Tobacco

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.

E-cigarette maker JUUL Labs announced Wednesday (April 25) that it will support federal and state initiatives to raise the minimum age to purchase tobacco products to 21.

House appropriators used a Tuesday (March 17) hearing on FDA’s fiscal 2019 budget request to delve into the agency's approach toward tobacco -- leading FDA Commissioner Scott Gottlieb to promise “very vigorous enforcement action” on youth use of vapor products in coming weeks.

FDA on Monday (April 16) issued a revised guidance that pushes back tobacco ingredient listing compliance dates for small-scale manufacturers to Nov. 8, sets a compliance date of May 8 for all other manufacturers and clarifies that the agency will not enforce tobacco ingredient listing submission requirements for certain tobacco product components or parts, including software, digital displays and electrical components.