FDA Policy/General

Tobacco Product Premarket Deadline Extension OK

The Maryland federal court has granted an FDA request to extend to 9/9 the 5/12 deadline for manufacturers of e-cigarettes, cigars, and other deemed new tobacco products that were on the market as of 8/8/16 to submit applications for premarket review. An agency statement said FDA had been working steadily toward the 5/12 deadline, but the coronavirus public health emergency had drastically impaired its ability to adhere to it.

Consistent with the original 7/12/19 court order setting the 5/12 deadline, FDA says, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to enforcement actions for up to one year from the deadline unless a negative action is taken by FDA on an application during that time.

The statement says FDA received numerous inquiries from the tobacco industry expressing concern that companies would be unable to complete premarket applications by the original 5/12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad.

“At this time FDA believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading Covid-19 to others by trying to meet the previous 5/12 deadline,” FDA says. “In the more than a dozen requests for an extension that FDA received, this public health concern was mentioned repeatedly.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome