dietary-foods

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TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
Presiding Officer for an Appeal and Informal Hearing; Technical AmendmentsRule2017-0535003/17/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of th … The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug Director, who is designated to preside over administrative appeals and at informal hearings on appeal, with references to Office of Regulatory Affairs Program Directors. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.presiding-officer-for-an-appeal-and-informal-hearing-technical-amendmentsFR-Doc-2017-05350
Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsRule2015-2815811/27/2015DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is adopting a regulation on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The regulation requires importers to verify that food they import into t … The Food and Drug Administration (FDA) is adopting a regulation on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The regulation requires importers to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA). The regulation will help ensure the safety of imported food.foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animalsFR-Doc-2015-28158
Reporting Information Regarding Falsification of DataProposed Rule2010-312302/19/2010DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study … The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.reporting-information-regarding-falsification-of-dataFR-Doc-2010-3123
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsRule07-303906/25/2007DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe 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 manufa … 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.https://www.federalregister.gov/documents/2007/06/25/07-3039/current-good-manufacturing-practice-in-manufacturing-packaging-labeling-or-holding-operations-forFR-Doc-07-3039
Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsRule07-303806/25/2007DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule ``Current Good Manufacturing Practice in Manufacturing, Pack … The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,'' published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.https://www.federalregister.gov/documents/2007/06/25/07-3038/petition-to-request-an-exemption-from-100-percent-identity-testing-of-dietary-ingredients-currentFR-Doc-07-3038
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary SupplementsProposed Rule03-540103/13/2003DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is proposing current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule would establish the minimum CGMPs necessary to ensure tha … The Food and Drug Administration (FDA) is proposing current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule would establish the minimum CGMPs necessary to ensure that, if you engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, you do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. The provisions would require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The proposed rule is one of many actions related to dietary supplements that we (FDA) are taking to promote and protect the public health.https://www.federalregister.gov/documents/2003/03/13/03-5401/current-good-manufacturing-practice-in-manufacturing-packing-or-holding-dietary-ingredients-andFR-Doc-03-5401
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