3584 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND to authorize the use, on food labels and drugs, and that health enhancement HUMAN SERVICES in food labeling, of health claims on the depends not only on consumption of a association between oat bran and particular food but also on other dietary Food and Drug Administration oatmeal and reduced risk of CHD. The practices, exercise, heredity, lifestyle, proposed rule was issued in response to and a host of other factors. The agency 21 CFR Part 101 a petition filed under section also agreed with the petitioner that the [Docket No. 95P±0197] 403(r)(3)(B)(i) of the Federal Food, Drug, requirement that the claim use the term and Cosmetic Act (the act) (21 U.S.C. ‘‘may’’ or ‘‘might’’ to relate the ability of RIN 0910±AA19 343(r)(3)(B)(i)). Section 403(r)(3)(B)(i) of oat bran or oatmeal to reduce the risk of Food Labeling: Health Claims; Oats the act states that the Secretary of heart disease is intended to reflect the and Coronary Heart Disease Health and Human Services (and, by multifactorial nature of the disease. The delegation, FDA) shall promulgate agency requested written comments on AGENCY: Food and Drug Administration, regulations authorizing health claims the proposed rule, including comments HHS. only if he or she determines, based on on the agency’s tentative decision to ACTION: Final rule. the totality of publicly available make the phrase ‘‘depends on many scientific evidence (including evidence factors’’ optional information. SUMMARY: The Food and Drug from well-designed studies conducted II. Summary of Comments and the Administration (FDA) is announcing its in a manner which is consistent with Agency’s Responses decision to authorize the use, on food generally recognized scientific labels and in food labeling, of health procedures and principles), that there is In response to the proposal, the claims on the association between significant scientific agreement, among agency received approximately 1,450 soluble fiber from whole oats and a experts qualified by scientific training letters, each containing one or more reduced risk of coronary heart disease and experience to evaluate such claims, comments, from consumers, (CHD). Based on its review of evidence that the claim is supported by such professional organizations, government submitted with comments to the evidence (see also § 101.14(c)). agencies, industry, trade associations, proposal, as well as of the evidence FDA considered the relevant scientific and health care professionals. described in the proposal, the agency studies and data presented in the The majority of the comments that the has concluded that the type of soluble petition as part of its review of the agency received agreed with one or fiber found in whole oats, i.e., beta (β)- scientific literature on oat bran and more provisions of the proposed rule glucan soluble fiber, is primarily oatmeal, i.e., rolled oats, and heart without providing grounds for this responsible for the association between disease. The agency summarized this support other than those provided by consumption of whole oats, including evidence in the proposed rule (61 FR FDA in the preamble to the proposal. oat bran, rolled oats, and whole oat 296). Many of these comments also requested flour, and an observed lowering of blood The proposed rule included modification of one or more provisions cholesterol levels. The agency has qualifying and disqualifying criteria for of the proposed rule. A few comments concluded that, based on the totality of the purpose of identifying foods eligible disagreed with the proposed rule and the scientific evidence, there is to bear the proposed health claim. The provided specific support for their significant scientific agreement among proposed qualifying criteria were that a positions. The agency has summarized qualified experts to support the food provide 13 grams (g) of oat bran or and addressed the relevant issues raised relationship between soluble fiber in 20 g of oatmeal, and that the oat bran in all comments in the sections of this whole oats and CHD. Therefore, FDA and oatmeal contain, without document that follow. β has decided to make the subject of the fortification, at least 1 g of -glucan A. Food Substance Associated with health claim ‘‘soluble fiber from whole soluble fiber. The proposal also Reduced Risk of CHD oats’’ and has concluded that claims on specified mandatory content and label Health claims have two essential foods relating the onsumption of soluble information for health claim statements elements: a food substance and a disease fiber from whole oats to reduced risk of and provided model health claims. or health-related condition (§ 101.14). heart disease are justified. FDA is As part of the requirements for the The agency proposed to authorize a announcing this action in response to a claim, the agency proposed to allow a health claim that diets high in oat bran petition filed by the Quaker Oats shortened version of the claim and oatmeal and low in saturated fat Company (the petitioner). describing the relationship between diets high in oat bran and oatmeal and and cholesterol may reduce the risk of DATES: The regulation is effective risk of heart disease that included a CHD. Further, in the proposal, the January 23, 1997. The Director of the referral statement to the location of the agency tentatively agreed with the Office of the Federal Register approves full claim. The proposed version of the petitioner’s position that, while current the incorporation by reference in full claim described the relationship research may not demonstrate that β- accordance with 5 U.S.C. 552(a) and 1 between diets low in saturated fat and glucan soluble fiber is the only CFR part 51 of a certain publication in cholesterol and high in oat bran and component of oats that affects blood 21 CFR 101.81(c)(2)(ii)(A), effective oatmeal and heart disease. FDA total- and low density lipoprotein January 23, 1997. requested data on whether permitting a (LDL)-cholesterol levels, potentially FOR FURTHER INFORMATION CONTACT: shortened claim will affect whether reducing the risk of CHD, β-glucan Joyce J. Saltsman, Center for Food Safety consumers will also read the full claim. soluble fiber can serve as a marker for and Applied Nutrition (HFS–165), Food The agency also proposed to make the the food substance that is the subject of and Drug Administration, 200 C St. SW., phrase ‘‘depends on many factors’’ the claim. Therefore, FDA tentatively Washington, DC 20204, 202–205–5916. optional information. The agency agreed concluded that the relationship is based SUPPLEMENTARY INFORMATION with the petitioner’s arguments that, on a daily intake of not less than 40 g based on an ever increasing background oat bran or 60 g oatmeal, without I. Background of health information made available fortification, that provide 3 g or more In the Federal Register of January 4, through various media, consumers per day β-glucan soluble fiber. The 1996 (61 FR 296), the agency proposed already understand that foods are not disease element of the claim is CHD, as Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3585 assessed by changes in serum total- and demonstrated effects of β-glucan affecting CHD risk. Other comments LDL-cholesterol levels in response to independent of the food. These cited studies that showed that oat β- the consumption of specified levels of comments cited references in FDA’s glucan soluble fiber has viscous oatmeal or oat bran. A number of proposed rule (Refs. 12, 15, 33, 35, 38) properties that are responsible for comments dealt with what should be and also provided additional references physiological effects on the glycemic the appropriate description of the food (Refs. 60 through 74) in support of their response (i.e., changes in blood sugar substance that is part of the health claim argument. According to these levels following ingestion of foods) and relationship. comments, this evidence suggests that β- suggested that the same viscous glucan soluble fiber can provide an properties may also play a role in 1. Terminology independent and meaningful effect and, affecting blood total cholesterol levels (Comment 1) in turn, supports that β-glucan is the (Refs. 60 and 69). Some comments stated that the primary component in whole oat On the other hand, some comments proposed claim seemed to be limited to products responsible for that effect on stated that, while β-glucan soluble fiber hot cereals because the agency used the CHD risk factors. A few comments also is an important factor, other term ‘‘oatmeal’’ to describe one of the noted that studies suggest a dose- components in the oat products, qualifying foods. A few comments response relationship between β-glucan including certain chemical suggested that the agency soluble fiber and the effect on blood characteristics and the tocotrienols that inappropriately used the term total- and LDL-cholesterol levels are part of the lipid fraction of whole ‘‘oatmeal’’ for the more technically because the degree of effect is linearly oats, also contribute to the association correct term ‘‘rolled oats,’’ the dry form related to the amount of β-glucan with CHD risk reduction. Thus, of the food before cooking or processing. consumed (Ref. 66). Conversely, some according to these comments, specifying The agency did not intend to limit the comments supported the agency’s requirements for only β-glucan soluble proposed claim to hot cereals. As proposed treatment of β-glucan soluble fiber in the proposed regulation is not suggested by the comments, the agency fiber as a marker for identifying a useful appropriate. was using the term ‘‘oatmeal’’ to be food product rather than as the active The agency has carefully reviewed the synonymous with the term ‘‘rolled component. comments and evidence submitted on oats,’’ i.e., the dry oat product. In addition, several comments cited the issue of the significance of the β- Likewise, the agency did not intend references to demonstrate that glucan in the oat products and is that use of the terms ‘‘oatmeal’’ and ‘‘oat processing of oat products in ways that persuaded that β-glucan soluble fiber is bran’’ would mean that only hot, cooked alter the physical structure of the β- the primary, but not the only, cereals could bear the claim. The glucan soluble fiber component (e.g., component in whole oats that affects proposed claim was intended to alter molecular structure and hence serum lipids. β-glucan thus plays a describe the relationship between oat viscosity) results in a loss of effect on significant role in the relationship bran and rolled oats which can be used blood total- and LDL-cholesterol levels between whole grain oats and the risk as single ingredients, such as in hot or (Refs. 63 through 64). Several comments of CHD. The agency reached this ready-to-eat cereals, or as components of also noted that FDA’s proposal cited the conclusion based on evidence that there other foods that are served either hot or Torrenen et al. study (Ref. 38), showing is a dose response between the level of cold. Under the proposal, any oat that a special processing technique, β-glucan soluble fiber from whole oats product meeting the eligibility when used with oat bran concentrate, and the level of reduction in blood total- requirements for the claim could bear appeared to reduce its effect on serum and LDL-cholesterol (Refs. 15 and 33), the claim. Because the term ‘‘rolled lipid levels. These comments cited the and that intakes of β-glucan soluble oats’’ is the technical term more loss of effect with changes in the fiber at or above 3 g per day were more commonly used to describe the dry form physical structure of β-glucan soluble effective in lowering serum lipids than of the food, the agency has replaced the fiber as evidence that there is a direct lower intake levels. These results are term ‘‘oatmeal’’ with ‘‘rolled oats’’ effect attributable to the presence of β- consistent with the results of the throughout this final rule. glucan soluble fiber, and that this effect individual human studies reviewed in is dependent not only on the chemical 2. Component of Oat Bran and Rolled the proposal. characteristics of the β-glucan soluble FDA, therefore, concludes that it is Oats Responsible for the Effect fiber but also on the retention of appropriate to change the food (Comment 2) important physical characteristics such substance that is the subject of this Some comments stated that the as viscosity. authorization for claims from oat bran proposed claim inappropriately focused Moreover, several comments cited and rolled oats to β-glucan soluble fiber on oat bran and rolled oats as providing references to show that it is the presence from whole oats. an effect on CHD risk. These comments of a highly viscous soluble fiber in the suggested that it was the type of soluble intestinal tract that is determinative of 3. Eligibility of Whole Oat Flour fiber in oat products, specifically β- the desired effect on CHD risk factors, (Comment 3) glucan, that was the primary component and that, holding all other factors A number of comments suggested that responsible for the relationship between constant, changes in viscosity of products containing whole oat flour the oat products and CHD. FDA had intestinal contents alone result in made from 100 percent oat groats noted in its proposal that β-glucan significant effects on blood total- and should be eligible to bear the health soluble fiber was closely associated with LDL-cholesterol levels (Refs. 72 through claim. The reasons given, some the observed effect, but at the time, the 74). These comments, which were supported by data, included: (a) agency tentatively concluded that β- submitted by fiber experts, suggested Evidence suggests that β-glucan soluble glucan soluble fiber served as a marker that the ability of β-glucan soluble fiber fiber is the primary contributor to the for the food with potential to reduce the to produce viscosity in the intestinal observed effect of oat bran and rolled risk of CHD. Comments offered support contents, while not the only mechanism oats, and whole oat flour contains β- for the view that β-glucan soluble fiber by which soluble fibers have an effect glucan; (b) whole oat flour is derived is more than just a marker in whole oats on CHD risk, can be a clinically from the same starting material as rolled by referencing studies that meaningful and independent factor oats (i.e., whole oat groats) and, other 3586 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations than the smaller particle size of whole subjects. Forty-three patients, aged 27 to whether whole oat flour can provide the oat flour, possesses a chemical and 68 years, with mild to moderate same benefits as rolled oats. physical composition virtually identical hypercholesterolemia participated in The animal studies cited by one to rolled oats (Ref. 57); (c) animal this placebo-controlled study. The study comment (Ref. 68) demonstrate that studies demonstrate that, like the β- consisted of three parts: a 4-week run- there is bioequivalence relative to these glucan soluble fiber from oat bran and in on a Step 1 diet (i.e., a diet with less important physical characteristics rolled oats, whole oat flour β-glucan than 30 percent calories from fat, less between whole oat flour and rolled oats. soluble fiber retains important physical than 10 percent calories from saturated When taken together, the available characteristics during digestion (Ref. fat, and less than 300 mg cholesterol), a evidence provides a basis for 68); and (d) data from a human study 2-week baseline, and a 4-week treatment concluding that it is appropriate to (Ref. 70) and several animal studies period. During the treatment period, make whole oat flour, as well as oat (Refs. 57, 66, and 71) show a positive subjects in the oat group continued to bran and rolled oats, the subject of the effect of ready-to-eat cereals made with adhere to the Step I diet and consumed authorized substance-disease whole oat flour on risk factors for CHD. one prepackaged portion (1.5 oz.) of relationship. One comment submitted a recent, cereal twice a day, resulting in an Therefore, for the purposes of unpublished human clinical trial in estimated total daily intake of 3 g β- § 101.81, the term ‘‘whole oats’’ which a ready-to-eat cereal made from glucan from whole oat flour. Body includes oat bran, rolled oats, and whole oat flour was used as the test weights were maintained at a constant whole oat flour. Changes to the codified product (Ref. 70). Results showed that level throughout the treatment period. sections of this rule to reflect the consumption of the cereal had a Although there were differences in total- inclusion of whole oat flour are significant effect on blood total- and discussed in section II.B. of this LDL-cholesterol levels as compared to , high density lipoprotein (HDL)-, and LDL-cholesterol levels between the document. the placebo cereal. While FDA has added whole oat flour In considering the comments groups at baseline, the authors used an as a subject of the health claim in this concerning the inclusion of whole oat analysis of covariance to adjust data to proceeding, it must caution that it has flour in this rulemaking, the agency has a common baseline. done so here only because of the close reviewed the evidence referenced in The results of the study showed that relationship of whole oat flour to the these comments, including the subjects consuming the whole grain oat substances that were the subject of the additional data submitted. The agency cereal experienced a significant proposal and the very narrow increment noted the similarity of whole oat flour decrease in total cholesterol (4.4 percent of evidence necessary to broaden the to rolled oats in terms of chemical and or 10.0 milligrams (mg)/deciliter (dL)) claim to include this substance. Given physical properties and type of and LDL-cholesterol (4.9 percent or 7.8 processing. After careful consideration the very tight timeframes that are mg/dL), and no significant difference in established by the statute, and the of the scientific evidence and the nature HDL-cholesterol, compared to the of the proposed health claim, FDA has agency’s interest in ensuring that placebo group. These results are scientifically valid claims are concluded that products made with consistent with the findings for oat bran whole oat flour from 100 percent oat authorized as quickly as possible, the and rolled oats, i.e., positive effects on agency cautions that it will not groats should be eligible to bear a claim. blood total- and LDL-cholesterol levels FDA originally proposed the health frequently be in a position to authorize in mildly hypercholesterolemic subjects claims about additional substances claim that is the subject of this adhering to a diet low in saturated fat rulemaking for oat bran and oatmeal (i.e, during the comment period. Thus, and cholesterol. Therefore, this study, rolled oats) because this was the claim interested people would be well along with evidence submitted by requested in the petition that began this advised, if they are aware of a substance comments showing compositional proceeding, and because the submitted that should be the subject of a health similarities between whole oat flour and evidence supported the relationship claim, to petition for authorization for a between the consumption of these foods rolled oats, provides sufficient evidence claim about the substance rather than and a reduced risk of CHD. However, for the agency to conclude that whole relying on the comment process to the agency did not conclude in its oat flour has the same effects relative to achieve that end. reduced risk of CHD as do oat bran and proposal that the effect was uniquely β rolled oats. Further, there is evidence 4. -glucan Soluble Fiber From Other that of oat bran and rolled oats, but Sources rather that the evidence submitted by that corroborates this conclusion that is the petitioner supported the provided by animal studies (Ref. 68). (Comment 4) relationship for these foods. The These animal studies addressed the Some comments, in noting the comments argued, and pointed to issue of retention of viscosity evidence to suggest that β-glucan evidence in the record as well as to characteristics during processing and soluble fiber is the component in oat evidence that they submitted that digestion. Because viscosity of intestinal bran and rolled oats responsible for supported their claim, that whole oat contents is known to be a critical factor their effect, further noted that the flour has a similar composition, and had in determining the ability of soluble evidence suggests that β-glucan soluble similar effects on blood cholesterol fibers to reduce the risk of CHD (Refs. fiber from other sources, such as barley levels, as oat bran and rolled oats. They 56, 72, and 73), and because viscosity is and oat gums, affects the risk of CHD in argued that, given these facts, it was the known to be affected by food processing the same way as β-glucan from the oat logical outgrowth of the proposal to procedures or, following ingestion, by bran and rolled oats (Refs. 61 through enlarge the substances that could be the the digestive system in ways that are 65, and 67). These comments requested subject of a claim as part of this final unpredictable (Refs. 56 and 65), that the proposed health claim be rule to include whole oat flour. evidence to demonstrate that the β- extended to any food product FDA notes that one study submitted glucan soluble fiber from whole oat containing a specified level of β-glucan with a comment examined the effect of flour retains the same level of viscosity soluble fiber from any source including whole oat flour-based cereal on serum in the digestive tract as does that from processed or novel sources of β-glucan lipids in mildly hypercholesterolemic rolled oats is crucial to the question of soluble fiber. Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3587

Several comments suggested that one FDA, therefore, lacks criteria for the same effects as that of β-glucan type of evidence to demonstrate that β- differentiating among those sources that soluble fiber from whole oats on the risk glucan soluble fiber from other food provide such effects and those that do of CHD. One comment discussed the sources can affect the risk of CHD is the not. This lack of evidence is of concern evidence for psyllium and its capacity studies showing similar effects on blood to the agency because, as discussed to affect serum lipid levels and thereby total- and LDL-cholesterol levels among previously, certain types of processing reduce the risk of CHD. These different β-glucan containing foods, may decrease the ability of the fiber to comments stated that, because other including barley and oats (Refs. 61 have the desired effect for reasons that soluble fibers and purified gums can through 65, and 67). Another comment are unpredictable and that vary from demonstrate cholesterol-lowering cited a study showing that variability in source to source. At the same time, it is effects, the agency should authorize a effects on serum cholesterol levels known that certain physical broad claim for soluble fibers and among different barley cultivars is characteristics related to the fiber’s reduced risk of CHD. associated with differences in amounts ability to maintain the viscosity of the Several comments suggested that of β-glucan soluble fiber (Ref. 64). intestinal contents must be present. consumers would benefit from a soluble While acknowledging that there is However, the extent to which this fiber and CHD claim in that it would be evidence suggesting that consumption capacity can be influenced by different consistent with dietary of β-glucan soluble fiber from a variety food sources or by processing is unclear. recommendations to consume diets high of food sources may help to lower blood Validated and accepted in vitro or in fiber and low in fat. However, some total- and LDL-cholesterol levels, and animal methods for identifying this of the comments noted that differences thus reduce the risk of CHD, the agency characteristic are not part of the in the source and method of processing disagrees that the claim should be administrative record for this whole oat β-glucan result in varied and extended at this time to all foods that rulemaking. unpredictable effects on the physical contain a specified amount of β-glucan Human clinical trials can be used to characteristics of the fiber, and that soluble from any source. The agency’s resolve these issues. However, in the these differences may apply to other decision to limit eligibility to bear a absence of clinical or other appropriate types of soluble fibers as well. The claim to oat bran, rolled oats, and whole types of data in the administrative comments stated that, therefore, a claim oat flour is based on several record, assumptions about the for soluble fiber and heart disease considerations. bioequivalence of all sources of β-glucan should only be extended to those First, the proposed subject of this soluble fiber cannot be made at this soluble fibers that have been rulemaking was oatmeal and oat bran time. demonstrated to reduce the risk factors and their effect on the risk of CHD. FDA In authorizing the claim for whole oat related to CHD. has examined in detail only the flour as a result of comments to the Another comment noted that, from a evidence for these oat products and proposal, FDA is relying on in vivo regulatory standpoint, a single claim on whole oat flour. Other food sources of (animal) studies as evidence of the the relationship between certain soluble β-glucan soluble fiber (oat and non-oat bioequivalence of whole oat flour fibers and heart disease would be more sources) have not been carefully relative to rolled oats. The agency feels manageable for the agency than would reviewed by FDA, nor has the totality of comfortable in doing so because there is be attempting to authorize individual the evidence on these other sources of a human study to demonstrate the health claims for all the different the fiber been submitted to the agency effectiveness of whole oat flour in soluble fiber sources that might be for review. Thus, the basis for including reducing the risk of CHD, as well as eligible to bear a CHD claim. The a wider range of food sources of β- information on the similarity in comment explained that, as other glucan beyond whole oats in the composition of whole oat flour to rolled soluble fibers are shown to qualify to regulation authorizing health claims is oats. It is unclear to what extent such in bear a soluble fiber/CHD claim, the not presented by the administrative vivo data from animal studies can be regulation could be amended to include record, and consideration of these other relied upon in the absence of the additional substance. sources is beyond the scope of this corroborating human data. FDA will FDA agrees with the comments that rulemaking. make decisions on this issue based on stated that there is evidence to suggest Nonetheless, the agency recognizes the totality of the available evidence. that consumption of a number of soluble that it is likely that consumption of Thus, future petitions for other sources fibers, in addition to β-glucan, affect other sources of β-glucan soluble fiber of β-glucan soluble fiber to be added as blood total- and LDL-cholesterol levels in addition to those that are the subject subjects of a health claim, which the and thus affect the risk of CHD. The of this rulemaking will affect blood agency anticipates receiving, should agency reviewed evidence to this effect cholesterol levels. For this reason, and specifically address the appropriateness, in evaluating the relationship between for reasons described elsewhere in this the protocol used to develop, and the total dietary fiber and CHD in the final document in response to related interpretation of, in vivo data from regulation published in the January 6, comments about other soluble fibers, animal studies in demonstrating 1993 Federal Register (58 FR 2552). The FDA is adopting a final rule that is bioequivalence among soluble fibers. agency noted, however, that there was structured so that it can be amended to some evidence that soluble fiber from establish a framework that will 5. Claims for Other Soluble Fibers different foods has different effects, and accommodate claims for other sources (Comment 5) that the analytical measure of soluble and types of soluble fibers and the risk Some comments stated that by fiber may not be adequately predictive of CHD. proposing the oat bran and rolled oats of its physiological effects (58 FR 2552 Second, there currently are no health claim, the agency has at 2562). Therefore, FDA encouraged generally accepted or validated criteria acknowledged that soluble fibers manufacturers to petition for a claim for for predicting which sources or themselves are an important functional their soluble fiber product if there was processed forms of β-glucan soluble component that affect serum lipid levels evidence to demonstrate that the fiber, beyond oat bran, rolled oats, and and thereby reduce the risk of CHD. particular soluble fiber-containing whole oat flour, are capable of reducing These comments suggested that other product is effective in lowering serum blood total- and LDL-cholesterol levels. soluble fibers have been shown to have lipid levels (58 FR 2552 at 2562). 3588 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations

Further, FDA agrees that its decision review the totality of evidence from can be used on the nutrition label under to authorize claims on the association other, non-oat sources of β-glucan § 101.9(c)(6)(i)(A). β-glucan is a between oat bran, rolled oats, and whole soluble fiber or other types of soluble technical term that presumably is not oat flour and CHD represents acceptance fiber, the agency finds that it is widely understood. that one type of soluble fiber, i.e., β- premature to authorize a broader claim Further, the agency has modified the glucan soluble fiber from whole oats, for ‘‘soluble fiber from certain foods.’’ regulation to reflect its decision to has been adequately shown The agency may, at some point, describe specifically the food substance scientifically to have this effect. decide to amend § 101.81 to cover types that is the focus of the claim and to list β However, while the agency agrees with of soluble fiber other than -glucan from the sources of β-glucan soluble fiber that the comments that there is considerable whole oats. If a manufacturer can have been shown to affect the risk of likelihood that a similar showing will be document, through appropriate studies, CHD. Thus, the agency has replaced the made for certain other soluble fibers, that a soluble fiber product has an effect discussion in proposed section (c)(2)(ii) based on the record now before the on blood total- and LDL-cholesterol on the presentation of the claim with a agency, it cannot take the steps levels, and thereby the product can be new discussion, ‘‘Nature of the suggested by the comments and broaden useful in reducing the risk of CHD, the substance: Eligible sources of soluble this claim. As the agency explained in manufacturer may petition to amend fiber.’’ This provision describes those the 1993 dietary fiber final rule, the § 101.81 to include that type of soluble sources of β-glucan soluble fiber that effect of individual soluble fibers needs fiber-containing product among the qualify for this claim. This section will to be documented on a case-by-case substances about which claims are be discussed in detail in section II.B., of basis. A concern about the ability of authorized. This case-by-case approach this document. is necessary because, as discussed in the particular soluble fibers to affect CHD Given the change in focus from oat oat bran and oatmeal proposal, soluble risk was expressed in several comments bran and rolled oats to soluble fiber fiber is a family of very heterogeneous to the oat bran and oatmeal proposal. As from whole oats, the agency is revising substances that vary greatly in their mentioned previously, those comments several sections of the proposed stated that only soluble fibers that have effect on the risk of CHD (61 FR 296). In summary, in its proposal, the regulation. First, the words ‘‘diets high been demonstrated to reduce serum in oatmeal and oat bran’’ has been lipids should qualify to bear a claim. agency was responding to a specific deleted from § 101.81(c)(2)(i) and The agency notes that a petition for petition to authorize claims about the reference to soluble fiber from whole soluble fiber from psyllium and risk of relationship between oat bran and rolled oats is being added, so that CHD is currently under consideration by oats and the reduced risk of CHD. In § 101.81(c)(2)(i) will read, relevant part, the agency. response to comments, however, FDA is As mentioned previously, in the 1993 now authorizing claims that describe ‘‘diets low in saturated fat and dietary fiber final rule, the agency the relationship between consumption cholesterol that include soluble fiber encouraged manufacturers to petition of only a specific type of soluble fiber, from whole oats.’’ The agency notes that for a health claim if the manufacturer β-glucan from whole oats, and reduced the statement ‘‘diets low in saturated fat could present scientific evidence to risk of CHD. and cholesterol and high in soluble fiber support the relationship between its As suggested by comments, on-going from * * *’’ cannot be used at this time soluble fiber product and risk of CHD research efforts are likely to build because the term ‘‘high’’ and its (58 FR 2552 at 2567). By encouraging support for the relationship between synonyms have been defined under manufacturers to petition for a more CHD and consumption of other soluble § 101.54(b) as meaning that the food specific health claim, the agency fibers not addressed in this rulemaking. contains 20 percent or more of the Daily implied that it would consider a new While the narrow focus of this Reference Value (DRV) per reference claim for those soluble fiber products rulemaking, and limitations on agency amount customarily consumed (RACC) that had been shown to affect the risk time and resources, preclude review of for a particular substance. There is no of CHD. However, the agency did not all such soluble fibers as part of this DRV for soluble fiber. While the agency commit to any particular course for how rulemaking, FDA will consider recognizes that it would be helpful to it would authorize health claims about amending § 101.81 to establish a encourage consumption of a specific a specific fiber source should it find framework that will allow the agency to amount of soluble fiber from whole oats, them to be justified. readily add the list of soluble fibers that it cannot do so in the absence of a DRV One way of doing so would be a can be the subject of a claim, as the for this nutrient. Therefore, the agency regulation about each particular evidence warrants. is wording § 101.81(c)(2)(i) to state that ingredient source of soluble fiber. This Therefore, in this final rule, FDA has the diet ‘‘include’’ soluble fiber from model is essentially the one that the revised the title of § 101.81 to read: whole oats, until such time that a DRV agency utilized in the proposal. An ‘‘Health claims; soluble fiber from for soluble fiber is established. The alternative approach would be to adopt whole oats and coronary heart disease.’’ agency intends to propose to establish a an umbrella regulation authorizing a For this health claim, the statement DRV for soluble fiber, and, once that claim for diets containing soluble fiber ‘‘soluble fiber from whole oats’’ is rulemaking is completed, assuming it from certain foods and CHD but intended to mean β-glucan soluble fiber results in a DRV, it plans to revisit the authorize the use of the claim for from whole oats. Based on information requirements in § 101.81 and propose specific food sources of soluble fiber provided in the petition and in some appropriate changes in the requirements only when consumption of those foods comments, the soluble fiber content of for the wording of the claim. Other has been demonstrated to help reduce whole oats is predominantly sections of the regulation that are the risk of heart disease. FDA agrees (approximately 87 percent or more) β- affected by these changes include with comments that this alternative glucan (Ref. 1, p. 22). Thus, the total § 101.81(a), (b), and (c)(2)(i)(D). mechanism would provide flexibility, soluble fiber content of whole oats Additionally, FDA has deleted the and that this flexibility may ultimately significantly reflects the β-glucan phrase ‘‘oat bran and oatmeal’’ in provide efficiency. However, based on present. Moreover, the term ‘‘soluble paragraphs (c)(2)(i)(A), (c)(2)(i)(E), the fact that it was not the agency’s fiber’’ is more familiar to consumers (d)(2), (d)(3), and (e) and replaced it charge, in responding to this petition to than ‘‘ β-glucan’’ because soluble fiber with the statement ‘‘diets low in Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3589 saturated fat and cholesterol that document. With the addition of 3 g per day, or that the nonlinear model include soluble fiber from whole oats.’’ paragraphs (c)(2)(i)(C) and (D), FDA has is a better statistical approach than is Other changes to the proposed redesignated proposed paragraphs the linear model. The data available regulation, in order of appearance, (c)(2)(i)(D) and (E) as paragraphs from the Davidson et al. study are include the following: the second (c)(2)(i)(E) and (F), respectively. insufficient to determine superiority of sentence of proposed § 101.81(a)(2) Section 101.81(d) contains optional the linear model compared to the states ‘‘* * * These populations also information that may be included in the curvilinear model. The results of the tend to have dietary patterns that are not claim. In paragraph (d)(4) of the studies that showed an effect of soluble only low in total fat, especially proposal, the agency proposed to permit fiber from oat bran, rolled oats, and saturated fat and cholesterol, but are manufacturers the option of describing whole oat flour, and the results of the also relatively high in fiber-containing oat bran and oatmeal as good sources of meta-analysis demonstrate that intakes fruits, vegetables, and grain products, soluble fiber. For the reason given of 3 g or more β-glucan are more likely such as oatmeal and oat bran.’’ The previously for the revision in paragraph to be effective. Thus, to use 2.5 g would agency is revising the last part of that (a)(3), the agency is deleting proposed be speculative, at best, and not sentence to read ‘‘* * * but are also paragraph (d)(4). FDA is replacing it supported by actual data. In contrast, relatively high in fiber-containing fruits, with new paragraph (d)(4), which states the use of 3 g per day is. Therefore, the vegetables, and grain products, such as ‘‘The claim may specify the name of the agency has concluded that, without whole oat products.’’ eligible soluble fiber.’’ Thus, the further data, there is no justification for Proposed § 101.81(a)(3) described oat manufacturer may refer to ‘‘beta-glucan concluding that 2.5 g per day is a more bran and rolled oats as good sources of soluble fiber’’ in the health claim. The appropriate estimate of the amount of β- soluble fiber and stated that scientific use of a specific soluble fiber name is glucan useful in reducing the risk of evidence demonstrates that these appropriate as optional information but CHD than is 3 g per day. products are associated with reduced is likely too technical to be of interest blood total- and LDL-cholesterol levels. to many consumers, and thus to require 7. Issues Related to a Food-specific In light of the changes in this final rule its inclusion in the claim would be Health Claim intended to focus on the relationship contrary to the agency’s desire to (Comment 7) between soluble fiber from whole oats provide for claims that are simple, Some comments stated that the and CHD, FDA has deleted the first concise, and easy for consumers to proposed claim for oat bran and oatmeal sentence in proposed § 101.81(a)(3) and understand. The rationale for this should not be authorized because it will revised the second sentence to state, change is discussed in more detail portray specific foods, i.e., oat products, ‘‘Scientific evidence demonstrates that under section II.D.4. of this document. as ‘‘magic bullets.’’ The comments diets low in saturated fat and β suggested that the claim would mislead cholesterol may reduce the risk of CHD. 6. Amounts of -glucan Soluble Fiber consumers in that it creates the Other evidence demonstrates that the Useful in Reducing the Risks of CHD impression that consumption of certain addition of soluble fiber from whole (Comment 6) foods (oat bran and oatmeal) alone will oats to a diet that is low in saturated fat One comment reexamined the data protect against CHD, and in that it and cholesterol may also help to reduce from the Davidson et al., study (Ref. 15) would not convey the concept that it is the risk of CHD.’’ Again, the agency concerning the level of β-glucan diets, not foods, that are important in notes that it realizes that information consumption per day that is needed to risk reduction. The comments suggested about the amount of soluble fiber from affect blood total cholesterol levels and that, as a result, consumers will be whole oats to consume would be helpful thereby reduce the risk of CHD. The discouraged from making other information for consumers, but until a results of the Davidson et al. study important, and perhaps more effective, DRV is established, such information suggested a dose-response relationship life-style changes to help reduce their cannot be provided. The agency has between the level of β-glucan intake and risk of CHD. Some comments suggested concluded that the statements in the amount of change in blood total that including reference to the diet in paragraph (a)(3) accurately represent the cholesterol. The petitioner presented the the claim will help prevent oat bran and relationship between diets low in data from this study in a linear rolled oats from appearing as ‘‘magic saturated fat and cholesterol and CHD regression model to show the change in bullets.’’ However, there were many and between soluble fiber from whole blood total cholesterol as a function of comments that stated that consumers oats and CHD. soluble fiber intake (Ref. 1, p. 26). The are aware that no one food is a ‘‘magic Proposed § 101.81(c)(2)(i)(C) linear regression model showed that an bullet’’ in reducing the risk of disease. described what the claim could state in estimated intake of 3 g per day soluble Other comments stated that a claim terms of a diet high in oat bran and fiber (i.e., β-glucan soluble fiber) is for an individual food, such as that oatmeal (paragraph (c)(2)(i)(C)(1)), and associated with a reduction in blood proposed for oat bran and oatmeal, is that the effect of a dietary intake of oat total cholesterol of about 5 percent. The appropriate and would also be helpful bran and oatmeal on risk of CHD was petitioner submitted the results of its to consumers because it would identify particularly evident when consumed as analysis as support for the conclusion products that contribute to healthy part of a diet low in saturated fat and that 3 g per day of β-glucan soluble fiber dietary practices. A few comments cholesterol (paragraph (c)(2)(i)(C)(2)). In is useful in affecting risks for CHD. expressed concern that consumers light of the change to a claim for soluble The comment stated that a nonlinear would inappropriately extrapolate from fiber from whole oats and the risk of model fits the data better than the the effects of consuming oat bran and CHD, FDA is deleting paragraph simple linear regression model. The rolled oats set out in the health claim (c)(2)(i)(C) and adding two new comment stated that, based on the and assume a similar effect for all foods paragraphs, (c)(2)(i)(C) and (D). These nonlinear model, 2.5 g/d β-glucan containing oat products, whether the new paragraphs list the terms for use in soluble fiber is necessary to lower blood foods are consistent with a total dietary specifying the soluble fiber and fat total cholesterol 5 percent. pattern for risk reduction of heart components of the claim (paragraphs The agency does not agree that there disease or not. The comments likened (c)(2)(i)(C) and (D), respectively) and are is sufficient evidence to conclude that this situation to the one that developed discussed further in this section of this 2.5 g per day is more appropriate than before the passage of the 1990 3590 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations amendments, when some high-fiber products that contain them. The agency product to be oat bran, it must have a food products bore a message from the stated that the β-glucan soluble fiber total β-glucan content of at least 5.5 National Cancer Institute suggesting that content of these products is an percent (dry weight basis (dwb)). As a there was a relationship between fiber appropriate marker for identifying the result of processing oat groats to oat and risk of cancer. There was a cholesterol-reducing potential of these bran, β-glucan soluble fiber is more proliferation of ingredient claims on products (61 FR 296 at 308) and concentrated. Therefore, oat bran products with trivial amounts of fiber. established levels for β-glucan in foods contains higher levels of this soluble A few comments stated that the that would qualify for the claim. fiber than rolled oats or oat flour. proposed claim for oat bran and oatmeal Based on its review of the comments, Some comments explained that the should be folded into the authorized however, the agency has concluded that level of β-glucan soluble fiber in rolled claim for fruits, vegetables, and grain β-glucan is the primary component of oats and oat flour more closely products and heart disease (i.e., whole oats that is responsible for the approximates the level of β-glucan in § 101.77). The comments stated that effect that consuming these foods has on oat groats. This level may range from 3 § 101.77 could be modified to permit the the risk of CHD. Therefore, the agency to 5 percent, depending on the specific terms ‘‘oat bran’’ and ‘‘oatmeal’’ in the has concluded that the substance- oat cultivar and on seasonal variation health claim. The comments explained disease relationship that is between crop years. One comment that § 101.77 already establishes the appropriately the subject of a claim is stated that the AACC had not adopted specific requirements for foods that that between β-glucan soluble fiber from a definition of rolled oats because the contain soluble fiber. The comments whole oats and CHD. To reflect this product, oatmeal, has been on the added that this would help prevent judgment, the agency has modified the market for over 100 years and is known individual foods, such as rolled oats, authorizing regulation to specify the to be a product made by rolling whole from appearing to be ‘‘magic bullets.’’ sources of β-glucan that are grain oats that have had 100 percent of The agency disagrees with the appropriately the subject of a claim. the hull removed. comments that stated that it should Section § 101.81(c)(2)(ii)(A) lists β- The agency is persuaded by the incorporate this health claim into the glucan soluble fiber and the whole oat comments that, based on the variability authorization for claims on the sources of this substance. It also sets out in β-glucan soluble fiber content of oat relationship between fruits, vegetables, the official Association of Official cultivars, a definition of the eligible and grain products and CHD (§ 101.77). Analytical Chemists International whole oat products that includes the β- Under § 101.77, soluble fiber is a marker (AOAC) method to be used to determine glucan soluble fiber content will help for identifying useful foods, but no the β-glucan content of the food. ensure that a source of whole oats that specific effect is attributed to the fiber. Paragraph (c)(2)(ii)(A) states that the bears a claim is consistent with those The claim that FDA is authorizing in eligible source of β-glucan soluble fiber shown in clinical studies to lower blood this proceeding is based on the is from the whole oat sources specified lipids. In its review of studies in the demonstrated effect of a certain type of in paragraphs (c)(2)(ii)(A)(1) through (3). proposal (61 FR 296 at 314), FDA soluble fiber (β-glucan soluble fiber) Paragraph (c)(2)(ii)(A)(1) lists oat bran, observed that the results of most of the from a specific food source (whole oats). paragraph (c)(2)(ii)(A)(2) lists rolled studies that failed to show a significant Therefore, the eligibility criteria and the oats, and paragraph (c)(2)(ii)(A)(3) lists effect of oat bran on serum lipids used scientific criteria set forth in § 101.81 whole oat flour. The totality of the oat bran that provided less than 5.5 are different from those set out in evidence establishes that consumption percent (dwb) of β-glucan soluble fiber § 101.77. The agency concludes, of these three sources of β-glucan (Refs. 13, 26, 27, 28, 36, and 41). For consequently, that the two claims soluble fiber as part of a diet that is low example, New Zealand oat bran was should not be combined. in saturated fat and cholesterol can described to contain β-glucan soluble The agency notes that, in this final reduce blood lipids and thus help fiber within a range of 3.7 to 4.4 percent rule, the relationship of whole oats to reduce the risk of CHD. (Ref. 26). In the studies that showed an reduced risk of heart disease is being effect of oat bran on serum lipid levels, described in terms of the total diet. As 1. Definition of Whole Oat Products the oat bran provided more than 5.5 discussed in more detail in response to In the proposal, the agency set out a percent (the exact amount cannot be comment 13 in section II.D.1. of this specific qualifying level of oat bran or determined in all studies) β-glucan document, diets low in saturated fat and rolled oats and β-glucan soluble fiber, (Refs. 8, 11, 12, 15, 17, 20, 23 through cholesterol are considered by expert i.e., 13 g of oat bran or 20 g or rolled 25, 29, 35, 39, and 42). groups to be the most effective dietary oats that provide 1 g of β-glucan soluble Thus, the agency agrees that adoption means of reducing heart disease risk fiber per RACC. of the AACC definition of oat bran (Ref. (Ref. 5). While soluble fiber from whole (Comment 8) 52), which requires that a product have oats can contribute to this effect, its role Some comments noted that the a total β-glucan content of at least 5.5 is generally recognized as being of variability in β-glucan soluble fiber percent (dwb) to qualify as oat bran, is smaller magnitude (Refs. 4 and 5). content of oat products may affect appropriate. This definition was Describing the relationship of a total whether these products qualify to bear developed to respond to the confusion diet low in saturated fat and cholesterol this claim. Several comments stated that among oat processors, as well as others that includes whole oats to the risk of to ensure that products contain the in industry and among home CHD will prevent the oat-containing appropriate amount of β-glucan soluble consumers, about a uniform identity of foods eligible to bear the claim from fiber, FDA needs to define oat bran the product that was receiving appearing to be ‘‘magic bullets.’’ because β-glucan soluble fiber levels widespread publicity with regards to its vary among cultivars. Most of these health benefits. Oat bran cannot be B. Specifications for the Nature of the comments encouraged adoption of the cleanly separated from the endosperm Food Substance Eligible to Bear the existing American Association of Cereal of oat groats (Ref. 52). Consequently, oat Claim Chemists’ (AACC) definition for oat bran contains some flour and is rich in In the proposal, the food substances bran. β-glucan soluble fiber, and debranned that were the subject of the claim were The comments pointed out that the oat flour contains some bran but oat bran and rolled oats and the AACC definition requires that for a contains significantly less β-glucan. Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3591

Consequently, it became essential that that there are other whole oat under § 101.81 because FDA is only the industry define what could be called substances, e.g., oat husks and fine oat authorizing claims on whole oat ‘‘oat bran.’’ It was the ‘‘rich’’ oat bran flour, that have not been shown to products. that has been used in clinical trials and provide this effect. Therefore, the agency finds that there that has been shown to lower serum 2. Testing of Oat Products to Ensure is no need for testing the physical lipids. β Retention of Characteristics properties of the -glucan soluble fiber Therefore, FDA is adding the AACC in processed products containing whole definition of oat bran (Ref. 52) to (Comment 9) grain oats. § 101.81(c)(2)(ii)(A)(1). It states that oat Some comments suggested that the bran is produced by grinding clean oat effect on blood lipids from consumption C. Nature of the Food Eligible to Bear groats or rolled oats and separating the of β-glucan soluble fiber from whole oat the Claim resulting oat flour by suitable means products is related to the molecular Proposed section § 101.81(c)(2)(iii)(A) into fractions, such that the oat bran weight and the solution viscosity of the β stated that for a food to be eligible to fraction is not more than 50 percent of -glucan. The comments stated that bear the claim, it must contain 13 g of the original starting material and processing methods can alter the size oat bran or 20 g oatmeal, and that the β β provides at least 5.5 percent (dwb) - and molecular weight of the -glucan oat bran or oatmeal must contain, molecule and may cause it to lose its glucan soluble fiber and a total dietary without fortification, at least 1.0 g of β- effect on blood cholesterol levels. The fiber content of 16 percent (dwb), and glucan soluble fiber per RACC. The comments suggested that to ensure that such that at least one-third of the total agency noted that consumption of 3 or the processed oat-containing food dietary fiber is soluble fiber. more g of oat β-glucan soluble fiber per product will provide the effects As discussed previously, there have day was associated with significant associated with the β-glucan soluble been no formally accepted definitions of reductions in blood total- and LDL- fiber in the starting material, i.e., oat the terms rolled oats and whole oat cholesterol levels. It tentatively bran, rolled oats, and whole oat flour, flour. However, based on data provided concluded that it is reasonable to the finished oat product should be in comments from fiber experts (Refs. 55 assume that a person could consume a tested to determine whether its β-glucan through 58), data from the U.S. total of at least 40 g oat bran, 60 g Department of Agriculture National soluble fiber has retained the physical oatmeal, or a combination of the two, to Nutrient Data Base (Ref. 75), and data properties, such as molecular weight, provide 3 g β-glucan soluble fiber in the provided in the petition (Ref. 1, p. 22 that it had in the starting material. course of three eating occasions a day. and Appendix II), the agency is The agency is not persuaded that providing general definitions for these there is a need for testing for the 1. Qualifying Criteria for Foods terms that reflect the type of whole oat molecular weight and solution viscosity (Comment 10) products used in clinical trials. As part of the β-glucan in products that contain of each definition, the agency is oat bran, rolled oat, or whole oat flour. Some comments agreed with the specifying the β-glucan soluble fiber and Although processing can produce proposal and emphasized that foods total dietary fiber contents of rolled oats extensive depolymerization of the β- should contain a significant amount of and whole oat flour that are required for glucan, oat bran and rolled oats were fed oat bran or oatmeal in order to qualify a product to qualify for this claim. to subjects in a variety of processed for this claim. A few comments stated In light of the evidence presented in foods as part of the scientific studies that the claim should be allowed only the proposal that some oat groats that evaluated the effects of these on foods for which a customary serving naturally contain low levels of β-glucan ingredients on blood cholesterol levels enables consumers to achieve the soluble fiber and, as a result, may not (see Table 1, 61 FR 296). Regardless of desired effect on the risk of disease (i.e., β have hypocholesterolemic properties, whether the whole oats were processed 3 g -glucan per serving of food). the agency finds it important to set a into cereals, muffins, breads, or other However, a number of comments minimum β-glucan content to ensure foods, or whether they were consumed suggested that it is unrealistic to assume the effectiveness of these oat products. hot or cold, the majority of oat products consumers will eat enough oat bran or In new § 101.81(c)(2)(ii)(A)(2), the significantly lowered blood lipids when oatmeal daily for the rest of their lives agency defines rolled oats, also known consumed as part of an appropriate diet. to lower their risk of cardiovascular as oatmeal, as a product produced from The agency noted that, in the few disease. 100 percent dehulled clean oat groats by studies that did not demonstrate Some comments suggested that the steaming, cutting, rolling, and flaking, cholesterol-lowering effects from the proposed qualifying levels of oatmeal, and that provides at least 4 percent consumption of oat bran or rolled oats, oat bran, and β-glucan were overly (dwb) of β-glucan soluble fiber with a the authors attributed the lack of an restrictive and prevented a number of total dietary fiber content of at least 10 effect to either the source of the oat important oat-containing foods from percent (Refs. 1, 55 through 58, and 75). cultivar, specifically a New Zealand bearing the claim. These comments In new § 101.81(c)(2)(ii)(3), the agency cultivar that had a low content of requested that the qualifying levels of is defining whole oat flour as a product soluble fiber (one case), or to an effect oat bran, oatmeal, or β-glucan be that is produced from 100 percent of processing to purify an extract of the lowered so that more products could dehulled, clean oat groats by steaming β-glucan soluble fiber (one case) (61 FR qualify to bear the claim. Several and grinding, such that there is no 296 at 305). Thus, the lack of an effect suggested that Americans are more significant loss of oat bran in the final in one of these cases was associated likely to increase their consumption of product, and that provides at least 4 with an unusually low level of β-glucan soluble fiber if they are presented with percent (dwb) of β-glucan soluble fiber in the oats. This problem is protected a wide variety of whole-grain oat- and 10 percent (dwb) total dietary fiber. against by the β-glucan content containing foods that may be eaten over FDA agrees with the comments that requirement in § 101.81(c)(2)(ii)(A)(1), the course of the day. The comments definitions to identify of the whole oat (2), and (3). In the other case, the lack suggested various qualifying levels for a substances that have been shown in of effect was associated with the use of food to bear the claim, ranging from 6 clinical studies to help reduce serum a highly processed oat gum extract. This to 15 g of oatmeal or from 4 to 11 g of lipids are important in light of the fact result does not represent a problem oat bran. 3592 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations

Some comments recommended deleted the requirement in proposed In this final rule, however, the agency setting only a level of β-glucan soluble § 101.81(c)(2)(iii)(A) that the food must has expanded the sources of whole oats fiber that must be contained in the food contain no less than 20 g oatmeal or 13 to include whole oat flour. Thus, many to qualify for this claim, rather than a g of oat bran that provides, without more whole oat-containing products level of oat bran or oatmeal as well as fortification, at least 1.0 g of β-glucan will be available to qualify to bear this a level of β-glucan soluble fiber. These soluble fiber and replaced it with a claim. This development increases the comments argued that the level of the β- requirement that focuses on the β- likelihood that whole oat products will glucan soluble fiber in the product is a glucan level. be consumed at four, instead of three, marker of the product’s usefulness in The agency has reviewed the eating occasions. Moreover, based on reducing the risk of CHD, and that if a discussions from the comments consumption data provided in a product contains the appropriate concerning the levels of β-glucan in a comment submitted by the petitioner, amount of β-glucan soluble fiber, it food. The agency disagrees with the whole oat products (including all oat should qualify to bear the claim no comments that suggested that the cereals, baked products, and snack matter how much oat bran or oatmeal it qualifying level of β-glucan soluble fiber foods) are consumed at four eating contains. The comments suggested a be low as 0.5 or 0.6 g per RACC to occasions a day, with breakfast being β range of qualifying -glucan levels from permit many more oat-containing the most popular time to consume oat β β 0.5 g -glucan to 3 g -glucan per products, e.g., crackers and cookies, to products (see Sup-1 to Docket No. 95P– serving. A number of different rationales qualify to bear the claim. As discussed 0197). Therefore, based on the expanded where presented in the comments to previously, an intake of 3 or more g of focus of this final regulation (to include justify these varying qualifying levels of β-glucan soluble fiber from whole oat whole oat flour) and on the additional β -glucan per serving. products is necessary to make a evidence from comments, the agency is One comment recommended a level significant impact on serum lipid levels. persuaded that the determination of the β β of 0.6 g -glucan soluble fiber per Using the minimum levels of β-glucan qualifying level of -glucan for a food to serving as the qualifying level instead of bear a claim should be based on four β soluble fiber for oat bran (5.5 percent) the proposed 1 g -glucan soluble fiber and rolled oats and whole oat flour (4 eating occasions a day (three meals plus because 0.6 g is more readily achievable percent) that the agency now specifies a snack) rather than on the proposed and thus would encourage the in new § 101.81(c)(ii)(A)(1) through (3) three. development of new soluble fiber- (see comment 8 in section II.B.1. of this The agency proposed a qualifying level of 1 g β-glucan soluble fiber per containing products. According to the document), products that contain a comment, this level is at least twice the serving based on the consumption of 3 minimum of 0.5 g β-glucan soluble fiber level of existing oatmeal-based bakery g per day (see comment 6 in section would contain about 9 g of oat bran or products such as cookies and crackers. II.A.6. of this document) distributed 12.5 g rolled oats or whole oat flour, or Some comments suggested that a over three eating occasions per day. a level between 9 and 12 g if a blend of qualifying level of 0.6 g β-glucan per Based on the same approach as that whole oats is used. To obtain a daily serving would make the qualifying used in the proposal, but adjusting it for intake of 3 g β-glucan from whole oats, criteria for this claim consistent with the increase in the number of servings it would require the consumption of six the authorized health claim for fruits, consumed per day, the intake of 3 g of or more servings. Similarly, if the oat β vegetables, and grain products and CHD. β -glucan is distributed over four Many comments stated that the products qualified with 0.6 g -glucan servings per day as part of four eating qualifying level of β-glucan soluble fiber soluble fiber, consumers would have to occasions (3 g divided by 4) and results per serving should not be based on three consume five or more servings of oat- in a criterion of 0.75 g per serving (i.e., servings of oat products per day but containing products daily. The agency RACC). rather on FDA’s usual basis of four finds that these levels of consumption, In providing for this qualifying level, eating occasions (three meals and a five or six or more servings per day, the agency wishes to point out that the snack) a day. The comments stated that highly unlikely. As mentioned in some approach used to derive the qualifying the agency did not adequately justify its of the comments, consumers should be level is somewhat different from that reliance on three eating occasions per able to consume a beneficial amount of used in authorizing other health claims. day, rather than on four. A few the nutrient based on typical American Specifically, the guiding principle for comments questioned whether eating patterns, i.e., four eating other health claims is to use the consumers would consume oatmeal and occasions per day. established definitions for ‘‘good other oat products three or four times a In the proposal, the agency source’’ or for ‘‘high’’ which day. One comment asked for evidence considered the number of eating characterize the amount of a nutrient that consumers will eat oat products occasions at which consumers might based on a percentage of the Daily Value three times a day every day. consume oat bran and rolled oats. The (DV) for the nutrient in a serving of As discussed earlier in this final rule, agency tentatively agreed with the food. In this way, products that qualify FDA has been persuaded that the petitioner’s arguments that it was to bear the claim contain a meaningful subject of the claim is appropriately β- unlikely that consumers would eat oat level of the substance per serving glucan soluble fiber from whole oats. bran or rolled oats 4 times a day, in compared to the recommended intake of Thus, to be eligible to bear the claim, a order to consume a daily intake of about the substance from all food sources. In food must contain the requisite amount 40 g oat bran or 60 g rolled oats, but that the case of this final rule, there is no DV of β-glucan soluble fiber from whole oat consumers should be able to consume for β-glucan soluble fiber or for soluble sources, rather than a specified amount this amount over three eating occasions fiber. of oat bran or rolled oats that provide a a day (61 FR 296 at 309). Based on the FDA has revised § 101.81(c)(2)(iii)(A) specific amount of β-glucan soluble petitioner’s submission, the agency to state ‘‘[T]he food shall contain at least fiber. considered that β-glucan soluble fiber 0.75 gram (g) per reference amount Given the changed focus of the final would come from only two sources, oat customarily consumed of whole oat regulation, the issues raised in the bran and rolled oats, which would limit soluble fiber from the eligible sources comments that addressed the levels of the number and types of products listed in paragraph (c)(2)(ii) of this oat bran and oatmeal are moot. FDA has available. section.’’ The statement in proposed Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3593

§ 101.81(c)(2)(iii)(A) regarding the suggesting that β-glucan be declared as bear the claim in the future, it is method for determining β-glucan a subcomponent of soluble fiber, the questionable whether requiring that the soluble fiber has been deleted because it comment also cited as precedent the consumers’ attention be drawn to a now appears under section new section regulation permitting β-carotene to be specific type of soluble fiber would be § 101.81(c)(2)(ii)(A) of this final rule, as declared as a subcomponent of vitamin helpful. The comment provided no discussed previously. A (§ 101.9(c)(8)(vi)). In addition, the information on how consumers would No comments were received on comment stated that the final regulation use and interpret such a declaration for proposed § 101.81(c)(2)(iii)(B) which should also permit optional declaration β-glucan. In the absence of such data, it requires that the food meet the nutrient of these nutrients elsewhere on the is difficult to conclude that declaration content requirements of § 101.62 for a label, consistent with § 101.13(i)(3). of β-glucan soluble fiber in the nutrition ‘‘low saturated fat,’’ ‘‘low cholesterol,’’ The agency has considered this label would assist consumers to any and ‘‘low fat’’ food. Therefore this comment in view of the previously greater degree than the declaration of paragraph is adopted without change, discussed conclusions concerning the soluble fiber. although it has been renumbered as food substance that is the subject of this Further, FDA notes that, as suggested § 101.81(c)(2)(iii)(C). claim, specifically β-glucan soluble fiber in the comment, declaration of soluble from whole oats. The suggestion in the fiber and β-glucan soluble fiber on the 2. Mixtures of Oat Products comment that soluble fiber be declared label other than in the Nutrition Facts (Comment 11) within the nutrition label is consistent panel, is permitted by § 101.13(i)(3). No Some comments stated that the with the change in focus of the claim additional authorization is needed for agency should allow a mixture of oat from oat bran and oatmeal to β-glucan such declarations. products that together within a single soluble fiber from whole oats. Since β- D. Provisions for Abbreviated and Full food product provide the total glucan is a soluble fiber, and the claim Claims qualifying level of β-glucan soluble fiber requires use of the term ‘‘soluble fiber,’’ to bear this claim. The comments stated FDA is requiring the declaration of the In addition to providing for a full that as long as the requisite amount of amount of soluble fiber per RACC or claim on the relationship between oat β-glucan soluble fiber is present, it labeled serving (which would include bran and rolled oats as part of a diet low should not matter if it is derived from the declaration of the amount of β- in saturated fat and cholesterol and risk a mixture. glucan) in the nutrition label in of CHD, the agency proposed an The agency agrees with this accordance with § 101.9(c)(6)(i)(A). In optional abbreviated claim. FDA suggestion and notes that it never this document, FDA is adding proposed in § 101.81(c)(2)(ii), intended not to allow a mixture of § 101.81(c)(2)(iii)(B), which reflects this ‘‘Presentation of the claim,’’ to provide whole oats to qualify for the proposed requirement. As a result of this action, that if a full statement of the claim claim. To clarify this fact, the agency FDA, as stated previously, is appears on a label or in labeling, other has revised § 101.81(c)(2)(iii) (Nature of redesignating proposed presentations of the claim may appear the food eligible to bear the claim) to § 101.81(c)(2)(iii)(B) as on the label or in labeling that do not state that the product must provide the § 101.81(c)(2)(iii)(C). include the information required in required level of soluble fiber per RACC FDA does not agree with the comment proposed § 101.81(c)(2)(i)(C)(2) as long from the eligible sources of whole oat that the specific amount of β-glucan as there is a referral statement from the soluble fiber listed in § 101.81(c)(2)(ii). should also be declared in the nutrition shortened to the full claim. The agency Therefore, a mixture of oat bran, rolled label. Declarations for β-carotene, which was concerned, however, about the oats, and whole oat flour may be used the comment uses as an analogy, are possibility that consumers may not read in a product that bears a claim so long made in terms of a percentage of the DV the complete claim, and thus that they as the product contains the requisite for vitamin A. In this case, there is no will not have all the facts necessary to amount of β-glucan soluble fiber per DV for soluble fiber or for β-glucan fully understand the significance of the RACC. soluble fiber. More importantly, use of claim and to comprehend the claim in the term ‘‘beta-glucan’’ as a subcategory the context of the daily diet. FDA asked 3. Nutrient Declaration for Soluble Fiber β of soluble fiber would likely be for data on whether the shortened claim and -glucan Soluble Fiber confusing to the consumer as ‘‘β- will affect the extent to which The agency proposed in § 101.81(d)(4) glucan’’ is primarily a technical term consumers read the full claim (61 FR that if the claim uses the term ‘‘soluble with which consumers are not familiar. 296 at 307). The agency also requested fiber,’’ which was to be optional, the Therefore, FDA is not providing for the comments on whether consumers will total soluble fiber content must be declaration of β-glucan on the nutrition be misled if the multifactorial nature of declared in the nutrition label, label. CHD is not stated as part of the claim consistent with § 101.9(c)(6)(i)(A). It should be noted that the agency is (61 FR 296 at 307). The agency proposed (Comment 12) making provision for optional label making optional the statement ‘‘a One comment suggested that the final statements in the claim relative to the disease caused by many factors.’’ rule require that the soluble fiber and β- amount of β-glucan considered useful in glucan contents of a food product reducing the risk of CHD (i.e., 3 g per 1. Appropriateness of Abbreviated bearing the health claim be declared in day) and to the contribution that one Claim and Wording of Full Claim nutrition labeling. The comment stated serving of the food makes toward (Comment 13) that, because β-glucan is the marker reaching the specified amount. As Many comments expressed concern nutrient in a qualifying product, it explained in section II.D.4. of this about the omission of reference to the should be included in the nutrition document, provision of this information diet in the proposed abbreviated claim. label. The comment cited other health is optional because of the agency’s Some comments suggested that the claim regulations specific to foods concerns about requiring long messages proposed abbreviated claim, which (rather than nutrients) (§§ 101.76 to and the possibility of consumer stated that ‘‘Diets high in [oat bran/ 101.78) as precedents for requiring information overload. Moreover, given oatmeal] may reduce the risk of heart declaration of the amount of the marker the potential for the broad range of disease,’’ will mislead consumers to nutrient in the nutrition label. In soluble fibers that may be eligible to think that the oat products will 3594 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations compensate for a diet that is high in as a referral (see § 101.14(d)(2)(iv)) to in reducing the risk of CHD and is saturated fat and cholesterol. The the full claim would serve both consistent with FDA’s conclusions in comments stated that other authorized consumer information needs and the authorizing the health claim for dietary health claims reinforce that overall motivational goals of the 1990 saturated fat and cholesterol and heart diets, not individual foods, can reduce amendments to encourage industry to disease (58 FR 2739, January 6, 1993). the risk of disease. Many comments use health claims on appropriate food Relative to the concerns about the stated that the abbreviated claim is products. appropriateness of the abbreviated misleading without the reference to a The agency proposed the abbreviated claim, the agency was mindful of those total diet that is low in saturated fat and claim because the petitioner requested comments that focused on concerns cholesterol. A few of the comments it, and because the agency tentatively about health claims being too wordy stated that the effects of oat bran or concluded that the information could be and too lengthy. This concern has been rolled oats on reducing the risk of CHD, more effectively communicated with an raised to the agency in various ways, in the absence of a low saturated fat and abbreviated claim in a prominent place including by a petition submitted by the cholesterol diet, is modest, so the with a referral to the full claim. The National Food Processors Association abbreviated claim may mislead agency did not intend for the (NFPA) (Docket No. 94P–0390). In consumers to think that eating oat abbreviated message to suggest to response to the NFPA petition, the products daily, without consuming a consumers that adding oats to the diet agency proposed several changes to the low saturated fat and cholesterol diet, was the only dietary modification requirements for health claims in the will significantly effect their risk of necessary to help them reduce the risk Federal Register of December 21, 1995 CHD. of CHD. (60 FR at 66206) (the 1995 proposal). At Some of the comments discussed diet The agency agrees with the comments that time, FDA stated that it had no as one of the more important modifiable that the dietary component of this desire for its regulations to risk factors for CHD. Many stated that a health claim is important for a complete unnecessarily stand in the way of the reference to the total diet should be a understanding of the relationship use of health claims and the mandatory part of the abbreviated claim. between the type of soluble fiber from presentation of the important The comments suggested that including whole oats and reduced risk of heart information contained therein. The reference to the diet in the claim will disease. FDA has been persuaded that agency stated that, while health claims help prevent oat bran and rolled oats there is the possibility that consumers are being used on the label and in from appearing to be ‘‘magic bullets.’’ may be misled if reference to the total labeling, they could be used more However, there were comments that diet were to be omitted in an extensively. The agency, therefore, stated that consumers are aware that no abbreviated version of this claim. Diets proposed to provide for shorter health one food is a ‘‘magic bullet’’ in reducing low in saturated fat and cholesterol are claims by making optional some of the the risk of disease. considered by expert groups to be the elements that are presently required. If Some of the comments stated that the most effective dietary means of reducing FDA finalizes the 1995 proposal as it agency did not present any data to show heart disease risk (Ref. 5). While soluble was proposed, many of the current full that consumers will read the full claim, fiber from whole oats can contribute to claims will be brief enough to permit which includes the statement on the this effect, its role is generally their use on the principal display panel. total diet, when it is located elsewhere recognized as being of smaller FDA is reviewing the comments on the food label relative to the received in response to the 1995 magnitude (Refs. 4 and 5). Selection of abbreviated claim. They concluded that proposal on changing the requirements foods with soluble fiber from whole oats consumers would be misled by the for health claims, but it has not is seen as a useful adjunct to selection limited information in the abbreviated completed its work on the final rule. of diets low in saturated fat and claim. Several comments stated that by Given that this proposal is pending, and cholesterol (Ref. 5). Therefore, the removing the qualifying portion of the given its relevance to many of the issues agency concludes that it would not be health claim (i.e., information about raised as a result of the proposal that is in the best interest of public health or total diet) from the most prominent the subject of this rulemaking, FDA has consistent with the scientific evidence location on the label, there was less decided to defer a decision on allowing to imply that selecting diets with likelihood this critical information for an abbreviated claim on β-glucan soluble fiber from whole oats is a would be read by consumers. soluble fiber from whole oats and the substitute for consuming diets low in Some comments supported FDA’s risk of CHD. The agency intends to saturated fat and cholesterol, and has proposal to permit use of an abbreviated resolve this matter in the context of the FDA revised § 101.81 to emphasize the health claim because it provided rulemaking based on the NFPA petition. flexibility and consumer-friendly importance of the diet. Proposed § 110.81(b)(2) stated, ‘‘* * * Thus, at this time, the agency is making language. Several comments in support provision only for a full claim. Thus, of the shortened claim mentioned its Scientific evidence demonstrates that diets high in oat bran and oatmeal and FDA has deleted proposed advantages in communicating § 101.81(c)(2)(ii), ‘‘Presentation of the information to consumers because it low in saturated fat and cholesterol are associated with lower blood total- and claim,’’ which provided for an was easily readable, compelling, and abbreviated claim, in this final rule. direct. The shortened claim was seen as LDL-cholesterol levels.’’ FDA has playing the role of a reminder to revised that sentence to state: 2. Research Study on the Abbreviated consumers about the core diet-disease * * * Scientific evidence demonstrates that Claim diets low in saturated fat and cholesterol are relationship that is the subject of the associated with lower blood total and LDL- (Comment 14) health claim. One comment cited cholesterol levels. Soluble fiber from whole A comment from the petitioner findings from FDA health claims focus oats, when added to a low saturated fat and included results from a consumer groups (Ref. 53), which reported that cholesterol diet, also helps to lower these research study that compared an consumers perceived full health claims blood levels and thus the risk of CHD. abbreviated oatmeal claim (‘‘A diet high as ‘‘too wordy, too vague, too academic, The revised statement emphasizes that in oatmeal may help reduce the risk of and much too long.’’ One comment consumption of a diet low in saturated heart disease’’) with a full fiber-heart stated the use of the abbreviated claim fat and cholesterol is an important factor disease health claim (‘‘Diets low in Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3595 saturated fat and cholesterol and high in and cholesterol’’ to the term ‘‘low fat.’’ claim, and replaced it with the grains, fruits and vegetables that contain No data were submitted to show that following model claim: ‘‘Soluble fiber fiber, particularly soluble fiber, may consumers would not be misled by such from foods such as [name of soluble reduce the risk of heart disease, a a simplification, and, as pointed out by fiber source from paragraph (c)(2)(ii) of condition associated with many comments, there is evidence that low fat this section or name of food product], as factors.’’) The data were from a national diets do not necessarily result in the part of a diet low in saturated fat and shopping mall intercept study of 826 benefits of low saturated fat diets. The cholesterol, may reduce the risk of heart consumers. Participants saw one of term ‘‘low fat’’ is defined in disease.’’ FDA has also deleted three mocked-up cereal packages that § 101.62(b)(iii)(2) as low in total lipid proposed § 101.81(e)(2) and (e)(2)(A) contained either the abbreviated claim, fatty acids. It therefore takes into and (B), which provided examples of the long claim, or no claim (control account not only saturated fat but also the shortened claim with the referral condition). polyunsaturated and monounsaturated statement, and replaced it with new The comment suggested that results fat. Further, the term does not include paragraph (e)(2), which gives another showed that the presence of either cholesterol. Therefore, the term ‘‘low example of a full claim. health claim, compared to the control fat’’ is not be sufficiently specific. Section 101.81(d) provides for condition, increased the number of optional information that the participants who recognized that a diet 4. Modifications of § 101.81 manufacturer may use to elaborate on high in oatmeal may help reduce the In light of the changes in this final the substance-disease relationship. New risk of heart disease. There were no rule to authorize a claim for diets low § 101.81(d)(4) states that the significant differences in terms of the in saturated fat and cholesterol that manufacturer may identify the specific impact of the claims on consumers’ include soluble fiber from whole oats, a type of soluble fiber that is the subject perceptions of the product or their number of additional modifications to of claim. For instance, the claim may beliefs about the diet-disease the proposed requirement for the claim state: ‘‘Beta-glucan soluble fiber from relationship. are required. whole oats, as part of a diet low in The data submitted by the petitioner The agency is revising saturated fat and cholesterol, may address issues related to the § 101.81(c)(2)(i)(A) to state that: ‘‘The reduce the risk of coronary heart interpretation of a specific abbreviated claim states that diets low in saturated disease.’’ The agency believes that the claim and are intended to provide fat and cholesterol that include soluble specification of β-glucan soluble fiber in support for an abbreviated claim on the fiber from whole oats ‘may’ or ‘might’ the wording of the claim is appropriate relationship that is the subject of this reduce the risk of heart disease.’’ as an option for the manufacturer but rulemaking. Because the FDA New § 101.81(c)(2)(i)(C) states: ‘‘In need not be a required component of the rulemaking that responds to the NFPA specifying the substance, the claim uses claim, because while scientifically petition is pending, the agency is the term ’soluble fiber’ qualified by correct, it may be information that is too deferring a final decision on whether to either the use of the name of the eligible technical for many consumers and thus make provisions for an abbreviated source of whole oat soluble fiber contrary to the agency’s desire to keep claim to describe this relationship. FDA (provided in (c)(2)(ii)) or the name of the the claim simple, concise, and easy for finds that there is nothing in this food product.’’ Examples of such consumers to understand. evidence that is sufficiently compelling statements are: ‘‘Soluble fiber from Proposed § 101.81(b)(2) stated, to persuade the agency that it is not whole oats * * *’’ and ‘‘Soluble fiber ‘‘Intakes of saturated fat exceed appropriate to defer this decision. from oatmeal * * *’’ In each case, the recommended levels in the diets of Therefore, the agency is forwarding the inclusion of information about the many people in the United States. petitioner’s comment and supporting source or the product qualifies the term Intakes of cholesterol are, on average, at data as a comment to the 1995 proposal soluble fiber so that the consumer is not or above recommended levels * * *.’’ (i.e., to Docket No. 94P–0390) so that misled to believe that all soluble fiber Based on recent data on cholesterol FDA can consider these results as part may reduce the risk of CHD. The intakes reported in the ‘‘Third Report on of that rulemaking. manufacturer may also clarify the Nutrition Monitoring in the United information for those product names States’’ (Ref. 77), which shows a 3. Use of ‘‘Low Fat’’ to Replace ‘‘Low in that do not indicate the name of the reduction in some cholesterol intake Saturated Fat and Cholesterol’’ soluble fiber source, for instance: levels, the agency has reconsidered (Comment 15) ‘‘Soluble fiber from the oat bran in this including of the second sentence and Two comments suggested that the product * * *.’’ has decided to delete it. statement ‘‘low in saturated fat and The agency is also adding new cholesterol’’ might be shortened to ‘‘low paragraph (c)(2)(i)(D), which states: ‘‘In 5. Multifactorial Nature of Disease fat’’ for the abbreviated claim only. specifying the fat component, the claim (Comment 16) These comments did not provide any uses the terms ′saturated fat′ and Several comments responded to data to show that consumers interpret ′cholesterol′.’’ This terminology is FDA’s question as to whether the statement ‘‘low fat’’ to mean ‘‘low in consistent with the authorized CHD consumers will be misled if the saturated fat and cholesterol.’’ health claims, §§ 101.75 and 101.77, multifactorial nature of CHD is not Another comment cautioned against regarding diets low in saturated fat and stated in the claim. These comments referring to a ‘‘low fat’’ diet because the cholesterol and risk of disease. supported the proposal to make optional scientific evidence showed that a low After careful consideration of the the statement ‘‘a disease caused by fat diet was not associated with reduced comments about claim wording and in many factors.’’ Several comments cited blood total cholesterol levels and hence view of the change in focus of the claim FDA Health and Diet Survey data that a reduced risk of CHD, while a diet low in response to comments, FDA has showed ‘‘American consumers in saturated fat and cholesterol did modified the model health claim understand that serious diseases like affect cholesterol levels. statements in § 101.81(e) to reflect the cancer and heart disease have multiple The agency finds that there is not changes it is making. Thus, FDA has causes, including factors such as diet, sufficient evidence to support deleted proposed paragraph (e)(1), heredity, smoking and stress’’ (Ref. 54). simplifying the term ‘‘low saturated fat which provided an example of a full One comment stated that consumers are 3596 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations sufficiently knowledgeable to appreciate FDA, therefore, concludes that the Another comment noted that in the that many factors affect risk of CHD, and information described in proposed regulation on implied nutrient content that a mandatory statement of this fact § 101.81(d)(8) be retained as optional claims (§ 101.65(c)(3)) and FDA’s would detract from the communication information, but the agency is discussion of implied claims in the of the core message because it would modifying the statement to reflect the January 6, 1993, final rule on nutrient make the claim longer, which would in change in the focus of the claim to β- content claims (58 FR at 2374), the turn deter manufacturers from using the glucan soluble fiber from whole oats. agency had provided that in some claim. Proposed paragraph (d)(8) has been contexts terms like ‘‘made with oat For the reasons set out in the proposal replaced with new § 101.81(d)(6), which bran’’ or ‘‘oat bran muffins’’ would be and in the absence of any objections to states: considered to imply that the food was the agency doing so, FDA has concluded A claim based on β-glucan soluble fiber a good source of dietary fiber. This that the statement ‘‘a disease caused by from whole oats may state that 3 g or more comment stated that once the health β many factors’’ should remain optional. per day of -glucan soluble fiber from whole claim appears on food labels, consumers FDA is adopting proposed paragraph oats may reduce the risk of CHD, provided will interpret the terms as implying the that the claim also states the contribution one (d)(1) without change. presence of a significant amount of β- serving of the product makes to this specified glucan soluble fiber consistent with the intake level for β-glucan soluble fiber. 6. Dietary ‘‘Context’’ of Claim message of the claim. The comment The amount of β-glucan per serving is (Comment 17) stated that, therefore, any such oat required here because without it, ingredient implied nutrient content Some comments stated that the consumers may be misled to believe that proposed claim would be misleading to β claim should be regulated as a claim the food contributes 3 g of -glucan about the amount of β-glucan soluble consumers because it provided no soluble fiber per serving. In making this indication of how much of the oat- fiber rather than as a more general claim provision, FDA wishes to point out that about dietary fiber. containing food would have to be if a variety of soluble fibers become consumed to reduce the risk of CHD. Recognizing that current FDA eligible to make this claim, it may be regulations do not permit ‘‘good source’’ One comment stressed the need for necessary to review and revise the explicit information in the health claim or ‘‘high in’’ claims about soluble fiber appropriateness of such ‘‘contextual.’’ in general or about β-glucan in about how much oat bran or oatmeal to As a result of this change, FDA has eat daily to affect the risk of disease, for particular, the comment suggested that renumbered proposed paragraphs (d)(6) FDA provide advice in this final rule example in terms of number of servings. and (d)(7) in the final regulation as The comment emphasized the need to that such claims could be made using paragraphs (d)(7) and (d)(8), the soluble fiber intake make it clear that the consumer should respectively. In the absence of recommendations cited in the regulation eat a certain amount every day in order comments on paragraphs (d)(7) and authorizing health claims about soluble- to benefit from consumption of these (d)(8), FDA has adopted these fiber containing fruits, vegetables, and foods. paragraphs without change. grain products and CHD (§ 101.77). In The agency agrees that consumers Proposed paragraph (d)(5) states: ‘‘The the preamble to the final rule may find ‘‘contextual’’ information, as claim may state that a diet low in establishing § 101.77 (58 FR 2573 well as additional information that saturated fat and cholesterol and high in through 2574), FDA had explained that specifies the nature of the relationship, oatmeal or oat bran is consistent with the 0.6 g soluble fiber eligibility helpful. However, in the absence of a ‘Nutrition and Your Health, Dietary criterion for bearing the claim derives DRV for soluble fiber, the agency cannot Guidelines for Americans,’ from 10 percent of the Life Science identify an amount of whole oat soluble * * *.’’ In light of the change in focus Research Organization (LSRO) fiber that represents a ‘‘good source’’ or of this claim to soluble fiber from whole recommended daily intake of soluble that is ‘‘high’’ in soluble fiber. Until the oats and in the absence of dietary fiber, i.e., about 6 g (Ref. 7). agency takes action to establish a DRV guidelines specific for soluble fiber, the Another comment disagreed with this for soluble fiber, it considers such agency is revising this statement to keep suggestion, however, stating that it information to be more appropriate as it consistent with ‘‘Dietary Guidelines would require decisions that are outside optional information. for Americans.’’ Therefore, the scope of this proposal. The comment The agency does not agree that § 101.81(d)(5) now states ‘‘* * * a diet stated that the proposal made no consumers would be misled if such low in saturated fat and cholesterol that mention of the possibility of a nutrient information were not provided, and the includes soluble fiber from whole oats’’ content claim regulation arising from mandatory inclusion of such optional is consistent with the dietary guidelines. the proposed health claim rule. In information would be inconsistent with addition, the comment stated that it the approach taken for other claims. For E. Other Comments would be speculative to conclude that the other authorized health claims, 1. Implied Claims any declaration (outside the ingredient §§ 101.72 through 101.80, the agency list) on the label of the whole oat has not required the level of detail (Comment 18) substance identified in the health claim suggested by these comments in the Some comments expressed concern regulation would constitute a nutrient wording of the claim. For example, the that, if FDA authorizes a health claim content claim. The comment stated that regulation authorizing health claims on that specifically mentions an oat the impact of label references to oats the relationship between diets low in ingredient, e.g., oat bran, oatmeal, or will depend on a variety of factors: The saturated fat and cholesterol and CHD whole oats, these terms will imply, extent of the market penetration of the does not require that the claim wherever they appear, that the food oats/CHD claim; the manner in which statement specify that saturated fat provides the effect described in the consumers who became aware of the should be less than 10 percent of claim. One comment suggested specific claim perceive that claim; whether the calories on a daily basis, or that limitations on how label statements claim leads consumers to become aware cholesterol should be limited to less about oat ingredients in a food could be of β-glucan at all; and whether they than 300 mg per day. FDA allows for the used, depending on the nature and consider it beyond its role as a marker optional provision of this information. amount of soluble fiber in the food. for measuring the effectiveness of oats Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3597 in improving serum cholesterol levels. needed, the agency can take action to This issue is outside the scope of this On the basis that this kind of establish appropriate regulations. rulemaking. This rulemaking addresses information is not available at this time, In addition, FDA advises that, as the question of whether to authorize a the comment opined that FDA should discussed previously in response to claim regarding the association between not adopt any final rules until it has comment 5 in section II.A.5. of this oat bran and rolled oats and the risk of more information on these issues. document, the agency intends to CHD. The process for amending a The agency agrees that a final propose to establish a DRV for soluble reference amount is set forth in § 101.12. fiber, which will provide the basis for regulation defining a nutrient content 4. Oat Gum Product claim is outside the scope of the nutrient content claims like ‘‘good proposal. FDA also agrees with the source of soluble fiber’’ and ‘‘high in (Comment 21) comment that it would be premature for soluble fiber.’’ The information in the One comment stated that, in the the agency to conclude that all comment recommending use of 6 g as proposal, the agency incorrectly declarations of relevant oat ingredients the DV can be fully evaluated in the concluded that the oat gum product on a food label (other than in the rulemaking to establish the DV for used in the study by Braaten et al. (Ref. 12), had not been characterized. The ingredient list) are implied claims. The soluble fiber. comment stated that the gum was regulation establishing general 2. Reference to Authoritative Bodies thoroughly described and characterized principles for health claims states that in other studies that were cited in the implied health claims ‘‘include those (Comment 19) One comment suggested permitting Braaten et al. study, and requested that statements, * * * that suggest, within the reference to third party authoritative FDA correct this statement to make clear context in which they are presented, bodies, including FDA, as part of the that the gum had in fact been that a relationship exists between the health claim. It was noted that in the characterized. The comment included a presence or level of a substance in the FDA health claims study (Ref. 53), copy of the studies but made no other food and a disease or health-related consumers expressed skepticism about request relative to consideration of these condition’’ (§ 101.14(a)(1)). In the health claims on food packages, in large data. preamble for that regulation (58 FR 2478 part because they did not realize health The agency acknowledges that the oat at 2483), FDA stated that it could not information on the front of the package gum used in the study by Braaten and establish a bright line definition of was regulated. coworkers was characterized in the implied health claims, and that labeling The agency advises that issues related information and studies submitted with claims needed to be considered in their to making specific provision for the comment (Refs. 56, 59, and 76). The entirety and in context to determine reference to authoritative bodies as part agency notes, however, that this whether the elements of a health claim of health claims statements is outside additional information was not are present. The agency took a similar the scope of this rulemaking. Under the submitted with the petition and was, position in the preamble of the final rule statute, FDA evaluates the relationship therefore, not part of the administrative establishing regulations for nutrient between a nutrient or food and a disease record available to the agency at the content claims (58 FR 2370 through being advanced as the subject of a time of the proposal. The studies 2374). In that document, FDA stated health claim. FDA authorization reflects submitted with the comment do not that whether a label statement is a a determination that there is significant alter the outcome of this final nutrient content claim will depend on scientific agreement that the rulemaking because oat gum, a purified the context in which it is presented, relationship is supported by the totality extract of oat bran, is not a whole grain taking the entire label into of publicly available data. Once a health oat product and was not one of the consideration. claim has been authorized by the substances that was the subject of the To change this position and find that agency, specific claims on labels are not petition. Although whole oat flour was terms such as ‘‘oat bran,’’ ‘‘rolled oats,’’ subject to prior review or approval not one of the substances in the petition, or ‘‘whole oat flour’’ are always in a because the agency does not approve the agency has included it in this final context that constitutes a nutrient specific claims (see section rule because it is a whole grain oat content or health claim, FDA would 3(b)(1)(A)(vii) of the 1990 amendments). product with similar nutritional need information that it does not have. Therefore, the agency does not agree properties to rolled oats, and there were The agency would need data showing that citing FDA as an authoritative body sufficient data in the administrative that consumers consistently interpret is appropriate. Under the general record from which to evaluate its these terms as implying the presence of physiological effectiveness. This type of β principles for health claims, a significant amount of -glucan, or that § 101.14(a)(1), the agency defines a evidence for purified oat gum is not consumption of the food will affect the health claim as including ‘‘third party’’ available in the administrative record. A risk of CHD. The comments did not references, so it does not object to the manufacturer may petition to amend provide this or any other kind of use of other third party endorsements, § 101.81 to include oat gum by information that FDA could use as a provided the food complies with all submitting such data. basis for the requested policy. requirements of the claim, and the While FDA remains concerned that III. Decision to Authorize a Health statement of endorsement is not false or Claim on the Relationship Between label statements not be misleading, it misleading. agrees with the comment that its policy Soluble Fiber From Whole Oats and of evaluating label statements on a case- 3. RACC CHD by-case basis provides adequate control. (Comment 20) FDA has considered all of the The agency reviews the entire label to One comment requested that FDA comments that it received in response to assess what emphasis is being placed on reevaluate its established RACC for its proposal to authorize a claim to the specific ingredients named. flavored instant oat products. The describe the relationship between oat However, if experience with label comment suggested that the RACC for bran and rolled oats and the risk of statements about oat ingredients or flavored sweetened hot cereals should CHD. The agency is authorizing this other information persuades FDA that be lowered from 55 g to 40 g which is claim although, based on comments, additional regulatory controls are the RACC for regular rolled oats. FDA has been persuaded to make a 3598 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations number of changes in the proposed impact on a substantial number of small 6. DHHS, PHS and the National Institutes provisions for the health claim. entities. of Health, ‘‘National Cholesterol Education FDA concludes that, rather than oat The authorization of health claims Program: Population Panel Report,’’ bran and rolled oats, the food substance about the relationship between β-glucan Bethesda, MD, 1989. that is the subject of the claim is β- soluble fiber from whole oats and CHD 7. LSRO, FASEB, ‘‘Physiological Effects and Health Consequences of Dietary Fiber,’’ glucan soluble fiber from whole oats. results in benefits and in costs only to Bethesda, MD, 1987. FDA further determines that the the extent that food manufacturers elect 8. Anderson, J. W., N. H. Gilinsky, D. A. relationship is scientifically valid in to take advantage of the opportunity to Deakins, S. F. Smith, D. S. O’Neal, D. W. that there is significant scientific use the claim. This rule will not require Dillon, and P. R. Oeltgen, ‘‘Lipid Responses agreement based on the totality of that any labels be redesigned, or that of Hypercholesterolemic Men to Oat-bran publicly available scientific evidence any product be reformulated. and Wheat Bran Intake,’’ American Journal of that β-glucan soluble fiber from whole The benefit of authorizing this type of Clinical Nutrition, 54:678–83, 1991. oats, as part of a diet low in saturated health claim is to provide for new 9. Anderson, J. W., D. B. Spencer, C. C. fat and cholesterol, may reduce the risk Hamilton, S. F. Smith, J. Tietyen, C. A. information in the market in the form of Bryant, and P. Oeltgen,‘‘Oat-bran Cereal of CHD. Decisions relating to provisions a claim linking consumption of soluble Lowers Serum Total and LDL Cholesterol in for an abbreviated version of the claim fiber from whole oats to the risk of CHD. Hypercholesterolemic Men,’’ American have been deferred and will be handled Costs will be incurred by small Journal of Clinical Nutrition, 52:495–499, in a separate rulemaking. entities only if they opt to take 1990. advantage of the marketing opportunity 10. Bartram, P., S. Gerlach, W. Scheppach, IV. Environmental Impact presented by this regulation. FDA F. Keller, and H. Kasper, ‘‘Effect of a Single The agency has previously considered cannot predict the number of small Oat Bran Cereal Breakfast on Serum the environmental effects of this rule as entities that will choose to use the Cholesterol, Lipoproteins, and announced in the proposed rule (61 FR claim. However, no firm, including Apolipoproteins in Patients with Hyperlipoproteinemia Type IIa,’’ Journal of 296). At that time, the agency small entities, will choose to bear the determined under 21 CFR 25.24(a)(11) Parenteral and Enteral Nutrition, 16:533– cost of redesigning labels unless they 537, 1992. that this action is of a type that does not believe the claim will result in 11. Beling, S., L. Detrick, and W. Castelli, individually or cumulatively have a increased sales of their product. ‘‘Serum Cholesterol Response to a Processed significant effect on the human Therefore, this rule will not result in Oat Bran Cereal Among environment. No new information or either a decrease in revenues or a Hypercholesterolemics on a Fat-modified comments have been received that significant increase in costs to any small Diet,’’ unpublished clinical trial submitted by would affect the agency’s previous entity. Accordingly, under the the Quaker Oats Co., 1991. determination that there is no Regulatory Flexibility Act, 5 U.S.C. 12. Braaten, J. T., P. J. Wood, F. W. Scott, M. S. Wolyneta, M. K. Lowe, P. Bradley- significant impact on the human 605(b), the Secretary certifies that this environment and that an environmental White, M. W. Collins, ‘‘Oat Beta-glucan final rule will not have a significant Reduces Blood Cholesterol Concentration in impact statement is not required. economic impact on a substantial Hypercholesterolemic Subjects,’’ European V. Analysis of Impacts number of small entities. Journal of Clinical Investigation, 48:465–474, 1994. FDA has examined the impacts of the VI. Paperwork Reduction Act 13. Bremer, J. M., R. S. Scott, and C. J. final rule under Executive Order 12866 This final rule contains no Lintott, ‘‘Oat Bran and Cholesterol and the Regulatory Flexibility Act (5 information collection or recordkeeping Reduction: Evidence Against Specific Effect,’’ U.S.C. 601–612). Executive Order 12866 requirements under the Paperwork Australia and New Zealand Journal of directs agencies to assess all costs and Reduction Act of 1995 (44 U.S.C. 3501 Medicine, 21:422–426, 1991. benefits of available regulatory et seq.). 14. Cara, L., C. Cubois, P. Borel, M. alternatives and, when regulation is Armand, M. Senft, H. Portugal, A. M. Pauli, necessary, to select the regulatory VII. References P. M. Bernard, and D. Lairon, ‘‘Effects of Oat Bran, Rice Bran, Wheat Fiber, and Wheat approach that maximizes net benefits The following references have been Germ on Postprandial Lipemia in Healthy (including potential economic, placed on display in the Dockets Adults,’’ American Journal of Clinical environmental, public health and safety Management Branch (address above) Nutrition, 55:81–88, 1992. effects; distributive impacts; and and may be seen by interested persons 15. Davidson, M. H., L. D. Dugan, J. H. equity). between 9 a. m. and 4 p. m., Monday Burns, J. Bova, K. Story, and K. B. Drennan, Executive Order 12866 classifies a through Friday. ‘‘The Hypocholesterolemic Effects of Beta- rule as significant if it meets any one of 1. The Quaker Oats Company, ‘‘Petition for glucan in Oatmeal and Oat Bran—A Dose- a number of specified conditions, Health Claim—Oat Products and Coronary controlled Study,’’ Journal of the American including having an annual effect on the Heart Disease,’’ March 22, 1995 [CP1]. Medical Association, 265(14):1833–39, 1991. economy of $100 million or adversely 2. Scarbrough, F. Edward, CFSAN, FDA, 16. Demark-Wahnefried, W., J. Bowering, and P. S. Cohen, ‘‘Reduced Serum affecting in a material way a sector of Letter to Ted Moeller, Quaker Oats Company, June 29, 1995. Cholesterol with Dietary Change Using Fat- the economy, competition, or jobs, or if 3. DHHS, Public Health Service (PHS), modified and Oat Bran Supplemented Diets,’’ it raises novel legal or policy issues. If ‘‘The Surgeon General’s Report on Nutrition Journal of the American Dietetic Association, a rule has a significant economic impact and Health,’’ U.S. Government Printing 90:223–9, 1990. on a substantial number of small Office, Washington, DC, 1988. 17. Gold, K. V. and D. M. Davidson, ‘‘Oat entities, the Regulatory Flexibility Act 4. National Research Council, National Bran as a Cholesterol-Reducing Dietary requires agencies to analyze regulatory Academy of Sciences, ‘‘Diet and Health,’’ Adjunct in a Young, Healthy Population,’’ options that would minimize the National Academy Press, Washington, DC, Western Journal of Medicine, 148:299–302, economic impact of that rule on small 1989. 1988. 5. DHHS, PHS and the National Institutes 18. Gormley, T. R., J. Kevany, J. P. Egan, entities. FDA finds that this final rule is of Health (NIH), ‘‘National Cholesterol and R. McFarland, ‘‘Investigation of the not a significant rule as defined by Education Program: Report of the Expert Potential of Porridge as a Executive Order 12866 and finds under Panel on Detection, Evaluation, and Hypocholesterolemic Agent,’’ Israel Journal the Regulatory Flexibility Act that the Treatment of High Blood Cholesterol in of Food Science and Technology, 2:85–91, final rule will not have a significant Adults,’’ NIH, Bethesda, MD, 1989. 1978. Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3599

19. He, J., M. J. Klag, P. K. Whelton, J-P. Kestin, M. Hegsted, D. M. Davidson, M. H. 46. Zhang, J. G. Hallmans, H. Andersson, Mo, J-Y. Chen, P-S. Mo, and G-Q. He, ‘‘Oats Davidson, L. D. Dugan, W. Demark- I. Bosaeur, P. Aman, P. Tidehag, R. Stenling, and Buckwheat Intakes and Cardiovascular Wahnefried, and S. Beling, ‘‘Oat Products E. Lundin, and S. Dahlgren, ‘‘Effect of Oat Disease Risk Factors in an Ethnic Minority of and Lipid lowering—A Meta-analysis,’’ Bran on Plasma Cholesterol and Bile Acid China,’’ American Journal of Clinical Journal of the American Medical Association, Excretion in Nine Subjects with Ileostomies,’’ Nutrition, 61:366–372, 1995. 267:3317–3325, 1992. American Journal of Clinical Nutrition, 20. Hegsted, M., M. M. Windhauser, K. 34. Saudia, T. L., B. R. Barfield, and J. 56:99–105, 1992. Morris, and S. B. Lester, ‘‘Stabilized Rice Barger, ‘‘Effect of Oat Bran Consumption on 47. Sempos, C. T., J. I. Cleeman, M. D. Bran and Oat Bran Lower Cholesterol in Total Serum Cholesterol Levels in Healthy Carroll, C. L. Johnson, P. S. Bachorik, D. J. Humans,’’ Nutrition Research, 13:387–398, Adults,’’ Military Medicine, 157:567–568, Gordon, V. L. Burt, R. R. Briefel, C. D. Brown, 1993. 1992. K. Lippel, and B. M. Rifkind, ‘‘Prevalence of 21. Kahn, R. F., K. W. Davidson, J. Garner, 35. Spiller, G. A., J. W. Farquhar, J. E. High Blood Cholesterol Among U.S. Adults. and R. S. McCord, ‘‘Oat Bran Gates, and S. F. Nichols, ‘‘Guar Gum and An Update Based on Guidelines from the Supplementation for Elevated Serum Plasma Cholesterol, Effect of Guar Gum and Second Report of the National Cholesterol Cholesterol,’’ Family Practice Research an Oat Fiber Source on Plasma Lipoproteins Education Program Adult Treatment Panel,’’ Journal, 10:37–46, 1990. and Cholesterol in Hypercholesterolemic Journal of the American Medical Association, 22. Kastan, H. H., S. Stern, D. J. A. Jenkins, Adults,’’ Arteriosclerosis and Thrombosis, 269:3009–3014, 1993. K. Hay, N. Marcon, S. Minkin, and W. R. 11:1204–1208, 1991. 48. Ross, Russell, ‘‘Atherosclerosis,’’ in Bruce, ‘‘Wheat Bran and Oat-Bran 36. Stewart, F. M., J. M. Neutze, and R. Cecil-Textbook of Medicine, J. B. Supplements’ Effects on Blood Lipids and Newsome-White, ‘‘The Addition of Oat Bran Wyngaarden, L. H. Smith, and J. C. Bennett, Lipoproteins,’’ American Journal of Clinical to a Low Fat Diet has no Effect on Lipid (editors), Harcourt Brace Jovanevich, Inc., Nutrition, 55:976–980, 1992. Values in Hypercholesterolaemic Subjects,’’ Philadelphia, p. 293, 1992. 23. Keenan, J. M., J. B. Wenz, S. Myers, C. New Zealand Medical Journal, 106:398–340, 49. Saltsman, Joyce J., CFSAN, FDA, Ripsin, and Z. Huang, ‘‘Randomized 1992. Memorandum to file, May 19, 1995. Controlled Cross-over Trial of Oat Bran in 37. Swain, J. F., I. L. Rouse, C. B. Curley, 50. DHHS and USDA, ‘‘Nutrition and Your Hypercholesterolemic Subjects,’’ Journal of and F. M. Sacks, ‘‘Comparison of the Effects Health: Dietary Guidelines for Americans,’’ Family Practice, 33:600–608, 1991. of Oat Bran and Low Fiber Wheat on Serum U.S. Gov. Printing Office, 273–930, 1990. 24. Kelley, M. J., J. Hoover-Plow, J. F. Lipoprotein Levels and Blood Pressure’’ New 51. Schultz, William B., FDA, Letter to Nichols-Bernhard, L. S. Verity, and H. B. England Journal of Medicine, 322:147–52, John R. Cady, National Food Processors Brewer, ‘‘Oat Bran Lowers Total and Low- 1990. Association, May 11, 1995. ¨ ¨ Density Lipoprotein Cholesterol but not 38. Torronen, R., L. Kansanen, M. 52. American Association of Cereal Uusitupa, O. Hanninen, O. Myllymaki, H. Chemists, Inc., ‘‘AACC Committee Adopts Lipoprotein in Exercising Adults with Harkonen, and Y. Malkki, ‘‘Effects of an Oat Oat Bran Definition,’’ Cereal Foods World, Borderline Hypercholesterolemia,’’ Journal of Bran Concentrate on Serum Lipids in Free- 34:1033–1034, 1989. the American Dietetic Association, 94:1419– living Men with Mild to Moderate 53. Levy, A., CFSAN, FDA, ‘‘Summary 1421, 1994. Hypercholesterolaemia,’’ European Journal of Report on Health Claims Focus Groups,’’ 25. Kestin, M., R. Moss, P. M. Clifton, and Clinical Nutrition, 46:621–627, 1992. June 15, 1995. P. J. Nestel, ‘‘Comparative Effects of Three 39. Turnbull, W. H. and A. R. Leeds, 54. Derby, B., CFSAN, FDA, Memorandum Cereal Brans on Plasma Lipids, Blood ‘‘Reduction of Total and LDL-cholesterol in to Victor Frattali, October 25, 1995. Pressure, and Glucose Metabolism in Mildly Plasma by Rolled Oats,’’ Journal of Clinical 55. Marlett, J. A., ‘‘Comparisons of Dietary Hypercholesterolemic Men,’’ American Nutrition and Gastroenterology,, 2:1–4, 1987. Fiber and Selected Nutrient Compositions of Journal of Clinical Nutrition, 52:661–6, 1990. 40. Grover, S. A., M. Abrahamowicz, L. Oat and Other Grain Fractions,’’ In: Oat Bran, 26. Leadbetter, J., M. J. Ball, and J. I. Mann, Joseph, C. Brewer, L. Coupal, S. Suissa, ‘‘The P. J. Wood (editor), published by the ‘‘Effects of Increasing Quantities of Oat Bran Benefits of Treating Hyperlipidemia to American Association of Cereal Chemists, in Hypercholesterolemic People,’’ American Prevent Coronary Heart Disease,’’ Journal of Inc., St. Paul, MN, p. 49–82, 1993. Journal of Clinical Nutrition, 54:841–845, the American Medical Association, 267: 816– 56. Wood, P. J., ‘‘Physiocochemical 1991. 822, 1992. Characteristics and Physiological Properties 27. Lepre, F. and S. Crane, ‘‘Effect of Oat 41. Uusitupa, M. I. J., E. Ruuskanen, E. of Oat (1–3), (1–4)-β-D-Glucan,’’ In: Oat Bran, Bran on Mild Hyperlipidaemia,’’ The Medical Makinen, J. Laitinen, E. Toskala, K. Kervinen, P. J. Wood (editor), published by the Journal of Australia, 157:305–306, 1992. and A. Kesaniemi, ‘‘A Controlled Study on American Association of Cereal Chemists, 28. Mackay, S. and M. J. Ball, ‘‘Do Beans the Effect of Beta-glucan-rich Oat Bran on Inc., St. Paul, MN, p. 83–112, 1993. and Oat Bran Add to the Effectiveness of a Serum Lipids in Hypercholesterolemic 57. Shinnick, F. L. and J. A. Marlett, Low-fat Diet?’’, European Journal of Clinical Subjects: Relation to Apolipoprotein E ‘‘Physiological Responses to Dietary Oats in Nutrition, 46:641–648, 1992. Phenotype,’’ Journal of the American College Animal Models,’’ In: Oat Bran, P. J. Wood 29. Marlett, J. A., K. B. Hosig, N. W. of Nutrition, 11:651–659, 1992. (editor), published by the American Vollendorf, F. L. Shinnick, V. S. Haack, and 42. Van Horn, L., L. A. Emidy, K. Liu, Y. Association of Cereal Chemists, Inc., St. Paul, J. A. Story, ‘‘Mechanism of Serum Liao, C. Ballew, J. King, and J. Stamler, MN, p. 113–138, 1993. Cholesterol Reduction by Oat Bran,’’ ‘‘Serum Lipid Response to a Fat-modified, 58. Vollendorf, N. W. and J. A. Marlett, Hepatology, 20:1450–1457, 1994. Oatmeal-enhanced Diet,’’ Preventive ‘‘Dietary Fiber Methodology and 30. O’Brien, L. T., R. J. Barnard, and J. A. Medicine, 17:377–386, 1988. Composition of Oat Groats, Brans, and Hall, ‘‘Effects of a High-Complex- 43. Van Horn, L., K. Liu, D. Parker, L. Hulls,’’ Cereal Foods World, 36:565–569, Carbohydrate Low-Cholesterol Diet Plus Bran Emidy, Y. Liao, W. H. Pan, D. Giumetti, J. 1991. Supplement on Serum Lipids,’’ Journal of Hewitt, and J. Stamler, ‘‘Serum Lipid 59. Wood, P. J., J. T. Braaten, F. W. Scott, Applied Nutrition, 37:26–34, 1985. Response to Oat Product Intake with a Fat- D. Riedel, and L. M. Poste, ‘‘Comparison of 31. O’Kell, R. T. and A. A. Duston, ‘‘Lack modified Diet,’’ Journal of the American Viscous Properties of Oat and Guar Gum and of Effect of Dietary Oats on Serum Dietetic Association, 86:759–764, 1986. the Effects of These and Oat Bran on Cholesterol,’’ Missouri Medicine, 85:726–728, 44. Van Horn, L., A. Moag-Stahlberg, K. Glycemic Index,’’ Journal of Agriculture and 1988. Liu, C. Ballew, K. Ruth, R. Hughes, J. Food Chemistry, 38:753–757, 1990. 32. Poulter, N., C. L. Chang, A. Cuff, C. Stamler, ‘‘Effects on Serum Lipids of Adding 60. Wood, P. J., J. T. Braaten, F. W. Scott, Poulter, P. Sever, and S. Thom, ‘‘Lipid Instant Oats to Usual American Diets,’’ K. D. Riedel, M. S. Wloynetz, and M. W. Profiles After the Daily Consumption of an American Journal of Public Health, 81:183– Collings, ‘‘Effect of Dose and Modification of Oat-based Cereal: A Controlled Crossover 88, 1991. Viscous Properties of Oat Gum on Blood Trial,’’ American Journal of Clinical 45. Whyte, J., R. McArthur, D. Topping, Glucose and Insulin Following an Oral Nutrition, 58:66–69, 1993. and P. Nestel, ‘‘Oat Bran Lowers Plasma Glucose Load,’’ British Journal of Nutrition, 33. Ripsin, C. M., J. M. Keenan, D. R. Cholesterol in Mildly Hypercholesterolemic 72:731–743, 1994. Jacobs, P. J. Elmer, R. R. Welch, L. Van Horn, men,’’ Journal of the American Dietetic 61. McIntosh, G. H., J. Whyte, R. McArthur, K. Liu, W. H. Turnbull, F. W. Thye, M. Association, 92:446–449, 1992. and P. J. Nestel, ‘‘Barley and Wheat Foods: 3600 Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations

Influence on Plasma Cholesterol Properties of Oat Fractions Enriched in (1 are not only low in total fat, especially Concentrations in Hypercholesterlemic 3)(1 4)-β-D-Glucan,’’ Cereal Chemistry, saturated fat and cholesterol, but are Men,’’ American Journal of Clinical 66:97–103, 1989. also relatively high in fiber-containing Nutrition, 53:1205–1209, 1991. (See 77. LSRO, FASEB, ‘‘Third Report on fruits, vegetables, and grain products, comments C–1177 and CR1). Nutrition Monitoring in the United States— such as whole oat products. 62. Chen, W. L., J. W. Anderson, and M. Executive Summary,’’ U.S. Government R. Gould, ‘‘Effects of Oat Bran, Oat Gum and Printing Office, Washington, DC, pp. ES–1– (3) Scientific evidence demonstrates Pectin on Lipid Metabolism of Cholesterol- ES–5, 1995. that diets low in saturated fat and Fed Rats,’’ Nutrition Reports International, cholesterol may reduce the risk of CHD. 24:1093–1098, 1981. List of Subjects in 21 CFR Part 101 Other evidence demonstrates that the 63. Fadel, J. G., R. K. Newman, C. W. Food labeling, Incorporation by addition of soluble fiber from whole Newman, and A. E. Barnes, oats to a diet that is low in saturated fat β reference, reporting and recordkeeping ‘‘Hypocholesterolemic Effects of -glucans in and cholesterol may also help to reduce Different Barley Diets Fed to Brolier Chicks,’’ requirements. Nutrition Reports International, 35:1049– Therefore, under the Federal Food, the risk of CHD. 1058, 1987. Drug, and Cosmetic Act and under (b) Significance of the relationship 64. Newman, R. K., S. E. Lewis, C. W. authority delegated to the Commissioner between diets low in saturated fat and Newman, R. J. Boik, and R. T. Ramage, of Food and Drugs, 21 CFR part 101 is cholesterol that include soluble fiber ‘‘Hypocholesterolemic Effect of Barley Foods amended as follows: from whole oats and risk of CHD—(1) on Healthy Men,’’ Nutrition Reports CHD is a major public health concern in International, 39:749–759, 1989. PART 101ÐFOOD LABELING the United States. It accounts for more 65. McIntyre, A., G. P. Young, T. Taranto, deaths than any other disease or group P. R. Gibson, and P. B. Ward, ‘‘Different 1. The authority citation for 21 CFR of diseases. Early management of risk Fibers have Different Regional Effects on Part 101 is revised to read as follows: Luminal Contents of Rat Colon,’’ factors for CHD is a major public health Gastroenterology, 101:1274–1281, 1991. Authority: Secs. 4, 5, 6 of the Fair goal that can assist in reducing risk of 66. Shinnick, F. L., J. M. Longacre, S. L. Packaging and Labeling Act (15 U.S.C. 1453, CHD. High blood total and LDL- Ink, and J. A. Marlett, ‘‘Oat Fiber: 1454, 1455); secs. 201, 301, 402, 403, 409, cholesterol are major modifiable risk Composition Versus Physiological Function 501, 502, 505, 701 of the Federal Food, Drug, factors in the development of CHD. in Rats,’’ Journal of Nutrition, 118:144–151, and Cosmetic Act (21 U.S.C. 321, 342, 343, (2) Intakes of saturated fat exceed 1988. 348, 351, 352, 355, 371). recommended levels in the diets of 67. Wang, L., R. K. Newman, C. W. 2. New § 101.81 is added to subpart E many people in the United States. One Newman, and P. J. Hofer. ‘‘Barley β-glucans Alter Intestinal Viscosity and Reduce Plasma to read as follows: of the major public health Cholesterol Concentrations in Chicks,’’ recommendations relative to CHD risk is § 101.81 Health claims: Soluble fiber from to consume less than 10 percent of Journal of Nutrition, 122:2292–2297, 1992. whole oats and risk of coronary heart 68. Gallaher, D. D., ‘‘Intestinal Contents disease (CHD). calories from saturated fat and an Viscosity of Rats Fed Oat-based Breakfast average of 30 percent or less of total Cereals,’’ Unpublished, November 26, 1996. (a) Relationship between diets low in calories from all fat. Recommended (See comment C-1412). saturated fat and cholesterol that daily cholesterol intakes are 300 69. Wood, P. J., J. T. Braaten, F. W. Scott, include soluble fiber from whole oats milligrams (mg) or less per day. K. D. Riedel, M. S. Wolynetz, and M. W. and risk of coronary heart disease—(1) Collins, ‘‘Effect of Dose and Modification of Scientific evidence demonstrates that Cardiovascular disease means diseases diets low in saturated fat and Viscous Properties of Oat Gum on Plasma of the heart and circulatory system. Glucose and Insulin Following an Oral cholesterol are associated with lower Glucose Load,’’ British Journal of Nutrition, Coronary heart disease (CHD) is one of blood total and LDL-cholesterol levels. 72:731–743, 1994. the most common and serious forms of Soluble fiber from whole oats, when 70. Reynolds, H. R., ‘‘The Effect of Whole cardiovascular disease and refers to added to a low saturated fat and Grain Oat Cereal on Serum Lipids,’’ diseases of the heart muscle and cholesterol diet, also helps to lower Unpublished study, 1996. (See comments C– supporting blood vessels. High blood blood total and LDL-cholesterol levels. 1197 and CR5). total cholesterol and low density (c) Requirements—(1) All 71. Ney, D. M., J. B. Lasekan, and F. L. lipoprotein (LDL)-cholesterol levels are requirements set forth in § 101.14 shall Shinnick, ‘‘Soluble Oat Fiber Tends to associated with increased risk of Normalize Lipoprotein Composition in be met. Cholesterol-fed Rats,’’ Journal of Nutrition, developing coronary heart disease. High (2) Specific requirements—(i) Nature 118:1455–1462. 1988. CHD rates occur among people with of the claim. A health claim associating 72. Gallaher, D. D., C. A. Hassel, and K. J. high total cholesterol levels of 240 diets low in saturated fat and Lee, ‘‘Relationships Between Viscosity of milligrams per deciliter (mg/dL) (6.21 cholesterol that include soluble fiber Hydroxypropyl Methylcellulose and Plasma (mmol/L)) or above and LDL-cholesterol from whole oats with reduced risk of Cholesterol in Hamsters,’’ Journal of levels of 160 mg/dL (4.13 mmol/L) or heart disease may be made on the label Nutrition, 123:1732–1738, 1993. above. Borderline high risk total or labeling of a food described in 73. Carr, T. P., D. D. Gallaher, C. H. Yang, cholesterol levels range from 200 to 239 and C. A. Hassel, ‘‘Increased Intestinal paragraph (c)(2)(iii) of this section, Contents Viscosity Reduces Cholesterol mg/dL (5.17 to 6.18 mmol/L) and 130 to provided that: Absorption Efficiency in Hamsters fed 159 mg/dL (3.36 to 4.11 mmol/L) of (A) The claim states that diets low in Hydroxypropyl Methylcellulose,’’ Journal of LDL-cholesterol. The scientific evidence saturated fat and cholesterol that Nutrition, 126:1463–1469, 1996. establishes that diets high in saturated include soluble fiber from whole oats 74. Gallaher, D. D., C. A. Hassel, K. J. Lee, fat and cholesterol are associated with ‘‘may’’ or ‘‘might’’ reduce the risk of and C. M. Gallaher, ‘‘Viscosity and increased levels of blood total- and LDL- heart disease; Fermentability as Attributes of Dietary Fiber cholesterol and, thus, with increased (B) In specifying the disease, the Responsible for the Hypocholesterolemic risk of CHD. claim uses the following terms: ‘‘heart Effect in Hamsters,’’ Journal of Nutrition, (2) Populations with a low incidence 123:244–252, 1993. disease’’ or ‘‘coronary heart disease’’; 75. USDA Nutrient Database for Standard of CHD tend to have relatively low (C) In specifying the substance, the Reference, Release 11, September, 1996. blood total cholesterol and LDL- claim uses the term ‘‘soluble fiber’’ 76. Wood, P. J., J. Weisz, P. Fedec, and V. cholesterol levels. These populations qualified by either the use of the name D. Burrows, ‘‘Large-Scale Preparation and also tend to have dietary patterns that of the eligible source of whole oat Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / Rules and Regulations 3601 soluble fiber (provided in paragraph clean oat groats by steaming and is consistent with ‘‘Nutrition and Your (c)(2)(ii)) of this section or the name of grinding, such that there is no Health: Dietary Guidelines for the food product; significant loss of oat bran in the final Americans,’’ U.S. Department of (D) In specifying the fat component, product, and provides at least 4 percent Agriculture (USDA) and Department of the claim uses the terms ‘‘saturated fat’’ (dwb) of β-glucan soluble fiber and a Health and Human Services (DHHS), and ‘‘cholesterol’’; total dietary fiber content of at least 10 Government Printing Office (GPO); (E) The claim does not attribute any percent (dwb). (6) A claim based on β-glucan soluble degree of risk reduction for CHD to diets (B) [Reserved] fiber from whole oats may state that an low in saturated fat and cholesterol that (iii) Nature of the Food Eligible to intake of 3 g or more per day of β-glucan include soluble fiber from whole oats; Bear the Claim. soluble fiber from whole oats may help and (A) The food shall contain at least reduce the risk of CHD, provided that (F) The claim does not imply that 0.75 gram (g) per reference amount the claim also states the contribution consumption of diets low in saturated customarily consumed of whole oat one serving of the product makes to this fat and cholesterol that include soluble soluble fiber from the eligible sources specified intake level for β-glucan fiber from whole oats is the only listed in paragraph (c)(2)(ii) of this soluble fiber; recognized means of achieving a section; (7) The claim may state that reduced risk of CHD. (B) The amount of soluble fiber shall individuals with elevated blood total- (ii) Nature of the substance. Eligible be declared in the nutrition label, and LDL-cholesterol should consult sources of soluble fiber. consistent with § 101.9(c)(6)(i)(A). their physicians for medical advice and (A) Beta (β) glucan soluble fiber from (C) The food shall meet the nutrient treatment. If the claim defines high or the whole oat sources listed below. β- content requirements in § 101.62 for a normal blood total- and LDL-cholesterol glucan soluble fiber will be determined ‘‘low saturated fat,’’ ‘‘low cholesterol,’’ levels, then the claim shall state that by method No. 992.28 from the ‘‘Official and ‘‘low fat’’ food. individuals with high blood cholesterol Methods of Analysis of the Association (d) Optional information—(1) The should consult their physicians for of Official Analytical Chemists claim may state that the development of medical advice and treatment; International,’’ 16th ed. (1995), which is heart disease depends on many factors (8) The claim may include incorporated by reference in accordance and may identify one or more of the information on the number of people in with 5 U.S.C. 552(a) and 1 CFR part 51. following risk factors for heart disease the United States who have heart Copies may be obtained from the about which there is general scientific disease. The sources of this information Association of Official Analytical agreement: A family history of CHD; shall be identified, and it shall be Chemists International, 481 North elevated blood total and LDL- current information from the National Frederick Ave., suite 500, Gaithersburg, cholesterol; excess body weight; high Center for Health Statistics, the National MD 20877-2504, or may be examined at blood pressure; cigarette smoking; Institutes of Health, or ‘‘Nutrition and the Center for Food Safety and Applied diabetes; and physical inactivity. The Your Health: Dietary Guidelines for Nutrition’s Library, 200 C St. SW., rm. claim may also provide additional Americans,’’ USDA and DHHS, GPO; 3321, Washington, DC, or at the Office information about the benefits of (e) Model health claim. The following of the Federal Register, 800 North exercise and management of body model health claims may be used in Capitol St. NW., suite 700, Washington, weight to help lower the risk of heart food labeling to describe the DC; disease; relationship between diets low in (1) Oat bran. Oat bran is produced by (2) The claim may state that the saturated fat and cholesterol that grinding clean oat groats or rolled oats relationship between intake of diets low include soluble fiber from whole oats and separating the resulting oat flour by in saturated fat and cholesterol that and reduced risk of heart disease: suitable means into fractions such that include soluble fiber from whole oats (1) Soluble fiber from foods such as the oat bran fraction is not more than 50 and reduced risk of heart disease is [name of soluble fiber source from percent of the original starting material through the intermediate link of ‘‘blood paragraph (c)(2)(ii) of this section or and provides at least 5.5 percent (dry cholesterol’’ or ‘‘blood total- and LDL- name of food product], as part of a diet β weight basis (dwb)) -glucan soluble cholesterol;’’ low in saturated fat and cholesterol, fiber and a total dietary fiber content of (3) The claim may include may reduce the risk of heart disease. 16 percent (dwb), and such that at least information from paragraphs (a) and (b) (2) Diets low in saturated fat and one-third of the total dietary fiber is of this section, which summarize the cholesterol that include soluble fiber soluble fiber; relationship between diets low in from [name of soluble fiber source from (2) Rolled oats. Rolled oats, also saturated fat and cholesterol that paragraph (c)(2)(ii) of this section or known as oatmeal, produced from 100 include soluble fiber from whole oats name of food product] may reduce the percent dehulled, clean oat groats by and coronary heart disease and the risk of heart disease. steaming, cutting, rolling, and flaking, significance of the relationship; and provides at least 4 percent (dwb) of (4) The claim may specify the name Dated: January 9, 1997. β-glucan soluble fiber and a total dietary of the eligible soluble fiber; William B. Schultz, fiber content of at least 10 percent. (5) The claim may state that a diet low Deputy Commissioner for Policy. (3) Whole oat flour. Whole oat flour in saturated fat and cholesterol that [FR Doc. 97–1598 Filed 1–22–97; 8:45 am] is produced from 100 percent dehulled, includes soluble fiber from whole oats BILLING CODE 4160±01±F