The FDA’s New Deeming Regulations– Preliminary Observations — Electronic Cigarettes

FDA’s proposed deeming regulation issued earlier today would cover a variety of products that meet the statutory definition of a “tobacco product,” including electronic cigarettes, cigars and pipe tobacco. This blog entry discusses three provisions that would apply to the tobacco products “deemed” to be subject to FDA regulation.

In particular, under the proposed regulation, these provisions apply to electronic cigarettes. The three provisions include: (1) mandatory health warnings for product packages and advertisements; (2) minimum age requirements; and (3) restrictions on the use of vending machines for the sale of covered products except in limited situations.

Health Warning Labels

With respect to the warning label, FDA’s proposed rule requires the following label for electronic cigarette packaging and advertising: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” For electronic cigarette packaging, the warning label must cover at least 30 percent of the package. For advertisements, the warning statement must be located in the upper portion “to maximize visibility” and it must occupy at least 20 percent of the area of the advertisement. The constitutionality of these warning labels could be an issue, similar to the successful First Amendment challenge lodged against the requirement that cigarettes contain graphic warning labels. However, according to FDA, non-nicotine containing electronic cigarettes would not be required to contain such warning labels as long as the manufacturer certifies and has data to support that its product does not contain nicotine.

Age Verification

Age verification is already required by retailers for sales of cigarettes and smokeless tobacco. In expanding the age verification requirement to electronic cigarettes (as well as other covered tobacco products), FDA stated that “the proposed rule would simplify retailer compliance with tobacco access restrictions” because all tobacco products in a retailer’s establishment would be “subject to the same age and identification requirements.”

Vending Machine Sales

Restrictions on vending machine sales already exist for the sale of cigarettes and smokeless tobacco. FDA’s proposed regulation imposes the same restrictions on the sale of electronic cigarettes (as well as other covered products). The sale of electronic cigarettes in vending machines will be prohibited unless the machines are in locations that prohibit anyone under the age of 18 from entering at any time.

For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco practice partner, at 804.697.1420 or by email.