Update 5/20/2016 – Access an archived version of our May 19 webinar on the deeming rule, featuring the FDA's Mitch Zeller. Click to access.
Update 5/9/2016 – We have created two helpful resources to explain the practical applications of the FDA's new authority:
• The Deeming Regulation: FDA Authority Over E-Cigarettes, Cigars, and Other Tobacco Products (2016)
• State and Local Tobacco Regulation in a Post-Deeming World (2016)
• Lawsuits Challenging the FDA’s Deeming Rule (2016)
May 5, 2016 – Today, the U.S. Food & Drug Administration took an important step to protect public health by issuing a final regulation extending its authority to regulate e-cigarettes, cigars, pipe tobacco, and hookah. The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products, but the law’s scope originally was limited to cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco. The Act gave the FDA the option to extend its regulatory reach to any tobacco product that it “deemed” to be within its authority and the FDA will now regulate all existing and future tobacco products.
What does it mean for the FDA to now have the authority to regulate these products? Over the next few days, the Tobacco Control Legal Consortium will fully analyze the regulation and provide educational materials to explain in more detail what the rule does and doesn’t do, and how it relates to state and local tobacco control efforts.
In the meantime, we congratulate the FDA on overcoming significant political barriers to finalize a rule to regulate e-cigarettes, all cigars, and other previously unregulated tobacco products. Federal oversight of these products is sorely needed, as the e-cigarette market has transformed from a fledgling industry to a global powerhouse over the past five years, and kids are using e-cigarettes and cigars at unprecedented rates. We commend the agency for taking this essential step, which now prohibits the sale of these products to minors throughout the U.S., requires health warning labels, and prohibits manufacturers and retailers from distributing free samples of these products. The FDA has shown great foresight by also asserting jurisdiction over any future tobacco products; it will be poised to more quickly address what has always been an evolving market due to industry efforts to thwart effective regulation of its products.
We are really pleased that the FDA addressed many concerns raised in our comment on the proposed rule. For instance, as we recommended, the FDA will now consider mix-your-own vape shops to be manufacturers, subjecting them to the registration and manufacturing requirements of the rule and corresponding FDA inspections. The FDA also somewhat tightened the timelines for deciding which of these newly regulated products can and cannot be sold at retail. While we were hoping for shorter timelines, what is in the final rule is much better than what was initially proposed.
While we’re glad to see that the FDA acknowledged concerns raised by us and others about flavored cigars and said that it will draft a proposed product standard to remove flavored cigars from the market, that’s not enough. The Tobacco Control Act prohibited flavored cigarettes (except menthol), but other products are available in an astonishing array of fruit, candy, dessert, and other youth-attractive flavors. It has been known for decades that adding menthol and these sweet flavors to tobacco products mitigates the harsh flavor of tobacco and increases youth initiation. Flavored products have no place in a regulatory framework intended to protect public health, and the FDA should remove all flavored products, including menthol-flavored cigarettes, from the U.S. market. We look forward to swift regulatory action on all current and future flavored tobacco products, especially in light of FDA’s acknowledgement in the regulation of the youth appeal of flavored e-liquid.
We look forward to working with the FDA and the public health community to develop additional policies to fill the gaps left by this regulation, ensuring that tobacco products do not make it into the hands of America’s youth or prolong adult addiction.
The Consortium, a program of the Public Health Law Center, will post its materials on the FDA Tobacco Action Center page of our website, but you are always welcome to contact our FDA team with questions:
Maggie Mahoney is the Executive Director of the Tobacco Control Legal Consortium at the Public Health Law Center