FDA Regulation Update 2016

FDA Regulations E Cigs 2016

The New FDA Regulations are Live!

FDA requirements are liveIn May, 2016, the U.S. Food and Drug Administration (FDA) loudly trumpeted its latest incursion into the lives of ordinary Americans with a press release announcing its approval of a new rule that would extend the agency’s tobacco regulatory authority to electronic cigarettes. Obviously, many in the e-cig industry were alarmed at the news for a variety of reasons – including the simple and obvious fact that the FDA’s choice to “deem” tobacco-free products to be tobacco-related is an obvious and tortured fiction of epic proportions. Despite that simple truth, those regulations are now a fact of life.

 

The Goal of a Tobacco-Free Generation

The mindset behind the new rules governing electronic cigarettes is truly Orwellian. The agency itself declared that “Today’s announcement is an important step in the fight for a tobacco-free generation.”Regardless of how one feels about e-cigarettes, that statement is patently ludicrous. The fact is that millions of people have utilized e-cig technology Becoming tobacco freeto escape their addiction to dangerous tobacco products. The very idea that we can create a “tobacco-free generation” by clamping down on a non-tobacco industry that has helped millions escape tobacco use is so absurd on its face that it is scarcely deserves to be debated.

Still, the real question is simple: will these actions have any real impact on public health? Will these new rules actually diminish tobacco use and benefit public health, have no impact at all, or create more problems for those trying to escape their tobacco addiction? To understand the real impact, it can be helpful to look at the changes going into effect:

  • By deeming e-cigs as tobacco, the agency will now enforce laws restricting access to e-cigarettes by minors.
  • The new rules require manufactures to submit product listings to the agency, including ingredients, so that the FDA can provide a “premarket review and authorization.”
  • Products will now have to contain health warnings – despite the absence of any clear scientific evidence that suggests that e-cigarettes pose any serious health risk.
  • Other silly rules designed for the tobacco industry that some enlightened souls in the FDA believe to be equally applicable to non-tobacco products.

 

The Impact

It’s easy to look at the lovingly-crafted list of FDA rules and leap to the conclusion that these must all be positive changes – otherwise, why would the agency move to enact them? The sad fact is that these are exactly the type of regulatory actions that Big Tobacco and its allies – the ones who actually create, market, and distribute harmful tobacco products, mind you – have long sought to rein in their electronic cigarette competitors. By enacting these regulations, the government is actually benefiting Big Tobacco by making it harder for its competitors to operate in the marketplace.

The product approval process alone can cost an estimated $1 million for each new product. For tobacco companies worth many billions of dollars, those costs are all but negligible. For small e-cig firms, they can be prohibitively expensive, and may even be enough to bar entry into the marketplace altogether.  In essence, by making it more difficult for e-cig companies to compete, the FDA is providing a boost to tobacco companies – and that is certainly no way to achieve its imagined “tobacco-free generation.”

 

The Bottom Line

The end result of this is still not clear, but some things seem likely. As e-cig manufacturers adapt to the higher costs associated with compliance with the standards imposed by their new imaginary status as “tobacco” peddlers, these companies will either go out of business or pass those costs on to their consumers. Tobacco users who want a cheaper and safer option for nicotine will lose one of the most attractive features of electronic cigarette usage: the cost savings. Tobacco usage is likely to remain the same or increase, as e-cigs become less attractive.

And that means more people dying due to tobacco use. No matter how these rules are spun by those with an agenda, making it more difficult for people to access healthier alternatives to tobacco will almost inevitably result in more people dying from tobacco. Sometimes, rules are necessary. Stupid rules, on the other hand, almost always have bad consequences. The consequences here are a matter of life and death.

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