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After 14-Year Delay, FDA Issues Regulations to Prevent Tobacco Sales to Youth


Regulations banning tobacco sales to minors, sales of cigarettes in less than 20-pack size, sample giveaways, and tobacco sponsorship of sports, music and other events have been released in final form by the U.S. Food and Drug Administration (FDA).

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said the final rule represents “the first time the U.S. government has put its full force behind specific, nationwide regulations intended to thwart the tobacco industry's continuing efforts to attract kids and turn them into lifelong addicts.”

The final rule is essentially a reissuance of a rule promulgated by FDA in 1996 but challenged in court by the tobacco industry. In 2000, the U.S. Supreme Court ruled that the agency's rulemaking was invalid because FDA did not have the authority to regulate tobacco. Congress gave the FDA such authority with the passage of the Family Smoking Prevention and Tobacco Control Act in 2009.

The FDA's final rule was announced at a press conference on March 19 and goes into effect on June 22. FDA said that it will collaborate with state governments to ensure enforcement and educate retailers about compliance.

“Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers,” said FDA Commissioner Margaret A. Hamburg, M.D. “Many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young. This is an avoidable personal tragedy for those kids and their families as well as a preventable public health disaster for our country. Putting these restrictions in place is necessary to protect the health of those we care most about: our children.”

The final rule also prohibits sales of cigarettes and smokeless tobacco in vending machines and self-service displays, bans the use of music and sound effects in audio tobacco ads, and bars the industry from selling or distributing items like hats and t-shirts with tobacco brands or logos.

The FDA also mandates that most tobacco advertising and labeling be displayed only in black text on a white background, but the industry has sued over this provision. A district court in Kentucky has temporarily blocked implementation of this rule, although the same court upheld the bulk of the FDA regulations.

Cheryl G. Healton, president and CEO of Legacy — a smoking-prevention program funded with proceeds from the 1998 nationwide tobacco settlement between the states and the tobacco industry — said that state attorneys general deserved credit for incorporating many elements of the 1996 FDA proposed rule into the Master Settlement Agreement and propelling tobacco regulatory efforts forward.

Philip Morris, the nation's largest tobacco company, supported the FDA regulation bill, and R.J. Reynolds said the FDA rulemaking was expected and that the company is already largely in compliance. However, Anthony Hemsley, vice president of corporate and government affairs at Commonwealth Brands — maker of Davidoff, Sonoma, Montclair and USA Gold brand cigarettes — bitterly condemned the FDA rule.

“The only way to create meaningful and proportionate regulations is to involve the industry,” said Hemsley. “Issuing rules that only serve to jeopardize a legal industry that contributes billions of dollars in excise taxes, employs thousands of people across the states and maintains a supply chain involving thousands of retailers and distributors makes absolutely no sense whatsoever.”

While stating that Commonwealth “fully supports measures that are specifically aimed at preventing youth smoking,” Hemsley said that the new rule was likely to result in costly litigation. “Instead of forming a relationship to develop reasonable goals, the FDA appears solely interested in listening to vociferous, anti-tobacco activists that have no concern for our adult consumers that purchase our legal products, or the viability or potential unintended consequences of what they are recommending,” he said.

David Rosenbloom, Ph.D., director of Join Together, said the long battle over tobacco regulation could serve as a blueprint for improved regulation of another addictive product widely consumed by youth: alcohol.

“Tobacco and alcohol companies target young people because they know that early smoking or drinking leads to high lifetime use of their products,” he said. “The rules on tobacco that were issued today are a major step toward protecting young people. They should be enforced and used as a model to restrict alcohol marketing to young people.”

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