Tech + Health

05.08.14

Will the Nanny State Target Cigars Next?

Cigar makers have long fought to keep their product from the FDA’s clutches. Now, in an unexpected turn, the FDA might finally back off.

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.

If FDA regulation makes it impossible to buy newly released cigars at a reasonable price, the incentives for black market imports will certainly rise. Cubans, anyone?

The FDA’s proposal suggests that regulators are receptive to the idea that taking on cigars would accomplish very little. While acknowledging that “all cigars are harmful and potentially addictive,” the proposal also notes that premium cigars may have little impact on youth smoking and that adults trying cigars are less likely to become addicted than those taking up cigarettes.

Although cigar smoking hasn’t been studied nearly as intensively as smoking cigarettes, existing studies back up the notion that they are relatively less dangerous. A study in Preventive Medicine found that cigar and pipe smokers were less likely to get lung cancer than smokers of cigarettes, and those who did tended to be the very heaviest users. A cohort study of 17,000 men tracked over 20 years published in The New England Journal of Medicine also found moderately increased risks for cigar smokers. A study in BMJ following 21,000 men found that cigarette smokers who switched to pipes or cigars significantly lowered their risk of dying from smoking-related diseases.

The upshot of the existing research is that casual consumption of cigars among adults, enjoyed in moderation and with the smoke puffed mostly in the mouth rather than inhaled directly into the lungs, is considerably less lethal than use of cigarettes, although the practice does of course carry some risk.

The FDA’s proposal offers two approaches to regulating cigars. Option 1 would extend its authority to all of them, treating them just like cigarettes and subjecting them to the same slow process of review. Option 2 would distinguish between premium cigars and the small cigars and cigarillos that are arguably more worrisome in regard to youth initiation, exempting the former from some or all of the FDA’s tobacco regulations.

To accomplish Option 2, the FDA has offered a new definition of premium cigars. Exempt cigars would be those wrapped in whole tobacco leaf, containing 100 percent leaf tobacco binder and primarily long filler tobacco, made by hand, lacking any sort of filter or mouthpiece, having no characterizing flavor other than tobacco, weighing more than 6 pounds per 1,000 units, and retailing for more than $10 per cigar.

This definition is pretty close to the one cigar makers have been pushing in their own bill, with one glaring and extremely problematic difference: It would set an effective price floor for all new cigars. One recent survey found that only about 15% of cigars currently sell for more than $10 apiece, so this would be a substantial increase for consumers. If FDA regulation makes it impossible to buy newly released cigars at a reasonable price, the incentives for black market imports will certainly rise. Cubans, anyone?

A second sticking point is the ban on characterizing flavors. The FDA has in mind flavors that are allegedly marketed to kids, but there are plenty of adult consumers who enjoy infused cigars of various kinds. It also remains unclear whether traditional practices such as aging tobacco in cedar or other woods might run afoul of the ban.

Nonetheless, the fact that the FDA is even willing to consider exempting cigars from regulation is cause for a sigh of relief from cigar smokers. The prospect that the FDA might end the premium cigar market as we know it has been a primary concern in recent years. Imagine if all new beer, wine, and spirits releases had to be essentially identical to bottles already on the market in 2007 and were subject to interminable review that kept most new products in regulatory limbo, or were forced to be sold at a price that made them too expensive for the average imbiber. Drinkers would be furious. Cigar smokers now are facing an identical prospect.

The agency should listen to feedback from consumers and refine its classification of premium cigars, defining them by their inherent qualities rather than their price, then follow through on the option of keeping them free from burdensome regulations of dubious value. At the population-level health effects the FDA concerns itself with, detailed pre-market review of individual products would be a waste of time and resources.

In regulation as in psychoanalysis, sometimes a cigar is just a cigar.