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[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

[[Page 12582]]

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
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