FDA Issues Regulations to Prevent Tobacco Sales to Youth

After a 14-year delay, 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.

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 re-issuance of a rule promulgated by the 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 the 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 last month and goes into effect June 22. The 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 Dr. Margaret A. Hamburg. "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.

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.

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."