Blind spot in FDA crackdown on flavored vapes

The U.S. government on Thursday began enforcing restrictions on flavored electronic cigarettes aimed at curbing underage vaping. But some teenagers may be one step ahead of the rules using disposables (Feb. 6)

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FDA approves first drug to treat peanut allergies

The Food and Drug Administration has approved the first treatment for children with peanut allergies. Allergy experts say the drug promises to lower the chances that an accidental bite of peanuts causes a severe reaction, but it’s not a cure. (Feb. 3)

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What’s Next for Juul

Since launching in 2015, Juul has dominated the e-cigarette market with its sleek design and flavored nicotine pods.

But what was once Silicon Valley’s $38 billion darling now faces Congressional investigations, criticism by the FDA, and a potential ban in the United States.

Juul was designed to help adult smokers quit cigarettes, but instead, has become the face of the youth vaping crisis.

So what exactly is next for Juul?

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What’s Next For Juul

Zantac recall continues as FDA investigates

Walmart has become the latest store to halt sales of the popular heartburn treatment Zantac after health regulators warned about a potentially dangerous contaminant in the drug. (Oct. 4)

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FDA to improve access to experimental cancer drugs

The Food and Drug Administration is launching a project aimed at giving more cancer patients a chance to try treatments that are not yet on the market but that have shown some promise in early testing. (June 3)

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Today in History for May 9th

Highlights of this day in history: The FDA approves the first birth control pill; FCC chief Newton Minow condemns TV programming; Richard Byrd and Floyd Bennett fly over the North Pole; Journalist Mike Wallace and singer Billy Joel born. (May 9)

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Today in History for March 27th

On this day in history: Martin Luther King Jr.’s son meets James Earl Ray in prison for assassinating his father; Comedian Milton Berle dies; the FDA approves Viagra; Quentin Tarantino is born. (March 27)

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FDA approves drug to treat postpartum depression

The U.S. Food and Drug Administration has approved the first drug specifically developed to treat postpartum depression. The agency on Tuesday approved Sage Therapeutics’ Zulresso, a physician administered IV drug given over 2 ½ days. (March 20)

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FDA approves party drug to treat depression

U.S. health officials have approved a medication related to the mind-altering drug ketamine as a new option for patients with severe depression. (March 6)

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Spinal device to treat pain shocks, burns patients

(26 Nov 2018) Medical device companies and doctors tout spinal-cord stimulators to treat patients suffering from wide range of pain disorders. But an investigation by AP found the devices rank third in injury reports to the FDA in 10 years. (Nov. 26)

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Spinal device to treat pain causes shocks, burns

(26 Nov 2018) Medical device companies and doctors tout spinal-cord stimulators to treat patients suffering from wide range of pain disorders. But an investigation by AP found the devices rank third in injury reports to the FDA in 10 years. (Nov. 26)

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AP Top Stories Novmber 20 P

(20 Nov 2018) Here are the top stories for Tuesday, November 20: No punishment for Saudi Arabia; Big losses on Wall Street; FDA warns against romaine lettuce; Recreational pot sales begin in Massachusetts.

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Vape Influencers Think FDA’s Crackdown On Juul Won’t Matter (HBO)

Today, the Food and Drug Administration announced its long-awaited e-cigarette regulations. The new rules, subject to approval, will require more stringent age verification for people buying flavored nicotine. In a statement announcing the rules, FDA commissioner Scott Gottlieb acknowledged that vaping is less harmful than cigarettes but said he was shocked at how widespread teen e-cigarette usage is, which he believes makes kids more likely to try smoking.

On Tuesday vaping giant Juul preemptively announced it would temporarily stop selling flavored nicotine vapor pods to retail stores, until they impose strict age verification mechanisms, like ID scanners. And on Juul’s website, users will have to provide the last four digits of their social security number to buy flavored pods.

But all of the new rules from the FDA probably won’t stop the army of kids on sites like Youtube and Instagram who are essentially evangelists for the coolness of vaping. Juul doesn’t sponsor any of these influencers. They get their money from companies that make third party Juul pods, other vape juices, or bigger vape rigs.

Juul has transformed the e-cigarette landscape in just a couple years. It’s now worth 15 billion dollars and controls 70% of the market. In other words, it has a lot to lose. Juuls have been incredibly easy to get, and incredibly easy to hide. And that’s made them a hit among high schoolers. Kids can hit the Juul in class without their teacher noticing, and school administrators have been begging for a solution.

So ahead of the FDA’s ruling, Juul moved to appease regulators, not just with the pause on flavors, but also by deleting its Facebook and Instagram accounts, so that it wouldn’t be seen as marketing to kids. But Dash Drips and Donny Smokes have no plans to stop posting.

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Why Horseshoe Crab Blood Is So Expensive | So Expensive

Horseshoe crab blood is a vital resource to the medical field. It’s unique in more ways than one: the blue color and its ability to identify bacterial contamination in small quantities. Horseshoe crab blood contains a special amebocyte that is separated and then used in FDA testing. There’s a lot of questions as to how blood harvesting affects the American horseshoe crab population, but some researchers are dedicated to the cause of protecting such a significant resource.

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Following is a transcript of the video:
Narrator: This blueish liquid is one of the most expensive resources in the world. No, it’s not the blue milk from “Star Wars.” It’s actually blood from a horseshoe crab, and the stuff this blood makes costs $60,000 a gallon. So why is it so expensive and who’s buying horseshoe crab blood?

The blue color comes from copper in the blood. But that’s not it’s most interesting feature. The blood contains a special clotting agent. It’s used to make a concoction called Limulus amebocyte lysate or LAL. Before LAL, scientists had no easy way of knowing whether a vaccine or medical tool was contaminated with bacteria. Like E. coli or salmonella. Scientists would inject vaccines into huge numbers of rabbits and then basically wait for symptoms to show up. But when LAL was approved for use in 1970, it changed everything. Drop a minuscule amount of it onto a medical device or vaccine, and the LAL will encase any gram-negative bacteria in a jelly cocoon. While it can’t kill the bacteria, the jelly seal is like a fire alarm. Alerting us to the presence of what could become a potentially lethal infection and prevent it from spreading.

Each year, the medical industry catches around 600,000 horseshoe crabs. The crabs are drained of 30% of their blood and up to 30% of the crabs don’t live through the process. The survivors are returned to the water, but no one really knows how well or if they recover. In 2016, the International Union for the Conservation of Nature bumped the American horseshoe crab up to vulnerable on it’s red list, one step below endangered. And the US population could keep falling, by as much as 30% over the next 40 years.

LAL Labs claim that the returned crabs eventually recover, but new evidence suggests that’s not always the case. Win Watson is trying to figure out what happens to the crabs when they’re put back in the sea.

Win Watson: So, the most immediate negative effect is mortality. Anywhere from 10% to 25% of the animals will die within the first couple days after bleeding.

Narrator: Bled crabs become disoriented and weak for a period of time, and females may have trouble spawning.

Watson: If they survive the first – I’ll say two weeks, week, two week — and they’re back in their natural habitat they did pretty well. 

Narrator: But it’s getting through those two weeks that’s the issue.

Watson: You know, based on our data and other’s I think that you need to treat them a little — if you’re going to get — increase their survival rate, right, you need to treat them better.

Narrator: Scientists are trying to find a synthetic alternative to help reduce the strain on the horseshoe crab population. But so far, LAL is still required by the FDA for this type of testing. So if these animals really aren’t recovering at the rate companies previously thought, we might eventually run out of crabs to bleed. If that happens, our lives and the lives of countless rabbits, might be at risk.

What Is CBD Oil And How Did It Become A $1 Billion Industry?

You might have noticed a lot of products lately that are infused with CBD. But what exactly is CBD? CBD stands for cannabidiol, and it’s part of the cannabis plant from which we also get marijuana. We spoke with Martin A. Lee, author of “Smoke Signals: A Social History of Marijuana – Medical, Recreational and Scientific” and the director of Project CBD to find out what exactly CBD is.

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Following is a transcript of the video:

Narrator: With all the weed trucks and imagery all over New York these days, you might think to yourself, “Hey, is marijuana legal now?”

Not quite.

What these companies are selling is actually something called CBD. It’s found in everything from lollipops to lattes.

And business is booming.

CBD products are part of what is estimated to be a roughly one billion dollar industry in the United States. And it’s perfectly legal.

So, what does CBD have that marijuana doesn’t?

Martin Lee: The fact of the matter is we’re kind of in the midst of a CBD craze right now.

Narrator: Martin Lee is the director of Project CBD, an educational platform that focuses on cannabis science and therapeutics.

Lee: CBD stands for cannabidiol. That’s a component of the cannabis plant that has significant therapeutic properties, but it’s not intoxicating. It doesn’t get you high like THC.

Narrator: As it happens, not all cannabis plants are created equal. Take a look at these two varieties. One is marijuana, the other is hemp. One gets you high, the other doesn’t. The key difference is what’s on the inside.

Lee: THC and CBD are the main components of the cannabis plant.

Narrator: THC is what makes you feel high, and marijuana plants are loaded with it.

Dave Chappelle: I don’t know about y’all, but I can’t even move.

Narrator: Hemp, on the other hand, has hardly any THC at all. But what it lacks in THC it makes up for with higher amounts of CBD. Now, CBD won’t get you high, but it does have a redeeming quality: it’s legal. And at least according to the marketing, it has a relaxing effect. So since this stuff is all the rage, let’s see how it’s made.

So, once you have a cannabis plant, one simple way to make extract can be done in your own kitchen.

Lee: As simple as using olive oil or butter and heating the trim from the plant or a little bit of the green material from the plant. Obviously that’s not very useful for mass industrial production, to be cooking up something in your kitchen with butter and cannabis.

Narrator: But the more common way involves a specialized, complex machine.

Lee: One very widespread way is using what’s called a supercritical CO2 extraction. It’s ground up to have the texture initially of like a coffee grind. And it’s poured into vessels, literally, of a supercritical CO2 machine. It will stay in that machine for upwards to 24 hours under different pressures and temperatures at different times of the extraction process. And ultimately you’ll end up with a thick, golden oil that’s very waxy in texture.

Narrator: You can also extract it using ethanol and hydrocarbons.

You can find this oil in a number of different products these days.

Lee: It can be administered in various different forms. It might be ingested, it might be applied topically.

Narrator: They even have CBD oil products for your pets. I stopped by a cafe in New York which sells all sorts of CBD-infused products. I tried a CBD matcha latte and a CBD macaroon. These snacks tasted great, and I felt a little more relaxed after, but it was hard to tell if the CBD was actually doing anything for me or if it was all in my head.

Scientists are actually still trying to figure out exactly how CBD affects the body.

Lee: So, there really is a scientific basis for understanding why CBD can work, but we’re still really a long way of mastering the hows.

Narrator: Still, CBD may have more benefits than just a relaxing afternoon. Some initial studies have shown that CBD can help with a number of different medical conditions. In fact, in June 2018, the FDA approved the first CBD drug, Epidiolex, which is used to treat epilepsy.

So, who knows?

Perhaps we’ll be seeing CBD in more places than just cannabis-decorated vans in the future.

Today in History for May 9th

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Highlights of this day in history: The FDA approves the first birth control pill; FCC chief Newton Minow condemns TV programming; Richard Byrd and Floyd Bennett fly over the North Pole; Journalist Mike Wallace and singer Billy Joel born. (May 9)

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The Biohacking Company Testing Drugs On Itself (HBO)

On October 17, 2017, Tristan Roberts, an activist and software engineer, injected himself with a chemical solution that he hoped would modify his genetic code to cure him of his HIV — and he live-streamed the entire thing on Facebook.

The gene therapy Roberts self-administered was not approved by the FDA: It was an experimental compound developed by a tiny startup called Ascendance Biomedical.

Roberts’s public self-experiment drew a new wave of attention to the practice of biohacking, an ill-defined term that means, in essence, biological research conducted outside of institutions like universities and pharmaceutical companies.

Ascendance Biomedical’s business model is based on a regulatory loophole: While it’s illegal to market something as medicine if it hasn’t been approved by the FDA, chemical research compounds, typically for use in science experiments, are openly bought and sold all the time — and, legally speaking, people are free to make the individual decision to test them on themselves.

But, like any other startup, Ascendance Biomedical is plagued by infighting, and their philosophical divisions reveal a deeper rift in the biohacking community: While some biohackers are motivated by a desire to subvert a drug approval process they believe has been corrupted by big pharma and the profit motive, others are simply entrepreneurs at heart

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How To Build A Better Flu Vaccine (HBO)

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The U.S. is in the midst of a record breaking flu season this year that is reaching levels as high as the 2009 H1N1 pandemic.

On a call with reporters last week, the CDC Acting Director Dr. Anne Schuchat painted a grim picture of what the rest of the flu season has in store— and there’s no sign this season is slowing down yet.

Predicting what flu strains will be circulating each year and what should be included in the annual vaccine is highly a choreographed decision that involves year round monitoring of influenza viruses across the globe.

Dr. Kathryn Edwards has spent over thirty years studying influenza and is the chair of the FDA committee that selects the strains. She says a particularly severe strain of influenza A called H3N2 may be why more people are getting so sick this year.

“We also know that the severity of an influenza season can depend not only on the virus but also on how well the vaccine that we are giving people matches the strain that’s circulating,” Edwards says.

There’s also evidence that the way the majority of vaccines are made, by growing the virus in chicken eggs, can cause changes in the H3N2 strain that ultimately weaken the vaccines effectiveness.

There are two types of non egg-based vaccines on the market and studies are underway to try and understand which work best. The jackpot though would be the development of a successful universal vaccine.

Calling it a universal vaccine is somewhat of a misnomer because researchers are skeptical that one shot will ever give lifelong protection against the flu but the idea is that a shot could be given at any time and offer years worth of protection against all flu strains including potential influenza pandemics. More than 30 candidates are in various stages of testing with a few already in the early stages of human trials.

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Locked Up and Forgotten: India’s Mental Health Crisis

India is currently suffering a mental health crisis. With only 43 government-run mental hospitals serving a population of 1.2 billion, resources are spread thin. What’s more, mental illness is highly stigmatized in India, especially among women, who are typically committed to mental health facilities with no legal rights, receiving involuntary treatment, and sometimes without a proper diagnosis.

VICE News travels to Maharashtra to investigate what it’s like to be deemed a woman with mental illness in India today.

Watch: Institutionalized: Mental Health Behind Bars – http://bit.ly/1DHIqYj

Read: Indian Drug Plants Are Freaking Out the FDA – http://bit.ly/1Vmq6a9

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India’s Mental Health Crisis (Trailer)

Watch the Full Length: http://bit.ly/1Lt16i8

India is currently suffering a mental health crisis. With only 43 government-run mental hospitals serving a population of 1.2 billion, resources are spread thin. What’s more, mental illness is highly stigmatized in India, especially among women, who are typically committed to mental health facilities with no legal rights, receiving involuntary treatment, and sometimes without a proper diagnosis.

VICE News travels to Maharashtra to investigate what it’s like to be deemed a woman with mental illness in India today.

Watch: Institutionalized: Mental Health Behind Bars – http://bit.ly/1DHIqYj

Read: Indian Drug Plants Are Freaking Out the FDA – http://bit.ly/1Vmq6a9

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