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Picture of sgalczyn
posted
Big Grin Points for the witty journalism - talk about a hard habit to break:

The US Food and Drug Administration made clear on Thursday, October 11 that it has a major bone to pick with an electronic-cigarette vendor that illegally pumped prescription erectile dysfunction drugs into unapproved e-liquid products intended for vaping.

The cocky company, HelloCig Electronic Technology Co. Ltd, even advertised the vape liquids with labels and images using drug brand names. For instance, it sold one of the vaping liquids as “E-Cialis HelloCig E-Liquid” alongside an image of a bottle and tablets of Eli Lilly’s erectile dysfunction drug Cialis. It also sold a product with the brand of an anti-obesity drug that had been pulled from the market in Europe for causing psychiatric disorders. The e-liquid really contained the erectile dysfunction drug in Viagra, the FDA found.

The throbbing mad agency issued a stiff warning and firmly threatened “civil money penalties, criminal prosecution, seizure, and/or injunction” if HelloCig didn’t pull its products off the market immediately. The company has 15 days to respond.

FDA Commissioner Scott Gottlieb blasted the company in a statement, saying:

There are no e-liquid products approved to contain prescription drugs or any other medications that require a doctor’s supervision. Prescription drugs are carefully evaluated and labeled to reflect the risks of the medications and their potential interactions with other medicines, and vaping active drug ingredients is an ineffective route of delivery and can be dangerous. There are no e-liquids that contain prescription drugs that have been proven safe or effective through this route of administration.

The FDA’s warning is part of an ongoing effort to deflate misleading and illegal claims on vaping products. The agency’s main goal is to block products that specifically entice youth to try addictive nicotine-containing products. Last month, Gottlieb declared that e-cigarette use among teenagers has “reached nothing short of an epidemic proportion of growth.”

“I use the word epidemic with great care,” he wrote in a statement at the time. “E-cigs have become an almost ubiquitous—and dangerous—trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.”

As such, the agency has banged away at e-cigarette companies and any questionable tactics. Most notably, the agency seized more than a thousand sales and marketing documents from popular e-cig maker Juul Labs during an unscheduled inspection a few weeks ago. Juul e-cigarettes resemble USB drive devices and have been wildly popular—particularly with teens. They currently make up the lion’s share of the e-cig market. The FDA’s primary concern is advertising and e-liquid flavorings, such as candy and fruit flavors, intended at hooking youngsters.

With that focus, FDA conducted lab analysis on HelloCig’s e-liquids, finding products that contained tadalafil (Cialis) and/or sildenafil (Viagra). The FDA also scrutinized the company’s product called “E-Rimonabant HelloCig E-Liquid,” which was marketed alongside an image of a bottle and tablets of Acomplia, an anti-obesity drug developed by Sanofi-Aventis. Acomplia was never approved by the FDA, but it had been previously approved in Europe in 2006. It was withdrawn from the market in 2008, however, after it was found to significantly increase the risk of psychiatric disorders. HelloCig’s e-liquid did not contain rimonabant (Acomplia), but it did contain undeclared sildenafil, the FDA found.

https://arstechnica.com/scienc...agra-in-vape-liquid/


"No matter where you go - there you are"
 
Posts: 4582 | Location: Eastern PA-Berks/Lehigh Valley | Registered: January 03, 2001Reply With QuoteReport This Post
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Picture of Ripley
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I can't speak to ED vaping but as a vaper myself, I've wondered about the value of the medium as a med delivery system. Many years ago my mom had a clumsy device for Albuterol that essentially produced a vapor. I guess it was the most effective way to treat her severe COPD. I don't know how much research may be going into meds by vapor, it may have some distinct advantages.




Set the controls for the heart of the Sun.
 
Posts: 8357 | Location: Flown-over country | Registered: December 25, 2008Reply With QuoteReport This Post
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15 days to respond???? Threatened a fine if they didn't pull their products off of the market immediately?????

What type of nonsense is this. For a stunt like this, the company should be fined heavily and put out of business permanently and whoever decided to put prescription drugs in it's products should go to jail.
 
Posts: 21335 | Registered: June 12, 2005Reply With QuoteReport This Post
Honky Lips
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quote:
Originally posted by jimmy123x:
15 days to respond???? Threatened a fine if they didn't pull their products off of the market immediately?????

What type of nonsense is this. For a stunt like this, the company should be fined heavily and put out of business permanently and whoever decided to put prescription drugs in it's products should go to jail.


Sounds like communist propaganda to me, but if you say so.
 
Posts: 8151 | Registered: July 24, 2009Reply With QuoteReport This Post
The Unmanned Writer
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Kind of a hard concept to grasp.






Life moves pretty fast. If you don't stop and look around once in a while, you could miss it.



"If dogs don't go to Heaven, I want to go where they go" Will Rogers

The definition of the words we used, carry a meaning of their own...



 
Posts: 14039 | Location: It was Lat: 33.xxxx Lon: 44.xxxx now it's CA :( | Registered: March 22, 2008Reply With QuoteReport This Post
Normality Contraindicated
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Reminds me of George Carlin's bit about the anti-porn guy:

“Our thrust is to prick holes in the stiff front erected by the smut dealers. We must keep mounting an offensive to penetrate any crack in his defenses. Let’s get on him. Let’s ram through a stiff bail law so it will be hard for him to get it up. It’ll be hard on us, but we can’t lick it by being soft!”


------------------------------------------------------
Though we choose between reality and madness
It's either sadness or euphoria
 
Posts: 2988 | Location: Tennessee | Registered: January 26, 2010Reply With QuoteReport This Post
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There is alway a heavy penalty for not pulling out as you are instructed.
 
Posts: 1040 | Location: Fort Worth, Texas | Registered: August 11, 2010Reply With QuoteReport This Post
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quote:
Originally posted by TXLe:
There is alway a heavy penalty for not pulling out as you are instructed.


Sort of a bone head move.


*********
"Some people are alive today because it's against the law to kill them".
 
Posts: 8228 | Location: Arizona | Registered: August 17, 2008Reply With QuoteReport This Post
Staring back
from the abyss
Picture of Gustofer
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Damn. After nearly 25 years I might have to start smoking again.

quote:
Originally posted by sgalczyn:
...and vaping active drug ingredients is an ineffective route of delivery and can be dangerous.

Actually, it is a very effective route of delivery (for some drugs).


________________________________________________________
"Great danger lies in the notion that we can reason with evil." Doug Patton.
 
Posts: 20125 | Location: Montana | Registered: November 01, 2010Reply With QuoteReport This Post
Thank you
Very little
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The fines are pretty stiff for this stuff...
 
Posts: 23556 | Location: Florida | Registered: November 07, 2008Reply With QuoteReport This Post
Step by step walk the thousand mile road
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I always thought you did the ED drugs before sex and the smoking after sex.
These guys realize there was a better profit margin having people smoking and taking ED drugs before sex and smoking and taking more ED drugs after sex.
This doubles their market share by having people using twice the product, a good move for a small firm.





Nice is overrated

"It's every freedom-loving individual's duty to lie to the government."
Airsoftguy, June 29, 2018
 
Posts: 31473 | Location: Loudoun County, Virginia | Registered: May 17, 2006Reply With QuoteReport This Post
Happiness is
Vectored Thrust
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Sneaking prescription ED meds into vaping liquid seems like a dick move.



Icarus flew too close to the sun, but at least he flew.
 
Posts: 6738 | Location: North Carolina | Registered: April 30, 2003Reply With QuoteReport This Post
SIG's 'n Surefires
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And if you're still vaping after 4 hours...



"Common sense is wisdom with its sleeves rolled up." -Kyle Farnsworth
"Freedom of Speech does not guarantee freedom from consequences." -Mike Rowe
"Democracies aren't overthrown, they're given away." -George Lucas
 
Posts: 6880 | Location: IL, due south of the Arch | Registered: April 20, 2005Reply With QuoteReport This Post
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