Regulatory science

The Family Smoking Prevention and Tobacco Control Act of 2009 (pdf) granted the FDA power to require appropriate testing of and evaluation of tobacco products. As the agency determines its limits and the extent of its authority, many new challenges have arisen in the field.

The development and differentiation in product design and content of electronic cigarettes is clearly one of the foremost challenges confronting the regulatory sciences arena. These products require scientific examination to determine both their short and long-term health effects.

The e-cigarette research agenda is a sprawling enterprise unto itself, ranging from toxicological studies on e-liquids and aerosol emissions to the addictive potential and abuse liability to the effects of e-cigarettes on smoking norms, particularly among youth. E-cigarettes are marketed as harm reduction and cessation devices, but some studies suggest, that use of electronic cigarettes can lead to “dual use” of both tobacco and electronic cigarettes.

In addition to e-cigarettes themselves, the relatively recent explosion in electronic nicotine delivery systems (ENDS) includes hookah pens, vape pens, tank systems and “mods,” some of which have the potential to overtake e-cigarettes in their popularity. These products are joined by other potentially reduced exposure products (PREPs) such as snus, orbs and lozenges. Along with cigars, cigarillos and blunts, these products are in need of greater scientific understanding and scrutiny. Similarly, we need a greater critical understanding of reduced nicotine and de-nicotinized cigarettes, their use and their abuse potential. The question of menthol in tobacco remains a major regulatory issue at the local, state and national level.

The potential benefit of graphic warning labels has not been thoroughly analyzed. And, given their potential to impact domestic tobacco control efforts, international trade agreements need to be better studied and understood.