FDA Releases Long Awaited Proposal to Regulate E-cigarettes, Cigars, and Other Tobacco Products

Federal Update: FDA Releases Long Awaited Proposal to Regulate E-cigarettes, Cigars, and Other Tobacco Products
April 24, 2014

This morning the U.S. Food and Drug Administration’s Center for Tobacco Products issued its long-awaited proposal to regulate e-cigarettes, cigars, little cigars, hookah, pipe tobacco and other tobacco products. When Congress passed The 2009 Family Smoking Prevention and Tobacco Control Act, it created FDA’s Center for Tobacco Products and gave it immediate authority over cigarettes, smokeless and roll-your-own tobacco products. In addition Congress gave authority to the agency to assert jurisdiction over other tobacco products, which FDA is finally doing today. The proposed regulation would also establish 18 as the nationwide minimum age for the legal purchase of tobacco products.

This regulation proposes to extend basic authorities found in the Tobacco Control Act to all other tobacco products (including e-cigarettes, cigars, little cigars, hookah, and pipe tobacco), such as:

  • Registration by all manufactures with FDA, including a list of all tobacco products they sell
  • Disclosure of ingredients by manufacturers to FDA
  • Prohibit the sales of tobacco products to anyone under the age of 18
  • Eliminate free sampling of all tobacco products
  • Good manufacturing practice requirements
  • Premarket review for any “new” tobacco product
  • Premarket review of any product wishing to make a “modified risk or harm” claim

One very troubling provision in the proposed regulation could create an exemption for certain types of cigars. The FDA is seeking public comment on this carve-out provision. The public comment period starts tomorrow and lasts for 75 days.

These regulations will go into effect once the Obama Administration makes them final. At that time, each provisions will be phased in.

To see the American Lung Association’s press release, click here.

-Lindsey Freitas

One Comment

  1. Mary Elizabeth
    Posted May 6, 2014 at 8:49 pm | Permalink

    I have been looking around for info about the new rules that the FDA proposed. Thank you for this very informative post. Cheers!


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