Food labeling: nutrient content claims, expansion of the nutrient content claim "lean". Final rule

The Food and Drug Administration (FDA) is amending its food labeling regulations for the expanded use of the nutrient content claim "lean" on the labels of foods categorized as "mixed dishes not measurable with a cup" that meet certain criteria for total fat, saturated fat, and cholesterol content. This final rule responds to a nutrient content claim petition submitted by Nestlé Prepared Foods Co. (Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). This action is also being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.     

Food labeling: health claims; soy protein and coronary heart disease. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is authorizing the use, on food labels and in food labeling, of health claims on the association between soy protein and reduced risk of coronary heart disease (CHD). Based on its review of evidence submitted with comments to the proposed rule, as well as evidence described in the proposed rule, the agency has concluded that soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of CHD by lowering blood cholesterol levels.     

Food labeling: health claims and labeling statements; dietary fiber and cancer; antioxidant vitamins and cancer; omega-3 fatty acids and coronary heart disease; folate and neural tube defects; revocation. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revoking its regulations codifying the agency's decision not to authorize the use of health claims for four substance-disease relationships in the labeling of foods, including dietary supplements: Dietary fiber and cancer, antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart disease, and the claim that 0.8 milligram (mg) of folate in dietary supplement form is more effective in reducing the risk of neural tube defects than a lower amount in conventional food. This action is being taken in response to a decision of the U.S. Court of Appeals for the D.C. Circuit invalidating these regulations and directing FDA to reconsider whether to authorize the four health claims. This action will result in the removal of the regulations but does not constitute FDA authorization of the four claims. FDA is completing its reconsideration of the claims and expects to issue decisions on all four claims by October 10, 2000.     

Food labeling: health claims; soluble fiber from certain foods and risk of coronary heart disease. Final rule

The Food and Drug Administration (FDA) is amending its regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease (CHD). The amendment exempts certain foods from the nutrient content requirement of "low fat." The exemption will apply if the food exceeds the "low fat" requirement due to fat content derived from whole oat sources. The amendment expands the use of this health claim to some whole oat products that are currently ineligible for the health claim. FDA is taking this action in response to a petition submitted by the Quaker Oats Co.     

Nutrition standards in the National School Lunch and School Breakfast Programs. Final rule

This final rule updates the meal patterns and nutrition standards for the National School Lunch and School Breakfast Programs to align them with the Dietary Guidelines for Americans. This rule requires most schools to increase the availability of fruits, vegetables, whole grains, and fat-free and low-fat fluid milk in school meals; reduce the levels of sodium, saturated fat and trans fat in meals; and meet the nutrition needs of school children within their calorie requirements. These improvements to the school meal programs, largely based on recommendations made by the Institute of Medicine of the National Academies, are expected to enhance the diet and health of school children, and help mitigate the childhood obesity trend.     

Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule,Treasury decision

TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.     

Food labeling: health claims; omega-3 fatty acids and the risk in adults of cardiovascular disease--FDA. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a claim relating to the relationship between omega-3 fatty acids and the risk in adults of cardiovascular disease. This interim final rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed statements that the petitioner submitted in that notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim because the statements submitted as the basis of the claim are not "authoritative statements" of a scientific body, as required by FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim. As provided for in section 301 of FDAMA, this interim final rule is effective immediately upon publication.     

Food labeling: health claims; calcium and osteoporosis, and calcium, vitamin D, and osteoporosis. Final rule

The Food and Drug Administration (FDA) is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis; eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and allow reference for the need of physical activity in either of the health claims to be optional rather then required. This final rule is, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness, LLC.     

Food labeling; nutrient content claims, definition of sodium levels for the term "healthy." Final rule

The Food and Drug Administration (FDA) is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim "healthy." The agency is retaining the currently effective, less restrictive, "first-tier" sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the "second-tier" (more restrictive) sodium level requirements for all food categories. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has determined that requiring the more restrictive sodium levels would likely inhibit the development of new "healthy" food products and risk substantially eliminating existing "healthy" products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term "healthy" will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients. The agency has also revised the regulatory text of the "healthy" regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for "healthy" into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.     

Food labeling: health claims; calcium consumption by adolescents and adults, bone density and the risk of fractures--FDA. Interim final rule

The Food and Drug Administration (FDA) is issuing this interim final rule to prohibit the use on foods of a claim relating to the relationship between calcium, bone density, and the risk of fractures. This interim final rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization act of 1997 (FDAMA). FDA is prohibiting the claim because section 303 of FDAMA does not apply when FDA has an existing regulation authorizing a health claim about the relationship between the nutrient and the disease or health-related condition at issue. A health claim concerning the relationship between calcium and osteoporosis is already authorized. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.     

Food labeling: health claims; dietary noncariogenic carbohydrate sweeteners and dental caries. Final rule

The Food and Drug Administration (FDA) is announcing its decision to authorize the use of a health claim regarding the association between sucralose and the nonpromotion of dental caries. Based on its review of evidence described in the proposed rule and comments submitted on the proposed rule, the agency has concluded that sucralose does not promote dental caries. Therefore, the agency has decided to amend the regulation that authorizes a health claim regarding noncariogenic carbohydrate sweeteners to include sucralose.     

Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.     

Food labeling: health claims; vitamin K and promotion of proper blood clotting and improvements in bone health in adults--FDA. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule too prohibit the use on foods of a health claim relating to relationships between vitamin K and the promotion of proper blood clotting and improvement in bone health in adults. This interim final rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed the notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim as a health claim because the claim does not characterize the relationship of the nutrient vitamin K to a disease or health-related condition, as required by section 303 of FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim as a health claim. Although the claim is not a health claim, it may be the type of claim permissible as a structure/function claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.     

Food labeling: health claims; D-tagatose and dental caries. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on sugar alcohols and dental caries, i.e., tooth decay, to include the sugar D-tagatose as a substance eligible for the dental caries health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); reimbursement of providers, claims filing, and participating provider program--Office of the Secretary, DoD. Final rule

This final rule implements provisions of the Department of Defense Appropriations Act, 1993, section 9011, which limits increases in maximum allowable payments to physicians and other individual professional providers (including clinical laboratories), authorizes reductions in such amounts for overpriced procedures, provides special procedures to assure beneficiary access to care, and establishes limits on balance billing by providers. Also, the final rule implements a provision of the National Defense Authorization Act for Fiscal Year 1992 that requires providers to file claims on behalf of CHAMPUS beneficiaries, builds into the CHAMPUS Regulation provisions that have been in effect for several years regarding the Participating Provider Program, and implements a new approach for CHAMPUS reimbursement for ambulatory surgery.     

Food labeling: health claims; garlic, reduction of serum cholesterol, and the risk of cardiovascular disease in adults--FDA. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a claim relating to the relationship between garlic, decreased serum cholesterol, and the risk in adults of cardiovascular disease. This interim final rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed the statement that the petitioner submitted in that notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim because the statement submitted as the basis of the claim is not an "authoritative statement" of a scientific body, as required by FDAMA; therefore, section 303 of FDAMA, does not authorize use of this claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.     

Food labeling: health claims; B-complex vitamins, lowered homocysteine levels, and the risk in adults of cardiovascular disease--FDA. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a claim relating to the relationship between B-complex vitamins (folic acid, vitamin B6, vitamin B12), lowering elevated serum homocysteine levels, and the risk in adults of cardiovascular disease. This interim final rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed statements that the petitioner submitted in that notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim because the statements submitted as the basis of the claim are not "authoritative statements" of a scientific body, as required by FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.     

Food labeling: health claims; dietary noncariogenic carbohydrate sweeteners and dental caries. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include isomaltulose as a substance eligible for the health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.     

Food labeling: health claims; antioxidant vitamins C and E and the risk of atherosclerosis, coronary heart disease, certain cancers, and cataracts--FDA. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a claim relating to the relationship between antioxidant vitamins C and E and the risk in adults of atherosclerosis, coronary heart disease, certain cancers, and cataracts. This rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed statements that the petitioner submitted in that notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim because the statements submitted as the basis of the claim are not "authoritative statements" of a scientific body, as required by FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.