on
the human environment. FDA received no comments on this determination
and, therefore, the agency is confirming this conclusion in this final
rule.
IV. Paperwork Reduction Act
In the proposal, FDA tentatively concluded that the proposed rule
contained no reporting, recordkeeping, labeling, or other third party
disclosure requirements, and that there were no ``information
collection'' requirements necessitating clearance by the Office of
Management and Budget. FDA received no comments on this tentative
conclusion. Therefore, FDA concludes that this rule imposes no
paperwork burden.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.70 is amended by adding new paragraph (j)(4) to read
as follows:
Sec. 101.70 Petitions for health claims.
* * * * *
(j) * * *
(4)(i) Within 270 days of the date of publication of the proposal,
FDA will publish a final rule that either authorizes use of the health
claim or
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explains why the agency has decided not to authorize one.
(ii) For cause, FDA may extend, no more than twice, the period in
which it will publish a final rule; each such extension will be for no
more than 90 days. FDA will publish a notice of each extension in the
Federal Register. The document will state the basis for the extension,
the length of the extension, and the date by which the final rule will
be published.
Dated: May 15, 1997.
William B. Schultz,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-13380 Filed 5-21-97; 8:45 am]
BILLING CODE 4160-01-F
