FDA regulation of tobacco

Almost everyone sees it as crazy that the tobacco industry is not regulated by a government agency with a primary responsibility to safeguard the health of Americans. Most who have given it some thought conclude that the Food and Drug Administration (FDA) is the most appropriate regulatory authority for tobacco. A bill that would give the FDA regulatory authority over the tobacco industry is currently being considered by US legislators and has already been approved by a committee of Congress. This bill, or earlier but very similar versions of it, has been around for years, but right now looks like its best chance ever of becoming law. Part of the reason is that it has the support not only of numerous tobacco control and public health organizations, but also of the nation’s largest tobacco company: Philip Morris USA.

My own view, which Ive already discussed on this blog, is that although this bill is far from perfect, it is a big step in the right direction and if it was up to me Id vote for it. Of course, if it were up to me (which its not), Id change some parts of it.

The part that concerns me most is the part that requires manufacturers to demonstrate that any product claiming to be less harmful than any other, can demonstrate this conclusively (which sounds OK) but also that they must demonstrate that the product will cause less harm overall in the population (including people who don’t use it). This seems like a pretty tall order, and some would say virtually impossible.

Part of the concern here is that this part of the bill will take away most of the incentive tobacco companies have to make their products less harmful. Why spend millions developing and marketing less harmful products when you wont be allowed to tell consumers that the new product will be less likely to kill you?

Now I don’t expect that part of the bill to stifle all attempts to develop and sell less harmful products, but it does appear to discourage those attempts. I believe it would be wiser to encourage them, and simultaneously restrict the ability to sell needlessly deadly products. Just to be clear, I’m not referring to cigarettes that have been slightly modified as potentially deserving to make the claim to be less harmful. But there are existing smokeless tobacco products that are much less harmful to users than cigarettes (e.g. they don’t cause lung cancer or COPD, two of the biggest causes of tobacco-caused morbidity and mortality). Why not enable these products to accurately state that they are much less harmful than smoking cigarettes? To require that it be proven that these products are less harmful not only to users, but that the net population effect is also less harm, is asking for the impossible. That would require a crystal ball, or 30 years of research, which couldn’t be done without the products on the market. And even then some would not be convinced. See the problem?

Despite this (and other) problems with the bill, I hope that this bill, or preferably an improved version of it, becomes law soon. But interestingly many experienced tobacco control experts strongly oppose the bill and would rather it doesn’t pass.

Here are some further posts on this topic and links to further information.

PhilipMorrisUSA’s view:

Here is the view of the Campaign for Tobacco Free Kids:

Here are some earlier posts on the topic of FDA regulation of tobacco:

10. “Lost” and FDA regulation of tobacco. 3/22/07

135. Congress votes for FDA tobacco regulation. 7/30/08

In my next post I’ll discuss the recent comments on this subject by one of tobacco control’s leaders (Professor Stan Glantz).
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About the Author

MA, MAppSci, PhD

Dr. Jonathan Foulds is an expert in the field of tobacco addiction.