Trump’s FDA nominee faces steep climb to reform tobacco regulation
As the U.S. Senate weighs whether to confirm Dr. Scott Gottlieb—President Trump’s pick to be commissioner of the Food and Drug Administration—there is an important question that he has not yet been asked in a public setting: is cigarette smoking a behavior or a disease?
This may strike some as a semantic distinction, but the answer matters quite a bit to the FDA’s future and to the prospects for reducing the 480,000 deaths we continue to see each year, all from a single product – the combustible cigarette.
The cigarette is the most hazardous and addictive tobacco product. Deaths from all other tobacco products are so few and so hard to discern from background noise that they are not even included in the statistics.
We long have known that those smokeless products that are widely available on the American and Scandinavian markets are, while not risk-free, far less hazardous than combustible cigarettes and likely less addictive. The same is true of e-cigarettes and related vapor devices. Unfortunately, the FDA deals with smoking as if it were a disease, not a behavior. It therefore dismisses the entire body of population research demonstrating lower risk in favor of a set of requirements that impose huge costs to duplicate such research for each product wishing to claim it poses lower risk than cigarettes or is effective for smoking cessation.
The FDA recently issued a request for comments on its proposed clarification of when products made or derived from tobacco are regulated as drugs. According to this “clarification,” a tobacco-related product can be either recreational or medicinal. It can provide enjoyment for the user or help the user quit smoking. It cannot do both.
Herein lies the rub. Since the law requires that any new tobacco-related product be beneficial to public health, and the only likely benefit is to help a smoker reduce or quit smoking, it’s not possible for any tobacco-related product not licensed as a drug to claim efficacy for smoking cessation. This flows necessarily from the FDA’s characterization of smoking as a disease, not a behavior. A product intended to treat a disease must be licensed as a drug.
Even a product approved by the FDA as lower in risk than cigarettes cannot claim that it would help a smoker reduce or quit smoking without being licensed as a drug. Such products can claim less harm, but cannot claim any public health benefit unless licensed as a drug.
While many smokers are addicted, many others are not. None of the kids experimenting with tobacco-related products are addicted. For them, and even for those addicted, smoking is a behavior, not a disease. Most want to cut down or quit to reduce their risk of potentially fatal tobacco-related illness, not because they see themselves as sick. They seek a consumer product to assist them, not a drug to treat what they do not perceive to be a disease.
From the perspective of manufacturers and users of e-cigarettes, related vapor products and other low-risk tobacco products, any product that is capable of satisfying a smoker’s urge to smoke will result in smoking fewer cigarettes and move the user in the direction of eventual cessation. How could it be any other way? Public health authorities castigate e-cig manufacturers and vendors for using the same marketing techniques previously used by cigarettes. But so long as they are prohibited by law from telling the truth to consumers about the far lower risk posed by e-cigs, how else could they market their products?
When dealing with a disease, a randomized controlled trial is the gold standard. This research design presumes the only important factor is the chemical profile of the product. It assumes that behavioral, social and economic factors have nothing to do with the efficacy of the product.However, when dealing with a behavior, open population studies are far more pertinent. The FDA does not accept these as evidence of efficacy because the FDA considers smoking to be a disease, not a behavior.
We need effective FDA regulation of all tobacco-related products to protect consumers against poorly made products, contraband and predatory marketing. We need such regulation to assure accurate information to consumers as to the risk and potential benefits posed by each type of product.
Instead, we have a system designed to keep new products off the market and to prevent anyone from claiming reduced risk or efficacy in smoking cessation, no matter how strong the evidence from behavioral and population studies. The current system protects big-tobacco cigarette companies and big pharma. It does not protect the public health.
