The Food and Drug Administration conducts economic analyses of all important proposed and final regulations. Each economic analysis includes an assessment of the costs, benefits, and cost-effectiveness of the action, as well as assessments of the costs, benefits and cost-effectiveness of the most promising alternative actions. The full economic impact analyses of significant FDA regulations are no longer (as of April 2012) published in the Federal Register but are available on this site.

To compare the effects of proposed regulations with the effects of promising alternatives, we estimate both the incremental benefits and costs associated with increasing the stringency of regulation and the incremental foregone benefits and cost savings associated with decreasing the stringency of regulation.

The information on incremental costs and benefits helps FDA management choose which controls to include and which to exclude when presented with the usual smorgasbord of ways to deal with a public health problem. The economic analysis may also point out ways to increase the cost-effectiveness of regulation. For example, the economic analysis may demonstrate that the incremental costs associated with a particular provision are very high, with little or no incremental public health effects. Identifying such provisions enables the FDA to revise proposed regulations in ways that substantially decrease costs without appreciably reducing public health benefits. 

Recent Regulatory Impact Analyses

2021

• Laboratory Accreditation for Analyses of Foods, Final Regulatory Impact Analysis - December 3, 2021
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Proposed Rule) Preliminary Regulatory Impact Analysis - December 2, 2021
• OTC Hearing Aids (Proposed Rule)- October 20, 2021
• Medical Device De Novo Classification Process (Final Rule) - October 5, 2021
• Premarket Tobacco Product Applications and Recordkeeping Requirements (Final Rule) Regulatory Impact Analysis - October 5, 2021
• Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Final Rule; Final Regulatory Impact Analysis - October 4, 2021
• Import Tolerances for Residues of Unapproved New Animal Drugs in Food (Final Rule) - September 21, 2021
• Regulations Regarding "Intended Uses" (Final Rule)- August 2, 2021

2020

• Revocation of the Human Tissue Intended for Transplantation Regulations and Human Dura Mater (Proposed Rule) - December 21, 2020
• French Dressing; Proposed Revocation of a Standard of Identity (Proposed Rule) Preliminary Regulatory Impact Analysis (PRIA) - December 21, 2020
• Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality (Proposed Rule) - December 18, 2020
• Importation of Prescription Drugs (Final Rule) - September 25, 2020
• Intended Uses (Proposed Rule) - September 23, 2020
• Requirements for Additional Traceability Records for Certain Foods (Proposed Rule) - September 23, 2020
• Revocation of the Test for Mycoplasma (Final Rule) - August 21, 2020
• Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods (Final Rule) - August 13, 2020
• Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices (Proposed Rule) - August 3, 2020
• Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) - July 29, 2020
• Annual Summary Reporting Requirements Under the Right to Try Act (Proposed Rule) - July 24, 2020
• Tobacco Products; Required Warnings for Cigarette Packages and Advertisements (Final Rule) - March 18, 2020
• Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (Final Rule) - March 6, 2020
• Definition of the Term “Biological Product” (Final Rule) - February 21, 2020

2019

• Importation of Prescription Drugs (Proposed Rule) - December 23, 2019
• Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications (Proposed Rule) - December 17, 2019
• Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Final Rule) - December 16, 2019
• Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format (Final Rule) - December 13, 2019
• Accreditation of Laboratories to Conduct Food Testing (Proposed Rule) - November 4, 2019
• Food Labeling: Calorie Labeling of Articles of Food Sold from Certain Vending Machines; Front of Package Type Size (Final Rule) - October 28, 2019
• Premarket Tobacco Product Applications and Recordkeeping Requirements (Proposed Rule) - September 25, 2019
• Amendment to Add a New Method for the Analysis of Sulfites in Foods (Proposed Rule) - September 17, 2019
• Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) - September 5, 2019
• Tobacco Products; Required Warnings for Cigarette Packages and Advertisements (Proposed Rule) - August 16, 2019
• New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food (Final Rule) - July 11, 2019
• Biologics License Applications and Master Files (Proposed Rule) - June 28, 2019
• Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Final Rule)  - April 12, 2019
• Proposed Rule to Revise the Allowable Level of Fluoride in Bottled Water to which Fluoride Has Been Added - April 03, 2019
• Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports (Proposed Rule) - April 02, 2019
• Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products (Final Rule) - April 2, 2019
• Elimination of 21 CFR 610.30 Test for Mycoplasma (Proposed Rule) - April 02, 2019
• Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection (Final Rule) - April 01, 2019
• Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems (Final Rule) - April 01, 2019
• 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 (Proposed Rule) - April 01, 2019
• Mammography Quality Standards Act; Amendments to Part 900 Regulations (Proposed Rule) - March 27, 2019
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E (Final Rule) - March 18, 2019
• List of Bulk Drug Substances That Can Be Used Compound Drug Products in Accordance With Section 503A of the Federal Food Drug and Cosmetic Act (Final Rule) - February 15, 2019
• Sunscreen Drug Products for Over-the-Counter Human Use; Proposal to Amend and Lift Stay on Monograph (Proposed Rule) -February 26, 2019

2018

• Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures (Final Rule) -December 17, 2018
• Definition of the Term "Biological Product" (Proposed Rule) -December 12, 2018
• Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Final Rule) -December 11, 2018
• Medical Device De Novo Classification Process (Proposed Rule) -December 07, 2018
• Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Proposed Rule) -November 15, 2018
• Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Final Rule) - December 11, 2018
• Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format (Proposed Rule) - September 13, 2018
• Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Proposed Rule) - September 12, 2018
• Food Labeling; Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size (Proposed Rule) - July 12, 2018
• Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories (Final Rule) - May 18, 2018
• Amendments to 21 CFR Part 3 - Product Jurisdiction (Proposed Rule) - May 15, 2018
• Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Compliance Dates (Final Rule)
• Crabmeat; Amendment of Common or Usual Name Regulation (Final Rule) - May 4, 2018
• Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses;" Partial Delay of Effective Date (Final Rule) - March 16, 2018
• Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices (Final Rule) - February 21, 2018
• Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Proposed Rule) - February 14, 2018
• Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by Center for Devices and Radiological Health (Proposed Rule) - January 17, 2018
• Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products (Proposed Rule) -January 26, 2018

2017

• New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator (Final Rule) - December 28, 2017
• Safety and Effectiveness for Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Final Rule) - December 20, 2017
• Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease (Proposed Rule) - October 31, 2017
• Nutrition Facts Label and Serving Size; Extension of Compliance Dates (Proposed Rule) - October 2, 2017
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E; Proposed Rule (Proposed Rule) - September 13, 2017
• Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date and Request for Comments (Interim Final Rule) - May 5, 2017
• Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products (Proposed Rule) - January 23, 2017
• Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" (Final Rule) - January 9, 2017

2016

• Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date (Final Rule) - December 30, 2016
• Postmarketing Safety Reporting for Combination Products (Final Rule) - December 20, 2016
• Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease (Interim Final Rule) - December 19, 2016
• General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet (Final Rule) - December 19, 2016
• Banned Devices; Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove (Final Rule) - December 19, 2016
• List of Bulk Drug Substances that can be used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act; Criteria and List (Proposed Rule) - December 16, 2016
• Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (Final Rule) - November 29, 2016
• Electronic Submission of Labeling for Certain Home-Use Medical Devices (Proposed Rule) - October 17, 2016
• Abbreviated New Drug Applications and 505(b)(2) Applications (Final Rule) - October 6, 2016
• Abbreviated New Drug Applications and 505(b)(2) Applications Use (Final Rule) -September 06, 2016 
• Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs (Final Rule) - August 31, 2016
• Good Laboratory Practice for Nonclinical Laboratory Studies - August 24, 2016
• Substances Generally Recognized as Safe (Final Rule) - August 17, 2016
• Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date - August 1, 2016
• Amendments to Registration of Food Facilities (Final Rule) - July 14, 2016
• Submission of FDA Import Data in the Automated Commercial Environment (Proposed Rule) - July 1, 2016
• Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph - June 30, 2016
• Use of Symbols in Labeling (Final Rule) - June 15, 2016
• Food Labeling: Revision of the Nutrition and Supplement Facts Labels (Final Rule) and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Final Rule) - May 27, 2016
• Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule) - May 26, 2016
• Antimicrobial Animal Drug Sales and Distribution Reporting (Final Rule) - May 11, 2016
• Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco May 10, 2016
• Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements (Final Rule) - May 10, 2016
• Banned Devices; Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior (Proposed Rule) - April 25, 2016
• Sanitary Transportation of Human and Animal Food (Final Rule) - April 6, 2016
• Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (Proposed Rule) - April 4, 2016 
• Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove (Proposed Rule) - March 22, 2016

2015

• Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Proposed Rule) - December 23, 2015
• General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products (Proposed Rule) - December 22, 2015
• Sunlamp Products; Proposed Amendment to Performance Standard (Proposed Rule) - December 22, 2015
• Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods (Proposed Rule) - November 18, 2015
• Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection (Proposed Rule) - November 17, 2015
• Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Final Rule) - November 13, 2015
• Foreign Supplier Verification Program (Final Rule) - November 13, 2015
• Standards for the Growing, Harvesting, Packing,and Holding of Produce for Human Consumption (Final Rule) - November 13, 2015
• General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet (Proposed Rule) - October 8, 2015
• Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" (Proposed Rule) - September 25, 2015
• National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions (Final Rule) - September 24, 2015
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Final Rule) - September 17, 2015
• FSMA Final Rulemaking for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Final Rule) - September 17, 2015
• Administrative Destruction of Certain Drugs Refused Admission to the United States (Final Rule) - September 15, 2015
• Food Labeling: Revision of The Nutrition and Supplement Facts Labels and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Proposed Rule) - July 27, 2015
• Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date (Final Rule) - July 10, 2015
• Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (Final Rule) - July 8, 2015
• The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements (Final Rule) - June 23, 2015
• Veterinary Feed Directive (Final Rule) - June 3, 2015
• Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (Final Rule) - May 22, 2015
• Antimicrobial Animal Drug Sales and Distribution Reporting (Proposed Rule) - May 20, 2015
• Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record (Proposed Rule) - May 1, 2015
• Designation of Official Names and Proper Names for Certain Biological Products (Proposed Rule) - May 1, 2015
• Amendments to Registration of Food Facilities (Proposed Rule) - April 9, 2015
• Abbreviated New Drug Applications and 505(b)(2) Applications (Proposed Rule) - February 6, 2015

2014

• Electronic Distribution of Prescribing Information for Human Prescriptions Drugs, Including Biological Products (Proposed Rule) - December 18, 2014
• Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling; Final Rule - December 4, 2014
• Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Final Rule) - December 1,  2014
• Food Labeling: Calorie Labeling of Articles of Food in Vending (Final Rule) - December 1, 2014
• FSMA Supplemental Notice of Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - September 29, 2014
• FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - September 29, 2014
• FSMA Supplemental Notice of Proposed Rulemaking for Foreign Supplier Verification Programs - September 29, 2014
• FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Supplemental Proposed Rule) - September 29, 2014
• Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products (Final Rule) July 10, 2014
• Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula (Final Rule) - June 10, 2014
• Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements (Final Rule) - June 10, 2014
• Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex (Final Rule) - May 30, 2014
• Administrative Detention of Drugs Intended for Human or Animal Use (Final Rule) - May 29, 2014
• Administrative Destruction of Certain Drugs Refused Admission to the United States (Proposed Rule) - May 6, 2014
• Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (Proposed Rule) - April 25, 2014
• Food Labeling: Revision of the Nutrition and Supplement Facts Labels (Proposed Rule) and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Proposed Rule) - March 3, 2014
• Medical Device Reporting: Electronic Submission Requirements (Final Rule) - February 14, 2014
• Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula (Interim Final Rule) - February 10, 2014
• Sanitary Transportation of Human and Animal Food (Proposed Rule) - February 5, 2014

2013

• Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule) - December 24, 2013
• Consumer Antiseptic Washes - December 17, 2013
• Veterinary Feed Directive - December 11, 2013
• Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products  - November 13, 2013
• Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Proposed Rule - November 4, 2013
• Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals - October 29, 2013
• Unique Device Identification System Final Rule - September 24, 2013
• Food Labeling; Gluten-Free Labeling of Foods - August 5, 2013
• Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors/ Certification Bodies - July 31, 2013
• Administrative Detention of Drugs Intended for Human or Animal Use - July 12, 2013
• Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex - June 19, 201
• Use of Certain Symbols in Labeling - April 19, 201
• Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products - February 26, 2013
• Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices - February 25, 201
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food - January 4, 2013
• Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption - January 4, 2013

2012

• Unique Device Identification System - November 19, 2012
• Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex - March 19, 2012

Resources For You

• Office of Planning
• Economics Staff