Monday, September 28, 2015

FDA's Proposed Rule on Allowable E-Cigarette Claims Runs Afoul of Both the Constitution and the Law

Last week, the FDA gave notice of its intent to promulgate a rule that clarifies the classification of e-cigarettes as either drugs or recreational tobacco products based on certain claims made by the seller. The rule also explains the type of claims that would deem an electronic cigarette brand to be a modified risk tobacco product.

Based on my analysis of the proposed rule, I believe that it runs afoul of both the Constitution and federal law. Moreover, promulgation of this rule would increase the popularity of electronic cigarettes among youth and make it harder to promote these products for harm reduction purposes that would substantially improve the public's health. Thus, I believe that the proposed regulation is not only unlawful, but that it is not in the best interests of the public's health.

The Rest of the Story

Let's start with the aspect of the proposed rule that I believe is unconstitutional, since that is simpler than the aspect which I believe runs afoul of federal law, which is more complicated.

Why the Proposed Rule Violates the Constitutional Rights of the E-Cigarette Companies

The proposed rule violates the free speech (First Amendment) rights of electronic cigarette companies by prohibiting them from making factual claims about their products that provide critical information needed by consumers and in a way that advances no legitimate government interest. Specifically, by applying the modified risk tobacco product provisions of the Family Smoking Prevention and Tobacco Control Act to electronic cigarettes, the FDA would thereby be prohibiting e-cigarette sellers from truthfully informing their consumers that electronic cigarettes:
  1. contain no tobacco; and
  2. are safer than cigarettes.
The first piece of information (e-cigarettes contain no tobacco) would be prohibited (without prior FDA approval) because the proposed rule defines as a modified risk claim one which states or implies that: "the tobacco product or its smoke does not contain or is free of a substance." Thus, any implication that e-cigarettes are free of tobacco (which is obviously a substance) would constitute a modified risk claim under the proposed rule. (Note: companies could inform consumers that e-cigarettes do not produce smoke because of an exception under section 911(b)(2)(C) of the Act.)

The second piece of information (e-cigarettes are safer than cigarettes) would be prohibited (without pre-approval from FDA) because the proposed rule defines as a modified risk claim one which states or implies that: "The tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products." Thus, any implication that e-cigarettes are safer than tobacco cigarettes would constitute a modified risk claim under the proposed rule.

In general, the courts have looked negatively upon attempts by the government to prevent corporate speech that provides purely factual information and is not misleading. In such situations, the courts are almost certain to apply the Central Hudson standards, which require that the regulation advances a significant government interest.

To be sure, the claims that e-cigarettes contain no tobacco and are safer than cigarettes are truthful. Moreover, they are not at all misleading. If anything, failing to inform consumers that electronic cigarettes are not "tobacco" products and that they are safer than cigarettes is extremely misleading to the public. We know this for sure because in the absence of such claims, an extraordinarily high proportion of the public believes that cigarette smoking is no more dangerous than vaping. This has created a dangerous situation that is undermining the protection of the public's health.

There is no substantial government interest in preventing companies from hiding from consumers truthful information that does not mislead and which is absolutely critical to their understanding of the comparative benefits of the product. Prohibiting cigarette companies from falsely implying, through the use of terms such as "light" or "mild," that certain cigarette brands are safer than others does advance a legitimate government interest because it prevents the public from being misled into thinking - incorrectly - that light cigarettes are safer than non-lights. Such a prohibition would certainly pass constitutional muster under the four prongs of the Central Hudson test.

In contrast, because electronic cigarettes truly are much safer than cigarettes and because they truly do not contain tobacco (which explains why they are much safer), prohibiting electronic cigarette companies from making such claims cannot possibly be intended or necessary to prevent misleading consumers in any way. The proposed prohibition serves no legitimate public health purpose and clearly would not get by even the second prong of Central Hudson.

The FDA's application of section 911 of the Tobacco Act to e-cigarettes would almost certainly be challenged by the e-cigarette industry, and I don't see any way in which those provisions, as applied to e-cigarettes, have any chance of passing the Central Hudson test. This would be a clear violation of the free speech rights of the e-cigarette companies.

In effect, this regulation would force companies to hide critical information from their customers, which is essentially forcing them to lie to their customers for no legitimate reason. Moreover, it would result in damaging public confusion about the relative safety of smoking compared to the use of a non-combusted, non-tobacco-containing product. This does not advance a public health purpose; it actually impedes the protection of the public's health.

Why the Proposed Rule Runs Afoul of Federal Law

The proposed rule would prohibit e-cigarette companies from informing consumers that e-cigarettes may be effective in helping smokers quit. According to the rule, smoking cessation claims imply a therapeutic effect of a product and thus result in the product being classified as a drug or device (or drug-device combination) rather than as a tobacco product. This would, of course, force such an e-cigarette off the market, as it would be prohibitively costly and time-consuming for a company to fund and conduct all the clinical trials necessary to get an e-cigarette approved as a drug.

However, I believe that the FDA is misinterpreting the Food, Drug, and Cosmetic Act (FDCA) because under FDCA, to be a drug claim a communication must either: (1) claim (or imply an intention) to prevent, cure, mitigate, or treat a disease; or (2) claim (or imply an intention) to affect the structure or function of the body.

Smoking is not a disease. It is simply a behavior. Nicotine dependence, in contrast, is classified as a "disease" (under the DSM manual). A claim that a product will change one's behavior is therefore not a drug claim, unless it states or implies that such a change will prevent, cure, mitigate, or treat a disease or states or implies that it will treat nicotine dependence (i.e., wean someone off nicotine by preventing nicotine withdrawal symptoms). Thus, the pure claim that e-cigarettes may help smokers quit - in the absence of any assertion that this will prevent disease or treat nicotine dependence - cannot be properly interpreted as a drug claim under the FDCA. (For a detailed treatment of this argument, see my previous commentary).

The reason why nicotine replacement products are properly classified as drugs is that they are intended specifically to treat nicotine dependence. They deliver nicotine with the sole purpose of preventing nicotine withdrawal symptoms and thus, helping a smoker get off of nicotine. There is no long-term intention for the smoker to continue using the nicotine replacement product beyond the act of quitting smoking. In fact, the FDA does not approve the use of these drugs as alternatives to cigarettes.

In contrast, electronic cigarettes are not intended purely for use in quitting smoking. The clear intention of these products is to replace smoking. In other words, the manufacturer truly desires that the customers will replace cigarettes with e-cigarettes, not that they will quit smoking and then immediately stop using e-cigarettes as well. In fact, the clear economic incentive is for these companies to get smokers to switch to e-cigarettes and then stay on e-cigarettes long-term. It is not in their interests for smokers to quit smoking via e-cigarettes and then stop using the e-cigarettes as well. Thus, there is no inherent intention to treat nicotine dependence. In fact, the entire strategy is the opposite. A person switches to e-cigarettes, which amounts to quitting smoking, but they remain dependent on nicotine.

So far as I am aware, no electronic cigarette company advises consumers to stop using e-cigarettes after a certain amount of time. The clear intention is to replace smoking. In other words, e-cigarettes are not properly considered drugs. Instead, they are recreational alternatives to smoking. They are an alternative form of nicotine delivery. The effect they have on quitting smoking is simply an inherent consequence of completely substituting e-cigarettes for cigarettes.

The FDA misinterprets the law because it automatically deems a smoking cessation claim to imply therapeutic intent. The FDA writes:

"Products made or derived from tobacco have historically been regulated as medical products when they are marketed for intended uses that fall within the disease prong. For example, FDA has approved a number of drug products made or derived from tobacco as nicotine replacement therapies with indications to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Accordingly, FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to be within FDA’s “disease prong” jurisdiction." ...

"As discussed previously, claims related to smoking cessation have long been recognized as claims conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with curing or treating nicotine addiction and its symptoms. For example, the approved labeling for nicotine replacement therapies includes the following statements: “Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.” Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of 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."

In writing that "claims related to smoking cessation have long been recognized as claims conferring drug or device jurisdiction," the FDA fails to explain that the reason why such claims have generally been recognized as conferring drug jurisdiction is that they state or imply an intent or effect of treating nicotine dependence by reducing nicotine withdrawal symptoms. As the FDA admits within the same paragraph, the approved labeling for NRT specifically states that the product is intended to "reduce withdrawal symptoms."

But the FDA misspeaks when it then states that smoking cessation claims have also long been associated with curing or treating nicotine addiction and its symptoms. No, cessation claims have not also been associated with treating addiction, they are drug claims because they are associated with treating addiction.

In contrast, as anti-smoking advocates are quick to acknowledge, electronic cigarettes do not treat addiction. They actually maintain addiction. Or at least that is their primary intent. They maintain addiction by providing an alternative to smoking. This is not a therapeutic intention, absent a specific claim or expressed intent to treat nicotine dependence or addiction or to prevent disease.

The effect of this rule would be to force e-cigarette companies to promote their products based on benefits that do not correspond to the primary intended use of the product. This completely contravenes the legislative intent of the Food, Drug, and Cosmetic Act. The purpose of the Act is to make sure that drugs are safe and effective, not to require that drug manufacturers hide the primary intended use of their products.

Moreover, by preventing companies from being truthful about the primary intended use of e-cigarettes, this rule would encourage (and serve as a de facto requirement) that companies promote their products in other ways, such as advertising them as being sexy, youthful, or glamorous or as being primarily intended for use in places where smoking is not allowed. This would have a negative effect on the public's health because it would make e-cigarettes more attractive to youth. In contrast, if e-cigarette companies were allowed to be truthful about the purpose of their products, the resulting advertising would lose its youth appeal (especially to nonsmokers).

Therefore, both of these proposed rules are not only without legal merit, but both are detrimental to the public's health.

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