57700 Federal Register / Vol. 64, No. 206 / Tuesday, October 26, 1999 / Rules and Regulations DEPARTMENT OF HEALTH AND CFR 101.70) establishes a process for tentatively concluded that the publicly HUMAN SERVICES petitioning the agency to authorize by available data supported an association regulation the use of health claims about between diets low in saturated fat and Food and Drug Administration a substance-disease relationship cholesterol and reduced risk of CHD (56 (§ 101.70(a)) and sets out the types of FR 60727 at 60737), and it confirmed 21 CFR Part 101 information that any such petition must that conclusion in the saturated fat/ [Docket No. 98P±0683] include (§ 101.70(f)). cholesterol final rule (58 FR 2739 at In response to the 1990 amendments, 2751). Food Labeling: Health Claims; Soy FDA also conducted an extensive Based on its review using the stated Protein and Coronary Heart Disease review of the evidence on 10 substance- criteria, and on its consideration of disease relationships. As a result of its comments received in response to the AGENCY: Food and Drug Administration, review, FDA has authorized claims for proposed rule entitled ``Health Claims; HHS. 8 of these 10 relationships, one of which Dietary Fiber and Cardiovascular ACTION: Final rule. focused on the relationship between Disease'' (56 FR 60582), FDA concluded SUMMARY: The Food and Drug dietary saturated fat and cholesterol and that the publicly available scientific Administration (FDA) is authorizing the reduced risk of CHD. CHD is the most information supported an association use, on food labels and in food labeling, common, most frequently reported, and between diets low in saturated fat and of health claims on the association most serious form of cardiovascular cholesterol and high in fruits, between soy protein and reduced risk of disease (CVD) (58 FR 2739, January 6, vegetables, and grain products (i.e., coronary heart disease (CHD). Based on 1993). Further, although the agency foods that are low in saturated fat and its review of evidence submitted with denied the use on food labeling of cholesterol and that are good sources of comments to the proposed rule, as well health claims relating dietary fiber to dietary fiber) and reduced risk of heart as evidence described in the proposed reduced risk of CVD (58 FR 2552), it disease (58 FR 2552 at 2572). In the rule, the agency has concluded that soy authorized a health claim relating diets 1993 dietary fiber and CVD final rule, in protein included in a diet low in low in saturated fat and cholesterol and response to a comment regarding the saturated fat and cholesterol may reduce high in fruits, vegetables, and grain apparent hypocholesterolemic products that contain dietary fiber properties of specific food fibers, FDA the risk of CHD by lowering blood (particularly soluble fiber) to a reduced again articulated its criteria for cholesterol levels. risk of CHD. evaluating diet and CHD relationships DATES: This regulation is effective In the proposed rule entitled ``Health (58 FR 2552 at 2567). FDA agreed that October 26, 1999, except for Claims and Label Statements; Lipids the effectiveness of naturally occurring § 101.82(c)(2)(ii)(B), which contains and Cardiovascular Disease'' (56 FR fibers in foods in reducing the risk of information collection requirements that 60727, November 27, 1991) (hereinafter CHD may be documented for specific have not been approved by the Office of referred to as the saturated fat/ food products. Further, the agency Management and Budget (OMB). Upon cholesterol proposed rule), FDA set out indicated that if manufacturers could approval, the FDA will publish a criteria for evaluating evidence on diet document, through appropriate studies, document in the Federal Register and CVD relationships. The agency that dietary consumption of the soluble announcing the effective date of those focused on those aspects of the dietary fiber in a particular food has a beneficial requirements. lipid and CVD relationship for which effect on blood lipids predictive of CHD FOR FURTHER INFORMATION CONTACT: the strongest scientific evidence risk, they should petition for a health Susan M. Pilch, Center for Food Safety andagreement existed. FDA noted that, claim for that particular product. In and Applied Nutrition (HFS±465), Food because of the public health importance response to two petitions that and Drug Administration, 200 C St. SW., of CHD, identification of ``modifiable'' documented such evidence, FDA has Washington, DC 20204, 202±205±4500. risk factors for CHD had been the authorized health claims for soluble SUPPLEMENTARY INFORMATION: subject of considerable research and fiber from certain foods and reduced public policy attention. The agency also risk of CHD in § 101.81 (21 CFR 101.81) I. Background Information noted that there is general agreement (62 FR 3600, January 23, 1997, and On November 8, 1990, the President that elevated blood cholesterol levels amended at 62 FR 15344, March 31, signed into law the Nutrition Labeling are one of the major ``modifiable'' risk 1997, and 62 FR 8119, February 18, and Education Act of 1990 (the 1990 factors in the development of CHD. FDA 1998). amendments) (Public Law 101±535). cited Federal Government and other In the Federal Register of November This new law amended the Federal reviews that concluded that there is 10, 1998 (63 FR 62977), and in response Food, Drug, and Cosmetic Act (the act) substantial epidemiologic and clinical to a petition from Protein Technologies in a number of important ways. One evidence that high blood levels of total International, Inc. (Ref. 1 and Ref. 2), the notable aspect of the 1990 amendments and low density lipoprotein (LDL)- agency proposed § 101.82 to provide for was that they provided procedures cholesterol are a cause of atherosclerosis health claims on the relationship of soy whereby FDA is to regulate health and represent major contributors to protein and reduced risk of CHD claims on food labels and in food CHD. Further, factors that decrease total (hereinafter referred to as the soy labeling. blood cholesterol and LDL-cholesterol protein proposed rule). In the soy In the Federal Register of January 6, will also decrease the risk of CHD. FDA protein proposed rule, FDA considered 1993 (58 FR 2478), FDA issued a final concluded that it is generally accepted the relevant scientific studies and data rule that implemented the health claim that blood total and LDL-cholesterol presented in the petition as part of its provisions of the act (hereinafter levels are major risk factors for CHD, review of the scientific literature on soy referred to as the 1993 health claims and that dietary factors affecting blood protein and CHD. The agency final rule). In that final rule, FDA cholesterol levels affect the risk of CHD. summarized this evidence in the soy adopted § 101.14 (21 CFR 101.14), High intakes of dietary saturated fat and, protein proposed rule and presented the which sets out rules for the to a lesser degree, of dietary cholesterol rationale for a health claim on this food- authorization and use of health claims are consistently associated with disease relationship as provided for by regulation. Additionally, § 101.70 (21 elevated blood cholesterol levels. FDA under the significant scientific VerDate 12-OCT-99 17:23 Oct 25, 1999 Jkt 190000 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\26OCR2.XXX pfrm03 PsN: 26OCR2 Federal Register / Vol. 64, No. 206 / Tuesday, October 26, 1999 / Rules and Regulations 57701 agreement standard in section containing one or more comments, from One comment reviewed additional 403(r)(3)(B)(i) of the act and § 101.14(c) consumers, consumer organizations, sources of information and reached the of FDA's regulations. professional organizations, government same conclusion. Proposed § 101.82(c)(2)(ii)(A) agencies, industry, trade associations, In the soy protein proposed rule, FDA identified the substance that is the health care professionals, and research also tentatively concluded that soy subject of the proposed claim as soy scientists. protein from Glycine max satisfied the protein from the legume seed Glycine About half of these submissions preliminary requirement of max. The soy protein proposed rule supported the proposed rule without § 101.14(b)(3)(i) that the substance be a included qualifying criteria for the providing grounds for this support other food that contributes taste, aroma, or purpose of identifying soy protein- than those provided by FDA in the nutritive value (63 FR 62977 at 62978). containing foods eligible to bear the preamble to the soy protein proposed Sources of soy protein identified in the proposed health claim. The proposal rule. The majority of the remaining soy protein proposed rule included also specified mandatory content for comments were generally supportive, foods composed of or derived from health claim statements; identified but requested modification of one or whole soybeans and foods that contain additional, optional information for more provisions of the proposed rule. processed soy protein ingredients: such statements; and provided model Some comments provided additional Isolated soy protein (ISP), soy protein health claims. data on the relationship between soy concentrate (SPC), soy flour (SF), In its evaluation of the scientific protein and CHD, including one texturized soy protein, or texturized evidence for a relationship between submission, originally submitted as a vegetable protein (TVP). In addition to consumption of soy protein and blood health claim petition and converted to protein, these foods and ingredients total and LDL-cholesterol levels, the a comment on the soy protein proposed contain other naturally occurring soy agency found the data suggestive but not rule (Ref. 3), that included a constituents, such as isoflavones, fiber, sufficient to establish a dose-response comprehensive review of available and saponins. The specific processing for this relationship. However, the scientific evidence about the steps employed determine the extent of agency did find consistent, clinically relationship.