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The Food and Drug Administration issued draft guidance Friday for how to test the toxicity of nicotine products that are meant to help smokers quit traditional "combustible" smoking, like e-cigarettes.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 This draft guidance is part of the agency's effort to help companies start applying as a therapeutic over-the-counter drug.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

Using apps to prevent deadly police encounters

Illustration: Sarah Grillo/Axios

Mobile phone apps are evolving in ways that can stop rather than simply document deadly police encounters with people of color — including notifying family and lawyers about potential violations in real time.

Why it matters: As states and cities face pressure to reform excessive force policies, apps that monitor police are becoming more interactive, gathering evidence against rogue officers as well as posting social media videos to shame the agencies.

Dan Primack, author of Pro Rata
11 hours ago - Technology

TikTok gets more time (again)

Illustration: Aïda Amer/Axios

The White House is again giving TikTok's Chinese parent company more to satisfy national security concerns, rather than initiating legal action, a source familiar with the situation tells Axios.

The state of play: China's ByteDance had until Friday to resolve issues raised by the Committee on Foreign Investment in the U.S. (CFIUS), which is chaired by Treasury secretary Steve Mnuchin. This was the company's third deadline, with CFIUS having provided two earlier extensions.

Federal judge orders Trump administration to restore DACA

DACA recipients and their supporters rally outside the U.S. Supreme Court on June 18. Photo: Drew Angerer via Getty

A federal judge on Friday ordered the Trump administration to fully restore the Deferred Action for Childhood Arrivals program, giving undocumented immigrants who arrived in the U.S. as children a chance to petition for protection from deportation.

Why it matters: DACA was implemented under former President Obama, but President Trump has sought to undo the program since taking office. Friday’s ruling will require Department of Homeland Security officers to begin accepting applications starting Monday and guarantee that work permits are valid for two years.