[Federal Register: April 27, 2005 (Volume 70, Number 80)]
[Rules and Regulations]               
[Page 21619-21621]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 172

[Docket Nos. 1998F-0052 and 1999F-0187 (formerly Docket Nos. 98F-0052 
and 99F-0187)]

Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Neotame

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections and denial of requests for a 


SUMMARY: The Food and Drug Administration (FDA) is responding to 
objections and is denying requests that it has received for a hearing 
on the final rule that amended the food additive regulations 
authorizing the use of neotame as a nonnutritive sweetener in food. 
After reviewing the objections to the final rule and the requests for a 
hearing, the agency has concluded that the objections do not raise 
issues of material fact that justify a hearing or otherwise provide a 
basis for revoking the amendment to the regulation.

FOR FURTHER INFORMATION CONTACT: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1267.


I. Introduction

    FDA published notices in the Federal Register on February 10, 1998 
(63 FR 6762), and February 8, 1999 (64 FR 6100), announcing the filing 
of food additive petitions, FAP 8A4580 and FAP 9A4643, respectively, by 
Monsanto Co. to amend the food additive regulations in Part 172 Food 
Additives Permitted for Direct Addition to Food for Human Consumption 
(21 CFR part 172) to provide for the safe use of neotame as a 
nonnutritive sweetener for tabletop use (FAP 8A4580) and for general-
purpose use in food (FAP 9A4643) where standards of identity do not 
preclude such use. The rights to these petitions were subsequently sold 
to the NutraSweet Co. In the Federal Register of July 9, 2002 (67 FR 
45300), FDA issued a final rule permitting the safe use of neotame as a 
sweetening agent and flavor enhancer in foods generally, except in meat 
and poultry. The preamble to the final rule advised that objections to 
the final rule and requests for a hearing were due within 30 days of 
the publication date (i.e., by August 8, 2002).

II. Objections and Requests for a Hearing

    Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(f)) provides that, within 30 days after publication 
of an order relating to a food additive regulation, any person 
adversely affected by such order may file objections, specifying with 
particularity the provisions of the order ``deemed objectionable, 
stating reasonable grounds therefore, and requesting a public hearing 
based upon such objections.'' 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.
    Under 21 CFR 171.110 of the food additive regulations, objections 
and requests for a hearing are governed by part 12 (21 CFR part 12) of 
FDA's regulations. Under Sec.  12.22(a), each objection must meet the 
following conditions: (1) Must be submitted on or before the 30th day 
after the date of publication of the final rule; (2) must be separately 
numbered; (3) must specify with particularity the provision of the 
regulation or proposed order objected to; (4) must specifically state 

[[Page 21620]]

provision of the regulation or proposed order on which a hearing is 
requested; failure to request a hearing on an objection constitutes a 
waiver of the right to a hearing on that objection; and (5) must 
include a detailed description and analysis of the factual information 
to be presented in support of the objection if a hearing is requested; 
failure to include a description and analysis for an objection 
constitutes a waiver of the right to a hearing on that objection.
    Following publication of the neotame final rule, FDA received three 
submissions, within the 30-day objection period, objecting to the 
agency's safety evaluation of neotame as a general-purpose sweetener. 
Two of the submissions are essentially identical in content and assert 
that all of the studies that were discussed in the neotame final rule 
are meaningless because they are based on aspartame, which they claim 
has never been proven to be safe for use in food. Both of these 
submissions requested a hearing. The third submission questions the 
validity of the agency's exposure estimate for neotame and its 
metabolites. This same submission also asks a number of questions 
regarding the clinical studies that were conducted on human tolerance 
to neotame. The submission requested a hearing on both of these issues.

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request 
for a hearing are set out in Sec.  12.24(b). Under that regulation, a 
hearing will be granted if the material submitted by the requester 
shows, among other things, the following: (1) There is a genuine and 
substantial factual issue 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 
requestor; a hearing will be denied if the data and information 
submitted are insufficient to justify the factual determination urged, 
even if accurate; and (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 action 
would be the same even if the factual issue were resolved in the way 
    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. denied, 
446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & 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. EPA, 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 (see Sec.  12.28).
    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 Ass'n 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 (see 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)). 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)).
    Even if the objections raise material issues of fact, FDA need not 
grant a hearing if those same issues were adequately raised and 
considered in an earlier proceeding. Once an issue has been so raised 
and considered, a party is estopped from raising that same issue in a 
later proceeding without new evidence. The various judicial doctrines 
dealing with finality can be validly applied to the administrative 
process. In explaining why these principles ``self-evidently'' ought to 
apply to an agency proceeding, the U.S. Court of Appeals for the 
District of Columbia Circuit wrote:
    The underlying concept is as simple as this: Justice requires 
that a party have a fair chance to present his position. But overall 
interests of administration do not require or generally contemplate 
that he will be given more than a fair opportunity.
Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 322 (D.C. Cir. 
1972). (See Costle v. Pacific Legal Foundation, supra at 215-220. See 
also Pacific Seafarers, Inc. v. Pacific Far East Line, Inc., 404 F.2d 
804 (D.C. Cir. 1968), cert. denied, 393 U.S. 1093 (1969).)
    In summary, a hearing request must 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 

IV. Analysis of Objections and Response to Hearing Requests

    FDA addresses each of the three objections in the following 
paragraphs, as well as the evidence and information filed in support of 
each, comparing each objection and the information submitted in support 
of it to the standards for granting a hearing in Sec.  12.24.
    Two submissions objected to the final rule asserting that all of 
the safety studies on neotame are meaningless because they are based on 
aspartame. Both submissions requested hearings on this point. As stated 
in the neotame final rule, to support the safety of neotame, the 
petitioner submitted, within the two petitions, a combined total of 113 
preclinical, clinical, and special studies, plus an additional 32 
exploratory and screening studies in a food master file on the safety 
of neotame and its metabolites, not aspartame. The objectors did not 
specifically address any of these studies. Further, the assertion that 
the safety evaluation of neotame is based on aspartame is baseless and 
completely false. FDA is denying the requests for a hearing on this 
point because there is no genuine and substantial issue of fact for 
resolution at a hearing, and a hearing will not be granted on the basis 
of mere allegations or denials or general descriptions of positions and 
contentions (Sec.  12.24(b)(1) and (b)(2)).
    The third objection questioned the agency's exposure estimate for 
neotame and the clinical studies that were conducted and requested a 
hearing on these issues. However, the submission

[[Page 21621]]

provided no information that would support a reevaluation of the 
agency's exposure estimate or the clinical studies that were conducted. 
Therefore, this submission provides no basis for FDA to reconsider its 
decision to issue the final rule on neotame. Moreover, this submission 
provides no basis for granting a hearing because a hearing request must 
include specifically identified reliable evidence that can lead to 
resolution of a factual issue in dispute. A hearing will not be granted 
on the basis of mere allegations or denials or general descriptions of 
positions and contentions (Sec.  12.24(b)(2)). Therefore, FDA is 
denying the hearing requested by this submission.

V. Summary and Conclusions

    Section 409 of the act requires that a food additive be shown to be 
safe prior to marketing. Under 21 CFR 170.3(i), a food additive is 
``safe'' if there is a reasonable certainty in the minds of competent 
scientists that the substance is not harmful under the intended 
conditions of use. In the final rule approving neotame, FDA concluded 
that the data presented by the petitioner to establish safety of the 
additive demonstrate that neotame is safe for its intended use as a 
general-purpose sweetener and flavor enhancer in foods. The final rule 
did not authorize the use of neotame in meat and poultry.
    The petitioner has the burden to demonstrate the safety of the 
additive in order to gain FDA approval. Once FDA makes a finding of 
safety, the burden shifts to an objector, who must come forward with 
evidence that calls into question FDA's conclusion (American Cyanamid 
Co. v. FDA, 606 F2d. 1307, 1314-1315 (DC Cir. 1979)).
    None of the three objections received contained evidence to support 
a genuine and substantial issue of fact. Nor has any objector 
established that the agency overlooked significant information in 
reaching its conclusion. Therefore, the agency has determined that the 
objections that requested a hearing do not raise any substantial issue 
of fact that would justify an evidentiary hearing (Sec.  12.24(b)). 
Accordingly, FDA is not making any changes in response to the 
objections and is denying the requests for a hearing.

    Dated: April 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8352 Filed 4-26-05; 8:45 am]