[Federal Register Volume 62, Number 51 (Monday, March 17, 1997)]
[Proposed Rules]
[Pages 12579-12582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6710]
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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: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations to provide a timeframe in which it will issue final
rules in rulemakings on health claims 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
proposal in response to a recent judicial decision.
DATES: Written comments by April 16, 1997. The agency is proposing that
any final rule that may issue based on this proposal become effective
30 days after the date of its publication.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., Rm. 1-23,
Rockville, MD 20857.
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
Section 403(r) of the Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 343(r)), which was added by the Nutrition Labeling and Education
Act of 1990 (the 1990 amendments), provides for claims on the label and
in the labeling of food that characterize the relationship of nutrients
to a disease or health-related condition. In providing for these
claims, called ``health claims,'' the act treats conventional foods
differently than dietary supplements. For conventional foods, the act
sets out the procedure and standard that FDA is to use in deciding
whether to authorize health claims. For dietary supplements, the act
states that health claims for these products are to be subject to a
procedure and standard established by regulation of the Secretary of
Health and Human Services (the Secretary), and by delegation FDA
(section 403(r)(5)(D) of the act).
In January 1994, FDA completed a rulemaking to implement the health
claim provisions of the act for dietary supplements. FDA decided to
adopt the procedure and standard established in the act for health
claims for conventional foods as the procedure and standard for dietary
supplements (59 FR 395 at 405, January 4, 1994). Thus, health claims
can be made for dietary supplements if FDA determines that the
relationship between the substance and disease that are the subjects of
the claim is scientifically valid, as well as truthful and not
misleading. The standard that
[[Page 12580]]
FDA uses in determining scientific validity is set out in 21 CFR
101.14(c) of the agency's regulations, as well as in section
403(r)(3)(B)(i) of the act. It requires that the agency determine,
based on the totality of publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles), that there is significant scientific agreement, among
experts qualified by scientific training and experience to evaluate
such claims, that the claim is supported by such evidence.
People interested in having the agency authorize health claims
about a particular nutrient-disease relationship may petition the
agency to do so (see Sec. 101.70 (21 CFR 101.70)). Under the procedure
adopted by FDA, which parallels that in section 403(r)(4)(A)(i) of the
act and, thus, applies to both conventional foods and dietary
supplements, within 100 days of the date that it receives the petition,
the agency will notify the petitioner by letter that the petition has
either been filed for comprehensive review or denied. If the agency
files the petition, within 90 days of filing, FDA will either deny it
or advise the petitioner that a proposal to authorize the use of health
claims about the subject substance/disease relationship will be
published in the Federal Register. However, consistent with section
403(r)(4)(A)(i) of the act, FDA made no mention in its regulations of
when a final rule on the health claim would be issued, even though it
was asked to do so by a number of comments (59 FR 395 at 420).
In the wake of its adoption of the regulations on health claims for
dietary supplements, FDA was sued several times by dietary supplement
trade associations, manufacturers, retailers, and individuals, on the
grounds that the agency regulations violate the First Amendment to the
United States Constitution. One of these cases, Nutritional Health
Alliance v. Shalala, 95 Civ. 4950 (RO) (S.D.N.Y.), was recently decided
by Judge Richard Owen. In its decision, the District Court reviewed
FDA's regulations under the four prong test, established in Central
Hudson Gas & Electric Corp. v. Public Service Commission of New York,
447 U.S. 557 (1980) (Central Hudson test), for determining whether a
particular regulation of commercial speech survives scrutiny under the
First Amendment.
After finding that not all potential health claims are inherently
misleading, and thus that such claims are entitled to some First
Amendment protection (slip op. at 7), the court concluded that FDA's
regulations were supported by a substantial governmental interest:
``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.) The court also found that
FDA's regulation directly and materially advanced the substantial
governmental interest. Thus, the court found no problem for FDA's
regulations under the first three parts of the Central Hudson test.
However, under the fourth part of the test, that the regulation be
narrowly tailored to advance the governmental interest, the court found
a vulnerability. While the District Court found that the regulations
did not cover more speech than necessary (slip op. at 8-9), it found
that, once the agency had proposed to allow a particular health claim,
the absence of a timeframe for the issuance of a final rule on whether
a health claim would be authorized failed to meet Central Hudson's
fourth prong and, thus, violated the First Amendment (slip op. at 9).
Accordingly, the court ordered FDA to establish a reasonable time
limit for the issuance of a final rule for a health claim on dietary
supplement labels. The court directed the agency to, within 90 days of
the date of its order (January 31, 1997), submit such a regulation to
the court for review of its reasonableness and for the entry of such
further orders as may be appropriate (slip op. at 12).
While FDA does not agree with aspects of the court's opinion, it
has decided that, on balance, given the general affirmance of the
agency's regulations in the court's opinion, the most efficient course
is to proceed to develop the regulation required by the court, to
submit it to the court for review, and not to appeal at this time.
Moreover, given the parallel procedures for dietary supplements and
conventional foods, FDA has decided to propose to establish a timeframe
for final rules on health claims for conventional foods as well as for
dietary supplements.
II. The Proposal
A. Time for Review
FDA has carefully considered how much time to provide for itself
between the issuance of a proposal to authorize a particular health
claim and the issuance of a final rule. On the one hand, it is
important that the agency establish a timeframe that it can reasonably
expect to meet on a regular basis. On the other hand, the agency should
not provide itself with so much time that authorization of a health
claim will be unreasonably delayed.
In 1994, in rejecting comments that requested the establishment of
such a timeframe, FDA expressed concern about various factors,
including work priorities, the availability of personnel, and
limitations on agency resources. It is significant to note that each of
these factors has been a problem in the health claim rulemakings that
FDA has completed since 1994. Thus, each of the above concerns
continues to cause the agency to question its ability to set a
timeframe to which it can reasonably expect, and can reasonably be
expected, to adhere. This is particularly the case because FDA has no
control over the number of petitions that are filed, and it is
obligated to review and act on the petitions that it receives.
Nonetheless, based on its experience since 1994 in issuing final rules
on folic acid and neural tube defects, sugar alcohols and dental
caries, and soluble fiber from whole oat products and coronary heart
disease, FDA finds that it can delineate the steps involved in the
production of a final rule and provide a reasonable estimate of how
long each step is likely to take.
The steps in the production of a final rule include:
1. A comment period--FDA generally provides 75 days for comments on
proposals. Because of the broad interest in health claims, however, FDA
provided 90 days or more for comments in the sugar alcohols and oat
bran and oatmeal rulemakings. To ensure that a final rule is issued as
quickly as practicable, FDA intends to adhere to a 75-day limit on
comment periods in future health claim rulemakings and to not consider
comments that are received after the close of the comment period.
2. Reviewing and responding to comments and developing a draft
final rule--The number of letters that FDA has received on health claim
proposals issued in response to petitions has ranged from as high as
approximately 1,500 letters, in response to the proposal on oatmeal and
oat bran and the risk of coronary heart disease, to as few as 20
letters in response to the proposal on sugar alcohols and the risk of
dental caries. The number of letters, however, understates the agency's
task in developing a final rule because many letters comment on more
than one issue. Thus, it is necessary for FDA to review the letters,
catalogue all the comments,
[[Page 12581]]
group related comments together, and then formulate a response to each
issue raised. This would seem to be a fairly straightforward process,
given that FDA has already made a tentative determination to authorize
the claim. In practice, however, this process has proven not to be a
simple one.
In the oat proceeding, FDA received a large number of comments that
requested that the agency authorize the claim for a substance not
covered by its tentative determination, whole oat flour. In deciding
how to respond to these requests, FDA had to balance the interest in a
prompt decision against the value to the public health of taking the
time to decide whether the important health information provided by the
health claim could appropriately appear on a broader range of foods. To
make this choice, development of the document had to be delayed while
the agency evaluated the scientific evidence supporting the request and
the import of that evidence. FDA ultimately chose to authorize the
health claim on a broader range of foods, but the time involved in
choosing this course added months to the time that it took FDA to
develop the final rule.
In addition, limitations on the agency's resources and the
competing priorities to which the agency is often subject can combine
to cause interruptions in the development of a final rule. For example,
the development of the final rule on sugar alcohols was interrupted on
two occasions because of the filing of new health claim petitions and
the agency's desire to conform to the statute's requirement that action
be taken on petitions within 190 days. The same people who were charged
with drafting the final rule also were responsible for drafting the
responses to the new petitions. Thus, the development of the final rule
on sugar alcohols was significantly delayed.
Moreover, in the development of final rules, FDA considers it
important to obtain input from other parts of the Department of Health
and Human Services (the Department) (such as from the National
Institutes of Health or from the Centers for Disease Control and
Prevention) and from other parts of the Federal Government (e.g. the
U.S. Department of Agriculture) that have relevant expertise. There is
a widespread expectation among the public, including the regulated
industry, that FDA will solicit this input, and given the public health
significance of the issues in a health claim proceeding, FDA considers
it important that it do so. Yet, obtaining the input of the experts
involved can add at least weeks to the process of developing a final
rule because the scientists that are consulted have their own work, and
FDA's request for review is in competition with that work. Moreover,
there sometimes are disagreements among the scientists consulted, and
these disagreements must be resolved before a final rule can issue.
For all these reasons, drafting a final rule involves much more
than reading comments, summarizing them, and preparing answers. FDA
tentatively concludes that, given the problems associated with this
task, it is reasonable to provide 5 months (150 days) between the close
of the comment period and the completion of a draft final rule that can
be forwarded to the Commissioner of Food and Drugs (the Commissioner)
for his or her signature.
3. Review and endorsement by the Commissioner--FDA tentatively
finds that it is appropriate to allow 1 month (30 days) for clearance
of the final rule for publication. Although the Commissioner has
generally been delegated sign off authority under the act by the
Secretary (21 CFR 5.10 of FDA's regulations), other factors, such as
final legal and policy review, require that 30 days be provided for
this aspect of the process.
For example, given the public health significance of health claims
and the involvement of various parts of the Department in the
development of health claim documents, there is continuing interest
from the Office of the Secretary in health claim matters. Thus, time
must be reserved to accommodate the Secretary, should he or she desire
to review the final rule. In addition, under Executive Order 12866, the
Office of Management and Budget (OMB) may choose to review a health
claim final rule although it has generally not done so. Given the
potential involvement of these other entities, FDA tentatively
concludes that it is appropriate to reserve 1 month for the review and
endorsement of any draft health claim final rule.
Taken together, these estimated timeframes total approximately 255
days. Based on these estimates, and the fact it is reasonable to allow
15 days for the inevitable slippage that occurs in the rulemaking
process, FDA is proposing to adopt Sec. 101.70(j)(4)(i), which states
that within 270 days of the publication of the proposal, FDA will
publish a final rule either authorizing the use of a health claim or
explaining why it has decided not to authorize one.
FDA notes that the 270 days that it is proposing for production of
a final rule is approximately 90 days less than the time that it took
from proposal to final rule in both the whole oat products and sugar
alcohols rulemakings. It is also 90 days less than the agency was
granted by the 1990 amendments between the proposals and final rules on
the 10 health claim topics that it was required to address.
Nonetheless, FDA is committed, as it told the court (slip op. at 10),
to issue final regulations as quickly as possible. Therefore, it is
proposing to abide by a 9-month timeframe.
B. Extension of Time
In its opinion, the District Court recognized that FDA may receive
information during the comment period that could require that the
agency rethink whether to authorize a health claim. The court stated
that such circumstances could be handled by an extension, founded on a
showing of cause (slip op. at 10 n. 14).
Consistent with the court's statement, FDA is providing in proposed
Sec. 101.70(j)(4)(ii) that it could grant itself an extension beyond
270 days if cause exists to justify such an extension. For example,
there may be circumstances in which the comments are of such volume
(e.g., the soluble fiber from whole oats rulemaking) or the controversy
surrounding an aspect of the health claim is so great (e.g., the folic
acid rulemaking) that the agency simply finds that it cannot meet the
270 day deadline. In such cases, under proposed Sec. 101.70(j)(4)(ii),
FDA will publish notice of the extension in the Federal Register. The
notice will explain the basis for the extension, the length of the
extension, and the date by which the final rule will be published. The
extension would be for no longer than necessary, and FDA would have to
explain the length of the extension. FDA expects to grant itself such
extensions only on rare occasions.
III. Analysis of Impacts
A. Economic Impact
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act. Executive Order 12866
directs agencies to assess all 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). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant
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regulatory action as defined by the Executive Order and so is not
subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The agency is proposing only to provide firms with a
timeframe in which they can expect health claim final rules to issue.
Thus, in accordance with the Regulatory Flexibility Act, the agency
certifies that this proposed rule will not have a significant economic
impact on a substantial number of small entities. Therefore, under the
Regulatory Flexibility Act, no further analysis is required.
B. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
IV. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting recordkeeping, labeling, or other third party disclosure
requirements. Thus there are no ``information collection'' requirements
necessitating clearance by OMB. However, to ensure the accuracy of this
tentative conclusion, FDA is seeking comment on whether this proposed
rule imposes any paperwork burden.
V. Effective Date
FDA is proposing to make the amendment to Sec. 101.70, contained
herein, effective 30 days after the publication of a final rule that
may issue based on this proposal.
VI. Comments
Interested persons may, on or before April 16, 1997, submit to the
Docket Management Branch (address above) written comments regarding
this proposal. FDA is limiting the comment period to 30 days because it
is necessary to do so if the agency is to comply with the District
Court's order of January 31, 1997, that it establish a timeframe for
issuance of final rules on health claims within 90 days of that order.
FDA could not publish a final rule within that timeframe if it
permitted the normal 75-day comment period.
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 my be seen in the Dockets Management Branch between 9
a.m. and 4 p.m., Monday through Friday.
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, it is
proposed that 21 CFR part 101 be 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, 501,
502, 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 331, 342, 343, 348, 351, 352, 355, 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 explains why the agency has decided not to authorize one.
(ii) For cause, FDA may extend the period in which it will publish
a final rule. FDA will publish notice of the extension in the Federal
Register. The document will explain the basis for the extension, the
length of the extension, and the date by which the final rule will be
published.
Dated: March 4, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-6710 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F
