The Food and Drug Administration introduced a proposed rule yesterday that would extend its existing authority over certain tobacco products. Under the proposed rule, FDA would now oversee electronic/e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco, and dissolvables. These products would be added to the ones already under FDA's authority--cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave FDA the authority to regulate the manufacture, distribution, and marketing of "tobacco products" to protect public health. The statute defines "tobacco products" as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)." The Act specifically delineated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco as products over which FDA had authority. But Congress also provided that FDA had authority over "any other tobacco product that the Secretary by regulation deems to be subject to this chapter." Accordingly, through this proposed rule, FDA is "deeming" electronic/e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco, and dissolvables to be "tobacco products" subject to FDA regulation. Under the rule, any future products that meet the statutory definition of "tobacco product" would also be deemed to be subject to FDA's authority.

Under the proposed rule, makers of these additional tobacco products will be subject to the same restrictions and requirements that exist for regulated tobacco products. These include:

  • possible enforcement actions against adultered or misbranded products;
  • submissions of ingredient listing and reporting of harmful constituents;
  • registration and product listing;
  • prohibitions against using modified-risk descriptors without prior FDA approval;
  • prohibitions on distributing free samples; and
  • premarket review requirements.

The proposed rule would also add the following requirements to the newly "deemed" products: (1) a minimum purchase age; (2) health warnings for product packaging and advertisements; and (3) a prohibition on vending machine sales, unless an establishment can ensure that persons under 18 are not allowed at any time.

FDA has provided a 75-day public-comment period and is specifically seeking comment on a number of topics, including: (1) whether to include certain cigars in the proposed rule, (2) whether certain of the newly added products should be considered "cigarettes" and be subject to the nonflavoring restriction on cigarettes; (3) how to regulate certain noncombustible tobacco products, such as e-cigarettes; and (4) whether all products should be required to carry addiction warnings, even if they are less hazardous than combustible products.

Once the proposed rule becomes final, the "deeming" provisions and age restrictions would become effective 30 days later. The proposed health-warning requirements would become effective 24 months later, but manufacturers with existing inventory could continue to introduce those products without the required warnings for 30 days.