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FDA issues final rule on all tobacco products

May 05, 2016

By Jennifer Garvin

Silver Spring, Md. — The U.S. Food and Drug Administration May 5 issued a final rule on tobacco products, expanding the agency's authority to regulate all tobacco — including e-cigarettes, hookah and cigars.

The new rule will make it illegal for retailers to sell any tobacco product to minors and will help the agency enforce the Family Smoking Prevention and Tobacco Control Act of 2009. With the changes, FDA hopes to "improve public health and protect future generations from the dangers of tobacco use," the agency said in a press release.

"Today's announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions," said Sylvia Burwell, secretary, Health and Human Services.

"While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb," said FDA, noting that e-cigarette use among high school students increased by 900 percent from 2011 to 2016 from 1.5 percent to 16 percent in 2015.

The Association has long advocated for tighter federal regulations on all forms of tobacco. In August 2014, ADA wrote a letter urging FDA to expand its regulation of products it deemed to be covered by the Family Smoking Prevention and Tobacco Control Act. 

FDA will also now require manufacturers of tobacco products to:

  • Register manufacturing establishments and providing product listings to the FDA;
  • Report ingredients, and harmful and potentially harmful constituents;
  • Require premarket review and authorization of new tobacco products by the FDA;
  • Place health warnings on product packages and advertisements; and
  • Not sell modified risk tobacco products (including those described as "light," "low," or "mild") unless authorized by the FDA.
For more information on the ADA's advocacy efforts on tobacco visit

The final rule will be published May 10. Until then, there is a prepublication PDF version here.