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Food and Drug Administration
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===Regulations=== The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on [[Form 483]].<ref>{{Cite journal |date=November 21, 2022 |title=Inspection Observations |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations |journal=Fda.gov |language=en |access-date=January 14, 2023 |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114025900/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations |url-status=dead }}</ref> In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply".<ref>{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm |title=Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply |publisher=Food and Drug Administration | vauthors = Gottlieb S |date=June 19, 2018 |access-date=June 20, 2018 |archive-date=July 24, 2018 |archive-url=https://web.archive.org/web/20180724202237/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm |url-status=dead}}</ref> One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable.<ref>{{Cite web |title=Federal Register :: Request Access |url=https://unblock.federalregister.gov/ |access-date=January 14, 2023 |website=unblock.federalregister.gov |archive-date=June 5, 2023 |archive-url=https://web.archive.org/web/20230605020052/https://unblock.federalregister.gov/ |url-status=live }}</ref><ref>{{Cite journal | author = Center for Food Safety and Applied Nutrition |date=September 9, 2020 |title=Full Text of the Food Safety Modernization Act (FSMA) |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma |journal=FDA |language=en |access-date=January 14, 2023 |archive-date=September 12, 2018 |archive-url=https://web.archive.org/web/20180912032805/https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm |url-status=dead }}</ref> The FDA also uses tactics of regulatory shaming,<ref>{{Cite journal | vauthors = Yadin S |date=2019 |title=Regulatory Shaming |journal=Environmental Law (Lewis & Clark) |volume=49 |page=41 |ssrn=3290017}}</ref> mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018, the agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from [[generic drug]] companies.<ref>{{Cite journal | vauthors = Yadin S |date=2019 |title=Shaming Big Pharma |url=http://yalejreg.com/shaming-big-pharma/ |journal=Yale Journal on Regulation Bulletin |volume=36 |page=17 |access-date=May 18, 2019 |archive-date=May 18, 2019 |archive-url=https://web.archive.org/web/20190518100524/http://yalejreg.com/shaming-big-pharma/ |url-status=live}}</ref> The FDA frequently works with other federal agencies, including the [[United States Department of Agriculture|Department of Agriculture]], the [[Drug Enforcement Administration]], [[U.S. Customs and Border Protection|Customs and Border Protection]], and the [[U.S. Consumer Product Safety Commission|Consumer Product Safety Commission]]. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.<ref>{{Cite journal |date=October 7, 2022 |title=What does FDA regulate? |url=https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate |journal=FDA |language=en |access-date=January 14, 2023 |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114030432/https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate |url-status=dead }}</ref>
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