Tobacco

Sen. Chuck Grassley (R-IA) is pressing FDA to provide more information about its recent spate of warning letters and civil monetary penalties to more than 1,300 e-cigarette companies.

FDA is evaluating the role that e-cigarette flavors play in driving youth use of the products and will factor that into a decision on whether to bump up the compliance deadlines for premarket review, FDA Commissioner Scott Gottlieb announced Wednesday (Sept. 12).

FDA is contemplating moving up the enforcement deadlines for premarket review of e-cigarettes in light of what Commissioner Scott Gottlieb declared is an epidemic of e-cigarette use among teenagers.

FDA released the first of what will be two draft guidances aimed at facilitating the development of orally inhaled nicotine-cessation products, like e-cigarettes and other electronic nicotine delivery systems (ENDS), that would go through FDA's approval process for nonprescription drug products sold over-the-counter, instead of being approved by the tobacco center.

Tobacco industry groups argue that FDA's efforts to set a maximum nicotine standard for combustible tobacco products may violate the Food, Drug and Cosmetic Act (FDCA) and Administrative Procedure Act (APA) because there is a lack of scientific evidence showing a reduction would be appropriate for protection of public health and because reducing nicotine levels to a proposed range of .3 to .5 milligrams per gram of tobacco filler is technically impossible to achieve due to the currently available manufacturing and processing methods.

The California Department of Public Health (CDPH) is calling on FDA to eliminate the sale of flavored tobacco products -- a request made just two months before San Francisco voted to uphold a ban on the sale of flavored tobacco products and before FDA granted requests to extend the comment deadline for its advance notice of proposed rulemaking that seeks information about the role flavored tobacco products play in initiation, use and cessation of tobacco products.

FDA and producers of so-called abuse-deterrent formulations of opioids -- dubbed ADFs -- are expected to discuss at an upcoming meeting whether the words “abuse-deterrent” should be changed or better described when associated with such products, coming as the agency also faces pressure from Congress to broach the issue.

In the next 12 months FDA plans to write safety standards for e-liquids and establish regulations for detaining tobacco products believed to be misbranded during inspections, according to the agency's spring 2018 regulatory agenda.

FDA Commissioner Scott Gottlieb, in a wide-ranging speech at the annual Food and Drug Law Institute conference Thursday (May 3), announced a slate of new agency projects, including: making e-cigarettes over-the-counter drug products; reorganizing the FDA drug center; rethinking the regulatory approach toward gene therapy; and developing a framework for regulating genetically modified animals.