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The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), is an important United States Supreme Court case in the development of American administrative law. It ruled that the Food, Drug, and Cosmetic Act did not give the Food and Drug Administration (FDA) the authority to regulate tobacco products as "drugs" or "devices." This was later superseded by the Family Smoking Prevention and Tobacco Control Act, which granted the FDA the authority to regulate such products.
Candy cigarettes are a candy introduced in the late 19th century made out of chalky sugar, bubblegum or chocolate, wrapped in paper and packaged and branded so as to resemble cigarettes. Some products contain powdered sugar hidden in the wrapper, allowing the user to blow into the cigarette and produce a cloud of sugar that imitates smoke, which comes out of the other end.
A menthol cigarette is a cigarette flavored with the compound menthol.
The drug policy in the United States is the activity of the federal government relating to the regulation of drugs. Starting in the early 1900s the United States government began enforcing drug policies. These policies criminalized drugs such as opium, morphine, heroine, and cocaine outside of medical use. The drug policies put into place are enforced by the Food and Drug Administration and the Drug Enforcement Administration. Classification of Drugs are defined and enforced using the Controlled Substance Act, which lists different drugs into their respective substances based on its potential of abuse and potential for medical use. Four different categories of drugs are Alcohol, Cannabis, Opioids, and Stimulants.
The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.
The Family Smoking Prevention and Tobacco Control Act, is a federal statute in the United States that was signed into law by President Barack Obama on June 22, 2009. The Act gives the Food and Drug Administration the power to regulate the tobacco industry. A signature element of the law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking. The Act also bans flavored cigarettes, places limits on the advertising of tobacco products to minors and requires tobacco companies to seek FDA approval for new tobacco products.
The Tobacco Products Scientific Advisory Committee (TPSAC) is an advisory panel of the United States Food and Drug Administration organized to provide advice, information and recommendations to the FDA commissioner on matters related to the regulation of tobacco products. It was created in accordance to the Family Smoking Prevention and Tobacco Control Act, signed into law by President Barack Obama on June 22, 2009. The Committee was inaugurated during its March 30–31, 2010 meeting.
Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress. With this statute, the Food and Drug Administration (FDA) was given the ability to regulate tobacco products.
There are smoking cessation policy initiatives by the United States government at federal, state and local levels.
This article is about the history of the United States Food and Drug Administration.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
Regulation of electronic cigarettes varies across countries and states, ranging from no regulation to banning them entirely. As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.
The scientific community in United States and Europe are primarily concerned with the possible effect of electronic cigarette use on public health. There is concern among public health experts that e-cigarettes could renormalize smoking, weaken measures to control tobacco, and serve as a gateway for smoking among youth. The public health community is divided over whether to support e-cigarettes, because their safety and efficacy for quitting smoking is unclear. Many in the public health community acknowledge the potential for their quitting smoking and decreasing harm benefits, but there remains a concern over their long-term safety and potential for a new era of users to get addicted to nicotine and then tobacco. There is concern among tobacco control academics and advocates that prevalent universal vaping "will bring its own distinct but as yet unknown health risks in the same way tobacco smoking did, as a result of chronic exposure", among other things.
A modified risk tobacco product (MRTP) is a legal designation in the United States for a tobacco product that poses lower health risks to individual users and the population as a whole when compared to existing products on the market such as cigarettes. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) broad authority to regulate tobacco products; the FDA's power extends to approving or rejecting MRTP applications.
A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States. The first PMTA, and only to date, was approved by US FDA on November 10, 2015, when the FDA authorized the marketing of eight Swedish Match North America Inc. snus smokeless tobacco products.
Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
Food safety in the United States relates to the processing, packaging, and storage of food in a way that prevents food-borne illness within the United States. The beginning of regulation on food safety in the United States started in the early 1900s, when several outbreaks sparked the need for litigation managing food in the food industry. Over the next few decades, the United States created several government agencies in an effort to better understand contaminants in food and to regulate these impurities. Many laws regarding food safety in the United States have been created and amended since the beginning of the 1900s.
The minimum purchasing age for tobacco in the United States before 2022 varied by state and territory. Since December 20, 2019, the smoking age in all states and territories is 21 after federal law was passed by Congress and signed by former President Donald Trump.
References
- ↑ "About U.S. FDA Center for Tobacco Products". Food and Drug Administration . Archived from the original on 2019-04-22. Retrieved 2019-12-16.
- ↑ "Family Smoking Prevention and Tobacco Control Act (Public Law 111-31)" (PDF). Archived (PDF) from the original on 2011-10-16. Retrieved 2011-09-20.
- ↑ "U.S. FDA Tobacco Products Information". Food and Drug Administration . Archived from the original on 2017-11-01. Retrieved 2019-12-16.
