Food Labeling: Label Statements on Foods for Special Dietary Use; ``Useful Only in Not Promoting Tooth Decay'' Disclaimer

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