- The Washington Times - Tuesday, July 16, 2019

The Food and Drug Administration said it is ready to speed up the review of e-cigarettes and tobacco-related products in order to tackle the youth vaping epidemic.

Its statement follows a Maryland district court judge’s decision late last week to have e-cigarette and tobacco-product manufacturers submit applications to the agency within 10 months that would allow products to enter or stay on the market, a response to a lawsuit brought against the FDA for delaying product reviews.

“This court decision comes at a time when I, like many others, are tremendously concerned about the rising use of e-cigarettes among our nation’s youth and especially the potential for them to become traditional cigarette smokers,” FDA acting commissioner Ned Sharpless said in a statement this week. “We cannot allow the next generation of young people to become addicted to nicotine because of e-cigarettes.”

He added U.S. District Judge Paul Grimm’s decision sets a “rapid pace” for the agency to receive and review applications to determine public health benefits and harms of a product.

The FDA had postponed the deadline for application submissions for e-cigarettes until August 2022.



It also would have let these products remain on the market indefinitely during the review process, which had no deadline, prompting opposition from health groups who cite a surge in e-cigarette use among youth.

E-cigarette manufacturers have until May 12 to submit their applications to the FDA, which then gets a year to review applications. The agency can remove products from manufacturers who do not submit their applications on time and any rejected applications also.

Last year, 3.6 million middle and high school students nationwide had used e-cigarettes, up from 1.5 million from the previous year, according to the FDA.

The rise in e-cigarette use can be attributed to manufacturers that introduced sweet-flavored, nicotine-loaded products like Juul without any review of their public health impact or appeal to children, according to a statement by the Campaign for Tobacco-Free Kids, American Academy of Pediatrics and other groups that filed the lawsuit against the FDA.

“The court’s decision can help reverse the youth e-cigarette epidemic if the FDA uses the review process to eliminate products that appeal to kids, especially the flavored products like Juul that have caused this epidemic. The key is for the FDA to enforce the law and take these products off the market,” said Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids.

Although the Campaign and other advocacy groups had asked the judge for an even shorter application deadline of 120 days, they called the new 10-month deadline “a dramatic improvement” from the deadline set by the FDA.

Gregory Conley, president of the American Vaping Association, said the court should expect the vaping and e-cigarette industry to appeal the ruling.

He said Judge Grimm was playing regulator in court, adding the ruling is a move toward the countdown of the extinction of the vast majority of small- and medium-sized manufacturers in the industry who cannot afford to submit review applications.

“We think that the initial decision and the timeline set out by the judge are both illegal and wrong on the law,” said Mr. Conley, commenting on how it’s a surprise the Trump administration would let a judge tell the government how to run its regulatory agency.

“Unless you are a vapor company whose science is subsidized by either cigarette sales or Wall Street investment, you do not stand much of a chance at all of even being able to successfully file an application, let alone get one approved,” he added.

The FDA said it will continue to expand its efforts to educate youth about the dangers of e-cigarettes and tobacco products, implement policies to keep tobacco products out of the hands of children, and take action to combat illegal sales of e-cigarettes to youth.

The agency also said it will finalize a proposed compliance policy that limits youth access to flavored tobacco products and flavored e-cigarettes, and launch its first e-cigarette prevention TV ads later this month.

It acknowledged that certain e-cigarette products “hold some promise” to help addicted adult smokers transition from traditional tobacco products such as cigarettes to possibly less harmful forms of nicotine. But the FDA said these products still pose a health risk and should stay out of the hands of children.

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