FDA Calls for Comment on Drug Therapy Proposal

We have arrived. The FDA is considering cozying-up even closer to Big Pharma in a proposed effort to mitigate youth tobacco and nicotine use through, you guessed it, more drug therapies. If you've spent more than 30 seconds researching the effects of drug therapies on helping smokers quit cigarettes, you'll see there's little evidence that they work for the majority of quitters, and even more evidence that many of these "therapies" actually have an adverse effect on those that use them, from depression symptoms to nausea, etc. Here we sit, though, nearly all the way through 2018, and the FDA has fallen back into the pit of "drugs will fix our problems", and if we don't express our displeasure with drugging up kids even-more, the FDA will continue their policy agenda of appeasing to pharmaceutical companies, for-profit advocacy groups, and bough-and-sold lawmakers.

Just to be clear, even though we shouldn't have to explain our position any further, we don't want anyone to smoke. Certainly not children. And that part extends to vaping, too. We don't want children vaping or using nicotine products. But when, if ever, have pharmaceutical drugs been used to stop people from consuming nicotine? Never. That's the answer. When Youth Smoking was at an all-time high, what did the FDA do? They focused on smoking as the culprit. "How do we get kids to stop smoking?" was the question at hand, not, "How do we get kids to stop using nicotine?" The FDA has a multitude of data at their disposal showing the extremely low number (if there is any at all) of adverse effects vaping has on human health. But, instead of relying on the data they have to form policies and agendas, they create a new problem and shift the public focus away from what the real problem is.

The problem here is not Nicotine. No matter what these for-profit "advocacy" groups tell you, Nicotine is not the issue. In fact, the data that is often used to argue that "nicotine has an adverse effect on youth brain development" is only pertinent if you ignore the data that shows caffeine has the same effect on youth brain development. You don't see the FDA or Truth going after Monster or Red Bull, but kids are drinking those by the fistful. The problem here, as always, comes back to tobacco giants being unable to foot the bill for mismanaged Tobacco Master Settlement funds.

Just for a little background, in 1999, the largest tobacco corporations in America settled a lawsuit from the United States government to prevent citizens from suing tobacco companies for selling them products that were killing them and lying about the dangers of consuming their products. While this seemed like a "Win" at the time, it opened the door for free-flowing cash that essentially went unchecked for decades. Each state was guaranteed a stipend paid by tobacco companies to pay for "damages" to the citizens of each state. This stipend was a variable sum of money on a yearly payout schedule to be paid by the tobacco companies to the state governments. While this was, by design, a sum of extra cash for the states to use to combat the effects of tobacco-related illnesses on the state's budgets, it quickly became a pot of money that the states used to accomplish pretty much anything other than curing tobacco-related diseases. States took these estimated payouts and used them, basically, as loan capital to fix roads and other government-funded public utilities under the guise that they would be able to pay off these loans with their yearly Master Settlement stipend.

Here's where vaping comes in. Because many smokers have chosen to vape as an alternative to their smoking habits, tobacco companies are paying out less and less each year to state governments based on their settlement clauses. Unfortunately, many of the state governments have already spent the expected stipends for each year. And, in anticipation of the funds, the states neglected the idea that a replacement for smoking would come along to divert consumer spending away from cigarettes. Now they're left, indebted to the taxpayers, without any way to pay off the loans they took out. Unless, that is, people keep smoking. If there are more smokers buying cigarettes, the states can pay off their debts, and can continue to fund whatever projects they seem to think are more important than the overall health and well-being of their citizens.

Back to the issue at hand. Here we sit, with a myriad of reasons to turn to vaping as a safe alternative to smoking, without any support from the state or federal governments because, well, they're in debt. And now, with millions of smokers turning to vaping, the state governments have no other choice but to stop people from vaping. How do they do that? They focus on the children. It's the oldest trick in the books, and for lack of a better word, it's bogus. Nicotine is now the primary focus of these for-profit groups, the FDA, and Big Pharma because they can't point the finger at vaping for causing all of these smoking-related diseases. Smokers have moved on to something safer, but the government doesn't want that. In fact, they can't even afford it.

So, what do they do? They shift public focus. As highlighted in a new proposal from FDA Commissioner Scott Gottlieb, the FDA may plan on turning, once again, to Big Pharma to solve their problems. Their newest "problem"? The Teen Vaping Epidemic. While we are not epidemiologists, we've addressed this point before. There are more teens drinking and smoking marijuana than vaping, still, vaping is the "epidemic".

“That the FDA finds that we need to hold such a hearing ‒ to discuss ways to use drug therapies to treat teen addiction to nicotine ‒ underscores the deeply troubling nature of the public health problem that we’re confronting,” said Commissioner Gottlieb in his statement Friday. Again, nicotine had never been the issue until vaping came along, so this wasn't an "epidemic" until he decided, willy-nilly we might add, that it was. According to the FDA's own data, approximately 11.7% of high school students vaped at least once in the last 30 days. Hold the phone. Nearly double that number drank alcohol in the same time period...

We're not here to stir-up conspiracy theories, but doesn't this move feel like it was inevitable? Gottlieb says there's an epidemic of teen nicotine-use, can't find a solution on his own, so who does he turn to? His friends in Big Pharma who are more than happy to be funded by the Federal Government to find a pharmaceutical therapy for teens.

Here's the irony in all of this: Nicotine replacement therapies contain nicotine. That's why they were invented: to replace the nicotine from your tobacco product. We don't want kids using nicotine products, you say? Then why are we proposing a solution to nicotine use that includes nicotine use? It makes little to no sense.

That's why, today, we ask you to participate in the Comment period for this proposed plan. Let the FDA know that you don't think it's appropriate for kids to be given Nicotine Replacement Therapies containing nicotine if the entire reason for the therapies is to stop kids from using nicotine. Let them know that the most-effective replacement therapy you found was vaping. Let them know that if they want to make it about the children, they're going to have to find a solution that doesn't negatively affect you and your choices. Finally, let them know the truth: Smoking kills. Vaping, on the other hand, saves lives. Here's a link to the web page for you to leave a comment: https://www.regulations.gov/document?D=FDA-2018-N-3952-0001

Until next week! VAPE ON!

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