FDA’s tobacco products regulation: what does the deeming rule do?

The federal Food and Drug Administration (FDA) recently released its final “deeming rule,” which extends the agency’s regulatory authority to all tobacco products, including electronic smoking devices, cigars, pipe tobacco, and hookah tobacco.

The deeming rule extends several provisions of the federal Tobacco Control Act to these new tobacco products. For example, these products are now subject to the federal prohibition on sales to minors, the federal prohibition on free sampling, federal warning label requirements, and the requirement that tobacco manufacturers register with the FDA and seek the agency’s review of new tobacco products.

What does this mean for localities?

Many localities have already adopted laws regulating the sale and use of electronic smoking devices, cigars, pipe tobacco, and hookah tobacco. Other jurisdictions are planning to do so, and may have questions about whether the deeming rule would affect local laws.

The deeming rule makes clear that state and local governments can continue to adopt and enforce laws relating to tobacco product sales, use, distribution, and advertising (within constitutional limitations). These state and local laws can be “in addition to, or more stringent, than, the requirements of the Tobacco Control Act and its implementing regulations.”

For example, the deeming rule would not affect states’ and localities’ ability to pass laws regulating where electronic smoking devices can be used, prohibiting sales of single cigars, or requiring retailers to obtain a local license to sell tobacco products of any kind. The deeming rule does identify some areas where local and state action could be preempted, including laws relating to tobacco product manufacturing standards and labeling. But the FDA indicated that the final deeming rule does not preempt any state or local laws in effect as of August 8, 2014 (the close of public comments on the proposed deeming rule).

In sum, the deeming rule likely does not affect most laws that states and localities already have on the books or are considering for future adoption. In fact, state and local laws remain important mechanisms for limiting exposure to secondhand smoke and reducing youth access to all tobacco products.

When does the deeming rule go into effect?

Many of the deeming rule’s requirements went into effect on August 8, 2016, including the prohibition on sales to minors, the prohibition on free sampling, and restrictions on tobacco product vending machines. Other requirements, such as those regarding warning labels, premarket review, tobacco product manufacturer registration, ingredient reporting, and restrictions on modified risk tobacco products, will go into effect between August 20, 2016, and May 10, 2018. For more information on these effective dates, please see the FDA document, Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products.

However, even with the rule in effect, states and localities maintain their authority to regulate where tobacco products can be used and how they can be sold. In fact, state regulation and local regulation remain crucial to implementing and enforcing restrictions on sales and use of emerging tobacco products.

Given the lengthy implementation period and the deeming rule’s recognition that the Tobacco Control Act “expressly preserves the authority” of states and localities to adopt tobacco control laws, it remains critical for states and localities to consider policy options for limiting exposure to all tobacco products. For more information on local options for regulating electronic smoking devices, cigars, and other tobacco products, see our Tobacco Control resources.