Name: Clive Bates: What are the regulations the FDA is enforcing on the e-cigarette market? | VIEWPOINT
Uploaded: 2017-10-24T16:03:22.000Z
Duration: 7 min 52 s
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Adverbs of manner

Sally: Last April, the FDA issued deeming regulations which officially put electronic

nicotine delivery devices under the umbrella of the FDA.

And in the course of doing so...well, that's what I'm...I'll throw that to you.

What has the FDA proposed, or enforcing, I should say?

Clive: With any regulation, your starting point should be what is the problem to which

this regulation is the solution, or what is the risk to which this regulation is the mitigation

And the problem for the FDA is that there isn't actually very much wrong.

So we've seen...there's now eight and a half...there's about 38 million smokers in the U.S., about

8 and a half million vapers, and about 2 and a half million of them are people who no longer

So that's now a large-scale phenomenon relative to smoking, around quarter of the kind of

Most people who do it are quite happy about it or they wouldn't be doing it.

Many people are getting short-term benefits from it.

Smoking prevalence amongst adults is a record low, and falling rapidly.

Smoking prevalence among teenagers, it's a record low and has been falling rapidly.

So what we get then is the hunt for the problem, and we see FDA spending a fortune on academic

We see CDC getting in alongside, problematizing the issue, okay?

So you'll see studies and you'll see talks about flavors, gateway effects, you know,

All of these things are essentially designed to create a sense of alarm that justifies

And one of the really terrible consequences of that is the misalignment of perceptions

of risk in the American public between what is real about e-cigarettes and what they think.

And roughly speaking, I think it's just over 5% of Americans would say e-cigarettes are

much less harmful than cigarettes, which is the right answer.

Thirty-seven percent say the same or worse, and another 36% say, "I don't know."

Sally: And that perception has been changing over the last few years in the direction of

So, to me, I mean, this is why Public Health England, Royal College of Physicians had come

out and been so clear about giving people an anchor, quantified anchor, you know, at

least 95% lower risk, so that it cuts through all the stuff that you're seeing in the newspapers

They say, "Well, no, if you put it context, it's all very, very much lower."

And I think that is a piece of collateral damage that has been done to the American

public by these agencies as they've tried to justify regulation, okay?

So next, we look at the regulation that they're actually proposing, which is...I mean, when

people ask me, "Is there anything good about the EU regulation?"

I say, "No, the only good thing is it's not the FDA, okay?"

And that is the only good thing you can say about it.

The FDA's regulation has a number of totally terrible features to it.

Very, very expensive, and it's very, very broadly applied to literally thousands of

products, product components, product variance, all need this full-scale authorization with

full justification to the FDA, repeated endlessly over and over again for roughly the same products

It's so massively wasteful, it's off the scale.

The second really negative feature of their regulation is you don't know what it takes

With the EU regulation, it's quite burdensome, but you do know that if you do the things

that are required, you can put your product on the market.

You know that with certainty that if you comply with quite clear regulations, it's on the

Somebody makes a decision to authorize your product and you don't know.

You don't know what their criteria are and how they will judge the evidence that you

put forward, what hurdle, evidential hurdles they want you to cross.

So that makes it harder for the companies who aren't giant tobacco companies to raise

Sally: Who can't even afford to...this application process.

They don't really know what the cost are going to be or how long it will take.

So how does that play into their financing?

Because it looks like a giant regulatory risk.

So many of them don't have particularly strong balance sheets, so they're looking to external

finance and refinancing their operations, and their investors go, "Well, this doesn't

And we've already seen NJOY go down for that reason, or that and amongst other reasons.

So I think it's very harmful, and there's arguments like, "Well, will it take out 90%

We shouldn't be having an argument about that.

You would be taking out 90% of something that is basically quite successful.

You know, large number of users, lowest-ever smoking rates.

Everybody's happy, and yet you think it's a good intervention to take out 90% of what's

They haven't assessed the likely unintended consequences that will flow from that intervention.

And it doesn't mean...it doesn't need that many extra smokers before you've got a detriment

that hugely outweighs any conceivable benefit from these regulations.

Sally: So what are the avenues of redress look like from the congressional legislative

And then we'll get into the other standpoint, which is the courts.

Well, I mean, the issue...I mean, tthere's two ways out of this.