FDA faces mounting pressure to release final e-cigarette flavor policy

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In a letter, a lawmaker is urging the US Food and Drug Administration to issue its compliance policy that would clear the market of unauthorized flavored e-cigarettes.

The letter follows President Donald Trump’s September 11 announcement that the FDA would be putting out “some very strong recommendations” regarding the use of flavored e-cigarettes in “a couple of weeks.”

When that announcement was made, US Health and Human Services Secretary Alex Azar said that it would take “several weeks” to put out final guidance on the policy, which would see “all flavored e-cigarettes other than tobacco flavor” removed from the market.

No policy has been announced yet.

“I urge you to put the flavor ban in place today before one more child gets hooked by flavored e-cigarettes. If you are unable to do that, then I request a briefing at your earliest convenience on the causes of the delay,” Rep. Raja Krishnamoorthi, chairman of the House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, said in a letter on Monday to FDA Acting Commissioner Dr. Ned Sharpless.

“It has now been six weeks, but FDA has not issued the compliance policy. Each day that flavors are on the market is another day for kids to pick up their first e-cigarette and start a lifetime of nicotine addiction,” Krishnamoorthi wrote.

In an email on Tuesday, an FDA spokesman said the agency will respond directly to Krishnamoorthi, that it intends to finalize its compliance policy “in the coming weeks” and that the FDA “plans to share more on the specific details of the plan and its implementation soon.”‎

“The FDA remains committed to our oversight of all tobacco products, including e-cigarettes, and to keeping all tobacco products out of the hands of youth.

“We share the belief that all tobacco products, including e-cigarettes, should never be marketed to, sold to, or used by kids — and we need to make every effort to prevent kids from getting hooked on nicotine. The companies making these products, the retailers selling them, and the online venues that help to fuel the teen popularity of, and access to, these products must redouble efforts to follow the law and not sell or market to kids.”

Walmart has stopped selling e-cigarettes and several retailers have announced plans to restrict the sale of flavored vapes, with critics saying the flavors target young people and get youth hooked on nicotine.

Last week, leading e-cigarette company Juul Labs announced it would stop selling several flavored products in the United States, including its mango, creme, fruit and cucumber flavors. The company said it would continue to sell tobacco, mint and menthol pods in US retail locations, but Juul will “continue to review our policies and practices in advance of FDA’s flavor guidance and have not made any final decisions,” according to a Juul spokesperson. “We are refraining from lobbying the Administration on its draft flavor guidance and will fully support and comply with the final policy when effective.”

Still, others said Juul didn’t go far enough and urged the government to take action on flavors.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said “This announcement shows why the Trump Administration must stand up to pressure from Juul and Altria and move forward with its plan to remove all flavored e-cigarettes from the market, including mint and menthol — as the Administration said it would do in its September 11 announcement.”

American Heart Association CEO Nancy Brown also said last week that “Congress and the administration should move forward without delay to remove all flavored e-cigarettes, including mint and menthol, from the market.”

Concern over e-cigarette use among young people — and an outbreak of vaping-related lung injuries that has sickened more than 1,400 people and killed 33 — has led to a backlash against vaping in the United States.

The US Centers for Disease Control and Prevention has said that the majority of lung injury cases are linked to products containing tetrahydrocannabinol, or THC, the main psychoactive compound in cannabis — but the exact cause of the outbreak remains unknown.

The CDC, FDA, state and local health departments, and other clinical and public health partners are continuing to investigate the multistate outbreak.

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