Category Archives: fda

The FDA proposes further restrictions to sales of flavored e-cig products

The FDA has drafted new guidance for the regulation of e-cigarettes, particularly with regards to flavored nicotine products. The first big change is that the FDA has bumped up the application due date by one year for FDA approval of flavored products. Manufacturers of all flavored ENDS (electronic nicotine delivery system) products will now have to submit premarket applications by August 8, 2021. The second change is introducing a new compliance policy with regards to flavored ENDS products. At the time that the current compliance policy was […]

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Biotech AI startup Sight Diagnostics gets $27.8M to speed up blood tests

Sight Diagnostics, an Israeli medical devices startup that’s using AI technology to speed up blood testing, has closed a  $27.8 million Series C funding round. The company has built a desktop machine, called OLO, that analyzes cartridges manually loaded with drops of the patient’s blood — performing blood counts in situ. The new funding is led by VC firm Longliv Ventures, also based in Israel, and a member of the multinational conglomerate CK Hutchison Group. Sight Diagnostics said it was after strategic investment for the Series C — specifically […]

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What the FDA’s restriction of e-cig flavors means for Juul

FDA Commissioner Scott Gottlieb has revealed his plans to combat underage use of e-cigs and nicotine, which has grown 78 percent among high school students from 2017 to 2018. The commissioner today announced a plan that would remove all flavored electronic nicotine delivery system products — with the exception of tobacco, mint, menthol or non-flavored products — from any store where children under the age of 18 can see them. So what does this mean for Juul, a company that reached a $10 billion valuation 4x faster […]

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The clock is ticking for e-cig companies to block underage users

The FDA is giving makers of e-cigarettes 60 days to come up with a more effective, forceful plan to combat underage use of the products. FDA Commissioner Dr. Scott Gottlieb is yet again moving the goal posts for e-cig companies. He now considers underage use of electronic nicotine delivery systems (ENDS) an epidemic, forcing the government to make a choice that we all knew was coming: save the smokers or save the kids? “I believe in the power of American ingenuity to solve a lot of problems, […]

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Juul tightens up social media to focus on former smokers switching to e-cigs

Juul Labs, the company behind the ever-popular Juul e-cig, has today announced a new policy around social media. This comes in the midst of Juul’s effort to get FDA approval, which has been made more arduous by the fact that the FDA has cracked down on Juul after learning how popular the device is with underage users. As part of the new policy, Juul will no longer feature models in pictures posted on Instagram, Twitter, or Facebook. FWIW, Juul doesn’t even have a Snapchat. Instead of using […]

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