Agency chief tells House appropriators that the FDA will carry out enforcement action in an effort to curb underage use of e-cigarettes.
The Food and Drug Administration is planning to soon take “aggressive” enforcement action against illicit commercial practices related to e-cigarettes, FDA Commissioner Scott Gottlieb said during a budget hearing Tuesday of the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies.
“We have authorities over these products to go in and inspect and impose [good manufacturing practice] standards, enforce age restrictions,” Gottlieb said. “I think you’re going to see us stepping into this fight in a vigorous way in the coming weeks. I look forward to coming back to brief you on what we’re doing. We’re going to be taking some action to address these concerns.”
Gottlieb was responding generally to a question by full committee ranking member Nita Lowey, D-N.Y., who asked why the FDA hadn’t taken action against e-cigarette manufacturer JUUL Labs, which she said appears to be violating an FDA regulation.
JUUL first introduced its mango and “cool cucumber” flavor pods to the market in 2017, apparently violating FDA’s “deeming rule,” which bans new e-cigarettes, among other nicotine products, from entering the market after Aug. 8, 2016, without undergoing an FDA pre-market review, Lowey said.
She then asked if the company submitted a pre-market application to FDA for those flavors.
“I don’t want to telegraph coming enforcement action,” Gottlieb responded.
Gottlieb said he believes e-cigarettes can help wean adult smokers off cigarettes, “but not if all they end up doing is hooking a whole generation of young people on nicotine. That is not tolerable for me, and we will be addressing this.”
Before mentioning that teachers, parents and students in her district have reported JUULs as being very popular among high schoolers, Lowey held up one of the e-cigarettes, which Gottlieb said looked similar to a USB flash drive.
On Wednesday, 11 senators led by Dick Durbin, D-Ill., wrote letters to JUUL and the FDA urging action to prevent underage e-cigarette use.
JUUL Labs CEO Kevin Burns signaled an increased focus by his company on curbing underage use of e-cigarettes.
“I received the letter and take this matter very seriously,” Burns said in an emailed statement. “I have been giving these issues a great deal of thought and we are finalizing a plan for new initiatives and actions JUUL Labs will be taking, which I look forward to sharing in the coming weeks. I share the concerns expressed in this letter about youth access and believe no young person should ever try JUUL. I look forward to discussing and working with members of Congress, the FDA and others about how we can make progress on preventing youth from ever using JUUL or other nicotine products.”
Subcommittee ranking member Sanford Bishop, D-Ga., thanked Gottlieb for his agency’s deferral of the date for which companies producing e-cigarettes on the market as of Aug. 8, 2016, would be required to submit formal applications similar to cigarette companies for federal approval to sell their products.
E-cigarette manufacturers will have until Aug. 8, 2022, for their products to be generally subject to the FDA’s set of standard tobacco regulations.
Bishop also touted pending legislation he and Rep. Tom Cole, R-Okla., introduced in February 2017 that would require the secretary of Health and Human Services, among other things, to issue regulations to require labeling to detail nicotine content and discourage youth usage.
As far as helping people quit smoking, “this is an area where innovation can have a big influence,” Bishop said.