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FDA issues final rule on all tobacco products

  • ADA News
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 rule also requires manufacturers "of all new tobacco products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007," FDA said. With its expanded authority, the FDA said it hopes it will "prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks."

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

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