Food labeling: health claims; antioxidant vitamin A and beta-carotene and the risk in adults of atherosclerosis, coronary heart disease, and in cancers--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 A and beta-carotene and the risk in adults of atherosclerosis, coronary heart disease, amd certain cancers. 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; 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; 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; zinc and the body's ability to fight infection and heal wounds 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 zinc and the body's ability to fight infection and heal wounds in adults. 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 tht 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; chromium and the risk in adults of hyperglycemia and the effects of glucose intolerance--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 chromium and the risk in adults of hyperglycemia and the effects of glucose intolerance. 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; 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; 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; 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.     

Medical devices; implementation of third party review under the Food and Drug Administration Modernization Act of 1997; emergency processing request under OMB review--FDA. Notice

The Food and Drug Administration (FDA) is announcing a program under which persons may be accredited to review premarket notifications and recommend initial classification of certain medical devices. At the same time, FDA is announcing the termination of the Third Party Review Pilot Program. This notice announces the criteria to accredit or deny accreditation to persons (Accredited Persons) who request to conduct premarket notification reviews consistent with provisions of the FDA Modernization Act of 1997 (FDAMA). FDA is also announcing that this proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA is requesting OMB approval within 45 days of receipt of this submission. FDA is taking this action to implement section 210 of FDAMA. The availability of guidance detailing the review of submissions, training for third party reviewers, and basic document processing by FDA is announced elsewhere in this tissue of the Federal Register.     

Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.     

Medical devices; exemptions from premarket notification; class II devices; vascular tunnelers. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medical devices; exemption from premarket notification; class II devices; triiodothyronine test system. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Action of 1997 (FDAMA).     

Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.     

Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice

The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified.     

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.     

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.     

General and plastic surgery devices; classification of the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to issue new regulations pertaining to the dissemination of information on unapproved uses (also referred to as "new uses" and "off-label uses") for marketed drug, including biologics, and devices. The proposal, which would implement the dissemination provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA), would describe the content of and establish procedures for a manufacturer's submissions to FDA before it may begin disseminating information on the new use. The proposal also would describe how manufacturers seeking to disseminate new use information must agree to submit a supplement for that use within a specified period of time, unless a supplemental application already has been submitted or FDA has exempted the manufacturer from the requirement to submit a supplement. The proposal also would provide for requests to extend the time period for submitting a supplement for a new use, and it would describe how a manufacturer can seek an exemption from the requirement to submit a supplement. Additionally, the proposal would discuss FDA actions in response to manufacturer's submissions, corrective actions that FDA may take, and recordkeeping and reporting requirements.