HomeWashington Letter2014 ▶ FDA Releases Proposed Rule to Regulate All Tobacco Products
FDA Releases Proposed Rule to Regulate All Tobacco Products

April 2014

This week, the Food and Drug Administration finally released the long-awaited proposed regulation to exert authority to regulate all tobacco products, including cigars, e-cigarettes, dissolvable tobacco products and any other novel product derived from tobacco. The proposed rule would establish important basic regulatory authority over all tobacco products including:

  • Prohibit the sales of tobacco products to anyone under the age of 18
  • Prohibit vending machine sales (except in places where only adults have access)
  • Registration by all manufactures with FDA, including a list of all tobacco products they sell
  • Disclosure of ingredients by manufacturers to FDA
  • 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
  • User fees for ally newly deemed products

The proposed rule is also notable for what it does not address. The rule would not ban TV or radio advertising for newly deemed products. Cigarettes are currently banned from TV and radio advertising. While FDA is accepting comments on this issue, the proposed rule does not take any action to ban candy-flavored cigars, cigarillos or e-cigarettes.

FDA is also seeking public comments on whether "premium" cigars should be exempt from regulation. While FDA has proposed a more extensive definition, the exemption would apply to large hand-rolled cigars that to do not have a "characterizing" flavor other than tobacco.

The tobacco control community and the American Thoracic Society have been waiting for the FDA deeming rule for over five years. While we are pleased that rule is finally out and the process can move forward, we are disappointed that FDA has not proposed more aggressive regulations of all tobacco products. The ATS is particularly concerned that FDA is considering exempting premium cigars from any regulation, allowing TV and radio ads for certain tobacco products, and taking no action on candy-flavored cigars and e-cigarettes. These are significant flaws and the ATS intends to make a strong case during the public comment period for why FDA should take more aggressive action in these areas.

Last Reviewed: October 2017