FDA says Juul ‘ignored the law’ and warns it may take action – gpgmail


The Food and Drug Administration has put vaping giant Juul on notice with a pair of letters calling the company out for misleading statements about its products and ongoing targeting of teens. It is demanding written answers to a boatload of pertinent questions and expects Juul to respond within two weeks or risk “even more aggressive action” by regulators.

The specific claims being disputed by the FDA have to do with Juul positioning itself as a smoking cessation product. Now, it may be obvious anecdotally that vaping is a good way to wean yourself off smoking. But unlike nicotine patches and other products, there isn’t a lot of documentation on the complete risk associated with vaping — and with several people dead of vape lung, there would seem to be some worth considering.

“Companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said Acting FDA Commissioner Ned Sharpless in a news release. “Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

Juul was reportedly directly targeting social media channels frequented by young people and, “despite commitments JUUL has made to address this epidemic, JUUL products continue to represent a significant proportion of the overall use of ENDS products by children. Some of this youth use appears to have been a direct result of JUUL’s product design and promotional activities and outreach efforts.”

In a recent Congressional hearing about the risk of “electronic nicotine delivery systems,” or ENDS, evidence was presented that a Juul representative told students that the company’s products were “much safer than cigarettes,” “totally safe,” and that the “FDA was about to come out and say it was 99% safer than cigarettes… very soon.”

Representations like these were apparently made far and wide, among students certainly and also among native American communities. They aren’t the kind of statements you can just say — tobacco cessation products are regulated, essentially medical products, and the FDA looks at them closely. Claims have to be documented and evaluated.

Juul seems to have been walking very close to the line in its public statements, and it’s likely that the company very carefully crafted these messages to convince people that its devices are good alternatives to smoking while not making any claims that would expose it to FDA attention. But they appear to have stepped over that line now and again and provoked exactly the kind of scrutiny they’d rather avoid.

“We request that you provide any and all scientific evidence and data, including consumer perception studies, if any, related to whether or not each statement and representation explicitly or implicitly conveys that JUUL products pose less risk, are less harmful, present reduced exposure, or are safer than other tobacco products,” the FDA told Juul.

Furthermore it asked Juul to explain why it uses a 5 percent nicotine concentration in its products, which could increase the likelihood of addiction, and why the company uses nicotine salts, a substance that reduces harshness and allows greater nicotine concentrations.

Likely independent of the ongoing investigation into lung problems seemingly caused by vaping, the FDA also requested “Aerosol particle size analysis of aerosol formed from your device,” “experimental design and data on pK studies from your device, your e-liquid, and combusted cigarettes,” comparisons between free nicotine and nicotine salt delivery, and “How the design and performance of your device and/or e-liquid, including the level, formulation, and delivery specifications of nicotine, affect lung deposition as related to the use and addictive potential of the product.”

In other words, tell us why you designed your product to be extra addictive and attractive to non-smokers, and whether this was in spite of knowing the substances created caused lung damage.

In a statement, Juul said that it was “reviewing the letters and will fully cooperate.”


10 minutes mail – Also known by names like : 10minemail, 10minutemail, 10mins email, mail 10 minutes, 10 minute e-mail, 10min mail, 10minute email or 10 minute temporary email. 10 minute email address is a disposable temporary email that self-destructed after a 10 minutes. https://tempemail.co/– is most advanced throwaway email service that helps you avoid spam and stay safe. Try tempemail and you can view content, post comments or download something

At-home blood testing startup Baze rakes in $6 million from Nature’s Way – gpgmail


By now, the venture world is wary of blood testing startups offering health data from just a few drops of blood. However, Baze, a Swiss-based personal nutrition startup providing blood tests you can do in the convenience of your own home, collects just a smidgen of your sanguine fluid through an MIT manufactured device, which, according to the company, is in accordance with FDA regulations.

The idea is to find out (via your blood sample) what vitamins you’re missing out on and are keeping you from living your best life. That seems to resonate with folks who don’t want to go into the doctor’s office and separately head to their nearest lab for testing.

And it’s important to know if you are getting the right amount of nutrition — Vitamin D deficiency is a worldwide epidemic affecting calcium absorption, hormone regulation, energy levels and muscle weakness. An estimated 74% of the U.S. population does not get the required daily levels of Vitamin D.

“There are definitely widespread deficiencies across the population,” CEO and Baze founder Philipp Schulte tells gpgmail. “[With the blood test] we see that we can actually close those gaps for the first time ever in the supplement industry.”

While we don’t know exactly how many people have tried out Baze just yet, Schulte says the company has seen 40% month-over-month new subscriber growth.

That has garnered the attention of supplement company Nature’s Way, which has partnered with the company and just added $6 million to the coffers to help Baze ramp up marketing efforts in the U.S.

I had the opportunity to try out the test myself. It’s pretty simple to do. You just open up a little pear-shaped device, pop it on your arm and then press it to engage and get it to start collecting your blood. After it’s done, plop it in the provided medical packaging and ship it off to a Baze contracted lab.

I will say it is certainly more convenient to just pop on a little device myself — although it might be tricky if you’re at all squeamish as you’ll see a little bubble where the blood is being sucked from your arm. For anyone who hesitates, it might be easier to just head to a lab and have another human do this for you.

The price is also nice, compared to going to a Quest Diagnostics or LabCorp, which can vary depending on what vitamins you need to test for individually. With Baze it’s just $100 a pop + any additional supplements you might want to buy via monthly subscription after you get your results.

Baze’s website will show your results within about 12 days (though Schulte tells gpgmail the company is working on getting your results faster). It does so with a score and then displays a range of various vitamins tested.

I was told that, overall, I was getting the nutrients I require with a score of 74 out of 100. But I’m already pretty good at taking high quality vitamins. The only thing that really stuck out was my zinc levels, which I was told was way off the charts high after running the test through twice. Though I suspect, as I am not displaying any symptoms of zinc poisoning, this was likely the result of not wiping off my zinc-based sunscreen well enough before the test began.

For those interested in conducting their own at-home test and aren’t afraid to prick themselves in the arm with something that looks like you might have it on hand in the kitchen, you can do so by heading over to Baze and signing up.


10 minutes mail – Also known by names like : 10minemail, 10minutemail, 10mins email, mail 10 minutes, 10 minute e-mail, 10min mail, 10minute email or 10 minute temporary email. 10 minute email address is a disposable temporary email that self-destructed after a 10 minutes. https://tempemail.co/– is most advanced throwaway email service that helps you avoid spam and stay safe. Try tempemail and you can view content, post comments or download something

What tech gets right about healthcare – gpgmail


We often hear how tech just doesn’t get the healthcare industry but how is it helping where government and big pharma can’t?

Why is tech still aiming for the healthcare industry? It seems full of endless regulatory hurdles or stories of misguided founders with no knowledge of the space, running headlong into it, only to fall on their faces.

Theranos is a prime example of a founder with zero health background or understanding of the industry — and just look what happened there! The company folded not long after founder Elizabeth Holmes came under criminal investigation and was barred from operating in her own labs for carelessly handling sensitive health data and test results.

But sometimes tech figures it out. It took years for 23andMe to breakthrough FDA regulations — it’s since more than tripled its business and moved into drug discovery.

And then there’s Oscar Health, which first made a mint on Obamacare and has since ventured into Medicare. Combined with Bright, the two health insurance startups have pulled in a whopping $3 billion so far.

It’s easy to shake our fists at fool-hardy founders hoping to cash in on an industry that cannot rely on the old motto “move fast and break things.” But it doesn’t have to be the code tech lives or dies by.

So which startups have the mojo to keep at it and rise to the top? Venture capitalists often get to see a lot before deciding to invest. So we asked a few of our favorite health VC’s to share their insights.

Phin Barnes – First Round Capital




10 minutes mail – Also known by names like : 10minemail, 10minutemail, 10mins email, mail 10 minutes, 10 minute e-mail, 10min mail, 10minute email or 10 minute temporary email. 10 minute email address is a disposable temporary email that self-destructed after a 10 minutes. https://tempemail.co/– is most advanced throwaway email service that helps you avoid spam and stay safe. Try tempemail and you can view content, post comments or download something