The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act or TCA) gave FDA immediate jurisdiction over cigarettes, no rx cigarette tobacco, smokeless tobacco, and roll-your-own tobacco. It also gave FDA authority to extend its jurisdiction over “other tobacco products” by issuing a regulation “deeming” those products subject to the statute. The TCA defines “tobacco product” broadly to include products made from or derived from tobacco, including their components, parts and accessories except for products already regulated as drugs (i.e., nicotine replacement therapy products).
In April, 2011, following an unsuccessful attempt to regulate e-cigarettes as drugs,  FDA indicated its intent to issue a regulation deeming all “tobacco products” subject to the TCA, but it did not issue a proposed “deeming” regulation until three years later, on April 25, 2014. FDA has established a seventy-five day period for public comment, expiring July 9, 2014. There is no statutory deadline for FDA to issue a final deeming rule.
What Products Does FDA Propose to Regulate?
The principal products that would be made subject to FDA regulation by the proposed rule are cigars and e-cigarettes, but the proposed rule would also cover all other tobacco products, including pipe tobacco, hookah tobacco, dissolvable tobacco products, gels, and any future products containing or derived from tobacco.
The proposed rule contains two alternative proposals for coverage of cigars and asks for public comment on which alternative FDA should adopt. Under one option, all cigars would be made subject to FDA jurisdiction. Under the other option, cigars designated as “premium cigars” would not be made subject to FDA jurisdiction at all. FDA notes that some have suggested that, although all cigars are harmful and potentially addictive, different kinds of cigars “may have the potential for varying effects on public health,” particularly if there are differences in youth initiation and frequency of use by youth and young adults. The proposed rule defines “premium cigars” as cigars which meet all of the following criteria: (1) wrapped in tobacco leaf; (2) contains 100% leaf tobacco binder; (3) contains primarily long filler tobacco; (4) is made by combining manually the wrapper, filler, and binder; (5) has no filter, tip, or non-tobacco mouthpiece and is capped by hand; (6) has a retail price (after any discounts or coupons) of no less than $10 per cigar (subject to inflation adjustment); (7) does not have a characterizing flavor other than tobacco; and (8) weighs more than six pounds per 1000 units.
Cigars are not currently regulated by the Food and Drug Administration (FDA). Under the Family Smoking Prevention and Tobacco Control Act, Congress immediately applied FDA’s new regulatory authority to cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco and gave FDA the authority to assert jurisdiction over all other tobacco products.
Congress did not exclude any tobacco product from potential regulation under the Tobacco Control Act so that FDA could evaluate the science and public health considerations of every tobacco product. Cigars clearly fall within the definition of “tobacco products” laid out in the Tobacco Control Act (i.e., “any product made or derived from tobacco that is intended for human consumption…”), and cigars are specifically mentioned in the statute (see Sec. 907 and Sec. 919).
The Tobacco Control Act gives FDA considerable flexibility to determine how to apply its regulatory authority to cigars and other tobacco products that were not immediately under FDA’s jurisdiction. FDA is not required to regulate all tobacco products like cigarettes and is not required to regulate all cigars in the same way.
A growing number of adults and youth are using electronic cigarettes, which provide a relatively new way to deliver the addictive substance nicotine without burning tobacco. Many questions remain about the long-term health effects of these products for individual users. It is not clear whether these products will help people quit, discourage smokers from quitting completely, or become a gateway to nicotine addiction and smoking for new users, including kids.
What are Electronic Cigarettes?
The term “electronic cigarettes” covers a wide variety of products now on the market, from those that look like cigarettes or pens to somewhat larger products like “personal vaporizers” and “tank systems.” Instead of burning tobacco, e-cigarettes most often use a battery-powered coil to turn a liquid solution into an aerosol that is inhaled by the user. There are a wide range of reusable e-cigarettes, which enable users to replace a nicotine-containing cartridge or refill a tank with a liquid solution, and there are disposable e-cigarettes, which cannot be refilled. Also growing in popularity are “mods,” which are units that users assemble themselves from separate component parts, to allow variation in battery power, style, and size.