On Thursday, I reported the U.S. District Court ruling in which a preliminary injunction was issued against the FDA taking any action to regulate electronic cigarettes as drugs/devices under the federal Food, Drug, and Cosmetics Act. Today, I discuss the implications of this ruling, assuming that it is upheld after further judicial review.
I believe that the court ruling, if upheld, will have the following major implications for electronic cigarettes:
1. Electronic Cigarettes Would Be Approved for Sale and Marketing in the United States
The major implication of the court's ruling is that electronic cigarettes will be defined as tobacco products, meaning that they will not be regulated as drugs/devices under the Food, Drug, and Cosmetic Act. Instead, they will be regulated as tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009.
The most important implication is that instead of being unapproved drugs subject to enforcement action which could have included taking the product off the market completely, electronic cigarettes would instead be in the category of tobacco products, and by virtue of their existence prior to the passage of the tobacco control act, they would be officially approved for sale and marketing in the United States.
Moreover, because the tobacco act precludes the FDA from banning any particular type of tobacco product, the FDA would not have the authority to remove electronic cigarettes from the market, even if the Agency wanted to take such action.
This would be a tremendous victory for public health because this potentially life-saving product which is clearly helping thousands of ex-smokers to stay off cigarettes would remain available. It would prevent these thousands of ex-smokers from returning to smoking, which would inevitably occur if electronic cigarettes were taken off the market.
Many public health groups, such as the Campaign for Tobacco-Free Kids, see it the opposite way. For example, the Campaign argued that the court's ruling dealt a "blow to public health." The Campaign's reasoning: "If upheld, Judge Leon’s decision opens a gaping loophole in the protection FDA has provided against the sale and distribution of non-tobacco products that a manufacturer laces with unregulated quantities of nicotine."
In other words, according to the Campaign, it is far better for smokers to consume traditional cigarettes that deliver thousands of chemicals and scores of carcinogens than it is to quit smoking and switch to a product that delivers nicotine without those chemicals and carcinogens, because we're not sure exactly what amount of nicotine is being delivered.
What a load of garbage!
Who cares whether there are differences in the amount of nicotine that the product delivers? Any variation in nicotine delivery will result in decreased addiction potential, not increased potential, as the Campaign asserts. Why do you think that the tobacco companies carefully regulate the amount of nicotine in their products? Simple. Because if the product delivers exactly the same amount of nicotine, it enhances the addiction potential.
Why is it better for smokers to continue smoking and suffer diseases and death from the chemicals and carcinogens in tobacco than to quit smoking altogether and instead use a nicotine-delivery product, even if the amount of nicotine delivered varies from cartridge to cartridge?
Jacob Sullum put it best when he questioned the scientific competence of the groups putting forward these senseless arguments: "In fact, as I've noted before, there is no question that puffing on a smoke-free e-cigarette is much less hazardous than lighting tobacco (or anything else) on fire and sucking the combustion products into your lungs. This is a point so obvious that only the FDA and a certain brand of zero-tolerance anti-tobacco activist would try to deny it."
Groups like the Campaign for Tobacco-Free Kids are zero-tolerance activist groups because they cannot tolerate the idea of someone going through the act of what looks like smoking a cigarette, even if it is orders of magnitudes safer for them. Better that they should die smoking a product with absolutely well-known hazards than use a product which looks like smoking and from a scientific basis, must be safer, but which looks like the person is still smoking. Either these groups are ignoring science for ideology, or their scientific judgment is severely impaired.
In summary, the first implication of the court's ruling (if upheld) is that it will save the American public from the scientific incompetence and/or blinding ideology of the anti-smoking groups. Electronic cigarettes will remain a legal and viable for smokers who are concerned about the effects that cigarettes are having on their health.
2. Electronic Cigarettes Could Not Market Their Products as a Smoking Cessation Device
A key provision of the court's ruling was that electronic cigarettes are not drugs or devices because they are not intended to affect the structure or function of the body or to treat any disease or condition. However, if electronic cigarettes were to be marketed primarily as a tool for smoking cessation, then they would suddenly meet the definition for a drug or device, and would be subject to regulation under the Food, Drug, and Cosmetic Act.
The implication of this aspect of the ruling is that electronic cigarettes may not be marketed primarily as a smoking cessation tool, even if there arises evidence that these products are effective for such a purpose.
This has unfortunate consequences for the public's health, because it will make it more difficult to convince smokers who are otherwise unable to quit to try quitting smoking using electronic cigarettes. Electronic cigarette distributors will simply have to live with this aspect of the ruling. They will have to discontinue and/or refrain from making any claims that their products are effective devices for smoking cessation.
3. Electronic Cigarettes Could Not Claim to Be Safer Than Traditional Cigarettes, or to Be Safer Alternatives to Smoking
Even though it is almost certainly true that electronic cigarettes are safer than traditional ones (i.e., vaping is much safer than smoking), electronic cigarette manufacturers would not be able to make such a claim because doing so would classify the product as a "modified risk tobacco product." Doing so would require an almost impossible task: demonstrate with solid scientific evidence that these products reduce disease among individuals and among the population as a whole. This would require long-term epidemiologic studies and/or clinical trials and it is unlikely that such a massive undertaking could be financed by these relatively small companies. It would also take long-term studies - looking out 20 years or so - to demonstrate that disease rates are lower. It simply will not happen. Thus, the effective implication of the ruling is that electronic cigarettes cannot be marketed as a safer alternative to smoking.
This implication is also unfortunate, but it is a direct result of the tobacco act's unscientific approach to harm reduction strategies.
4. Electronic Cigarettes Could Claim to Reduce Delivery of Certain Constituents, But Would Have to Undertake Studies and Receive FDA Approval, Which is Unlikely
A major implication of the court's ruling is that in order to market electronic cigarettes as devices which reduce the delivery of certain tobacco constituents (chemicals and carcinogens), electronic cigarette distributors would have to obtain FDA approval. This is because if they made such claims, electronic cigarettes would be classified as "modified risk tobacco products" making "reduced exposure" claims. They would have to first show that it is anticipated that these products would reduce disease. That would be quite easy. However, the companies would also have to produce market research data showing that the provision of this information to consumers will not result in the perception that electronic cigarettes are safer than traditional cigarettes. This would be a much more difficult undertaking and would likely require companies to "fix" the results by asking inappropriately worded questions. It is therefore possible, but unlikely, that this approval could be obtained.
Thus, combining implications #1 through #4, the net effect of the court's ruling is that electronic cigarettes would be approved and permanently allowed on the market, but they would most likely not be able to make any claims regarding effectiveness in smoking cessation, relative safety compared to traditional cigarettes, or even reduced exposure to cigarette smoke constituents.
Of course, public health agencies and organizations could make such claims. Essentially, electronic cigarettes would have to be marketed purely as alternative smoking devices, and the promotion of the product as a safer alternative to smoking would have to be done by outside sources, such as public health agencies and groups, physicians, etc.
5. Electronic Cigarettes Could Not Be Sold Legally to Minors and Would Be Subject to Sales and Advertising Restrictions to Prevent Their Sale to Minors
As tobacco products, electronic cigarettes would most likely be subject to the sales and advertising restrictions put upon tobacco products by the Family Smoking Prevention and Tobacco Control Act. They could not be sold to minors, would not be able to advertise in media with high youth exposure, and would be subject to sales restrictions, such as age identification checks and other measures.
This implication is a good one, because it helps ensure that electronic cigarettes will not find their way into the hands of minors. This is a significant concern of many public health groups. The classification of electronic cigarettes as tobacco products would substantially ease this concern, as these products would be regulated in a similar manner as other tobacco products in terms of their sale to minors.
6. States Would Most Likely Not Be Able to Ban Electronic Cigarettes
As tobacco products under the Family Smoking Prevention and Tobacco Control Act, electronic cigarettes would be subject to the preemption clause in the legislation which prohibits state and local governments from issuing tobacco product standards that are different from those under the provisions of the federal law. Thus, it may be that states are not authorized to promulgate their own bans on electronic cigarettes.
According to section 916(a)(2)(A): "No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products."
The key question, then, is whether a ban on a particular type of tobacco product is considered as relating to "tobacco product standards." Tellingly, the Act's provision in which the FDA is precluded from banning any particular type of tobacco product is part of the "Tobacco Product Standards" section of the legislation (section 207). Thus, it is most likely the case that a ban on electronic cigarettes would be considered a tobacco product standard.
This most likely means that states may not ban electronic cigarettes, because such an action is in violation of the preemption clause in section 916(a)(2)(A). This may be the single most important implication of the court's decision. I have not yet seen any commentary in which this implication has been mentioned. But it is an important one because in the absence of a federal ban on electronic cigarettes, many states will likely pursue bans of their own. The court's decision appears to me to protect electronic cigarettes from state bans. This would not apply, however, to brands of electronic cigarettes that are advertised as smoking cessation products (because such products would not be defined as tobacco products and thus would not be protected by the preemption provision of the tobacco act).