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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The Food and Drug Administration issued draft guidance Friday for how to test the toxicity of nicotine products that are meant to help smokers quit traditional "combustible" smoking, like e-cigarettes.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 This draft guidance is part of the agency's effort to help companies start applying as a therapeutic over-the-counter drug.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.

Go deeper:

Go deeper

DiDi to delist from NYSE under Chinese govt pressure

Illustration: Sarah Grillo/Axios

Chinese ride-hail giant DiDi said it will delist from the New York Stock Exchange, following a Chinese government crackdown on foreign listings.

Why it matters: This reflects how geopolitical tensions are bleeding into the capital markets.

Updated 31 mins ago - Health

Omicron cases confirmed in 5 U.S. states

A healthcare worker inserts a Covid-19 rapid test into a machine in Denver, Colorado. Photo: Daniel Brenner/Bloomberg via Getty Images

Hawaii became on Thursday the fifth state to confirm the newly discovered Omicron variant after New York announced five new cases earlier in the day.

The latest: In Hawaii, the variant was found in an unvaccinated O'ahu resident with moderate symptoms who had previously been infected with COVID-19, per a state health department statement. The variant has also been confirmed in California, Colorado and Minnesota.

Senate Dems receive max donations from Nord Stream 2 lobbyist

Illustration: Annelise Capossela/Axios

A major Democratic donor and Nord Stream 2 lobbyist has made maximum campaign contributions this year to Senate Majority Leader Chuck Schumer and vulnerable Senate Democrats, campaign finance records show.

Why it matters: If pressure from the White House to vote against reimposing sanctions on the Russia-backed natural gas pipeline weren't enough, Democrats who back such legislation also will be at loggerheads with one of their party's top fundraisers.