19 Aug 2011 Tobacco Regulation: Can the European Union Learn From the United States FDA?

In a piece for The Guardian, I suggest that the European Union (EU) should look to the U.S Food and Drug Administration (FDA) as a model for tobacco regulation.

No, that doesn’t mean I think the FDA is doing a very good job with its new regulatory powers. Rather, it is indicative how poorly regulators are doing in Europe.

Under the spotlight, is how governments regulate modified risk tobacco products. As I explain,

Compared to cigarettes, most newer tobacco products – including smokeless tobacco (or snus), dissolvable tobacco, and e-cigarettes – are less harmful for the user. In a 2008 report, the World Health Organisation’s (WHO) study group on tobacco product regulation (pdf) stated, “There is little question that, in general, smokeless tobacco products are less harmful than combusted tobacco products such as cigarettes.” This is because nicotine, while highly addictive, is not particularly bad for you. This is similar to caffeine in sugary soda: it’s the excess sugar, not the caffeine, that does the real damage by causing obesity.

Next week, the FDA will be holding a workshop on the issue, and I’ll be offering comments as part of the program. At issue, as I explain in my op-ed, is whether

these new tobacco products (can) help smokers reduce their tobacco-related disease risks. This approach – known as “harm reduction” – is generally accepted in public health circles. It underpins, for instance, methadone clinics for heroin addiction and condom use to reduce sexually transmitted diseases.

While it seems that “harm reduction” ought to be promoted as tool to help people quit smoking, as usual, regulators are throwing up road-blocks.

Many prohibitionists dream of a world without tobacco – smoking is so reviled among public health campaigners that they have a hard time acknowledging that some tobacco products are far less dangerous than others. But the FDA, to its credit, has engaged two separate panels, an internal one and an external one at the Institute of Medicine, to evaluate the science behind new tobacco products. The rosters are fairly one-sided and the questions are somewhat biased, but at least there is a process where science is at the forefront.

But in the EU, they aren’t even pretending to develop a clear regulatory process with science as the guide.

Other countries can learn from the United States, which has a transparent decision-making process, fixed timetables and puts the science first on public health issues. By contrast, the European Union does not have such a process in place. Updates to the EU’s tobacco directive have fallen behind, and revision is sorely needed. According to the EU’s obsolete regulatory scheme, all tobacco products are banned with the exception of those meant to be smoked or chewed. So while cigarettes and chewing tobacco are legal and widely available, products likes snus and dissolvables are either banned or in an undefined regulatory netherworld. A friend of mine in London who has been struggling to quit smoking is forced to buy his snus when he comes to New York on business. This is no way for governments to help people give up smoking.

I admit, it may be wishful thinking to suggest that FDA should be a model for other governments. But so far, the FDA has only been asking (albeit the wrong) questions, rather than making much policy. So for now, I’ll give them the benefit of the doubt, but will also be watching them closely. Stay tuned.