When the FDA announced that it intends to extend its authority to cover additional tobacco products, the press jumped to report on how this might impact e-cigarettes. The coverage usually missed the other big story in the agency’s proposal: That the comprehensive new rules may exempt premium cigars entirely.
Ever since the FDA was given authority over cigarettes in 2009, cigar makers have been pushing a bill in Congress to keep stogies out of the agency’s purview. That an industry would try to protect itself from FDA regulation is not surprising. That the FDA might agree with them is. And given the agency’s record on cigarettes, keeping its hands off of premium cigars is the right idea.
At issue is the requirement that any tobacco products covered by the FDA be approved by the agency before being sold to the public. The intent of the law was to protect public health by ensuring that new cigarettes are no more dangerous than those already on the market, a review process that was intended to take only a few months.
It sounds good in theory. In practice, the FDA has done more to restrict competition than to protect public health. The agency has more than 150 employees working on reviews and has received more than 3,500 applications for new products. It has managed to rule on only 34 of them, and only two brands of cigarettes have ever made it through the process. It has ordered only four off the market, a mostly symbolic gesture targeting a foreign brand that had stopped exporting to the United States years ago.
Perhaps this regulatory hassle would be worthwhile if it actually protected public health, but it’s far from clear that it does. The only obvious impact of the reviews is making the market for cigarettes less competitive. (These anti-competitive effects surely come as no surprise to the Philip Morris executives who negotiated the law putting the FDA in charge of tobacco, which their competitors aptly dubbed it the “Marlboro Monopoly Act”.)
Pre-market review is inconvenient for the relatively commodified cigarette market. For premium cigars, which are released in hundreds of different brands, blends, shapes, and sizes every year, it would be disastrous. It would make the market considerably less interesting, forcing any new releases to be explicitly modeled on cigars already for sale in 2007. At the FDA’s current pace, less than 1% of new cigars would be granted approval, and the entire exercise would be pointless. It’s questionable whether the agency’s review of cigarettes, which have been studied exhaustively, can truly ascertain population-level health effects based on minor differences between products. It’s fantastical to believe that it could find a science-based way to do the same for the endless variety of cigars.
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