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Tobacco regulation: Kneecapping the FDA

The U.S. Food and Drug Administration barely had time to start regulating cigarettes before legislation was introduced to weaken its authority.

The Family Smoking Prevention and Tobacco Control Act was passed in 2009 with sweeping majorities in both houses; its primary goal was to reduce the terrible toll that smoking takes on Americans’ health, especially by discouraging young people from taking up the habit. The law gave the FDA the authority to regulate the advertising and packaging of cigarettes, along with ingredients such as nicotine and flavorings that affect how easily the public is drawn into smoking and how addictive the habit is once started. As required in the law, for example, the FDA banned candy flavorings in cigarettes, which make the product more appealing to underage smokers and young adults.

But now that the agency is taking meaningful steps against smoking, Rep. Denny Rehberg (R-Montana) has added an amendment to the agriculture appropriations bill that would restrict the FDA’s authority over cigarettes and a host of other matters. Currently, the FDA is considering whether to ban one of the most popular and profitable ingredients — menthol — but Rehberg’s amendment would keep it from taking that action. No longer would the FDA be able to consider a substance’s tendency to attract smokers or make cigarettes more addictive. Rather, the FDA could only ban or limit ingredients that are found to make the cigarette physically more harmful than existing products. Menthol has not been found to do that; it does its damage by drawing people into smoking and keeping them there. Menthol masks the flavor and irritation of cigarette smoke; menthol cigarettes are perceived by consumers as “light” or less dangerous, though they aren’t. Studies have found that menthol makes it easier for young smokers to get started and harder for habitual smokers to stop. Unlike restrictions on fruit flavors, a ban on menthol could dramatically affect smoking rates — one-fourth of smokers prefer menthol brands — which is exactly why the tobacco industry is fighting any such restrictions.

In addition to the tobacco provisions, the law would limit the FDA’s authority to reject new drugs as long as they had any benefit, even if they fell far short of promises or carried significant risks, and it would be unable to restrict the use of routine, preventive antibiotics in livestock, which has been identified as a significant source of drug-resistant bacteria. About 80% of the antibiotics in this country are used to promote growth in livestock and prevent epidemics from sweeping through herds and flocks under crowded conditions. The measure has been passed by the House Appropriations Committee.

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It’s unlikely that Congress would ultimately approve a measure to gut the nation’s system for vetting pharmaceuticals and medical devices. But legislative compromises could weaken efforts to reduce smoking and the overuse of antibiotics in feedlots.

The provisions in Rehberg’s amendment are part of the contradiction in our society’s attitudes toward tobacco. Cigarettes have no health benefits, and they cost taxpayers billions of dollars each year in Medicaid expenses alone to care for smoking-related illnesses. For all the justifiable concern about obesity, smoking remains the leading cause of premature death in this country. The goal of the original legislation was to reduce the rates of sickness and death from cigarettes, and especially to protect impressionable youngsters. It would be a mistake to back away from that goal now.


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