Tuesday, March 13, 2012

FDA Press Statement on Surgeon General's Report Highlights FDA Actions to Protect Youth From Cigarettes ... Which is Bupkes

The FDA last week issued a press statement in response to the release of the Surgeon General's report on youth smoking. The statement highlighted the actions of the agency to prevent smoking among youth during the first two years of its jurisdiction over cigarettes.

According to the statement, those accomplishments are as follows:

1. "implementing the law's ban of cigarettes with fruit, candy, and certain other flavors."

2. "enforcing the age of 18 as the national minimum age of purchase for these products, the ban on vending machine sales, the ban on sales of single cigarettes and give-away of free samples of cigarettes, the ban on use of brand name sponsorship of concerts and sporting events, the requirements for new smokeless tobacco warnings to communicate health risks, and the prohibition on misleading advertising claims that imply products are safer."

3. "conducting inspections to ensure that tobacco retailers comply with these requirements; to date, more than 40,000 retail inspections have been completed."

The Rest of the Story

The rest of the story is that none of the three interventions about which the FDA is boasting are effective in preventing youth smoking and therefore, the FDA has so far done virtually nothing to reduce youth smoking.

Let's take the interventions one by one:

1. "implementing the law's ban of cigarettes with fruit, candy, and certain other flavors."

Guess the total number of cigarette brands made by the Big Tobacco companies that contained fruit or candy flavorings and which were taken off the market, and the total youth market share for these products:

Was it:

a. 15 brands, 18% of the youth cigarette market;
b. 10 brands, 12% of the youth cigarette market;
c. 4 brands, 3% of the youth cigarette market;
d. 2 brands, 1% of the youth cigarette market; or
e. 0 brands, 0% of the youth cigarette market.

The correct answer is:

e. 0 brands, 0% of the youth cigarette market.

The FDA has not taken a single flavored cigarette manufactured by Big Tobacco off the market. The "rest of the story" is that there were no such products on the market to be taken off. Youths were not smoking flavored or candy cigarettes (if you don't include menthol). They were smoking menthol cigarettes, as well as the name-brand products: Marlboros, Newports, and Camels.

The only minor effect of the cigarette flavoring ban was to take some Indonesian cigarettes off the market and a few minor brands. Together, these accounted for less than 0.1% of the market.

Thus, this intervention has had no impact on youth smoking.

2. "enforcing the age of 18 as the national minimum age of purchase for these products, the ban on vending machine sales, the ban on sales of single cigarettes and give-away of free samples of cigarettes, the ban on use of brand name sponsorship of concerts and sporting events, the requirements for new smokeless tobacco warnings to communicate health risks, and the prohibition on misleading advertising claims that imply products are safer."

The minimum age for purchase of cigarettes has been enforced for years, and it has been enforced by specific regulation for about 17 years. The ban on vending machine sales, sales of single cigarettes, and give-away of free samples of cigarettes was already enforced in many states and localities, and will have minimum if any effect on youth smoking. The requirements for new smokeless tobacco warnings will not have any impact, just as the old cigarette warnings have no impact. The prohibition on misleading advertising claims, such as the elimination of terms such as "light," have had no effect because cigarette companies simply substituted color patterns to signify the identify of these brands.

Thus, this set of interventions will have minimal, if any, impact on youth smoking.

3. "conducting inspections to ensure that tobacco retailers comply with these requirements; to date, more than 40,000 retail inspections have been completed."

Several meta-analyses have demonstrated that these youth access interventions have no impact on youth smoking. There is no relationship between tobacco sales rates to minors and youth smoking prevalence. There are simply too many other ways for youth to obtain cigarettes. Moreover, even if only a few stores are willing to sell to minors, that is enough to maintain the needed supply for youth smokers. This intervention is not only ineffective, but it is also a huge waste of time and resources.

The rest of the story, then, is that so far, the FDA has done virtually nothing to substantially reduce youth smoking. That might be fine, except for the fact that the agency is boasting about its non-existent accomplishments. This sounds more like something that the Campaign for Tobacco-Free Kids would do, not a federal regulatory agency.

Don't get me wrong. This is not all the FDA's fault. After all, the Tobacco Act gives the FDA virtually no ability to take the measures necessary to substantially reduce youth smoking. That was by design. That is the entire point of the law. The Tobacco Act was not a legitimate public health measure. It was a piece of political propaganda, designed to allow anti-smoking groups and politicians to boast that they were fighting Big Tobacco, when instead, all they were doing was creating a tobacco control government bureaucracy that would say much yet do very little. It would make the American public think that their politicians and anti-smoking groups were taking action to reduce tobacco-related morbidity and mortality, but without them actually having to take the courageous actions that would be necessary to accomplish anything meaningful.

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