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AAP: FDA e-cigarette regulations don’t go far enough :

November 15, 2018

The Food and Drug Administration (FDA) is placing new restrictions on flavored e-cigarette sales as teen use skyrockets, but the Academy says they don’t go far enough to address the growing public health crisis.

The regulations come amid new data from federal health officials showing more than 3 million high school students and 570,000 middle school students were current e-cigarette users this year, spikes of 78% and 48% respectively over 2017.

“It’s clear we have a problem with access to, and appeal of these products to kids, and we’re committed to utilizing the full range of our regulatory authorities to directly target the places kids are getting these products and address the role flavors and marketing are playing in youth initiation,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.

His plan includes:

  • limiting the in-person sale of flavored e-cigarette products to age-restricted locations (excluding mint and menthol flavors);
  • heightening the age verification for online sales of flavored e-cigarette products (excluding mint and menthol flavors);
  • removing e-cigarette products marketed to children;
  • banning flavors in cigars; and
  • banning menthol in cigarettes and cigars.

The FDA did not provide details on when the restrictions would go into effect as some must go through a regulatory process.

AAP President Colleen A. Kraft, M.D., M.B.A., FAAP, commended the steps to ban menthol cigarettes and flavored cigars, but stressed the FDA must do more to protect children from e-cigarettes.

“Even with new sales restrictions announced today by FDA preventing flavored e-cigarettes from being sold at certain brick and mortar storefronts, teens will still find ways to access them,” Dr. Kraft said in a statement. “E-cigarette products that appeal to children have no business in the marketplace, period. FDA must take stronger action to protect young people.”

E-cigarettes contain toxic chemicals and nicotine that is addictive and can harm developing brains. Studies have found teens who use e-cigarette are more likely to try combustible cigarettes.

In March, the Academy and other health groups sued the FDA saying it is putting children at risk by allowing the e-cigarettes to stay on the market while they await a review that was extended to 2022.

The FDA announced in September it would give five of the largest manufacturers 60 days to come up with plans to keep their products out of the hands of teens. JUUL, which makes devices that resemble USB flash drives and contain high levels of nicotine, said Tuesday it would stop selling flavored pods to retail stores, restrict sales on its website to adults 21 and older and shut down social media accounts.

Last week, the AAP and other health groups sent a letter to the FDA urging it to enforce pre-market review of tobacco products, remove flavored tobacco products that have not been thoroughly vetted, and further restrict e-cigarette marketing and sales to minors.

“Pediatricians will not rest until these dangerous products are off the market and out of the hands of children and adolescents,” Dr. Kraft said.

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