Food and Drug Administration
United States federal agency
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March 26 2025 | Marty Makary was appointed as Commissioner of Food and Drugs by President Donald Trump, becoming the 26th Commissioner. |
February 2025 | FDA food division head Jim Jones quit in protest of 89 staff layoffs by the Donald Trump administration. |
January 20 2025 | Robert Califf resigns as FDA Commissioner, with Sara Brenner becoming the acting commissioner following his departure. |
2022 | Politico published an article highlighting structural and leadership problems in the FDA's food division, suggesting the agency is not prioritizing food safety and may be overly influenced by industry lobbying. |
December 29 2022 | President Biden signed the '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', introducing stricter regulations for cosmetics. The new act requires compliance with serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). |
February 17 2022 | Robert Califf was reappointed as Commissioner of Food and Drugs by President Joe Biden. |
2020 | During the coronavirus pandemic, FDA granted emergency use authorization for critical medical supplies including personal protective equipment (PPE), in vitro diagnostic equipment, ventilators, and other medical devices to support the COVID-19 response. |
March 18 2020 | FDA postponed most foreign facility inspections and all domestic routine surveillance facility inspections in response to the coronavirus pandemic, adapting to the public health crisis. |
December 17 2019 | Stephen Hahn was appointed as Commissioner of Food and Drugs by President Donald Trump. |
April 5 2019 | Scott Gottlieb resigned as Commissioner, with Norman Sharpless serving as Acting Commissioner. |
2018 | FDA cooperated with Interpol and international regulatory and law-enforcement agencies in Operation Pangea XI, targeting 465 websites selling illegal and potentially dangerous prescription drugs, focusing on uncovering complex online drug transaction laundering schemes. |
2018 | FDA published an online 'black list' naming dozens of branded drug companies allegedly using unlawful or unethical means to impede competition from generic drug companies, employing a regulatory shaming tactic. |
December 2018 | National Capital Planning Commission approves a new master plan for FDA campus expansion. |
June 2018 | FDA released new guidelines to help food and drug manufacturers implement protections against potential attacks on the U.S. food supply, including the Intentional Adulteration (IA) rule requiring strategies to reduce risks in vulnerable facilities and processes. |
2017 | FDA Reauthorization Act passed, projecting a 64% increase in employees to 18,000 over the next 15 years. |
June 8 2017 | First FDA request in history to recall an effective drug (oxymorphone hydrochloride) over potential misuse. |
May 11 2017 | Scott Gottlieb was appointed as Commissioner of Food and Drugs by President Donald Trump. |
2016 | Additional implementation deadlines for FDA rules were set as part of the litigation settlement. |
February 22 2016 | Robert Califf was appointed as Commissioner of Food and Drugs by President Barack Obama. |
2015 | The FDA agreed to meet specific implementation deadlines for certain rules as part of the settlement with consumer groups. |
September 17 2015 | FDA published the final rule for mandatory preventive controls for food facilities, requiring food facilities to implement a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan, including evaluation of hazards, preventive steps, monitoring, record-keeping, and corrective actions. |
August 2015 | FDA planned to finalize proposed rules regarding alcoholic beverage facilities and spent grain regulation by August 2015. |
April 1 2015 | Margaret Hamburg's term ended, with Stephen Ostroff serving as Acting Commissioner. |
2013 | The FDA held its first public comment period for the Food Safety Modernization Act, receiving tens of thousands of comments from stakeholders. |
January 10 2013 | FDA and Health Canada initiated a 'first of its kind' regulatory alignment on common cold indications for certain over-the-counter antihistamine ingredients. |
2012 | Consumer groups Center for Food Safety (CFS) and the Center for Environmental Health sued the FDA for failing to meet implementation deadlines for the Food Safety Modernization Act. |
October 22 2012 | The US FDA updated its food facility registration system, requiring all facilities registered before October 1, 2012, to renew their registration. Failure to renew would result in prohibited entry for foreign products and illegal trade for domestic facilities. |
October 1 2012 | Deadline for facilities to be considered registered prior to the new FDA food facility registration system update. |
March 2012 | FDA's Senior Advisor Sherri McGarry reported on a pilot project to trace food products and prevent illnesses, identifying specific food items including tomatoes, frozen Kung Pao-style dishes, jarred peanut butter, and dry packaged peanut/spice products for tracing. |
2011 | One year after the Act's enactment, the FDA had fallen behind on expected progress, including implementing science-based produce standards, completing foreign supplier verification rules, and creating guidance for reducing allergy risks in schools. |
2011 | CDC estimated that annually 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, highlighting the critical need for improved food safety legislation. |
June 12 2011 | Food companies became required to develop comprehensive food safety plans, including hazard analysis, preventive controls, sanitation procedures, employee hygiene training, environmental monitoring, recall plans, supplier verification, and food allergen control programs. |
February 2011 | President Barack Obama and Canadian Prime Minister Stephen Harper issued a 'Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness', creating the Canada-United States Regulatory Cooperation Council (RCC) to increase regulatory transparency and coordination between the two countries. |
January 4 2011 | President Barack Obama signed the Food Safety Modernization Act (FSMA) into law, granting the FDA new regulatory powers over food production, including mandatory recall authority and comprehensive oversight of food growing, harvesting, and processing. |
2010 | The FDA Food Safety Modernization Act was signed into law alongside the Government Performance and Results Modernization Act. The initial five-year implementation was projected to cost $1.4 billion, though full funding was not secured at the time of signing. |
December 21 2010 | House of Representatives approves the Food Safety and Modernization Act with a vote of 215 to 144. |
December 19 2010 | Senate passes the corrected Food Safety and Modernization Act by unanimous consent via voice vote. |
November 2010 | Senate initially passes the Food Safety and Modernization Act with a 73-25 vote, but the vote is invalidated due to a tax provision constitutional issue. |
This contents of the box above is based on material from the Wikipedia articles FDA Food Safety Modernization Act, Commissioner of Food and Drugs & Food and Drug Administration, which are released under the Creative Commons Attribution-ShareAlike 4.0 International License.