Emergency approvals (EUA) Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic.
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. 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". 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. The FDA also uses tactics of regulatory shaming, 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. The FDA frequently works with other federal agencies, including the
Department of Agriculture, the
Drug Enforcement Administration,
Customs and Border Protection, and the
Consumer Product Safety Commission. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.
Food and dietary supplements The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the
United States Congress and interpreted by the FDA. Pursuant to the
Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the
labeling of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods,
food additives, added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and
dietary supplements. Dietary supplements or dietary ingredients include vitamins, minerals, herbs,
amino acids, and
enzymes. Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the
Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating the safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having a satisfied requirement.
"FDA-Approved" vs. "FDA-Accepted in Food Processing" The FDA does not approve applied coatings used in the
food processing industry. There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like
Polytetrafluoroethylene (Teflon) are not and cannot be considered as FDA Approved, but rather, they are a "FDA Compliant" or "FDA Acceptable".
Medical countermeasures (MCMs) Medical countermeasures (MCMs) are products such as
biologics and
pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by the federal government. It helps support "partner" agencies and organisations prepare for
public health emergencies that could require MCMs.
Medications .|alt= The
Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different
excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to
new molecular entities: drugs that are not based on existing medications.
New medications New drugs receive extensive scrutiny before FDA approval in a process called a
new drug application (NDA). During the
first Donald Trump presidency, the agency worked to make the drug-approval process go faster.'''''' Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Drugs being produced by a new manufacturer can be approved through one of two faster processes: the
Abbreviated New Drug Application (ANDA) or the
505(b)(2) regulatory pathway for complex generic or biosimilar medications. Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of
ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.)
Advertising and promotion The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and the issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the
Federal Trade Commission. The FDA also implements regulatory oversight through engagement with third-party enforcer firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines. The drug advertising regulation contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether the drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term
off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising
COVID-19 vaccines during the period in which they had only been approved under
Emergency Use Authorization.
Post-market safety surveillance After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its
MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of
post-market safety surveillance, FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional
clinical trials, called Phase IV trials. In some cases, the FDA requires risk management plans called
Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that the drug is used safely. For example,
thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many
opioid drugs have REMS programs to avoid addiction and diversion of drugs.
Generic drugs Generic drugs are chemical and therapeutic equivalents of
name-brand drugs, normally whose patents have expired. This is called an
Abbreviated New Drug Application (ANDA). 80% of prescription drugs sold in the United States are generic brands.
Generic drug scandal In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the
United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of
Pittsburgh. When its application to manufacture generics was subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in
racketeering and violations of
antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications," and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancat, and Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drug makers, and two companies (
Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug
Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the
U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs, now deemed safe enough for use without a
medical practitioner's supervision, like
ibuprofen.
Ebola treatment In 2014, the FDA added an
Ebola treatment being developed by Canadian pharmaceutical company
Tekmira to the
Fast Track program, but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a
major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016.
Coronavirus (COVID-19) testing During the
coronavirus pandemic, FDA granted
emergency use authorization for
personal protective equipment (PPE), in vitro diagnostic equipment,
ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the
USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died.
Vaccines, blood and tissue products, and biotechnology The
Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a
Biologics License Application (BLA), similar to that for drugs. The original authority for government regulation of biological products was established by the 1902
Biologics Control Act, with additional authority established by the 1944
Public Health Service Act. Along with these Acts, the
Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the
National Institutes of Health; this authority was transferred to the FDA in 1972.
Medical and radiation-emitting devices .|alt= The
Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all
medical devices, as well as overseeing the manufacturing, performance, and safety of these devices. The definition of a medical device is given in the FD&C Act, and it includes products from the simple
toothbrush to complex devices such as implantable
neurostimulators. CDRH also oversees the safety performance of non-medical devices that emit certain types of
electromagnetic radiation. Examples of CDRH-regulated devices include
cellular phones,
airport baggage screening equipment,
television receivers,
microwave ovens,
tanning booths, and
laser products. CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.
"FDA-Cleared" vs "FDA-Approved" Clearance requests are required for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.
Cosmetics Cosmetics are regulated by the
Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see
Cosmeceutical). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect. According to the industry advocacy group, the
American Council on Science and Health, though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play a role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022,
President Biden signed the '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc.
Veterinary products The
Center for Veterinary Medicine (CVM) is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of
bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by the
United States Department of Agriculture.
Tobacco products The FDA regulates
tobacco products with authority established by the 2009
Family Smoking Prevention and Tobacco Control Act. This act requires color warnings on cigarette packages and printed advertising, and text warnings from the
U.S. surgeon general. The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of
R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration.
R.J. Reynolds,
Lorillard,
Commonwealth Brands,
Liggett Group and
Santa Fe Natural Tobacco Company have filed suit in
Washington, D.C. federal court claiming that the graphic labels are an
unconstitutional way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf. A
First Amendment lawyer,
Floyd Abrams, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny. The
Association of National Advertisers and the
American Advertising Federation have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged. In November 2011, federal judge
Richard Leon of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The
U.S. Supreme Court ultimately could decide the matter. In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes. The proposed regulation, identified as RIN 0910-AI76, titled
"Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products," seeks to reduce the nicotine content in cigarettes to approximately 0.7 milligrams per gram of tobacco.
Regulation of living organisms With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Ronald Sherman permission to produce and market
medical maggots for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device. In June 2004, the FDA cleared
Hirudo medicinalis (medicinal leeches) as the second living organism legal to use as a medical device. The FDA also requires that milk be
pasteurized to remove bacteria.
International Cooperation In February 2011, President
Barack Obama and Canadian prime minister
Stephen Harper issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness" and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries." Under the RCC mandate, the FDA and
Health Canada undertook a "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter
antihistamine ingredients (GC 2013-01-10)." A more recent example of the FDA's international work is their 2018 cooperation with regulatory and law-enforcement agencies worldwide through
Interpol as part of Operation Pangea XI. The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of
opioid,
oncology, and
antiviral prescription drugs to U.S. consumers. The agency focused on
transaction laundering schemes in order to uncover the complex online drug network. ==Science and research programs==