Exploring the Regulations on Tobacco

January 15, 2016  |  Tobacco

While people often assume that the regulation of tobacco is a recent introduction, the history of tobacco regulation goes back centuries.

While the practice of burning tobacco and inhaling its smoke started around 5000 to 3000 BC, it did not become a popular trading commodity until the 16th century. Most people assume that the debate about tobacco being unhealthy is something that started in the 20th century, but the leaf assumed major medical, economic, industrial, and social implications since John Rolfe successfully cultivated tobacco in Virginia

While both medical authorities and social observers have attacked tobacco for the damage that it has done and continues to do, it has proven a substantial source of revenue for the federal government and states alike.

Constant regulatory controls

smoke-free-lawsAs is the case with alcohol, tobacco has had regulated control over the quality and quantity of production for a long time. However, when compared to the sumptuary laws that affect the sale and distribution of tobacco, they are quite a bit weaker than those that have targeted alcohol. While consumption under certain circumstances was outlawed at various times in different jurisdictions, the consumption as a whole was never prohibited throughout the United States

While today’s regulation is associated with the use of cigarettes (or cigars and pipes to a lesser extent) the availability of cigarettes in the United States before the 1870s was low. During the mid-19th century most of the domestically consumed tobacco was chewed  instead of smoked [ii].

Pre-FDA regulation

Even though we have gotten used to the Food and Drug Administration (FDA) being heavily involved in the regulation of food products, it was not until recently that tobacco regulation by the FDA started to take shape. Before 1996, the regulation of tobacco products had nothing to do with the FDA. In fact, tobacco products were controlled by a combination of congressional and state regulation. Most of the state laws at that point were directly related to the sale of tobacco products, including licensing of distributors and selling to minors. Around the 1950s, the legal purchase age for tobacco differed in each state, but there were laws in place to prohibit the sale of tobacco products to minors

The introduction of the Federal Cigarette Labeling and Advertising Act

The first federal mandate was in 1965 when the FCLAA (Federal Cigarette Labeling and Advertising Act) was passed by the United States congress after Surgeon General Luther Terry had linked smoking to bronchitis and lung cancer a year earlier. The FCLAA made it mandatory that all cigarette packs carried a health warning. The FCLAA was followed by the Public Health Cigarette Smoking Act that President Richard Nixon signed into law in 1970. Not only did this ban the advertisement of cigarettes on television and radio, but it also required an updated warning on cigarette packages.

The “FDA rule”

The FDA issued the “FDA rule” in 1996, which affirmed the FDA’s authority over tobacco products and introduced new rules to reduce and prevent the use of tobacco by children. Intended regulations included prohibiting brand name sponsorships, imposing more rigorous advertising regulations, prohibiting outdoor advertising of tobacco products near playgrounds or schools, and prohibiting non-face-to-face sales of tobacco products.

Because of the harsh regulations, the tobacco companies sued to question the FDA’s authority. In 2000, the Supreme Court decided in that Congress did not give the FDA authority over tobacco and tobacco marketing, this ruling was defined in the ruling FDA v. Brown & Williamson Tobacco Corp [iii].

Because of this temporary setback, Congress was forced to provide the FDA explicit authority to regulate tobacco and tobacco marketing. They finally established this in 2009 with the Family Smoking Prevention and Tobacco Control Act.

Family Smoking Prevention and Tobacco Control Act

Family Smoking Prevention and Tobacco Control ActPresident Barack Obama signed this act (also referred to as the FSPTC Act) into law on June 22, 2009. It finally gives the FDA the ability to regulate tobacco products, meaning it will forever change the scope of tobacco policy within the United States. While President Obama was very much in favor of signing the bill, the previous President (George W. Bush) had made it clear he would veto the bill if it came through.

The final edition of the bill spanned 84 total pages, and provides the FDA with comprehensive control on the sale of tobacco products in the United States. Much of the legislation in the FSPTC Act targets smokeless tobacco products and cigarettes. The act gave the FDA the following powers:

  • Tobacco companies have to submit a list of ingredients for any item they import into or sell in the United States.
  • Tobacco companies have to reveal the nicotine content in their products. They also have to create nicotine content standards and eliminate or reduce other harmful substances.
  • Tobacco packaging warnings have to be made larger, and have to take up half of the front and back panel area.
  • The use of terms such as “light” and “mild” have to be regulated, meaning that tobacco products have to conform to certain specific standards before they are allowed to use these terms.
  • The FSPTC Act led to the creation of the Tobacco Products Scientific Advisory Committee. This committee is designed to inform the FDA on tobacco product related issues.

The future of FDA regulation

Even though it has taken a long time for the FDA to have the legal right to regulate the sale of tobacco products, there is no denying that now that they have it, we will see drastic changes in regulation. The next steps appear to be the regulation of Internet sales, both for traditional tobacco and smokeless alternatives. One thing is certain; the FDA is only just getting started when it comes to tobacco regulation in the United States.


[i] Morison, S. E. The Oxford History of the American People, New York: Oxford University Press, 1965, 93-94. National Interagency Council on Smoking and Health. “State Activities,” Bulletin, July-September 1971, 1.

[ii] Gottsegen, J. J. Tobacco-A Study of its Consumption in the United States, New York-Chicago: Pitman Publishing Corp., 1940, 8-10, 28, 87, 147, 153, 155.

[iii] Suing the Tobacco and Lead Pigment Industries: Government Litigation as Public Health Prescription by Donald G. Gifford. Ann Arbor, University of Michigan Press, 2010