FDA Sets Strategic Tobacco Regulation Priorities
Zeller presentation highlights continuum of risk, compliance enforcement
MINNEAPOLIS -- Five years ago this month the Family Smoking Prevention and Tobacco Control Act was signed into law and authorized the Food and Drug Administration (FDA) to regulate tobacco products. Over the past five years, the FDA has issued regulations on cigarettes, roll-your-own tobacco, and smokeless tobacco products.
On April 24, the FDA’s Center for Tobacco Products (CTP) released its proposed deeming regulations to extend the agency’s authority to cigars, pipe tobacco, electronic cigarettes, hookah tobacco, dissolvable products and nicotine gel.
Recently, on June 11, FDA Center for Tobacco Products Director Mitch Zeller gave a presentation at a Legacy Foundation conference regarding the “Strategic Priorities” for federal tobacco regulations. In his presentation, Zeller highlighted the following priorities for regulating tobacco products:
1. Creating the building blocks to develop rules and guidance including the proposed deeming regulations, tobacco product testing and reporting requirements, and establishing and funding a tobacco research agenda.
2. Pursuing strategic priorities that include developing product standards that can improve public health and withstand legal challenges from the tobacco industry.
3. Establishing a comprehensive nicotine regulatory policy that recognizes there is a continuum of nicotine-containing products.
4. Adopting pre-market and post-market controls through regulations and product review because “as the regulatory gatekeeper, CTP now stands between tobacco products and consumers.”
5. Focusing on compliance and enforcement by expanding the state retail inspection program to all remaining states.
6. Educating the public about the health implications of tobacco use.
A copy of the slide presentation detailing the FDA’s strategic priorities used by Zeller for this presentation at the Legacy Foundation can be found here.