[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]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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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.

-----------------------------------------------------------------------

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