Wednesday, August 19, 2015

U.S. District Court Decision May Cast Doubt on Constitutionality of FDA's Upcoming E-Cigarette Regulations

A recent decision by a U.S. District Court (for the Southern District of New York) casts serious doubt on the constitutionality of the soon-to-be-released FDA deeming regulations for electronic cigarettes.

The ruling involved the question of whether drug companies may promote their products for off-label uses if such statements are factual and not misleading. The decision, explained in detail here, held that the FDA cannot prosecute a drug manufacturer for marketing a "misbranded" product based solely on the promotion of that drug for off-label purposes. The court ruled that such a prosecution would violate the First Amendment rights of the company, so long as it is making factual and non-misleading statements about the off-label uses.

Specifically, such a prosecution would not meet the third and fourth prongs of the Central Hudson test. First, it would not advance the government's interest in ensuring accurate communication to consumers because banning truthful, non-misleading statements does not advance such a purpose. Second, it violated the fourth prong of Central Hudson because the prohibition is far broader than necessary to advance the government's interest in ensuring that the information given to consumers about pharmaceutical products is accurate and non-misleading.

The Rest of the Story

This case has important potential implications for the e-cigarette deeming regulations that I expect the FDA to release shortly. Specifically, the case casts doubt on the constitutionality of what I expect will be the application of the modified risk provisions of the Family Smoking Prevention and Tobacco Control Act (section 911) to electronic cigarettes.

Should the FDA take such an action, it would mean that no electronic cigarette company could even mention to its customers that the product does not contain tobacco, or even that it does not produce smoke. Such statements would render the products to be "reduced exposure" products and would require pre-approval from the FDA. Section 911 clearly specifies that if a company suggests that its tobacco product does not produce a particular substance or is free of a substance contained in another tobacco product, then it is making a reduced exposure claim, which is not permissible without pre-approval.

Obtaining such approval would be impossible because the company would have to show that consumers do not infer that not containing tobacco or not producing smoke means that the product is likely safer than real tobacco cigarettes. Obviously, consumers are going to correctly infer that the absence of tobacco and combustion does indeed make e-cigarettes safer. Since these reduced exposure claims could never gain approval, the deeming regulations would essentially ban companies from making these truthful, non-misleading statements.

However, under the reasoning expounded in the New York district court decision, such a prohibition would likely be viewed as violating the free speech rights of the e-cigarette companies because it fails to satisfy the third and fourth prongs of Central Hudson. No government interest is advanced by forcing companies to essentially lie about the two most important features of their products: (1) the absence of tobacco; and (2) the absence of smoke (i.e., combustion). Prohibiting such truthful and non-misleading speech does nothing to advance the government's interest in ensuring that consumers receive accurate and non-misleading information about the safety or relative safety of different tobacco products.

In fact, such a prohibition would make it impossible for companies to truthfully and accurately communicate to consumers the relative safety of electronic cigarettes compared to tobacco cigarettes, which would essentially ensure that consumers are deeply misled about the relative safety of these two different types of "tobacco products." Thus, the prohibition not only fails to advance the government's purpose, but it directly contravenes that purpose. This would likely be viewed upon as a particularly unjustified intrusion into commercial free speech.

The rest of the story, then, is that I believe that the FDA's deeming regulations will be challenged successfully in court on the grounds that section 911, as applied to electronic cigarettes, infringes upon the free speech rights of electronic cigarette companies.

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