[Federal Register Volume 60, Number 139 (Thursday, July 20, 1995)]
[Rules and Regulations]
[Pages 37502-37506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17502]
[[Page 37501]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 101
Labeling of Food for Human Consumption; Foods for Special Dietary Use
and Disclaimer ``Useful Only In Not Promoting Tooth Decay'': Final Rule
Sugar Alcohol and Dental Caries; Health Claims: Proposed Rule
Federal Register / Vol. 60, No. 139 / Thursday, July 20, 1995 / Rules
and Regulations
[[Page 37502]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 91N-384L, 91N-0384, and 84N-0153]
RIN 0905-AD08
Food Labeling: Label Statements on Foods for Special Dietary Use;
``Useful Only in Not Promoting Tooth Decay'' Disclaimer
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; denial of request for a hearing; confirmation of
effective date; denial of requests for a stay of effective date and for
reconsideration.
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SUMMARY: The Food and Drug Administration (FDA) is denying the requests
for a hearing on the objections to its final rule that amended the
regulations on foods for special dietary use to conform them to the
requirements of the Nutrition Labeling and Education Act of 1990 (the
1990 amendments). After reviewing the objections to the amendment and
the request for a hearing, the agency has concluded that the objections
do not raise an issue of material fact that justifies granting a
hearing or revoking the agency's action. Nor have they convinced the
agency that it is appropriate for it to revoke its action. The agency
also received requests for a stay of the effective date of the final
rule and for reconsideration of the decision concerning the use of the
``Useful Only in Not Promoting Tooth Decay'' disclaimer for ``sugar-
free'' foods. FDA is denying these requests. FDA is confirming the
effective date of the final rule.
EFFECTIVE DATE: May 8, 1994.
FOR FURTHER INFORMATION CONTACT: Gerad L. McCowin, Center for Food
Safety and Applied Nutrition (HFS-151), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4561.
SUPPLEMENTARY INFORMATION:
I. Introduction
Prior to 1993, FDA regulated ``no-'' and ``low-calorie'' foods as
foods for special dietary use under part 105 (21 CFR part 105). FDA had
promulgated Sec. 105.66 to provide for label statements on products for
reducing or maintaining caloric intake or body weight. Terms such as
``low calorie,'' ``reduced calorie,'' and ``sugar free,'' which could
be used to highlight foods useful in the maintenance or reduction of
body weight, were included in this section.
Over time, however, more and more people have become concerned with
healthier eating and have begun to follow the suggestion in Dietary
Guidelines for Americans to maintain a healthy weight. Consequently,
terms such as ``low'' or ``reduced calories'' and ``sugarless'' have
come to be used on foods intended for consumption by the general
population. As such, these terms have lost their special significance
in the labeling of foods intended solely for special dietary uses.
Accordingly, FDA came to see that these terms should be defined under
the 1990 amendments as nutrient content claims.
In the Federal Register of November 27, 1991 (56 FR 60421), the
agency published a document entitled ``Food Labeling: Nutrient Content
Claims, General Principles, Petitions, Definition of Terms''
(hereinafter referred to as the nutrient content claims proposal). In
that document, FDA proposed to define terms that describe the caloric
level in a food and related sugar claims, terms which had been
regulated as special dietary use claims in Secs. 105.66 and 101.60 (21
CFR 101.60), as nutrient content claims.
In particular, FDA proposed to define the terms ``low calorie,''
``reduced calorie,'' ``sugar free,'' and ``no added sugar'' in
Sec. 101.60. Because the definitions of these terms in Sec. 105.66
would be redundant, and because these terms would no longer be
necessary as special dietary use claims, FDA proposed in the nutrient
content claims proposal to revise Sec. 105.66 (c), (d), and (f) to
reference the appropriate paragraphs in Sec. 101.60. At the same time,
FDA proposed in Sec. 101.60(o)(8) to permit sugarless chewing gums to
bear sugar free claims provided that the label also bear, when the food
is not low or reduced calorie, a statement such as ``Not a reduced
calorie food,'' ``Not a low calorie food,'' ``Not for weight control,''
or ``Useful Only in Not Promoting Tooth Decay.'' The agency also noted
that it planned to reevaluate the determination of usefulness in not
promoting tooth decay of gums sweetened with sugar alcohols (56 FR
60421 at 60437).
FDA tentatively concluded, however, that there was a significant
portion of Sec. 105.66 that remained appropriate for regulating foods
that are for special dietary use. Such foods are those specifically
represented or purported to be useful as part of a weight control plan,
as opposed to those that are simply represented as being low or reduced
in calories (although such products can be useful in reducing or
maintaining body weight). The agency proposed to retain those
provisions in Sec. 105.66.
Numerous comments that responded to the nutrient content claims
proposal supported the continued allowance of the statement ``Useful
Only in Not Promoting Tooth Decay'' in proposed Sec. 101.13(o)(8) on
the label of chewing gums that claim to be ``sugar free.'' However, at
least one comment suggested that only the statements ``not a reduced
calorie food'' and ``not a low (free) calorie food'' were appropriate.
The comment specifically suggested that FDA should disallow the
statement ``useful only in the prevention of tooth decay'' with ``sugar
free'' claims. The comment also implied that FDA should disallow the
statement ``not for weight control'' with ``sugar free'' (58 FR 2302 at
2325, January 6, 1993).
Based upon its review of the comments, FDA determined that there
was no compelling reason to disallow the statement ``not for weight
control.'' However, the agency concluded that the statement ``Useful
Only in Not Promoting Tooth Decay'' should not be allowed because it is
an unauthorized health claim; that is, it is a statement that
characterizes the relationship of a nutrient (i.e., the sugar alcohol
used in the product) to a disease (i.e., dental caries). Further, the
agency deleted, as unnecessary, the exemption in proposed
Sec. 101.13(o)(8) that would have allowed a ``sugar free'' claim on
chewing gums containing sugar alcohols and the statement about not
promoting tooth decay, because the agency had decided not to define
sugar alcohols as ``sugars.'' Therefore, FDA deleted the proposed
paragraph (o)(8) from the final rule adopting Sec. 101.13. The final
rules effecting this change, entitled ``Food Labeling: Nutrient Content
Claims, General Principles, Petitions, Definition of Terms; Definitions
of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol
Content of Food'' (58 FR 2302) (hereinafter referred to as the nutrient
content claims final rule) and ``Food Labeling: Label Statements on
Foods For Special Dietary Use'' (58 FR 2427) (hereinafter referred to
as the special dietary use final rule), published in the Federal
Register of January 6, 1993.
II. Amendment to Section 105.66
A. Objections and Requests for a Hearing
Following publication of the special dietary use final rule, a
manufacturer, a trade association, and a ``working group'' of
manufacturers filed timely objections to the rule revising
Sec. 105.66(f)
[[Page 37503]]
by removing the statement ``Useful Only in Not Promoting Tooth Decay''
from those statements that can be used in conjunction with a ``sugar
free'' claim. They requested a formal evidentiary hearing on their
objections. Two other manufacturers submitted general comments, and a
professional association resubmitted, as comments to the special
dietary use final rule, comments that it had filed regarding the
November 27, 1991, proposed rules on food labeling.
The provision of Sec. 105.66(f) that was the subject of the
objections was adopted under section 701(e) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 371(e)). Section 701(e)(1) of the
act provides that any person adversely affected by a regulation issued
under that section may file objections, specifying with particularity
the provisions of the order ``deemed objectionable, stating reasonable
grounds therefor'' and may request a public hearing based upon such
objections. Under section 701(e) of the act, objections and a request
for a hearing on a particular regulation act to automatically stay or
delay the effective date of the action to which objections are raised
(section 701(e)(2) of the act). Thus, the revision to Sec. 105.66(f)
that would remove the statement ``Useful Only in Not Promoting Tooth
Decay'' from those statements that can be used in conjunction with a
``sugar free'' claim was automatically stayed as of February 5, 1993.
B. Standards for Granting a Hearing
FDA may deny a hearing request if the objections to the regulation
do not raise genuine and substantial issues of fact that can be
resolved at a hearing. Specific criteria for determining whether a
hearing has been justified are set forth in 21 CFR 12.24(b). A hearing
will be granted if the material submitted shows that: (1) There is a
genuine and substantial issue of fact for resolution at a hearing. A
hearing will not be granted on issues of policy or law; (2) the factual
issue can be resolved by available and specifically identified reliable
evidence. A hearing will not be granted on the basis of mere
allegations or denials or general descriptions of positions and
contentions; (3) the data and information submitted, if established at
a hearing, would be adequate to justify resolution of the factual issue
in the way sought by the person. A hearing will be denied if the
Commissioner concludes that the data and information submitted are
insufficient to justify the factual determination urged, even if
accurate; (4) resolution of the factual issue in the way sought by the
person is adequate to justify the action requested. A hearing will not
be granted on factual issues that are not determinative with respect to
the action requested, e.g., if the Commissioner concludes that the
action would be the same even if the factual issues were resolved in
the way sought, or if a request is made that a final regulation include
a provision not reasonably encompassed by the proposal; and (5) the
action requested is not inconsistent with any provision in the act or
any regulation in this chapter particularizing statutory standards. The
proper procedure in those circumstances is for the person requesting
the hearing to petition for an amendment or waiver of the regulation
involved.
A party seeking a hearing is required to meet a ``threshold burden
of tendering evidence suggesting the need for a hearing.'' Costle v.
Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980) reh. den., 445
U.S. 947 (1980), citing Weinberger v. Hynson, Wescott & Dunning, Inc.,
412 U.S. 609, 620-621 (1973). An allegation that a hearing is necessary
to ``sharpen the issues'' or to ``fully develop the facts'' does not
meet this test. Georgia Pacific Corp. v. U.S. E.P.A., 671 F.2d 1235,
1241 (9th Cir. 1982). If a hearing request fails to identify any
factual evidence that would be the subject of a hearing, there is no
point in holding one. In judicial proceedings, a court is authorized to
issue summary judgment without an evidentiary hearing whenever it finds
that there are no genuine issues of material fact in dispute and a
party is entitled to judgment as a matter of law. (See Rule 56, Federal
Rules of Civil Procedure.) The same principle applies in administrative
proceedings.
A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact concerning which a meaningful
hearing might be held. Pineapple Growers Association v. FDA, 673 F.2d
1083, 1085 (9th Cir. 1982). Where the issues raised in the objection
are, even if true, legally insufficient to alter the decision, the
agency need not grant a hearing. Dyestuffs and Chemicals, Inc. v.
Flemming, 271 F.2d 281 (8th Cir. 1959), cert. denied, 362 U.S. 911
(1960). FDA need not grant a hearing in each case where an objector
submits additional information or posits a novel interpretation of
existing information. (See United States v. Consolidated Mines &
Smelting Co., 455 F.2d 432 (9th Cir. 1971).) In other words, a hearing
is justified only if the objections are made in good faith, and if they
``draw in question in a material way the underpinnings of the
regulation at issue.'' Pactra Industries v. CPSC, 555 F.2d 677 (9th
Cir. 1977) (see also Community Nutrition Institute v. Young, 773 F.2d
1356 (D.C. Cir. 1985)). Finally, courts have uniformly recognized that
a hearing need not be held to resolve questions of law or policy. (See
Citizens for Allegan County, Inc. v. FPC, 414 F.2d 1125 (D.C. Cir.
1969); Sun Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir.), cert. denied,
358 U.S. 872 (1958).)
In summary, a hearing request should present sufficient credible
evidence to raise a material issue of fact, and the evidence must be
adequate to resolve the issue as requested and to justify the action
requested.
C. Analysis of Objections and Request for a Hearing and Related
Comments
1. The three objectors and one of the comments stated that the
agency had not provided adequate notice or opportunity for comment on
its decision to remove the provision providing for the use of the
statement ``Useful Only in Not Promoting Tooth Decay.'' The objectors
presented a number of arguments as support. First, two of the objectors
stated that all of the previous proposals related to the final rule
implied that the agency was going to retain the phrase ``Useful Only in
Not Promoting Tooth Decay.'' Secondly, one objector stated that the
meaning of the agency's statement in the nutrient content claims
proposal that it planned at some point to reevaluate its earlier
determination regarding sugar-free products was at least ambiguous. The
other two objectors stated that this statement only served to alert
interested persons that FDA may decide in the future to propose
revisions to the rule allowing use of the statement ``Useful Only in
Not Promoting Tooth Decay'' but that such revisions could have gone in
either direction. These objectors concluded that the decisions to
delete Sec. 105.66(f) and to subject the phrase ``Useful Only in Not
Promoting Tooth Decay'' to the requirements of health claims were in no
sense logical outgrowths of FDA's November 1991 proposal.
In considering the objection that the agency did not provide
adequate notice and opportunity for comment in its actions revoking the
provision for the phrase ``Useful Only in Not Promoting Tooth Decay,''
it is important to understand exactly what FDA did in the nutrient
content claims proposal. FDA was not merely proposing to carry forward
the provisions of the ``sugar free'' claim unchanged from the existing
regulations. Rather, FDA was proposing to find that a fundamental
change in the character of this claim had been worked
[[Page 37504]]
by the 1990 amendments; i.e., it had changed from a special dietary use
claim that was directed at a limited segment of the population to a
nutrient content claim directed to the general population. Thus, FDA
was not merely proposing to change the location of the provisions on
this claim. It was asking whether the ``sugar free'' claim is an
appropriate nutrient content claim, and whether it is appropriate to
retain the qualifiers that had been used to clarify this claim.
The question that the objectors' arguments raise is whether the
agency's decision that the ``Useful Only in Not Promoting Tooth Decay''
statement is a health claim, under the requirements of the 1990
amendments, and that it cannot be used as a qualifier of the nutrient
content claim, is the logical outgrowth of the proposal. In Chocolate
Manufacturers Association v. Block, 755 F.2d 1098, 1105 (4th Cir.
1985), the Fourth Circuit said that the question that the logical
outgrowth test raises is whether the final rule materially altered the
issues involved in the rulemaking; that is, whether the final rule
substantially departed from the terms or substance of the proposed
rule.
In its final decision on the ``Useful Only in Not Promoting Tooth
Decay'' statement, FDA was acting well within the scope of the proposed
rule. The issue in the proposal was whether ``sugar free'' and its
qualifiers constituted an appropriate nutrient content claim, and that
is the issue that the agency decided in the final rule.
The key point in considering the adequacy of the notice that FDA
provided is the fact that FDA never specifically raised the question of
whether the ``Useful Only in Not Promoting Tooth Decay'' qualifier
could be considered to be a health claim. The question that, thus, must
be considered is whether this omission was sufficiently significant as
to provide a basis for concluding that the agency did not give proper
notice.
This question is answered by International Harvester Co. v.
Ruckelshaus, 478 F.2d, 615, 632 n.51 (D.C. Cir. 1973). In Footnote 51,
the court stated:
As we have stated in an analogous context of rule-making
proceedings before the Federal Communications Commission, where
petitioners have argued that the Commission was ``changing the rules
in the middle of the game'' when it took into consideration factors
not specifically indicated in its Section 4(a) notice under the
Administrative Procedure Act, 5 U.S.C. Sec. 1001(a), ``[s]urely
every time the Commission decided to take account of some additional
factor it was not required to start the proceedings all over again.
If such were the rule the proceedings might never be terminated.''
Owensboro On the Air v. United States, 104 U.S. App. D.C. 391, 397,
262 F.2d, 702, 708 (1958); Logansport Broadcasting Corp. v. United
States, 93 U.S. App. D.C. 342, 346, 210 F.2d, 24, 28 (1954).
Thus, the agency need not have mentioned the specific factor on which
it ultimately relied in the proposal as long as the basic issue
remained the same, which it did.
In the nutrient content claims proposal, FDA was raising the
question of whether particular statements are appropriate to be made as
nutrient content claims for food products. With respect to one such
statement, ``Useful Only in Not Promoting Tooth Decay,'' several
comments were received in support of, and one comment in opposition to,
retention of this statement as part of the ``sugar-free'' claim. FDA's
decision was that this statement was not a nutrient content claim.
Thus, the objectors' arguments that an adequate notice and opportunity
for comment were not provided, and that the final rule was not the
logical outgrowth of the proposal, are without merit.
2. In arguing that the agency had not provided adequate notice and
an opportunity for comment, one objector referred to a statement by the
agency concerning the persuasiveness of data in supporting the
noncariogenicity of sugar alcohols (polyols) that appeared in the final
rule entitled ``Food Labeling: Mandatory Status of Nutrition Labeling
and Nutrient Content Revision, Format for Nutrition Label''
(hereinafter referred to as the ``mandatory nutrition labeling final
rule'') (58 FR 2079 at 2099). The firm also pointed to other statements
made by FDA in reference to health claims and its intentions regarding
sugar alcohols that the objector claimed evidenced that FDA's action
was motivated by doubts about the validity of the ``Useful Only in Not
Promoting Tooth Decay'' claim.
Nowhere did FDA say, as the objector implies, that it became aware
of new data casting doubt about the noncariogenic properties of sugar
alcohols. What the agency did say was that it wanted to ensure that the
statement continued to be valid. It is clear, however, that the
agency's final action on the ``Useful Only in Not Promoting Tooth
Decay'' statement was not motivated by any concern about the continuing
validity of the claim. It was based solely on the legal conclusion
about the status of the claim that the agency reached after
reconsidering whether to continue to provide for use of the statement
in light of the comments that were submitted (see 58 FR 2302 at 2326).
Thus, the objector's argument that there was no suggestion that FDA had
become aware of new information casting doubt on the noncariogenic
attributes of sugarless products is simply beside the point.
3. The objectors argued that the statement ``Useful Only in Not
Promoting Tooth Decay'' has a long history of use, and that its history
of use was as a disclaimer and not as a claim. The objectors argued
that, as a disclaimer, the phrase is an integral part of the nutrient
content claim ``sugar free'' and, thus, under the provisions of the
last sentence of section 403(r)(1) of the act (21 U.S.C. 343(r)(1)),
i.e., ``a claim subject to clause (A) is not subject to clause (B),''
cannot be treated as a health claim.
Before the passage of the 1990 amendments, how the statement
``Useful Only in Not Promoting Tooth Decay'' had been used may have had
some significance in determining whether to permit its continued use.
However, the agency had to review the use of the statement in view of
the changed circumstances effected by the new law. Under section
403(r)(1)(B) of the act, a claim that characterizes the relationship of
any nutrient which is of the type required in section 403(q)(1) or
(q)(2) of the act to be in the label or labeling of a food to a disease
or a health-related condition is a health claim. The statement on tooth
decay meets both elements of this definition. Sugar alcohols are a
category of nutrients for nutrition labeling purposes (see 21 CFR
101.9(c)(6)(iii)), and tooth decay is a disease. Thus, no matter how
this claim has been used, the agency must pay attention to the law as
it is now written, and the law says that if such a statement appears on
the food label, it will misbrand the food unless authorized by FDA
under section 403(r)(3) of the act. The agency was merely recognizing
what the law requires on its face in saying in the nutrient content
claims final rule that the phrase ``Useful Only in Not Promoting Tooth
Decay'' is a health claim. It does not meet the definition of nutrient
content claim because it does not provide any information that
constitutes a nutrient content claim; i.e., that characterizes the
level of any nutrient.
4. The objectors also argued that the phrase ``Useful Only in Not
Promoting Tooth Decay'' is an integral, indispensable part of the
nutrient content claim that provides important information to help the
consumer understand the intent of the ``sugar free'' claim. In making
this argument, the objectors relied on the history of the
[[Page 37505]]
``sugar free'' claim as a special dietary use claim, and the fact that
section 403(j) of the act on foods for special dietary use says such
food is misbranded ``unless its label bears such information concerning
its vitamin, mineral, and other dietary properties as the Secretary
determines to be, and by regulation prescribes as, necessary in order
fully to inform purchasers of its value for such uses.''
Assuming that section 403(j) of the act is relevant to how a
nutrient content claim is defined, what the objectors do not recognize
or deal with is the fact that section 403(j) of the act is a grant of
discretion to the Secretary (``as the Secretary determines'') with
regard to what information is necessary to inform consumers of the
value of a food for special dietary use. FDA must exercise its
discretion in accordance with the law, however. Section 403(r)(1)(B) of
the act on its face makes the statement ``Useful Only in Not Promoting
Tooth Decay'' a health claim and not a nutrient content claim or an
indispensable part of a nutrient content claim. Thus, the act, as
revised by the 1990 amendments, precludes the agency from treating this
statement in any other way than as a health claim. Thus, the agency's
discretion under section 403(j) of the act (and, given the agency's
decision to treat ``sugar free'' as a nutrient content claim, under
section 403(r)(1)(A) of the act) is limited by section 403(r)(1)(B) of
the act. ``Useful Only in Not Promoting Tooth Decay'' simply is not
available for use as part of a nutrient content claim.
5. The objectors argued that, because ``Useful Only in Not
Promoting Tooth Decay'' had not been viewed as a drug claim, it is not
a health claim. The objectors stated that there has never been any
indication during the use of the statement that it constituted a drug
claim.
FDA believes that this argument misinterprets the intent of the
1990 amendments and is without merit. The fact that, under section
201(g)(1) of the act (21 U.S.C. 321(g)(1)), a claim that is authorized
under section 403(r)(3) or 403(r)(5)(D) of the act would not subject a
food to regulation as a drug has apparently somehow created the
incorrect impression that the process for authorizing a health claim
for a food is an alternative to obtaining approval for a drug claim.
There is nothing in either section 201(g)(1) or section 403(r) of the
act that either states or implies that health claims are claims that
would be drug claims if not authorized by the agency. The fact that an
authorized health claim will not make a food product a drug does not
mean that an unauthorized health claim will.
In contrast to a drug claim, a health claim provides information
about how diet can help reduce a person's risk of developing certain
diet-related diseases. The ``Useful Only in Not Promoting Tooth Decay''
statement does exactly what a health claim is supposed to do. It tells
the consumer that including foods sweetened with sugar alcohols in his
or her diet will affect his or her risk of developing dental cavities.
(The question of the scientific validity of this claim is addressed in
a proposal published elsewhere in this issue of the Federal Register.)
Thus, there is nothing in the act that would preclude regulating
``Useful Only in Not Promoting Tooth Decay'' as a health claim. Quite
the contrary, the act compels that this claim be regulated as such a
claim.
6. A comment from a manufacturer noted that the date for submission
of objections to the final rule provided that objections must be
submitted by December 10, 1992, rather than being 30 days after the
date of publication in the Federal Register (i.e., February 4, 1993).
The letter contained no specific objections concerning the content of
the final rule.
The error identified in the comment occurred in the ``Objections''
section of the special dietary use final rule (58 FR 2427 at 2430). The
caption DATES at the beginning of the document listed the correct date
of February 5, 1993, for the submission of objections and requests for
hearing. Additionally, FDA published a document in the Federal Register
of April 1, 1993 (58 FR 17104), correcting the reference to December
10, 1993. FDA is not aware of any difficulty presented to objectors by
the presence of the incorrect date in the special dietary use final
rule. Therefore, it finds nothing in their comment that would warrant
further action by the agency.
D. Conclusions on Objections and Request for a Hearing
Under part 12 (21 CFR part 12), a request for a hearing shall be
granted if there is a genuine and substantial issue of fact. The
arguments presented by the various objectors did not present any
genuine and substantial issues of fact. Accordingly, having fully
considered the issues raised by the objectors in regards to the special
dietary use final rule, FDA finds that they have no merit and is hereby
denying the requests for a hearing.
III. Amendment to Section 101.60
A. Request for a Stay of Effectiveness
A trade association and a ``working group'' of manufacturers
independently submitted the same joint petition requesting that the
agency stay the effectiveness of the issuance of Sec. 101.60(c) while
the specific issues raised in their joint petition are being
reconsidered. They also asked for a stay of any administrative action
by FDA under its determination that ``Useful Only in Not Promoting
Tooth Decay'' is an unauthorized health claim. Finally, they asked that
FDA issue an affirmative statement on enforcement policy with respect
to the disclaimer during the period of May 8, 1993, to May 8, 1994.
FDA provides in part 10 (21 CFR part 10) of its regulations that an
interested person may request that the agency stay the effective date
of any administrative action (Sec. 10.35).
The agency is responding to the various requests for
reconsideration in this document. Because FDA has determined that a
hearing need not be held on the amendments to Sec. 105.66 and that
there is no basis for reconsideration of the decision and regulations
in question, the question of a stay pending reconsideration is moot.
However, FDA notes that the new provisions of Sec. 105.66(f) were
stayed automatically by the operation of section 701(e) of the act upon
the filing of objections to the special dietary use final rule.
Additionally, the agency notes that it has refrained administratively
from taking any action pending its resolution of the objections and
requests for a hearing. Also, under its enforcement discretion, the
agency plans no regulatory action on the use of the phrase ``Useful
Only in Not Promoting Tooth Decay'' pending its final action on the
proposal published elsewhere in this issue of the Federal Register in
response to the health claim petition that has been submitted for sugar
alcohols.
B. Request for Reconsideration
A trade association of manufacturers and a ``working group'' of
manufacturers independently filed a joint petition for reconsideration
of the agency's decision ``concerning the use of the `useful only in
not promoting tooth decay' disclaimer for `sugar free' foods.'' The
petitioners requested reconsideration of the agency's decisions to: (1)
Remove existing Sec. 105.66(f) from the republished rules governing the
labeling of foods for special dietary uses; (2) add new Sec. 101.60(c)
without including ``Useful Only in Not Promoting Tooth Decay'' as a
permitted disclaimer, where appropriate for caloric sugar free
products; and (3) take the position in the preamble to the nutrient
content claims regulation that this disclaimer represents an
unauthorized health
[[Page 37506]]
claim. The petitioners made the same arguments in support of their
request for reconsideration that they made in support of their
objections to the agency's actions and determinations concerning the
phrase ``Useful Only in Not Promoting Tooth Decay'' (see discussion in
section II of this document).
Under Sec. 10.33(b), an interested person may request
reconsideration of all or part of a decision of the agency. The agency
may grant a petition for reconsideration when it determines that
reconsideration is in the public interest and in the interest of
justice. The agency shall grant a petition for reconsideration in any
proceeding if it determines that all of the following apply: (1) The
petition demonstrates that relevant information or views contained in
the administrative record were not previously or not adequately
considered; (2) the petitioner's position is not frivolous and is being
pursued in good faith; (3) the petitioner has demonstrated sound public
policy grounds supporting reconsideration; and (4) reconsideration is
not outweighed by public health or other public interests.
The agency has discussed in section II of this document its
findings with respect to each of the arguments presented in the
petitions for reconsideration. The arguments presented by the petitions
do not identify any information that was not properly considered or
that raises a genuine issue of fact. Accordingly, finding that they are
without merit, FDA is denying the petitions for reconsideration of its
decision concerning the statement ``Useful Only in Not Promoting Tooth
Decay.'' Further, the agency notes that the petition for
reconsideration is now moot based upon the submission by the
petitioners of a health claim petition concerning the noncariogenicity
of sugarless food products sweetened with sugar alcohols, and the
agency's tentative decision discussed elsewhere in this issue of the
Federal Register, to grant that petition.
Dated: July 7, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-17502 Filed 7-19-95; 8:45 am]
BILLING CODE 4160-01-P
