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Browse 101 rules and proposed rules from the Federal Register.
101
Total Regulations
Showing 1–30 of 101
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The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Ecoflora Cares, c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in pet foods at levels consistent with good manufacturing practice.
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Kemin Industries, Inc., proposing that we amend our food additive regulations to provide for the safe use of chromium propionate as a source of chromium in food for layer and breeding chickens.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the methods of analysis regulation, which describes an FDA policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is issuing this action because the existing regulation is no longer necessary.
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule revoking the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture, and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards) at levels consistent with good manufacturing practice (GMP), to lower the heavy metal specifications for lead, arsenic, and mercury, and to add a specification for cadmium. We are taking this action in response to a color additive petition (CAP) submitted by GNT USA, LLC (GNT or petitioner).
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products under the jurisdiction of the United States Department of Agriculture (USDA), infant formula, or foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of the added color is authorized by such standards. We are taking this action in response to a color additive petition (CAP) submitted by Phytolon, Ltd. (Phytolon or petitioner).
The Food and Drug Administration (FDA, the Agency, or we) is classifying the electrical tongue nerve stimulator to treat motor deficits into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the electrical tongue nerve stimulator to treat motor deficits. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule "Medical Devices; Quality System Regulation Amendments" (QMSR Final Rule). This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform regulatory references, and ensure accuracy and clarity in the Agency's regulations.
The Food and Drug Administration (FDA, Agency, or we) is announcing the withdrawal of the proposed rule entitled "Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products," which published in the Federal Register of December 27, 2024. FDA is taking this action in response to comments received during the comment period for the proposed rule that warrant further consideration and assessment prior to issuing final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products pursuant to the Modernization of Cosmetics Regulation Act of 2022.
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Green Innovation GmbH, proposing that we amend our food additive regulations to provide for the safe use of hydrolyzed lignin as a source of neutral detergent soluble fiber in food for broiler chickens, laying hens, turkeys, growing swine, sows, lactating dairy cows, beef cattle, sheep, goats, salmonids, and adult dogs at no more than 1% of the food on a weight basis or 10 kilograms per metric ton of food.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the field generator positioning device into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anchored esophageal sheath into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the anchored esophageal sheath. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.
The Food and Drug Administration (FDA or we) is confirming the effective date of August 29, 2025, for the order that appeared in the Federal Register of July 15, 2025. The order amends the color additive regulations to provide for the safe use of gardenia (genipin) blue as a color additive, at levels consistent with good manufacturing practice (GMP), in sport drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy.
The Food and Drug Administration (FDA or we) is confirming the effective date of September 22, 2025, for the direct final rule published in the Federal Register of July 17, 2025, revoking 11 standards of identity for canned fruits and vegetable products that are no longer sold in the United States.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its prior notice regulation to add a requirement that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued ("post-refusal" and "post-hold" submission) or responses to requests for FDA review have been issued and beginning October 1, 2026, add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number. The rule will also finalize certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.
The Food and Drug Administration (FDA or we) is correcting a final rule entitled "New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address" that appeared in the Federal Register of August 22, 2025. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June of 2025. The final rule published with an inadvertent error. This document corrects that error.
On May 6, 2024, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule amending the definition of "in vitro diagnostic products" in FDA's regulations. On March 31, 2025, a federal district court vacated that rule. This final rule reverts to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.
The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.
The Food and Drug Administration (FDA) is making technical amendments to its radiological health regulations to correct an error. On January 20, 2023, FDA published a final rule entitled "Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products" that inadvertently deleted certain existing regulatory text from the Code of Federal Regulations. This action corrects the error by restoring the inadvertently deleted regulatory text. This action is editorial in nature and is intended to ensure accuracy and clarity in FDA's regulations by restoring inadvertently deleted regulatory text.
The Food and Drug Administration (FDA or we) is proposing to issue an order that would remove the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. Based on certification data, it appears that Orange B is no longer used for coloring the casings or surfaces of frankfurters and sausages and has not been certified for use as a color additive in food marketed in the United States since 1978. Because the authorized use of Orange B appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in yogurt and other cultured dairy products fermented with Lactobacillus delbrueckii, subspecies bulgaricus (L. delbrueckii, subsp. bulgaricus), and Streptococcus thermophilus (S. thermophilus) at a level higher than is currently permitted. We are taking this action in response to a food additive petition filed by General Mills, Inc. (General Mills or petitioner). We are also updating the reference for the vitamin D<INF>3</INF> specifications.
The Food and Drug Administration (FDA or we) is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. We are taking this action in response to a food additive petition filed by Cargill, Inc. (Cargill or petitioner).
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Biomin GmbH, proposing that we amend our food additive regulations to provide for the safe use of zearalenone hydrolase to degrade zearalenone in swine food at no less than 10 U/kg complete feed (U = the five-fold enzymatic activity that hydrolyzes 1 [micro]mol zearalenone per minute in a solution of 5 mg/L zearalenone).
The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Arthritis Advisory Committee (Committee). Due to that termination, this final rule removes the Committee from the Agency's list of standing advisory committees in 21 CFR 14.100.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the postnatal chromosomal copy number variation detection system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the postnatal chromosomal copy number variation detection system's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.