HomeWashington Letter2014 ▶ ATS Comments on FDA Tobacco Deeming Rule
ATS Comments on FDA Tobacco Deeming Rule

August 2014

The ATS submitted comments on the Food and Drug Administration's proposed rule to regulate all tobacco products including cigars and e-cigarettes. The ATS comments supported many of the steps FDA proposed, but encouraged the agency to take additional steps to regulate all tobacco products. ATS agreed with FDA's proposal to:

  • 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)
  • Register all manufactures with FDA, including a list of all tobacco products they sell
  • Disclose ingredients by manufacturers to FDA
  • Eliminate free sampling of all tobacco products
  • Require good manufacturing practices
  • Require premarket review for any "new" tobacco product
  • Require premarket review of any product wishing to make a "modified risk or harm" claim
  • Establish user fees for ally newly deemed products

While ATS supports the FDA's proposed steps, the ATS comments urged FDA to take additional steps to regulate tobacco products including banning of candy-flavored tobacco products, effective regulation of internet sales, banning tobacco sponsorship of cultural events, banning tobacco branded merchandize, requiring child proof liquid nicotine containers and banning self-service displays for tobacco products.

However, ATS strongly rejected FDA's proposal to exempt "premium" cigars from FDA regulation. The ATS forcefully argued that cigars, like all tobacco products, contain nicotine and other toxic substances that make tobacco products addictive and deadly.

The ATS also objected to FDA's proposal to discount the public health benefits of reduced tobacco use by as much as 80% because of consumers "lost pleasure" from no longer using tobacco products. ATS noted applying the "lost pleasure" economic model to tobacco addiction was inappropriate because the majority of smokers say they wish they never started smoking and would like to quit.

In 2009, Congress passed legislation giving the agency authority over all tobacco products, but legislation directed FDA to take immediate action on cigarettes and roll-your-own tobacco. However, FDA did not take any action other tobacco products until the release of the proposed rule.

Last Reviewed: October 2017