Source: https://www.federalregister.gov/documents/2005/04/27/05-8352/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-neotame
Timestamp: 2018-03-19 21:30:57
Document Index: 742770383

Matched Legal Cases: ['art 172', 'art 172', 'art 12', 'art 12', '§\u200912', '§\u200912', '§\u200912', '§\u200912', '§\u200912']

A Rule by the Food and Drug Administration on 04/27/2005
Docket Nos. 1998F-0052 and 1999F-0187 (formerly Docket Nos. 98F-0052 and 99F-0187)
https://www.federalregister.gov/d/05-8352 https://www.federalregister.gov/d/05-8352
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).
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 § 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 the Start Printed Page 21620provision 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.
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 § 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 (§ 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 Start Printed Page 21621provided 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 (§ 12.24(b)(2)). Therefore, FDA is denying the hearing requested by this submission.
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 (§ 12.24(b)). Accordingly, FDA is not making any changes in response to the objections and is denying the requests for a hearing.
[FR Doc. 05-8352 Filed 4-26-05; 8:45 am]