Editors Note: The FDA Center that regulates the tobacco industry is turning out to be the “regulator of all regulators”; not only because it has attracted some of the most talented personnel in the agency but because it is has an independent source of funds—-direct charges to the tobacco industry. Reports are that the budget for the Center will eventually approach 3/4 of a billion dollars per year. Funds of this magnitude will overshadow by far the advocacy efforts of the industry. The recent initiatives announced by the Center regarding the longitudinal study of smokers and its nicotine standards program will be presented in a manner which will challenge the ability of the public and the industry to challenge them because of their breadth, depth, complexity and sheer volume resulting from an overwhelming level of resources which may or may not attain an acceptable level of quality.
N. B. To those overseas firms not subject to US regulation: just wait until the Center with its vast resources goes global!
FDA Plans $600 Million Anti-Smoking Campaigns
MICHAEL FELBERBAUM 11/ 2/11 03:50 PM ET Associated Press
RICHMOND, Va. — The Food and Drug Administration is planning to spend about $600 million over five years to educate the public about the dangers of tobacco use. Declines in U.S. smoking rates have stalled in recent years.
Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products, told The Associated Press that the multimedia campaigns are aimed at reducing death and disease caused by tobacco, which is responsible for about 443,000 deaths a year in the U.S.
The first campaign will target youth, minorities and other groups including gays, the military and people with disabilities. Ads will run in print and on TV, and the campaign will also use social media such as Facebook, Twitter and YouTube.
Deyton said the FDA’s investment reflects the significant health impact that tobacco use has on the nation. There are about 46 million adult smokers in the U.S. The share of Americans who smoke has fallen dramatically since 1970, from nearly 40 percent to about 20 percent. But smoking levels haven’t changed since about 2004.
“One of the big lessons that I’ve learned is that we might have great public health programs, but they will fail if we do not adequately educate the public about them,” Deyton said, adding that it wouldn’t be helpful “if we just sat back and put out regulations and didn’t say anything about them.”
The agency already has started other public education efforts like the “Break the Chain” campaign to encourage retailers to enforce federal tobacco laws. Upcoming campaigns will include educating the public on the ingredients in tobacco products.
Tobacco companies will foot the bill through fees charged by the FDA under a 2009 law that gave the agency authority over the tobacco industry.
The FDA collected nearly $260 million in user fees for fiscal 2009 and 2010 combined, and should collect $450 million this year. User fees will grow to $712 million by 2019. Fees are collected quarterly and based on each company’s share of the U.S. tobacco market.
The primary target audience for the FDA’s first campaign is youth aged 13-17, young adults aged 18-24 and people who influence teens, including parents, family members and peers. Other audiences of special interest include minorities, gays, people with disabilities, the military, pregnant women, people living in rural areas, and low-income people.
The FDA said tobacco use almost always starts during adolescence and teenagers may be more susceptible to nicotine addiction. About 3,450 kids in the U.S. try their first cigarette every day and 850 become daily smokers, according to the National Survey on Drug Use and Health.
Deyton said the agency hopes the first campaign under the contract will coincide with new graphic warning labels set to appear on cigarette packs by September 2012. The labels, which are being challenged by some tobacco companies, include images of the corpse of a dead smoker, diseased lungs, a smoker wearing an oxygen mask and a man wearing an “I Quit” T-shirt.
The agency plans to contract with outside companies to develop and execute the campaigns.
The U.S. Centers for Disease Control and Prevention also has tobacco-related health education programs.
News of the campaign follows an announcement last month that the FDA and the National Institutes of Health are launching a joint, large-scale, national study of tobacco users to monitor and assess the behavioral and health impacts of tobacco regulations. It will follow more than 40,000 users of tobacco-product and those at risk for tobacco use ages 12 and older.
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Great thoughts. The regulated community at FDA should pay great attention to the CTP and its work. The paths being created under tobacco could easily transcend drugs, devices and other regulated entities…if they dare look beyond the subject matter to see the forest.