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.
Minimum age to purchase tobacco products. Sale from the age 19 Sale from the age 18 Sale from the age 17 Sale from the age 16 No minimum age |
Prior to 1996, the FDA played no role in the regulation of tobacco products, and regulations were controlled through a combination of state and congressional regulation. Most state laws dealt with the sale of tobacco products, including the issue of selling to minors and licensing of distributors. By 1950, most states had laws prohibiting the sale of tobacco products to minors, which at the time, the purchase age differed in each state. In 2020 the federal government required states to set a minimum age of at least 21 years to purchase tobacco products, which was amended in all states by 2020. [2]
In 1964, Surgeon General Luther Terry issued a report on smoking and health saying that tobacco causes lung cancer and is a main contributor to bronchitis. Members of the Federal Trade Commission read the report the day it was released and quickly proposed a mandatory cigarette label that warned, "CAUTION: cigarette smoking is dangerous to your health and may cause death from cancer and other diseases." However, legislation ultimately passed by Congress required a warning label with less dire language: "CAUTION: CIGARETTE SMOKING MAY BE HAZARDOUS TO YOUR HEALTH." [3] [4] In 1965, the United States Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA), which required a health warning on all cigarette packs. In 1970, President Richard Nixon signed the Public Health Cigarette Smoking Act, which banned cigarettes ads on the radio or television. It also required an updated warning on the cigarette packages which read: "Warning: The Surgeon General has determined that cigarette smoking is dangerous to your health."
In 1996, the FDA issued the "FDA Rule," which asserted its authority over tobacco products and issued a rule intending to prevent and reduce tobacco use by children. The intended regulations included prohibiting non-face-to-face sales of tobacco products, prohibiting outdoor advertising of tobacco products near schools or playgrounds, imposing more stringent advertising regulations, and prohibiting brand-name sponsorship, among other things.
After the regulations were issued in 1996, tobacco companies sued. In the 2000 Supreme Court case FDA v. Brown & Williamson Tobacco Corp. , the court ruled that Congress had not given the FDA authority over tobacco and tobacco marketing.
As a result, Congress was forced to provide explicit FDA authority to regulate tobacco and this was finally accomplished via the passage of the Family Smoking Prevention and Tobacco Control Act in 2009.
The Family Smoking Prevention and Tobacco Control Act (also known as the FSPTC Act) was signed into law by President Barack Obama on June 22, 2009. This bill changed the scope of tobacco policy in the United States by giving the FDA the ability to regulate tobacco products, similar to how it has regulated food and pharmaceuticals since the passing of the Pure Food and Drug Act in 1906.
President Barack Obama, who has himself struggled with smoking addiction,[ citation needed ] praised the law, saying that it will save American lives.[ citation needed ] The Obama administration had previously voiced support for such an act, while former President George W. Bush had threatened to veto the law after it had passed the United States House of Representatives in 2008.[ citation needed ] Much opposition to the law from Congress came from tobacco-growing states such as North Carolina, whose representatives said they felt that the FDA was not fit to take on the large task of regulating tobacco products.[ citation needed ]
The act gives the FDA comprehensive control on tobacco products for sale in the United States. Much of the legislation is targeted specifically at cigarettes and/or smokeless tobacco products. The act gives the FDA the power to: [5]
The Center for Tobacco Products (CTP) is the branch of the FDA created in response to and for the implementation of the Family Smoking Prevention and Tobacco Control Act. The FDA currently has eight divisions, each of which is responsible for protecting some aspect of the public health. The main duties of the Center for Tobacco control include:
The Center for Tobacco Products is the newest branch of the FDA, and officially was opened on August 19, 2009. Lawrence Deyton, M.D., M.S.P.H, was appointed the first director of the center. Mitch Zeller, JD, became the Director of CTP in March 2013. Zeller was the associate commissioner and director of FDA's first Office of Tobacco Programs until 2000, when the Supreme Court decided that Congress did not give the FDA authority over tobacco products and tobacco product marketing.
A ban on flavored tobacco, as mandated by the Family Smoking Prevention and Tobacco Control Act, was implemented by the CTP on September 22, 2009. This law bans the sale or distribution of any cigarettes containing an artificial or natural flavor other than tobacco. This ban does not apply to menthol.
The Family Smoking Prevention and Tobacco Control Act called for the creation of a Tobacco Products Scientific Advisory Committee (TPSAC), and the inaugural meeting for this committee was held on March 30–31, 2010. The main purpose of the committee is to assess health and safety issues concerning tobacco products, and then provide advice, information, or recommendations to the Commissioner of Food and Drugs based on their findings. Some specific reports they are responsible for include:
The committee has 12 members, one of which is the chair of the committee. The members are chosen by the Commissioner and are individuals with expertise in the field of medicine, science or technology involving tobacco products. There are 9 voting members, all of whom work in the health care profession in specialties relevant to tobacco use (such as pulmonology, cardiology, toxicology, etc.). One member will be either a federal or local government employee, and one will be a representative of the general public. The three non-voting members will include representatives of various parts of the tobacco industry: one representative of the growers, one of the manufacturing industry, and one of the small-business tobacco manufacturing industry. All members will serve four-year terms.
Five tobacco companies, including Lorillard Tobacco Company, L.P., and R. J. Reynolds Tobacco Company, filed a civil lawsuit in federal court against the United States and the FDA in response of the legislation. The suit was filed in Bowling Green, Kentucky, home to Commonwealth Brands, another tobacco company named in the suit.
The plaintiffs' (the tobacco companies) objections to the Family Smoking Prevention and Tobacco Control Act and policies decided upon by the Center for Tobacco Control included:
Notably, the tobacco companies argued that the increased size of warning labels on cigarette packing and new restrictions on the design of the packaging interfere with their First Amendment rights to communicate with adult consumers. In addition, they argued against the ban on publicizing relative risk claims about their products, which would apply to light cigarettes and various forms of smokeless tobacco on First Amendment grounds.
Judge Joseph H. McKinley, Jr. issued his Opinion of the Court on January 4, 2010. In reviewing the arguments of the plaintiffs and defendants, McKinley, Jr. ruled largely, but not completely, in favor of the United States and the FDA. Judge McKinley, Jr. ruled that a full ban of graphics and colors on all advertisements and packaging does infringe on the First Amendment rights of tobacco companies to communicate with their adult consumers without reasonably limiting the products’ appeal to youths. However, Judge McKinley, Jr. sided with the defendants on all other contested issues. He ruled that requiring enlarged warnings on packaging is reasonable because it serves to better alert the public about adverse health effects of smoking. He also found that giving the FDA the ability to regulate the use of the relative risk claims did not infringe on the First Amendment rights of the plaintiffs.
American tobacco giants did not universally oppose FDA regulation upon the passing of the Family Smoking Prevention and Tobacco Control Act. Altria Group, the parent company of Philip Morris USA, has spoken out in support of the legislation. According to its website, Philip Morris has favored "tough but reasonable federal regulation of tobacco products by the Food and Drug Administration." The company also says that the legislation can be beneficial to adult consumers, and that they want "to work with the FDA as it implements a comprehensive national regulatory framework."
Philip Morris has not always supported such broad tobacco regulation. In 1996, they joined other tobacco companies in the major lawsuit that eventually led to FDA v. Brown & Williamson Tobacco Corp. being argued before the Supreme Court. However, since 2000, the company has supported "meaningful tobacco regulation." Philip Morris, the maker of Marlboro brand cigarettes and over a dozen other brands, has much to gain in this legislation. By further reducing tobacco companies’ ability to advertise, Philip Morris’ current US market share of 50% is in effect solidified as other companies are less able to convince consumers to switch to their products. The only downside for Philip Morris is that all companies will be taxed in proportion to their market share.
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.
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), is an important United States Supreme Court case in U.S. 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 90's 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 infused with the compound menthol which imparts a “minty” flavor to the smoke. Menthol also decreases irritant sensations from nicotine by desensitizing receptors, making smoking feel less harsh compared to regular cigarettes. Some studies have suggested that they are more addictive. Menthol cigarettes are just as hard to quit and are just as harmful as regular cigarettes.
Ventilated cigarettes are considered to have a milder flavor than regular cigarettes. These cigarette brands may be listed as having lower levels of tar ("low-tar"), nicotine, or other chemicals as "inhaled" by a "smoking machine". However, the scientific evidence is that switching from regular to light or low-tar cigarettes does not reduce the health risks of smoking or lower the smoker's exposure to the nicotine, tar, and carcinogens present in cigarette smoke.
Tobacco politics refers to the politics surrounding the use and distribution of tobacco.
Tobacco control is a field of international public health science, policy and practice dedicated to addressing tobacco use and thereby reducing the morbidity and mortality it causes. Since most cigarettes and cigars and hookahs contain/use tobacco, tobacco control also concerns these. E-cigarettes do not contain tobacco itself, but (often) do contain nicotine. Tobacco control is a priority area for the World Health Organization (WHO), through the Framework Convention on Tobacco Control. References to a tobacco control movement may have either positive or negative connotations, depending upon the commentator.
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.
Smoking in Iceland is banned in restaurants, cafés, bars and night clubs as of June 2007. A large majority of Icelanders approve of the ban. At the time the ban went into effect, almost one in four Icelandic people were smokers.
Plain tobacco packaging, also known as generic, neutral, standardised or homogeneous packaging, is packaging of tobacco products, typically cigarettes, without any branding, including only the brand name in a mandated size, font and place on the pack, in addition to the health warnings and any other legally mandated information such as toxic constituents and tax-paid stamps. The appearance of all tobacco packs is standardised, including the colour of the pack.
There are smoking cessation policy initiatives by the United States government at federal, state and local levels.
The Center for Tobacco Products (CTP) was established by the United States Food and Drug Administration as a result of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in June 2009. The FDA center was responsible for the implementation of the Family Smoking Prevention and Tobacco Control Act.
Tobacco smoking in the Philippines affects a sizable minority of the population. According to the 2015 Global Adult Tobacco Survey (GATS) conducted under the auspices of the Philippines' Department of Health, Philippine Statistics Authority, the World Health Organization, and the United States Centers for Disease Control and Prevention, 23.8 percent of the adult population were "current tobacco smokers". This figures represented 16.6 million of 69 million adult Filipinos.
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.
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 vape shop is a retail outlet specializing in the selling of vaping products, though shops selling derived psychoactive cannabis products have increased since the passage of the 2018 Farm Bill. There are also online vape shops. A vape shop offers a range of vaping products. The majority of vape shops do not sell vaping products that are from "Big Tobacco" companies. In 2013, online search engine searches on vape shops surpassed searches on e-cigarettes. Around a third of all sales of vaping products take place in vape shops. Big Tobacco believes the independent vape market is a threat to their interests.
The Philippine Tobacco Institute, Inc. is private organization incorporated under Philippine law. It represents, expresses and effects the opinions of the tobacco industry in the Philippines.
As nicotine is highly addictive, marketing nicotine-containing products is regulated in most jurisdictions. Regulations include bans and regulation of certain types of advertising, and requirements for counter-advertising of facts generally not included in ads. Regulation is circumvented using less-regulated media, such as Facebook, less-regulated nicotine delivery products, such as e-cigarettes, and less-regulated ad types, such as industry ads which claim to discourage nicotine addiction but seem, according to independent studies, to promote teen nicotine use.
The Vaporized Nicotine and Non-Nicotine Products Regulation Act, officially recorded as Republic Act No. 11900, is a law in the Philippines which aims to regulate the "importation, sale, packaging, distribution, use and communication of vaporized nicotine and non-nicotine products and novel tobacco products", such as electronic cigarettes and heated tobacco products. It lapsed into law on July 25, 2022. As a proposed measure, the law was known as the Vape Regulation Bill.
Brian King is an American Epidemiologist who currently serves as the Director of the Food and Drug Administration’s Center for Tobacco Products (CTP). He was appointed to his role in July 2022.
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