Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on sugar alcohols and dental caries, i.e., tooth decay, to include the sugar D-tagatose as a substance eligible for the dental caries health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.
This rule is effective July 3, 2003.Start Further Info
FOR FURTHER INFORMATION CONTACT:
James E. Hoadley, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.End Further Info End Preamble Start Supplemental Information
In the Federal Register of December 2, 2002 (67 FR 71461), the agency published an interim final rule to amend the regulation in part 101 (21 CFR part 101) that authorizes a health claim on the relationship between sugar alcohols and dental caries (§ 101.80) to include the sugar D-tagatose, a novel food ingredient. Under section 403(r)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i)), FDA issued this interim final rule in response to a petition filed under section 403(r)(4) of the act. Section 403(r)(3)(B)(i) of the act states that the Secretary of Health and Human Services (and, by delegation, FDA) shall issue a regulation authorizing a health claim only if he or she determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence (see also § 101.14(c)). Section 403(r)(4) of the act sets out the procedures that FDA is to follow upon receiving a health claim petition.
On January 9, 2002, Arla Foods Ingredients amba, DK-8260 Viby, Denmark (the petitioner) filed a petition requesting that the agency: (1) Amend § 101.80 to include the sugar D-tagatose as one of the substances eligible to bear the dental caries health claim; (2) amend § 101.9, the nutrition labeling regulation, to exclude D-tagatose from the definition of “sugars” (§ 101.9(c)(6)(ii)), thereby allowing a “sugar free” nutrient content claim; and (3) modify the text of § 101.80 because D-tagatose is not a sugar alcohol (Ref. 1). FDA filed the petition for comprehensive review in accordance with section 403(r)(4) of the act on April 19, 2002.
FDA considered the scientific evidence presented in the petition as part of its review of the scientific literature on D-tagatose and dental caries, as well as information previously considered by the agency on the etiology of dental caries and the effects of slowly fermentable carbohydrates. The agency summarized this evidence in the interim final rule (67 FR 71461 at 71463). Based on the available evidence, FDA concluded that dental caries is a disease for which the U.S. population is at risk; D-tagatose is a food, because it contributes taste and other technical effects listed in 21 CFR 170.3(o) to food; the use of D-tagatose in food is safe and lawful; and there is significant scientific agreement among qualified experts that D-tagatose does not promote dental caries (67 FR 71461 at 71462 through 71464). Consequently, FDA published an interim final rule amending § 101.80 to authorize a dental caries health claim for D-tagatose.
As discussed in the interim final rule, the agency believes that it would be false and misleading for D-tagatose containing foods to bear a “sugar free” claim because D-tagatose is a sugar (67 FR 71461 at 71466). Consequently, rather than exempting D-tagatose from the definition of “sugars” as requested by the petitioner, the agency instead exempted D-tagatose from the “sugar free” requirement of § 101.80. To address the incongruity of a sugar-containing food bearing the dental caries health claim and to inform consumers about the uniqueness of D-tagatose as a noncariogenic sugar, we added the requirement that the claim identify D-tagatose as a sugar that, unlike other sugars, does not promote the development of dental caries. Accordingly, although products containing D-tagatose are not permitted to be labeled as “sugar-free,” they are authorized to state that D-tagatose sugar does not promote, or may reduce the risk of, tooth decay.
II. Summary of Comments and the Agency's Response
The agency received one comment in support of the petition from a manufacturer prior to publication of the interim final rule. Comments from seven consumers were sent to this docket during the comment period, none of which were relevant to this rulemaking.
Given the absence of contrary evidence on the agency's decisions announced in the interim final rule, FDA is adopting as a final rule, without change, the interim final rule that amended § 101.80 to include D-tagatose as a substance eligible for the dental caries health claim.
III. Environmental Impact
The agency has determined under 21 CFR 25.32(p) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
IV. Analysis of Impacts
A. Regulatory Impact Analysis
We have examined the economic implications of this final rule as required by Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Start Printed Page 39832Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).
With this final rule, FDA is adopting without change the provisions of the interim final rule published in the Federal Register of December 2, 2002. The interim final rule amended the regulation authorizing a health claim on the relationship between sugar alcohols and dental caries to include the sugar D-tagatose as a substance eligible for the health claim. We assessed the costs and benefits of the interim final rule in that Federal Register document (67 FR 71461 at 71468 and 71469). By now reaffirming that interim final rule, FDA has not imposed any new requirements. There are, therefore, no additional costs and benefits associated with this final rule.
B. Regulatory Flexibility Analysis
We have examined the economic implications of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant impact on a substantial number of small entities, the Regulatory Flexibility Act requires the agency to analyze regulatory options that would minimize the economic impact of the rule on small entities.
Because this final rule does not impose any new costs on firms, we certify that this final rule will not have a significant impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.
C. Unfunded Mandates
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires that agencies prepare a written statement of anticipated costs and benefits before issuing any final rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 in any one year (adjusted annually for inflation). The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for this rule, because the rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation-adjusted statutory threshold is $113 million.
V. Paperwork Reduction Act
FDA concludes that the labeling provisions of this final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food labeling health claim on the association between D-tagatose and the nonpromotion of dental caries is a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public.” (5 CFR 1320.3(c)(2)).
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule has a preemptive effect on State law. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal Statute to preempt State law only where the statute contains an express preemption provision, there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 403A of the act (21 U.S.C. 343-1) is an express preemption provision. That section provides that “no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce” certain food labeling requirements, unless an exemption is provided by the Secretary of Health and Human Services (and by delegation, FDA). Relevant to this final rule, one such requirement that States and political subdivisions may not adopt is “any requirement respecting any claim of the type described in section 403(r)(1) of the act made in the label or labeling of food that is not identical to the requirement of section 403(r) * * *” (section 403A(a)(5) of the act (21 U.S.C. 343-1(a)(5)). Prior to the effective date of this final rule and the interim rule that preceded it, this provision operated to preempt States from imposing health claim labeling requirements concerning D-tagatose and reduced risk of dental caries because no such requirement had been imposed by FDA under section 403(r) of the act. Under this final rule and the interim rule that preceded it, States are preempted from imposing any health claim labeling requirements for D-tagatose and reduced risk of dental cares that are not identical to those required by this rule. Section 403A(a)(5) of the act displaces both State legislative requirements and State common-law duties. Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., concurring in part and concurring in judgment); id. at 510 (O'Connor, J., joined by Rehnquist, C. J., Scalia, J., and Thomas, J., concurring in part and dissenting in part); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., joined by Thomas, J., concurring in judgment in part and dissenting in part). Although this rule has preemptive effect in that it would preclude States from issuing regulations or adopting or enforcing any requirements, including state tort-law imposed requirements, for health claims about D-tagatose and reduced risk of dental caries that are not identical to the requirements of the interim final rule as adopted by this final rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act.
Section 4(e) of the Executive order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” Similarly, section 6(c) of the Executive order states that “to the extent practicable and permitted by law, no agency shall promulgate any regulation that has federalism implications and that preempts state law, unless the agency, prior to the formal promulgation of the regulation * * * consulted with State and local officials early in the process of developing the proposed regulation.” This requirement, that FDA provide the States with an opportunity for appropriate participation in this rulemaking, has been met. FDA sought input from all stakeholders through publication of the interim final rule in the Federal Register. No comments from State or local government entities were received.
In conclusion, the agency believes that it has complied with all of the applicable requirements under the Executive order and has determined that the preemptive effects of this rule are consistent with Executive Order 13132.
The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.Start Printed Page 39833
1. Arla Foods Ingredients amba, “Petition to Amend the Regulation for 21 CFR Sec. 101.80 to Authorize a Noncariogenicity Dental Health Claim for D-tagatose,” CP-1, Docket No. 02P-0177, January 9, 2002.Start Amendment PartEnd Amendment Part Start Signature
Dated: June 30, 2003.
Assistant Commissioner for Policy.
[FR Doc. 03-16949 Filed 7-1-03; 10:06 am]
BILLING CODE 4160-01-S