U.S. FDA publishes rule to protect our children that restrict advertising and marketing of tobacco products..

March 19, 2010 - U.S. Food & Drug Administration (FDA) announced a final tobacco ruling Wednesday that restricts the sale, distribution, and marketing of cigarettes and smokeless tobacco products to protect children and adolescents. Published March 19, 2010, the new rules becomes effective June 22, 2010, and has the force and effect of law.

Click here to view the FDA "Protecting Kids from Tobacco" webpage.

The ruling is designed to "help our kids stay healthy by making it harder to target them," according to U.S. Health & Human Services (HHS) Secretary Kathleen Sebelius. According to Sebelius, every day nearly 4,000 kids under age 18 try their first cigarette, and 1,000 of those children become daily smokers. "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," she claimed. "I don't think it's any accident that the three brands that spend the most on advertising—Marlboro, Camel and Newport—are preferred at higher rates by children than adults."

According to HHS Assistant Secretary for Health Howard K. Koh: the regulations secure cooperation of manufacturers and retailers and establish a uniform federal standard for sales, distribution and marketing of cigarettes and smokeless tobacco. "The regulations also strengthen enforcement, and the FDA will become responsible for ensuring that retailers are in compliance as part of its growing public health mission," Koh said during a press conference.

The rules are part of broad new powers Congress granted to the FDA last year, when it passed landmark legislation to regulate the $89 billion tobacco industry. The law prevents the FDA from banning nicotine or tobacco, but it gives the agency vast authority to regulate the ingredients in tobacco products and the way they are distributed, sold and marketed.

FDA commissioner Margaret Hamburg outlined the rules, which give the FDA the authority to:
* Prohibit the sale of cigarettes or smokeless tobacco to people younger than 18.
* Prohibit the sale of cigarette packages with fewer than 20 cigarettes.
* Prohibit the sale of cigarette and smokeless tobacco in vending machines, self-service displays or other impersonal modes of sales, except under very limited conditions.
* Restrict free samples of cigarettes or smokeless tobacco products.

Hamburg said the ruling also means the FDA has additional authority over marketing and merchandising of tobacco-related products.

The ruling:
* Prohibits tobacco brand name sponsorship of any athletic, musical, or other social or cultural event, or any team or entry in those events.
* Prohibits gifts or other items in exchange for buying cigarettes or smokeless tobacco products.
* Requires that audio ads use only words with no music or sound effects.
* Prohibits the sale or distribution of items, such as hats and tee shirts, with tobacco brands or logos.

In addition, the agency is weighing whether to issue an additional rule for outdoor advertising, such as billboards.

Hamburg said the FDA will contract with states to carry out tobacco retailer inspections, issue a small business compliance guide and an action plan to help enforce restrictions, and embark on a large outreach effort to further educate audiences about changes in the sales, distribution and marketing of cigarettes and smokeless tobacco. "So these are all important new activities that will make a real and enduring difference, and importantly address the deep concerns about the problem of youth smoking in this country."

As for enforcement, Lawrence Deyton, director of the FDA's Center for Tobacco Products said the FDA will participate in inspection of retail establishments and will work with states to assist in inspections and enforcement. "Violations of these rules could engender warning letters, civil money penalties, seizure, non-tobacco sale orders, injunctions—even criminal penalties, of course depending upon the severity of the infraction," he said.

In the first legal challenge to the new law, a U.S. District Judge Joseph H. McKinley Jr. in January knocked down two of the rules. R.J. Reynolds Tobacco and Lorillard, the country's second- and third-largest tobacco producers, argued that certain provisions violated their First Amendment rights to free speech. They filed a complaint in Kentucky, the state with the highest number of adult smokers. (Federal judge - upheld most of law that regulates tobacco but struck down limits on advertising..) The FDA is appealing that part of the ruling. While the appeal is pending, the agency has not said whether it will enforce the rule regarding the use of color and imagery in advertising.

Anti-smoking groups and public health organizations argue that tobacco companies, which spend $35 million each day on marketing, have continued to direct advertising to teens and children in subtle ways. The 'Prevent All Cigarette Trafficking (PACT) Act' now awaiting the president's signature will bar the U.S. Postal Service (USPS) from serving as the delivery service for online cigarette and smokeless sellers.

References: New FDA rules will greatly restrict tobacco advertising and sales by Lyndsey Layton - Washington Post Staff Writer, The Washington Pots, 32/19/2010; Better to Burn Out FDA targets tobacco use by minors, while Congress tackles Internet sales by Linda Abu-Shalback Zid, Convenience Store/Petroleum (CSP) Daily News, 3/19/2010.