Thursday, May 01, 2014

FDA: Electronic Cigarettes Should Be the Only Consumer Product that is Not Allowed to Tell Consumers the Truth About Its Primary Benefit

I am aware of no consumer product on the market that is prohibited by federal law or regulation from truthfully informing consumers of the primary benefit of that product.

If the FDA goes ahead with its proposal to subject electronic cigarettes to section 911 of the Family Smoking Prevention and Tobacco Control Act, e-cigarettes will become the first such product.

The proposed deeming regulations would immediately prohibit electronic cigarette companies from informing consumers of the following, each of which is true:
  • that the primary purpose of electronic cigarettes is to provide a safer alternative to smoking;
  • that electronic cigarettes do not contain any tobacco, and are therefore a tobacco product only in a legal/regulatory sense;
  • that electronic cigarettes contain much lower levels of tobacco-specific nitrosamines and many other carcinogens than tobacco cigarettes;
  • that electronic cigarette use is much safer than smoking.
In my view, it is impossible to justify this aspect of the FDA's proposed deeming regulations because any restrictions on marketing to adult consumers should be based on the need to prevent companies from transmitting false, misleading, or deceptive information. Prohibiting companies from telling consumers the truth does not advance any legitimate government interest.

For this reason, I believe there is a serious question as to the constitutionality of this provision of the deeming regulations. The government cannot interfere with commercial speech unless that interference is necessary to promote a legitimate government interest. The only way that the government could show that a ban on stating that electronic cigarettes are safer than tobacco cigarettes advances a legitimate government interest would be to provide evidence that electronic cigarettes are not safer than real cigarettes. Since such evidence does not exist, the government would have a difficult time making the case. Therefore, I believe that if the deeming regulations are promulgated in their current form, this aspect of the regulations will be successfully challenged by the electronic cigarette industry.

I am not aware of any other federal law or regulation that prohibits companies from telling consumers the truth about their products as it relates to the primary benefit of the product. Hopefully, the FDA will see the error in its proposal and will reconsider its decision to subject electronic cigarettes to the provisions of section 911.

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