Saturday, August 17, 2019

Saturday, August 17, 2019

Trade association monitoring court order for FDA to speed up review of vaping products


A trade association is taking a “wait and see” stance following a federal court ruling that orders the Food and Drug Administration to speed up its review of vaping products.

The U.S District Court in Maryland found that the decision by the FDA to allow manufacturers a five-year window, announced in 2017 and running until 2012, before a review will take place is contrary to the Tobacco Control Act. The FDA may appeal the decision.

Alex Schriver, in a statement on behalf of the Vapor Technology Association, a trade group, said the “case could result in significant changes to FDA’s compliance policy and deadlines for filing premarket submissions” for “new tobacco products” on the market in mid-2016.

“However, at this time, we do not view this development as having any immediate impact on industry’s ability to continue marketing such products,” Schriver said in the email statement  to Tobacco News Wire.

A number of groups, including the American Association of Pediatrics, the American Cancer Society Cancer Action Network, and the Campaign for Tobacco-Free Kids, sued the FDA over the agency allowing manufacturers a 2012 deadline prior to providing information on the use of vaping products.

U.S. District Judge Paul Grimm of Maryland last week ruled that the FDA decision to delay review of the products is contrary to the Tobacco Control Act.

“Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that are approved,” Grimm wrote.

In a statement, the American Association of Pediatrics cheered the ruling, arguing it is vital for the FDA to move quickly on the issue of vaping.

“The AAP applauds the judge’s ruling,” president Kyle Yasuda said. “The FDA oversight over the sales and marketing of these harmful products has languished for too long.”

“With the epidemic of e-cigarette use by teens, it is incumbent on the FDA to act expeditiously to hold manufacturers accountable for products that contain nicotine and harmful chemicals.”

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US Food and Drug Administration

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