In a “clarification” published this week in the Federal Register, the Food and Drug Administration indicates that e-cigarettes cannot legally be sold as tools to quit smoking unless their manufacturers go through the prohibitively expensive process of getting them approved as new pharmaceutical products. The FDA also says e-cigarettes cannot legally be sold as a less hazardous alternative to the conventional kind unless their manufacturers go through the prohibitively expensive process of getting them approved as “modified risk tobacco products.” The upshot is that e-cigarette companies are forbidden to be honest about the main benefits offered by their products, a form of censorship that is bound to retard the shift from smoking to vaping, thereby endangering lives that could have been saved by switching to a much less dangerous nicotine habit.
The FDA’s new rule is supposed to clarify when “a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product.” That can happen in two ways, one of which is “if the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” The FDA regulates nicotine products such as gum and patches as medical products, based on the dubious premise that nicotine addiction is a disease, the treatment for which is nicotine in a different form. The label on Nicorette gum, for instance, identifies it as a “stop smoking aid” that “reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.” As far as the FDA is concerned, selling e-cigarettes as a competing form of nicotine replacement for smokers trying to quit (which is what they are) puts them in the same regulatory category as Nicorette:
Claims related to smoking cessation have long been recognized as evidence of intended use conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with intended uses of curing or treating nicotine addiction and its symptoms….Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of intended therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose.
The FDA does not explicitly rule out any reference or allusion to smoking cessation in the marketing of e-cigarettes. The agency even allows that “evidence may be developed showing that, in some situations, ‘smoking cessation’ is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco.” It’s a mystery why new evidence would be required to prove that point, since that surely is the way that millions of people who have used e-cigarettes to quit smoking understand the concept. In any case, the FDA promises to “closely scrutinize ‘smoking cessation’ claims,” creating a strong presumption that will encourage manufacturers to steer clear of the subject. The FDA says “the rule’s treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products.” It adds that disclaimers of therapeutic intent generally will not be sufficient to keep e-cigarettes out of that category.
Boston University public health professor Michael Siegel, an advocate of vaping as a harm-reducing alternative to smoking, questions the FDA’s legal reasoning, arguing that smoking (unlike nicotine addiction), is a “health-related behavior,” not a disease. Hence “a claim that e-cigarettes are intended to help someone quit smoking is not necessarily a claim that the product is intended to treat a disease.” Rather, “The intention is to help alter a health-related behavior.” The FDA pretends to address this argument but conspicuously fails to do so:
Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence….
Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult smokers want to quit smoking completely for health reasons. Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose.
The FDA seems to be saying a product that helps people quit smoking is a drug because it prevents disease. By that logic, a host of products aimed at achieving a healthier lifestyle, ranging from motivational calendars (an example Siegel mentions) to exercise equipment, would qualify as drugs under the Food, Drug, and Cosmetic Act.
The FDA claims it is trying to prevent the “consumer confusion” that would be caused by an honest and open discussion of the benefits offered by e-cigarettes:
FDA believes that the potential for consumer confusion is increasing. This is especially true when tobacco-derived products that may otherwise appear to be products intended for recreational use make claims related to quitting smoking and treatment of nicotine addiction….
FDA continues to believe that there is consumer confusion about the intended uses of marketed products made or derived from tobacco. Evidence that at least some consumers are confused about the intended uses of products can be found in the comments themselves. We received many comments from individuals who began using e-cigarettes because they believed that e-cigarettes would help them quit smoking. Moreover, as noted in two comments, studies have shown that many consumers are using e-cigarettes to attempt to quit smoking despite the fact that no e-cigarette has been approved for use as a smoking cessation aid. We believe that the rule will help to mitigate this confusion and help ensure that consumers do not mistakenly use tobacco products, which are inherently dangerous, for medical uses.
It is hard to overstate the bureaucratic, pseudoscientific arrogance on display here. According to the FDA, smokers who switch …read more