food and drug law | Wex | US Law | LII / Legal Information Institute

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class="container-fluid"> <div class="row"> <div title="Definitions Frame"></div> <div id="extracted-content"> <div id="main-content"> <h1 class="title" id="page-title">food and drug law</h1>  <h2 class="element-invisible">Primary tabs</h2> <div id="content1"> <article about="/wex/food_and_drug_law" class="node-6387 node node-wex-cck en view-mode-full clearfix" typeof="sioc:Item foaf:Document"> <header> <span class="rdf-meta element-hidden" content="food and drug law" property="dc:title"></span> </header> <div class="field field-name-body field-type-text-with-summary field-label-hidden"> <div class="field-items"> <div class="field-item even" property="content:encoded"><p dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e95">Food production has been regulated in the United States since the mid–1800s. But it was not until 1906, when both the Food and Drug Act (</span><a href="https://www.law.cornell.edu/wex-cgi/wexlink?wexns=USC&wexname=21:1">21 U.S.C. 1 et seq.</a>) and the Meat Inspection Act (<a href="https://www.law.cornell.edu/wex-cgi/wexlink?wexns=USC&wexname=21:601">21 U.S.C. 601 et seq.</a>) were enacted, that the government took major steps to protect consumers. The Food and Drug Act <a href="https://www.law.cornell.edu/wex/prohibition">prohibited</a> <a href="https://www.law.cornell.edu/wex/interstate_commerce#:~:text=Interstate%20commerce%20is%20the%20general,or%20money%20across%20state%20borders.">interstate commerce</a> in misbranded and adulterated foods, drinks, and drugs. While it has since been repealed, new laws regulate a wide range of <a aria-label="Definitions - consumer" href="https://www.law.cornell.edu/definitions/uscode.php?width=840&height=800&iframe=true&def_id=15-USC-567770122-707328610&term_occur=999&term_src=#:~:text=The%20term%20%E2%80%9Cconsumer%E2%80%9D%20means%20an,representative%20of%20such%20an%20individual.">consumer</a> products.</p> <p dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e780-9084-11ef-b8c7-e9213680cfdc">The </span><a href="http://www.fda.gov/">Food and Drug Administration</a> (FDA) is one of the oldest consumer protection agencies in this country. Since 1979, it has been part of the <a href="http://www.hhs.gov/">Department of Health and Human Services</a>. It regulates products that account for over one fourth of all consumer spending. The FDA protects the public from unsafe foods to drugs and from medical devices to cosmetics. It also protects the <a href="https://www.law.cornell.edu/wex/right#:~:text=1.,2.">rights</a> and safety of patients in <a href="https://weillcornell.org/referring_physicians/clinical-trials#:~:text=Clinical%20trials%20are%20the%20principal,order%20to%20improve%20patient%20care.">clinical trials</a> of new medical products and monitors the promotional activities of drug and device manufacturers. The FDA even regulates the labeling of all packaged foods and the safety of the nation's blood supply.</p> <p dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e781-9084-11ef-b8c7-e9213680cfdc">Among important related laws passed in the United States are: the </span><a href="https://www.law.cornell.edu/uscode/html/uscode21/usc_sec_21_00000301----000-notes.html">Food Additives Amendment of 1957</a>, requiring the evaluation of food additives to establish safety; the Delaney Clause of 1958, forbidding the use of substances found in foods causing cancer in laboratory animals; the <a href="https://www.law.cornell.edu/uscode/text/21/chapter-9">Food, Drug, and Cosmetic Act of 1938</a>, regulating cosmetics and therapeutic devices; the <a href="https://www.law.cornell.edu/wex-cgi/wexlink?wexns=USC&wexname=21:360e">Kefauver–Harris Drug Amendments of 1962</a>, requiring drug manufacturers to show that their drugs were safe; and the <a href="https://www.law.cornell.edu/uscode/text/21/343-1">Nutrition Labeling and Education Act of 1990</a>, requiring all packaged foods to carry labels with nutrition information.</p> <h4 dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e782-9084-11ef-b8c7-e9213680cfdc">Federal Material</span></h4> <h5 dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e783-9084-11ef-b8c7-e9213680cfdc">U.S. Constitution and Federal Statutes</span></h5> <ul dir="ltr"> <li role="presentation"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e784-9084-11ef-b8c7-e9213680cfdc"><a aria-label="21 U.S.C." href="https://www.law.cornell.edu/wex-cgi/wexlink?wexns=USC&wexname=21">21 U.S.C.</a></span></li> <li role="presentation"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e785-9084-11ef-b8c7-e9213680cfdc"><a href="https://www.law.cornell.edu/anncon/search/index.html?query=food+and+drug+and+law">CRS Annotated Constitution</a></span></li> </ul> <h5 dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e786-9084-11ef-b8c7-e9213680cfdc">Federal Regulations</span></h5> <ul style="list-style-type:disc;"> <li aria-level="1" dir="ltr"> <p dir="ltr" role="presentation"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e787-9084-11ef-b8c7-e9213680cfdc"><a href="https://www.law.cornell.edu/cfr/cfr.php?title=21">Title 21 C.F.R.</a></span></p> </li> </ul> <h5 dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e788-9084-11ef-b8c7-e9213680cfdc">Federal Judicial Decisions</span></h5> <ul style="list-style-type:disc;"> <li aria-level="1" dir="ltr"> <p dir="ltr" role="presentation"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e789-9084-11ef-b8c7-e9213680cfdc">U.S. Supreme Court:</span></p> <ul style="list-style-type:disc;"> <li aria-level="2" dir="ltr"> <p dir="ltr" role="presentation"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e78a-9084-11ef-b8c7-e9213680cfdc"><a href="https://www.law.cornell.edu/supct/search/index.html?query=%28food+and+drug%29+or+drug+or+FDA">Recent Decisions on Food and Drug Issues</a></span> </p> </li> </ul> </li> </ul> <h4 dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e78b-9084-11ef-b8c7-e9213680cfdc">State Material</span></h4> <h5 dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e78c-9084-11ef-b8c7-e9213680cfdc">State Statutes</span></h5> <ul dir="ltr"> <li role="presentation"> <p><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e78d-9084-11ef-b8c7-e9213680cfdc"><a href="https://www.law.cornell.edu/topics/state_statutes.html#agriculture">State Statutes Dealing with Agriculture</a></span></p> </li> <li role="presentation"> <p><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e78e-9084-11ef-b8c7-e9213680cfdc"><a href="https://www.law.cornell.edu/topics/state_statutes.html#health">State Statutes Dealing with Health</a></span></p> </li> </ul> <h4 dir="ltr"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e78f-9084-11ef-b8c7-e9213680cfdc">Key Internet Resources</span></h4> <h5 dir="ltr" role="presentation"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e790-9084-11ef-b8c7-e9213680cfdc">Federal Agencies</span></h5> <ul style="list-style-type:disc;"> <li aria-level="2" dir="ltr"> <p dir="ltr" role="presentation"><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e791-9084-11ef-b8c7-e9213680cfdc"><a href="http://www.fda.gov/">U.S.Food and Drug Administration</a></span></p> </li> </ul> <p><span id="docs-internal-guid-b4bc085d-7fff-48de-34ce-afae620a5e958773e792-9084-11ef-b8c7-e9213680cfdc">[Last updated in May of 2023 by the</span><a href="https://www.law.cornell.edu/lii/about/lii_staff/wdt"> Wex Definitions Team</a>]</p> </div> </div> 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