FDA Issues Sweeping Rules for E-Cigarettes | Practical Law

FDA Issues Sweeping Rules for E-Cigarettes | Practical Law

The Food and Drug (FDA) Administration have issued a final rule that extends federal regulatory authority to e-cigarettes and imposes a series of sweeping news laws restricting their sale and that of other tobacco products.

FDA Issues Sweeping Rules for E-Cigarettes

Practical Law Legal Update w-002-2289 (Approx. 5 pages)

FDA Issues Sweeping Rules for E-Cigarettes

by Practical Law Commercial Transactions
Law stated as of 06 May 2016 • USA (National/Federal)
The Food and Drug (FDA) Administration have issued a final rule that extends federal regulatory authority to e-cigarettes and imposes a series of sweeping news laws restricting their sale and that of other tobacco products.
On May 5, 2016, the Food and Drug Administration (FDA) issued its final rule that extends federal regulatory authority over e-cigarettes and imposes new restrictions on the sale e-cigarettes and other tobacco products. These new regulations will go into effect 90 days after publication in the federal register, which is scheduled to occur on May 10, 2016.

Amending the Tobacco Control Act

The new rule amends the definition of "tobacco product" under the Food, Drug, and Cosmetic Act's (FDCA) Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) to include electronic nicotine delivery systems (ENDS) and their components and parts. The FDA provides a non-exhaustive list that is now included in the definition of "tobacco product" for:
  • ENDS and their components and parts:
    • e-cigarettes;
    • e-liquids;
    • atomizers (a device that emits the e-liquid);
    • cartomizers (atomizers and replaceable fluid-filled cartridges);
    • digital display/lights to adjust settings;
    • clearomisers (a device that emits the e-liquid);
    • tank systems (a device that emits the e-liquid);
    • flavors;
    • vials that contain e-liquids; and
    • programmable software.
  • Components and parts used with waterpipe tobacco:
    • flavor enhancers and the vials in which they are contained;
    • hose cooling attachments;
    • water filtration base additives (including flavored);
    • flavored waterpipe tobacco charcoals and the wrappers or boxes that contain the charcoals;
    • bowls;
    • valves;
    • hoses; and
    • heads.
The new regulations do not cover accessories intended to be used with the human consumption of the tobacco product that do not contain tobacco, and are either:
  • Not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product.
  • Intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product, but solely to either:
    • control the moisture or temperature of the stored product; or
    • provide an external heat source to initiate but not maintain combustion of a tobacco product.

Regulatory Requirements and Restrictions on Newly Covered Tobacco Products

Upon the effective date of the final rule (August 8, 2016), the newly deemed products will be subject to the same FDCA provisions and relevant regulatory requirements as the other defined tobacco products, including:
  • Enforcement action against products determined to be adulterated or misbranded.
  • Required submission of ingredient listing and reporting.
  • Required registration of tobacco product manufacturing establishments and product listings.
  • Prohibition against sale and distribution of products with modified risk descriptors and claims.
  • Prohibition on the distribution of free samples (same as cigarettes).
  • Premarket review requirements.
The FDA has also established restrictions for the newly covered tobacco products, including:
  • Requirement of a minimum age of 18 for purchase (effective 90 days from the date of publication of the final rule (August 8, 2016)).
  • Requirement of health warnings for product packages and advertisements (effective 24 months from the date of publication of the final rule (May 10, 2018), with an additional 30-day period for existing inventory manufactured before the effective date).
  • Prohibition of vending machines for such products, unless the vending machine is located in a facility that ensures individuals under 18 years old are prohibited from entering at any time (effective 90 days from the date of publication of the final rule (August 8, 2016)).

Additional Requirements for Cigars

The final rule also adds requirements for cigars and cigar packages, including the requirement that cigar packages have a fifth surgeon general warning for the previously excluded category, "Tobacco Use Increases the Risk of Infertility, Stillbirth, and Low Birth Weight". The new warning must read: "WARNING: Cigar use while pregnant can harm you and your baby."
For more information on the regulation of tobacco, see Practice Notes, Advertising: Overview: Industry Specific Regulation: Tobacco and Online Advertising and Marketing: Legal Regulation of Online Advertising and Marketing: Tobacco Products.