The U.S. Food and Drug Administration issued a final rule containing a broad set of federal requirements designed to significantly 
curb access to and the appeal of cigarettes and smokeless tobacco products to children and adolescents in the United States. Published March 19, 2010, the new rule becomes effective June 22, 2010, and has the force and effect of law.
Titled Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, the new rule restricts the sale, distribution, and promotion of these products to make them less accessible and less attractive to kids. Among other things, the rule prohibits the sale of cigarettes or smokeless tobacco to people younger than 18, prohibits the sale of cigarette packages with less than 20 cigarettes, prohibits distribution of free samples of cigarettes, restricts distribution of free samples of smokeless tobacco, and prohibits tobacco brand name sponsorship of any athletic, musical or other social or cultural events. The entire rule can be found at www.fda.gov/protectingkidsfromtobacco.
“This ruling is a critical piece of a coordinated effort to save lives, lower costs, and reduce suffering from heart disease, cancer and other tobacco-related illness,” said HHS Secretary Kathleen Sebelius. “Today, we’re addressing a larger public health effort to prevent our children from becoming the next generation of Americans to die early from tobacco-related disease. This is a great step toward a healthier America.”
“Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers. 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,” said FDA Commissioner Margaret A. Hamburg, M.D. “Putting these restrictions in place is necessary to protect the health of those we care most about: our children.”
Enforcement of the new rule will begin once it becomes effective on June 22, 2010. FDA will work closely with States and Territories to ensure that retailers comply with the rule. FDA will also work with the retail community over the coming months to educate them about the new requirements and assist them in understanding how to comply with them and help protect our children and adolescents from these addictive products.
Manufacturers and retailers who do not comply with the rule may be subject to enforcement action.
The rule was originally crafted in the 1990s by the Food and Drug Administration. After being set aside by the Supreme Court, it was included as a key provision of the 2009 Family Smoking Prevention and Tobacco Control Act.
Under the U.S. Food and Drug Administration rules, tobacco companies such as Reynolds American Inc and Altria Group Inc’s Philip Morris could no longer use brand names to sponsor sporting and other events or to sell merchandise such as hats and T-shirts.
Free samples and vending machine sales would be limited to adult-only establishments, while advertising that may be seen by youth must be limited to black-and-white text, a contentious free-speech issue that had already been rejected by one court.
The rules “will help our kids stay healthy by making it harder for tobacco companies to target them with harmful and addictive products,” U.S. Health Secretary Kathleen Sebelius said.
Officials last tried to curb tobacco marketing to youth in 1996. Those rules, issued under President Bill Clinton, were overturned when the Supreme Court ruled in 2000 that the FDA had overstepped its authority.
Various U.S. states have also restricted some aspects of tobacco marketing under a 1998 settlement with the industry.
This time the FDA is moving under a new law giving it oversight authority. President Barack Obama, a Democrat who has struggled to stop his own smoking, signed the bipartisan bill last year.
The new authority already faces a legal fight from some manufacturers, including Lorillard Inc, in a case that could eventually go before the Supreme Court.
Companies argue the restrictions are unconstitutional, but a U.S. District Court judge in January backed most limits except for those regarding text-only advertisements.
Both the FDA and the companies plan to appeal.
$35 MILLION A DAY
Health officials say smoking is no longer on the decline.
Tobacco use, which had been falling over the years, is now flat, according to the U.S. Centers for Disease Control and Prevention. About 20 percent of older teenagers and adults smoke, and 6 percent of younger teenagers use cigarettes.
Smoking has long been known to cause cancer, lung disease and other expensive, chronic conditions that can lead to death. Second-hand smoking also poses threats.
U.S. officials hope that by curbing marketing efforts they can help prevent young people from picking up the habit.
Still, they face an uphill battle against an industry that according to the FDA spent nearly $13 billion in promotions in 2006, or roughly $35 million a day.
The new FDA regulations call on manufacturers and retailers to be responsible for carrying out the provisions, but FDA spokeswoman Kathleen Quinn said the agency still has a “full range of enforcement tools” such as warning letters and fines.
A spokesman for Reynolds, the second-largest U.S. tobacco company and a plaintiff in the lawsuit, said the company takes “no action directly or indirectly to target youth.”
Lorillard did not return a request for comment
Altria, which is not involved in the lawsuit and is the only tobacco company that backs FDA oversight, said its Philip Morris USA and U.S. Smokeless Tobacco Company units were reviewing the regulations.
STILL EASY TO OBTAIN
While the FDA said Thursday’s rules are mostly identical to those issued in 1996 with some added exemptions, more data has come out over the years backing the need for more controls.
It added that despite state laws preventing sales to those under age 18, cigarettes are still easy to obtain.
“Part of the reason is that despite a ban on direct marketing to young Americans, tobacco companies have still found ways to reach out to them,” Sebelius said.
Numerous consumer advocacy groups such as the Campaign for Tobacco-Free Kids and the American Cancer Society applauded the new rules.
But Michael Siegel, a Boston University public health professor, said the government is wasting resources with rules likely to be overturned by the Supreme Courts and should instead launch its own ad blitz.
“There’s no mystery … the way you reduce smoking is by aggressively advertising just like industry,” he said.
With smoking rates flat and increasing smoking bans in public places, companies such as Reynolds and Star Scientific are shifting to newer tobacco products in flavored, dissolvable formats that some worry may also entice children.
FDA officials are examining such candy-like products as well as the impact of mint-like menthol flavored cigarettes.
