[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]]

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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

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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