Aug 3, 2018

FDA aims to help e-cigarettes apply for drug status

An e-cigarette next to a normal filter cigarette. Photo: Malte Christians/dpa/Getty Images

The Food and Drug Administration issued draft guidance Friday for how to test the toxicity of nicotine products that are meant to help smokers quit traditional "combustible" smoking, like e-cigarettes.

Why it matters: Manufacturers are able to designate e-cigarettes as either a tobacco product or a smoking cessation novel drug to the FDA — but none of them are in the drug category. This draft guidance is part of the agency's effort to help companies start applying as a therapeutic over-the-counter drug.

Background: Currently manufacturers can apply their e-cigarettes for approval under FDA's Center for Tobacco Products or its Center for Drug Evaluation and Research (CDER). If the company wants to market their product as a novel nicotine replacement therapy (NRT), they will need to apply to CDER.

Details: The guidance is the first of two the FDA is planning to issue over the next couple of months, with this one focused on showing how manufacturers can test for "toxicity concerns" in the different types of chemicals in the liquid.

  • It looks at different types of toxicology studies, including genetic toxicology and developmental and reproductive toxicology.

Industry response: Juul, a popular e-cigarette brand, tells Axios:

"We welcome Commissioner [Scott] Gottlieb’s statements, and the agency’s efforts to provide guidance on ways to give options to smokers seeking to move away from combustible tobacco."

Meanwhile, the agency is still mulling over whether nicotine levels should be lowered or flavors limited in e-cigarettes.

Congress is also getting into the mix. Sens. Dick Durbin and Lisa Murkowski introduced on Wednesday a bipartisan bill called the SAFE Kids Act that called for restrictions on e-cigarette flavors but would allow manufacturers one year to prove to the FDA that their flavors help adults quit, don't increase youth initiation, and don't raise the risk of harm to the user.

Plus, 11 medical professional organizations in mid-July showed their support with an amicus brief for a lawsuit against the FDA led by the American Academy of Pediatrics, alleging the FDA’s failure to apply pre-market review to new tobacco products is causing harm to children who are becoming addicted to the nicotine.

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Updates: George Floyd protests continue past curfews

Protesters on Tuesday evening by the metal fence recently erected outside the White House. Photo: Olivier Douliery/AFP via Getty Images

Protests over the death of George Floyd and other police-related killings of black people continued Tuesday night across the U.S. for the eighth consecutive day — prompting a federal response from the National Guard, Immigration and Customs Enforcement and Customs and Border Protection.

The latest: Protesters were still out en masse for mostly after curfews were in force in cities including Washington, D.C., New York City, Los Angeles and Portland — where police used pepper spray and flash bangs on a group throwing projectiles at them during an "unlawful assembly," per KATU. Portland police said this group was separate to the thousands of demonstrators who protested peacefully elsewhere in the city.

Primary elections test impact of protests, coronavirus on voting

Election official at a polling place at McKinley Technology High School in Washington, D.C. Photo: Drew Angerer/Getty Images

In the midst of a global pandemic and national protests over the death of George Floyd, eight states and the District of Columbia held primary elections on Tuesday.

Why it matters: Joe Biden, the presumptive Democratic nominee, needs to win 425 of the 479 delegates up for grabs in order to officially clinch the nomination. There are a number of key down-ballot races throughout the country as well, including a primary in Iowa that could determine the fate of Rep. Steve King (R-Iowa).

Iowa Rep. Steve King defeated in GOP primary

Rep. Steve King. Photo: Alex Wroblewski/Getty Images

State Sen. Randy Feenstra defeated incumbent Rep. Steve King in Tuesday's Republican primary for Iowa's 4th congressional district, according to the Cook Political Report.

Why it matters: King's history of racist remarks has made him one of the most controversial politicians in the country and a pariah within the Republican Party.