Regulation of tobacco by the U.S. Food and Drug Administration
Encyclopedia
Family Smoking Prevention and Tobacco Control Act
The Family Smoking Prevention and Tobacco Control Act, is a United States federal law that gives the Food and Drug Administration the power to regulate the tobacco industry...
by the United States Congress
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
. With this statute, the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) was given the ability regulate tobacco
Tobacco
Tobacco is an agricultural product processed from the leaves of plants in the genus Nicotiana. It can be consumed, used as a pesticide and, in the form of nicotine tartrate, used in some medicines...
products.
Pre-FDA regulation
Prior to 1996, the FDA played no role in the regulation of tobacco products, and was 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, all states had laws prohibiting the sale of tobacco products to minors, which at the time, the purchase age differed in each state.In 1964, Surgeon General
Surgeon General of the United States
The Surgeon General of the United States is the operational head of the Public Health Service Commissioned Corps and thus the leading spokesperson on matters of public health in the federal government...
Luther Terry issued a report on smoking and health saying that tobacco causes lung cancer and is a main contributor to bronchitis
Bronchitis
Acute bronchitis is an inflammation of the large bronchi in the lungs that is usually caused by viruses or bacteria and may last several days or weeks. Characteristic symptoms include cough, sputum production, and shortness of breath and wheezing related to the obstruction of the inflamed airways...
. Subsequently, in 1965, the US Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA), which required a health warning on all cigarette packs. In 1970, President Richard Nixon
Richard Nixon
Richard Milhous Nixon was the 37th President of the United States, serving from 1969 to 1974. The only president to resign the office, Nixon had previously served as a US representative and senator from California and as the 36th Vice President of the United States from 1953 to 1961 under...
signed the Public Health Cigarette Smoking Act
Public Health Cigarette Smoking Act
The Public Health Cigarette Smoking Act is a United States federal law, passed in 1970, designed to limit the practice of smoking. It required a stronger health warning on cigarette packages, saying "Warning: The Surgeon General Has Determined that Cigarette Smoking Is Dangerous to Your Health"...
, 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 sponsorships, among other things.
After the regulations were issued in 1996, tobacco companies sued. In the 2000 Supreme Court
Supreme Court of the United States
The Supreme Court of the United States is the highest court in the United States. It has ultimate appellate jurisdiction over all state and federal courts, and original jurisdiction over a small range of cases...
case FDA v. Brown & Williamson Tobacco Corp.
FDA v. Brown & Williamson Tobacco Corp.
FDA v. Brown & Williamson Tobacco Corp., is an important case in the development of American administrative law.-Legal principle:The scope of authority held by an agency is determined by the agency's organic statute...
, 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
Family Smoking Prevention and Tobacco Control Act
The Family Smoking Prevention and Tobacco Control Act, is a United States federal law that gives the Food and Drug Administration the power to regulate the tobacco industry...
in 2009.
Family Smoking Prevention and Tobacco Control Act
The Family Smoking Prevention and Tobacco Control Act (also known as the FSPTC Act) was signed into law by President Barack ObamaBarack Obama
Barack Hussein Obama II is the 44th and current President of the United States. He is the first African American to hold the office. Obama previously served as a United States Senator from Illinois, from January 2005 until he resigned following his victory in the 2008 presidential election.Born in...
on June 22, 2009. This bill forever 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
Pure Food and Drug Act
The Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...
in 1906.
President Barack Obama
Barack Obama
Barack Hussein Obama II is the 44th and current President of the United States. He is the first African American to hold the office. Obama previously served as a United States Senator from Illinois, from January 2005 until he resigned following his victory in the 2008 presidential election.Born in...
, who has himself struggled with smoking addiction, praised the law, saying that it will save American lives. The Obama administration had previously voiced support for such an act, while former President George W. Bush
George W. Bush
George Walker Bush is an American politician who served as the 43rd President of the United States, from 2001 to 2009. Before that, he was the 46th Governor of Texas, having served from 1995 to 2000....
had threatened to veto the law after it had passed the United States House of Representatives
United States House of Representatives
The United States House of Representatives is one of the two Houses of the United States Congress, the bicameral legislature which also includes the Senate.The composition and powers of the House are established in Article One of the Constitution...
in 2008. Much opposition to the law from Congress came from tobacco-growing states such as North Carolina
North Carolina
North Carolina is a state located in the southeastern United States. The state borders South Carolina and Georgia to the south, Tennessee to the west and Virginia to the north. North Carolina contains 100 counties. Its capital is Raleigh, and its largest city is Charlotte...
, whose representatives felt that the FDA was not fit to take on the large task of regulating tobacco products.
The act itself, which spans eighty-four pages in its final edition, 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
Smokeless tobacco
Smokeless Tobacco may refer to:* Dipping tobacco, a type of tobacco that is placed between the lower or upper lip and gums.* Chewing tobacco, a type of tobacco that is chewed.* Snuff, a type of tobacco that is insufflated or "snuffed" through the nose....
products. The act gives the FDA the power to:
- Require tobacco companies to submit an ingredients list of any product sold or imported in the United States
- Require tobacco companies to make public the nicotine content of their products and to adopt standards of nicotine content and to reduce or eliminate other harmful substances present
- Enlarge warnings on tobacco packaging so that they take up 50% of the front and back panel area
- Regulate the use of terms such as "mild" and "light" by requiring that tobacco products conform to certain standards regarding these terms
- Create a Tobacco Products Scientific Advisory Committee to help inform the FDA on issues relating to tobacco products
The law in its entirety can be found here:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111.pdf
Center for Tobacco Control
The Center for Tobacco Control (CTC) 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:- Set performance standards
- Review applications for new and modified risk tobacco products before they reach the market
- Require and control warning labels
- Establish and enforce advertising restrictions
The Center for Tobacco control 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.
Flavored tobacco
A ban on flavored tobacco, as mandated by the Family Smoking Prevention and Tobacco Control Act, was implemented by the CTC 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.Tobacco Products Scientific Advisory Committee
The Family Smoking Prevention and Tobacco Control Act called for the creation of a Tobacco Products Scientific Advisory CommitteeTobacco Products Scientific Advisory Committee
The Tobacco Products Scientific Advisory Committee 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...
(TPSAC), and the inaugural meeting for this committee was held on March 30–31, 2010. The main purpose of the committee is to asses 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:
- Impact of menthol in cigarettes on public health
- Impact of dissolvable tobaccoDissolvable tobaccoDissolvable tobacco is a tobacco product. Unlike ordinary chewing tobacco, it dissolves in the mouth. Major tobacco manufacturers that sell dissolvable tobacco products include R. J. Reynolds Tobacco Company and Star Scientific...
on public health - Effect of changing nicotine yields in tobacco products, and whether there is a certain level below which nicotine doe not product dependence
- Any application for a modified risk tobacco product
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.
Protecting children from tobacco
On March 19, 2010, the FDA issued a set of regulations, as required under the Family Smoking Prevention and Tobacco Control Act, concerning tobacco and kids and adolescents. These regulations were created with the intent of decreasing the appeal and accessibility of tobacco products to kids and adolescents, and there are rules concerning the sale and distribution of tobacco products as well as marketing.The new rules include:
- Making it illegal for cigarettes or smokeless tobacco to be sold to anyone under 18 years of age
- Prohibiting the sale of cigarette packages with fewer than 20 cigarettes in them
- Not allowing cigarettes or smokeless tobacco to be sold in any "impersonal mode of sale (i.e in a vending machine or self-service display)
- Prohibiting free samples of cigarettes or smokeless tobacco
- Prohibiting tobacco brand name products to sponsor social, cultural, athletic, or musical events
- Prohibiting gifts in return for the purchase of cigarettes or smokeless tobacco
- Prohibiting the distribution (or sale) of any items with tobacco logos or brand names
- Requiring that audio ads have no music or sound effects, only words
This set of regulations covers cigarettes and smokeless tobacco (it does not cover cigars or pipe
Pipe
Pipe may refer to:* Pipe , a hollow cylinder following certain dimension rules* Smoking pipe* Pipe or butt, a cask measurement* Pipe , a type of metal casting defect...
or hookah
Hookah
A hookah A hookah(Gujarati હૂકાહ) A hookah(Gujarati હૂકાહ) (Hindustani: हुक़्क़ा (Devanagari, (Nastaleeq) huqqah) also known as a waterpipe or narghile, is a single or multi-stemmed (often glass-based) instrument for smoking in which the smoke is cooled by water. The tobacco smoked is referred to...
tobacco). Pre-existing state laws that are not covered by these regulations, or are more stringent than these regulations (such as making 19 the minimum age to purchase tobacco), will remain in effect.
These regulations will be enforced through inspections by combination of FDA employees and FDA commissioned state employees. These rules will become effective on June 22, 2010.
Suing the FDA
Five tobacco companies, including Lorillard Tobacco CompanyLorillard Tobacco Company
Lorillard Tobacco Company is an American tobacco company marketing cigarettes under the brand names Newport, Maverick, Old Gold, Kent, True, Satin, and Max. Lorillard is a member of the National Black Chamber of Commerce.- History :...
, 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, Inc., 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:
- A full ban on the use of colors and graphics on cigarette and smokeless tobacco packaging
- A ban on the ability for a tobacco company to sponsor an event or piece of merchandise with their brand name
- The FDA’s authorization of "further restrictions", allowing federal, state, local, and Indian governments to enact legislation more strict than the Family Smoking Prevention and Tobacco Control Act
- A mandated size increase of tobacco warnings on packaging, including "color graphics depicting the negative health consequences of smoking to accompany the label statements"
- The FDA’s ability to regulate relative risk claims made on Modified Risk Tobacco Products (MRTP’s)
- Requiring that products may not advertise the fact that they are regulated by the FDA
- A ban on all forms of outdoor advertising
- A ban on the ability to include samples and gifts with the sale of tobacco products
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
First Amendment to the United States Constitution
The First Amendment to the United States Constitution is part of the Bill of Rights. The amendment prohibits the making of any law respecting an establishment of religion, impeding the free exercise of religion, abridging the freedom of speech, infringing on the freedom of the press, interfering...
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 the relative risk claims did not infringe on the First Amendment rights of the plaintiffs.
Support from Philip Morris
Surprisingly, American tobacco giants did not universally oppose FDA regulation upon the passing of the Family Smoking Prevention and Tobacco Control Act. Altria GroupAltria Group
Altria Group, Inc. is based in Henrico County, Virginia, and is the parent company of Philip Morris USA, John Middleton, Inc., U.S. Smokeless Tobacco Company, Inc., Philip Morris Capital Corporation, and Chateau Ste. Michelle Wine Estates. It is one of the world's largest tobacco corporations...
, the parent company of Philip Morris USA
Philip Morris USA
Philip Morris USA is the United States tobacco division of Altria Group, Inc. Philip Morris USA brands include Marlboro, Virginia Slims, Benson and Hedges, Merit, Parliament, Alpine, Basic, Cambridge, Bucks, Dave's, Chesterfield, Collector's Choice, Commander, English Ovals, Lark, L&M, Players and...
, 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 vs. Brown and Williamson Tobacco Corporation 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 halted 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.
See also
- Regulation of food and dietary supplements by the U.S. Food and Drug AdministrationRegulation of food and dietary supplements by the U.S. Food and Drug AdministrationThe regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration...
- David Aaron KesslerDavid Aaron KesslerDavid Aaron Kessler is an American pediatrician, lawyer, author, and administrator...
External links
- Final Decision of Commonwealth Brands, Inc. (et al.) v. United States of America (et al.) http://www.rjrt.com/uploadedFiles/Content/LawsAndTaxes/FederalRegulations/Commonwealth-USA%20-%20Decision.pdf
- Full text of the Family Smoking Prevention and Tobacco Control Act http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111.pdf
- The FDA webpage for tobacco products http://www.fda.gov/TobaccoProducts/default.htm
- The history of tobacco from tobacco.org http://www.tobacco.org/History/Tobacco_History.html
- The CDC webpage on tobacco http://www.cdc.gov/tobacco/