Food Labeling; Health Claims and Label Statements; Request for Scientific Data and Information

The Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (the act), directed the Secretary of Health and Human Services, among other things, to evaluate the scientific evidence on 10 substance-disease relationships to determine their scientific validity as the basis for health claims in food labeling. For conventional foods, the 1990 amendments state that a health claim is permitted only if FDA determines that there is significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence, including evidence from well- designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles (section 403(r)(3)(B)(i) of the act (21 U.S.C. 343(r)(3)(B))). While the 1990 amendments allowed FDA to consider a different scientific standard for health claims for dietary supplements (section 403(r)(5)(D) of the act (21 U.S.C. 343(r)(5)(D))), FDA issued regulations in 21 CFR 101.14(c) in 1994 that applied the same standard as that used for health claims for conventional foods (59 FR 395, January 4, 1994). FDA conducted rulemakings in which it reviewed the scientific evidence for all 10 substance-disease relationships. Although the agency issued regulations authorizing health claims for most of these relationships, it concluded that there was insufficient scientific agreement regarding the scientific validity of the four health claims listed in the Summary section of this document. Therefore, the agency issued regulations providing that these claims were not authorized. (See Sec. 101.71(a), (c), (e) (21 CFR 101.79(c)(2)(i)(G)).

Several dietary supplement marketers and nonprofit organizations that had submitted comments during the health claims rulemakings filed suit in Federal district court on constitutional and statutory grounds seeking, among other things, authorization to make the following health claims for use in the labeling of dietary supplements: (1) ``Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer,'' (2) ``Consumption of fiber may reduce the risk of colorectal cancer,'' (3) ``Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease,'' and (4) ``0.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.'' Their constitutional and statutory challenges were rejected in the district court; however, on appeal the district court decision was reversed, and FDA was instructed to reconsider the four health claims (Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)). As a first step in complying with the court's decision, FDA intends to reevaluate the scientific evidence for the four substance- disease claims listed above. The agency is now in the process of preparing scientific summaries on each of these four topics. To ensure that all relevant scientific evidence is considered in the rulemaking process and to allow timely development of these summaries, FDA is requesting that anyone who has or is aware of relevant scientific data, research study results, or information related to these four substance- disease relationships submit the materials to Dockets Management Branch (address above). Such information, if submitted to FDA, must be considered publicly available. If used in the agency's scientific review, information submitted to FDA will become part of the public record for the evaluation of these relationships. The agency has established four dockets to compile information relating to each of the four topic areas; docket numbers are as specified in Table 1 below. FDA advises that the Federal Register documents listed in the footnotes to the table have been incorporated into each of the referenced dockets (Docket Nos. 91N-0101, 91N-0098, 91N-0103, and 91N-100H). FDA is requesting data and information other than the information contained or referred to in these Federal Register documents. As a guideline, therefore, the agency is requesting data and information from 1992 to the present for the four topic areas. FDA is allowing 75 days for the submission of data. Individuals and organizations submitting information or data relating to a specific topic should submit two copies of the information to the Dockets Management Branch (address above) by November 22, 1999. Separate submissions should be made for each topic area, and each submission should be identified with the appropriate docket number given below. Submissions received may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Table 1 ------------------------------------------------------------------------ Topic Docket No. ------------------------------------------------------------------------ Antioxidant vitamins and cancer 91N-0101 \1\ and \2\ Fiber and colorectal cancer \3\ 91N-0098 and \4\ Omega-3 fatty acids and coronary 91N-0103 heart disease \5\ and \6\ Folic acid (dietary supplement vs. 91N-100H food form) and neural tube defects \7\ and \8\ ------------------------------------------------------------------------ \1\ ``Food Labeling: Health Claims and Label Statements; Antioxidant Vitamins and Cancer,'' Department of Health and Human Services, Food and Drug Administration, proposed rule, Federal Register (56 FR 60624 to 60651, November 27, 1991). \2\ ``Food Labeling: Health Claims and Label Statements; Antioxidant Vitamins and Cancer,'' Department of Health and Human Services, Food and Drug Administration, final rule, Federal Register (58 FR 2622 to 2660, January 6, 1993). \3\ ``Food Labeling: Health Claims; Dietary Fiber and Cancer,'' Department of Health and Human Services, Food and Drug Administration, proposed rule, Federal Register (56 FR 60566 to 60582, November 27, 1991). \4\ ``Food Labeling: Health Claims and Label Statements; Dietary Fiber and Cancer,'' Department of Health and Human Services, Food and Drug Administration, final rule, Federal Register (58 FR 2537 to 2551, January 6, 1993). \5\ ``Food Labeling: Health Claims and Label Statements; Omega-3 Fatty Acids and Coronary Heart Disease,'' Department of Health and Human Services, Food and Drug Administration, proposed rule, Federal Register (56 FR 60663 to 60689, November 27, 1991). \6\ ``Food Labeling: Health Claims and Label Statements; Omega-3 Fatty Acids and Coronary Heart Disease,'' Department of Health and Human Services, Food and Drug Administration, final rule, Federal Register (58 FR 2682 to 2738, January 6, 1993). \7\ ``Food Labeling: Health Claims and Label Statements; Folate and Neural Tube Defects,'' Department of Health and Human Services, Food and Drug Administration, proposed rule, Federal Register (58 FR 53254 to 53295, October 14, 1993). \8\ ``Food Labeling: Health Claims and Label Statements; Folate and Neural Tube Defects,'' Department of Health and Human Services, Food and Drug Administration, final rule, Federal Register (61 FR 8752 to 8781, March 5, 1996).

Dated: September 1, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-23337 Filed 9-7-99; 8:45 am] BILLING CODE 4160-01-F