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Regulations

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Countries must establish regulatory frameworks that reduce, if not eliminate, the harm caused by the use of tobacco products. These frameworks may require different policies for different products depending on the associated risks.

Regulations should guide the use of tobacco products in ways that eliminate or minimize harm. Regulations can effectively do this throughout the lifecycle of the product—from the time tobacco leaves are grown to the disposal of tobacco product waste. Regulations should correspond to the WHO Framework Convention on Tobacco Control and other guidance, and should be adjusted depending on the customs and political environments of specific countries.

Regulatory aspects related to tobacco products are described in greater detail in many chapters of The Tobacco Atlas. This chapter provides an overview of the regulatory lifecycle and exemplifies how regulations at every level have the potential to minimize harm. Growing regulations (see Growing Tobacco) protect tobacco farmers from the harms associated with handling tobacco leaves, and limit the tobacco industry’s impact on land use, especially in low- and middle-income countries. Manufacturing regulations protect consumers by monitoring the processes by which products are made, and can restrict additives that make smoking more addictive or appealing to youth.

Packaging and labeling regulations (see Warnings & Packaging) help to diminish the appeal of tobacco and the temptation to use tobacco products by requiring them to be sold in plain packaging or packaging that effectively portrays health warnings. Because it is important to reduce the attractiveness of tobacco, marketing regulations (see Marketing Bans) make it more difficult for the tobacco industry to communicate a deceptive link between smoking and the promise of a more attractive lifestyle. Tax policies (see Taxes), along with marketing regulations that restrict promotional price discounts and coupons, make cigarettes less affordable. Point of purchase restrictions can limit the availability of tobacco products, especially to youth.

Regulations on where products can be used (see Smoke-free Policies) protect smokers and those exposed to second-hand smoke by prohibiting smoking in certain areas. Disposal regulations (see Environmental Harm) can help ensure that cigarette butts, which are toxic waste, are disposed of appropriately, or that cigarette manufacturers are held responsible for collecting and disposing of cigarette waste.

This regulatory framework must evolve with the advent of novel nicotine products that purportedly reduce harm. New nicotine-delivery systems may help people to move away from deadly combustible products, but the question remains whether the regulations governing tobacco products should apply to these alternatives (see E-cigarettes and Nicotine Delivery Systems).

Stages of Tobacco Regulation

At each stage of the life of tobacco products, there are many opportunities to limit the harm they can cause.

Growing

  • Regulate pesticide use
  • Provide occupational safety and health safeguards for farmers, including labor protections
  • Protect the environment and prevent deforestation that occurs from tobacco curing and agricultural practices
  • Prohibit all incentives to grow tobacco, such as subsidies

Manufacturing

  • Ensure safe manufacturing practices
  • Set product standards, including regulating nicotine content and additives

Packaging and Labeling

  • Establish plain/standardized packaging as the gold standard
  • Require warning labels, including graphic or pictorial images
  • Disclose ingredients and emissions
  • Ban “kiddie”-sized packs and sale of single cigarettes

Marketing

  • Ban or restrict advertising, promotion and sponsorships
  • Restrict health claims or language suggesting reduced risk, including descriptors such as “mild” or “light”
  • Ban free samples
  • Restrict price promotions, including coupons and discounts

Tax Policies

  • Implement higher tobacco excise taxes
  • Earmark taxes for tobacco control or other public health programs
  • Require application of tax stamps to packaging

Point of Purchase

  • Require retail licensing
  • Set a minimum age of purchase
  • Mandate face-to-face transactions rather than self-service
  • Ban vending machines
  • Ban prominent displays in retail environments

Product Use

  • Enforce smoke-free public places (indoor and outdoor)
  • Ban smoking in multi-family dwellings, homes, cars with children as passengers

Disposal

  • Establish litter and environmental clean-up regulations

“While we support effective evidence-based tobacco regulation, we do not support regulation that PREVENTS ADULTS FROM BUYING AND USING TOBACCO PRODUCTS or that imposes unnecessary impediments to the operation of the legitimate tobacco market.” -Philip Morris International, “Regulating Tobacco Products,” 2014

As of January 2, 2014, 108 municipalities and three states include e-cigarettes as products that are prohibited from use in smoke-free environments.

Global Regulatory Examples: Europe

Case studies relating to the stages of tobacco regulation

PRODUCT USE
Ireland
The first country to institute an outright BAN ON SMOKING IN WORKPLACES, in March 2004. Offenders can face up to EUR3000 fines.

MANUFACTURING
France
In 2009, in an effort to prevent youth smoking, ADOPTED A LAW
RESTRICTING USE OF FLAVORING INGREDIENTS IN CIGARETTES.
This law has impacted sales of vanilla, orange, and chocolate cigarettes in the country.

PRODUCT USE
France
In February 2014, the UK government voted to make it a CRIMINAL OFFENSE TO SMOKE IN CARS WHEN CHILDREN ARE PASSENGERS.

“Why should society continue to sanction companies that create no social value and CREATE SO MUCH HARM FOR SO MANY, in the process of creating profits for so few?” -Patricia McDaniel and Ruth Malone, American Journal of Public Health, 2012.

Global Regulatory Examples: Americas

Case studies relating to the stages of tobacco regulation

Global Regulatory Examples: Asia

Case studies relating to the stages of tobacco regulation

Global Regulatory Examples: Australia

Case studies relating to the stages of tobacco regulation

PACKAGING AND LABELING
Australia
Experienced a decline in smoking after REQUIRING PLAIN/STANDARDIZED PACKAGING FOR CIGARETTES.

Global Regulatory Examples: Africa

Case studies relating to the stages of tobacco regulation

PRODUCT USE
Zambia
81% OF SMOKERS IN ZAMBIA SUPPORT A TOTAL BAN on tobacco products if government provides help for quitting.

“JTI supports the regulation of tobacco product ingredients, provided that it is coherent, scientifically sound and necessary to meet valid regulatory objectives. However, rather than propose a science-based approach to ingredients regulation, the FCTC Partial Guidelines propose regulation ‘aimed at reducing tobacco product attractiveness.’” -JTI, 2012, Regulation of Ingredients

Global Regulatory Examples: Middle East

Case studies relating to the stages of tobacco regulation

MARKETING
Islamic Republic of Iran
One of the first countries in the Eastern Mediterranean Region to completely BAN ALL FORMS OF TOBACCO ADVERTISING, PROMOTION, AND SPONSORSHIP.

In the Russian Federation, a sweeping anti-smoking bill in 2013, tax increases in 2014, and an economic downturn resulted in a 12% drop in cigarette consumption in what had been the world’s second largest market.

The Russian Federation demonstrated that regulations, especially when Combined, have the potential to make big decreases in tobacco consumption.

Resources

Sources

Alpert L. Russian Cigarette Consumption Drops 12% on Antismoking Rules – WSJ.com. The Wall Street Journal. 2014 May 30 [cited 2014 Jul 8];

US Regulation of Nicotine

Current regulatory status of nicotine products sold in the USA

Product
Evidence on Safety and Pre-Market Approval
TV Ads
Flavors
Minimum Age of Purchase
Excise Taxes
Warning Labels
Limits on Where Product Can Be Used

E-CIGS
None, but less harmful than combusted cigarettes
First time on TV in 40 years
Not regulated (Licorice, Bubble gum, Cotton candy, etc.)
No Federal law, 25 states restrict to 18
None
None
None, tobacco companies want e-cigs to be used anywhere

TOBACCO PRODUCTS
Products known to be deadly
Banned
Menthol allowed for cigarettes; no ban on flavors for smokeless tobacco, cigars, and cigarillos
Minimum age required to purchase
Taxes imposed
Required
Limits imposed

Rx DRUG DELIVERY DEVICE
Evidence of safety as cessation aid available
Extensive broadcast and print ads
Banned
Minimum age required to purchase
N/A
Required
None

Rx CESSATION AIDS
Evidence of safety as cessation aid available
Allowed, but limited
Not Regulated
Minimum age required to purchase
N/A
Required
None

Current US regulation of nicotine-containing products varies greatly.

Resources

Sources

U.S. Food and Drug Administration. Consumer Updates > FDA 101: Smoking Cessation Products. 2015 [cited 2015 Jan 30].

U.S. Food and Drug Administration. Flavored Tobacco > Flavored Tobacco Product Fact Sheet. 2011 [cited 2015 Jan 30].

U.S. Food and Drug Administration. Guidance, Regulations & Compliance > Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet. 2014 [cited 2015 Jan 30].

U.S. Food and Drug Administration. Guidance, Regulations & Compliance > Section 204 of the Tobacco Control Act – Smokeless Tobacco Labels and Advertising Warnings. 2012 [cited 2015 Jan 30].

U.S. Department of Health and Human Services. Menthol Cigarettes | Smokefree.gov. 2015 [cited 2015 Jan 30].

Raul Seballos. New Research: E-Cigs Safer Alternative to Regular Cigarettes — Health Hub from Cleveland Clinic. 2014 [cited 2015 Jan 30].

Nixon signs legislation banning cigarette ads on TV and radio — History.com This Day in History — 4/1/1970. 2014 [cited 2015 Jan 30].

Americans for Nonsmokers’ Rights. Smokefree Lists, Maps, and Data – no-smoke.org. 2015 [cited 2015 Jan 30].

David Beasley. Ten states, District of Columbia allow minors to buy e-cigarettes -CDC | Reuters. 2014 [cited 2015 Jan 30].

U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General, 2014 Atlanta, USA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health 2014.

Boonn A. STATE EXCISE TAX RATES FOR NON-CIGARETTE TOBACCO PRODUCTS. Campaign for Tobacco-Free Kids; 2011.

EU Tobacco Regulation

Provisions of the EU Tobacco Products Directive, 2014

In March 2014, the European Union adopted the final version of the EU Tobacco Products Directive aimed at updating tobacco regulation in terms of manufacture, presentation and sale of tobacco products in the EU. A partial list of the provisions of the directive include:

  • Requiring larger pictorial health warnings, covering two thirds of the front and back of packs
  • Banning flavored cigarettes and rolling tobacco
  • Banning slim lipstick style packs, which are attractive to young females
  • Banning packs with novelty openings – like those that slide open – which are attractive to boys
  • Requiring a standard shape for all cigarette packs, which must contain at least 20 cigarettes
  • Requiring that the tobacco industry conduct studies on additives
  • Implementing new anti-illicit-trade measures, including a track-and-trace scheme, to reduce smuggling
  • Regulating e-cigarettes for the first time

In response to the devastating effect of tobacco on the health of its citizens, the EU formally approved new rules governing tobacco products, including oral tobacco and e-cigarettes.

“It’s the wild, wild west right now. Everybody fears F.D.A. regulation, but honestly, we kind of welcome some kind of rules and regulations around this liquid.” -Chip Paul, CEO, Palm Beach Vapors

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