The FDA has declared war on vaping. The deeming regulations aren’t rules any vaping business can work with. They’re an attack on what we do and who we are, and vapers are right to feel mad and betrayed. The regs are as bad as the most pessimistic advocates expected — or maybe even worse.
Don’t let anyone kid you. If you’re a manufacturer or seller of vapor products in the US, this is a death sentence for your business. And if you’re a consumer of anything other than cigalikes, it’s going to reduce your choices of legal products to almost zero. As it stands, on August 8 the vaping market will be frozen. You will not be able to make or sell any new products without approval from the FDA. Beyond that, vendors will have two years to file their pre-market tobacco applications. Each application for approval to sell “tobacco products” will probably cost over a million dollars, and there is no guarantee it will be accepted by the FDA.
The requirements are extreme. Aside from exacting scientific studies, you will have to prove that your product has a net benefit to the overall public health. It’s an impossible standard to meet. If you don’t have several million dollars to gamble with, you can’t survive if these regulations go into effect. That’s intentional on the FDA’s part. They know we can’t live in the world of extreme and exacting tobacco regulations and compliance. Our only hope is to stop the regulations from choking the thing that we love and depend on.
The Vapor Technology Association has a pretty good summary of what we know so far. And Mark Dickinson of Clarityse sums it up neatly: “The sheer scale of the regulatory burden is very likely to be the death knell for the huge majority of independent manufacturers and vape stores in the US, with almost all products currently available being taken off the market in 2-3 years time. It will also bring to an immediate halt all the US based innovation that has been so prevalent in the last few years.”
While claiming to protect children from nicotine addiction, Mitch Zeller and his agency have delivered a carefully crafted ban of all vapor products, except perhaps cigalikes made by Big Tobacco. They justify this by quoting the National Youth Tobacco Survey (NYTS) that shows vaping among teenagers growing. But they ignore the National Institute on Drug Abuse survey that showed only 20 percent of teens use nicotine in their e-cigs. The NYTS surveys don’t even ask whether kids use nicotine — or if they’re regular users or have just taken a single puff in the last 30 days. How convenient! They also ignore that all surveys show teen smoking at its lowest level ever. It’s not about smoking anymore; the objection is now to nicotine itself.
The FDA specifically says that nicotine in pharma products like patches and gum is not addictive or dangerous. But they ignore all evidence that the same may be true of nicotine in vapor products and couch their regulation in the lie that they’re protecting kids from “a lifetime of addiction.” If your company’s name is Pfizer or Johnson & Johnson, your tobacco-derived nicotine is a safe, non-addictive medicine. If your name is Joe’s Vape Juice, you’re a producer of deadly addictive poison that is a menace to society.
The age limit on buying vapor products that goes into effect on August 8 is window dressing. 48 states already ban sales to minors (and the others don’t because “health groups” fought against the minor bans because they wanted other restrictions included). But the FDA is playing this as an example of “protecting children.” And most of the mainstream media is swallowing it whole.
Meanwhile, the most dangerous consumer product in the history of the world will remain available and protected from competition. Adult smokers desperate for a way out will have the option of buying ineffective junk from the same companies that make the cigarettes that are killing them — or, if they want to jump through hoops and skirt the law, they can seek out black market vape products. Many will just keep smoking.
The FDA wants to hand the vapor market to the supposed enemies of tobacco control on a silver platter. Call it a gift, a token offering to the tobacco industry that has learned to play so well within the restrictive regulatory framework they built together. The FDA loves Big Tobacco, but not because of bribes or collusion. It’s because they speak the same language and inhabit the same world — the world of legalistic government business regulations. The tobacco industry knows how to play this game, and has the resources available to play it.
In the UK, voices of logic have won the day. Public Health England and the Royal College of Physicians have advocated a harm reduction approach that includes encouraging smokers switching to vaping to avoid cigarettes. The FDA, afraid of criticism from their friends in the pharma-funded anti-nicotine “health” groups, went in the polar opposite direction: prohibition.
No! We still have avenues open to fight this thing. But everyone needs to stop pretending that this pathway of pre-market applications and substantial equivalence is one we can walk. The deemings regs are a ban, plain and simple. But we need to get busy and act now. We have to get embrace the fact that we are the only ones who have a chance to stop the deeming ban from killing vaping as we know it. No white knight is riding in to protect us. What should we do now? Here’s what: