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At least 127 records · Page 7Linked to original sources

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.

Adult↗

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.

Adolescent↗

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.

Dental Caries↗

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.

Adult↗

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.

Adult↗

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.

Adult↗

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.

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