FDA Deeming on Electronic Cigarettes – What’s the Hold-Up?

Vaper’s Vortex

September 15, 2015

“The Obama administration has failed to finalize federal regulations for e-cigarettes nearly a year and a half after a proposed rule was issued, which has public health advocates clamoring for a decision to quickly rein in the growing industry.”


That is a quote from a recent article in the Washington Examiner, Health groups fume over delayed e-cigarette rules. The latest example of pressure being applied to the FDA to expedite their initial ruling on electronic cigarettes. The FDA has received a letter with the same theme from nine U.S. Senators. Another one signed by 40 state Attorney Generals. Still others signed by 20+ public health organizations. So what’s the hold-up?

Sales to Minors

From the Washington Examiner article, Vince Willmore, spokesman for the Campaign for Tobacco Free Kids:

“Right now we have a wild west market of products with e-cigarettes.”

Willmore went on to say that a “federal ban” is needed to reign in those states that have not passed laws prohibiting sales to minors. The article states that “at least 46 states” have passed those laws. Apparently those last four states are annoying the hell out of CTFK. I guess that’s their definition of a “wild west market”.

If there is one aspect of the e-cigarette debate that is agreed on by virtually everyone, it is the fact that e-cigarettes are an adult consumer product. An FDA ruling to that effect would produce zero controversy. Doesn’t seem likely that the question of sales to youth is delaying FDA action.

Advertising

Big Tobacco is marketing to kids. Note that I said “Big Tobacco”, not the vaping industry as a whole. So something meaningful needs to be done about BT’s advertising of vaping products geared toward youth. There is some legal precedent regarding restrictions imposed on BT for cigarette advertising. Nevertheless, restricting BT advertising for electronic cigarettes would not be easy. The courts have ruled that “commercial free speech” is protected under the First Amendment.

Safety

The Washington Examiner again quotes Willmore:

“Oversight is not just needed to protect children, but also adults.”

Protect adults? From what?

Public health and politicians are quick to point out that nobody knows the long term health implications of e-cigarettes. You can’t know the long term health implications of a product that hasn’t been on the market long term. What can be done, and has been done many times in the past, is to extrapolate long term risks on the basis of what is known about short term risks. Study after study have conclusively shown the safety of electronic cigarettes relative to combustible tobacco. So again, protect adults from what?

Opinions vs. Regulations

Unlike the CDC, ACS, ALA, CTFK and countless other “public health” organizations, the FDA is a regulatory body. The FDA does not have the option of implementing regulatory requirements based on the opinions of anti-tobacco, anti-nicotine and anti-vaping activists. The FDA is mandated to regulate within the authority it has been granted under the 2009 TCA, consistent with available science, and in the interests of the health and safety of the population.

There is almost no legal precedent, no “case law” on which to base regulatory decisions. Electronic cigarettes are a new, unique and disruptive product. A second year law student could easily raise questions that would serve as the basis for lengthy and costly litigation.

Frieden vs. Zeller

There is a reason why CDC’s Frieden is a medical doctor and CTP’s Zeller is an attorney.

Frieden has proven, “beyond a reasonable doubt”, that he can say anything he chooses to say. He can bias study results to fit his own personal agenda. He can choose to ignore any and all studies, regardless of how numerous, regardless of how well done, that conflict with his crusade.

He can manipulate the media. He can manipulate billions of dollars of federally funded research grants. And he can do so with almost total impunity from legal action. All in the name of “expert opinion”.

When we look at the challenges faced by Zeller, the picture is dramatically different.

Zeller cannot exercise regulatory authority based on his personal opinion. Zeller cannot, in the interest of “quick enforcement action”, ignore dozens of studies focused on the relative safety of e-cigarettes. Zeller cannot hide behind the absence of science regarding the “long term” safety of e-cigarettes.

Michael Felberbaum, spokesman for the FDA:

“Rulemaking is a complex process.”

Experts with decades of public health experience are in almost unanimous agreement – whatever action the FDA ultimately takes is certain to be challenged. Litigation that could delay the implementation of new regulations for years. With a price tag in the tens of millions of dollars.

Legal Issues

Phil Daman, CEO and president of the Smoke Free Alternatives Trade Association:

“The FDA knows it is not allowed to expand its jurisdiction to vapor products.”

With all due respect to Mr. Daman, I’m not sure that is not a little over-stated. But whether or not it is over-stated will depend on FDA’s answer to some very difficult questions.

  • “What is the definition of a “tobacco product?” It has been repeatedly suggested that e-cigarettes are a “tobacco product” because the majority of them contain nicotine derived from the tobacco plant. So if FDA rules that e-cigarettes are a “tobacco product”, what implications would that have for FDA approved nicotine replacement therapy products? A multi-billion dollar product line for Big Pharma. Is nicotine the defining factor or not? Will the courts allow FDA to have it both ways?
  • “Is the ‘grandfather date’ legally defensible?” If Congress or the FDA allows the 2007 grandfather date to stand, it surely will be challenged in court. The letter dated November 24, 2014 and signed by six members of the U.S. House of Representatives’ leadership would no doubt figure prominently in the court’s deliberation. The letter states that the February 15, 2007 date was nothing more than a clerical formality:

“Importantly, February 15, 2007 was selected as the grandfather date for the originally regulated products simply because it was the date the Tobacco Control Act was introduced in the 110th Congress.”

  • “Is harm reduction a legal basis on which to base public health regulatory policy?” Numerous studies led to the recent report by Public Health England (roughly equivalent to the CDC in the U.S.) stating that e-cigarettes are 95% safer than smoking. PHE even went so far as to recommend that Britain’s National Health Service offer e-cigarette prescriptions as a tool for smoking cessation. Harm reduction is not only broadly accepted, it is even endorsed by the CDC in many areas including treatment for heroin addiction and slowing the spread of HIV. Why the opposition to e-cigarettes? What’s more important – harm reduction or minimizing potential, but unidentified, risks?
  • The concept of “evidence-based” policy is widely accepted. The evidence regarding e-cigarettes, also widely accepted. The question is – “What sort of policy should result from the evidence?” Public health law scholar Wendy Parmet writing for the Connecticut Law Review:

“Public health laws that are strongly rooted in, and indeed arise from, the public, may face a quite different fate than those that derive from the good intentions of public health policymakers alone.”

Much More

  • Warning labels – Yes? No? What should the wording be? Will it hold up in court?
  • Diacetyl, acetyl-propionyl, acrolein – Easy to regulate (prohibit). Challenging to enforce. Who is responsible? E-liquid manufacturers? Retailers? Flavor extract manufacturers?
  • Manufacturing standards – Clean rooms? Product standards (batteries)? Imports?

What’s the hold-up? Maybe a more fundamental, more important question is what’s the risk?

In the name of science, in the name of harm reduction, in the name of public health, in the name of saving lives – let’s get real. The primary risk to public health is not electronic cigarettes. The primary risk to public health is excessive regulatory action based on media hype and political pressure from politicians scrambling to replace shrinking tax revenues from declining smoking rates.

That is the risk. And that is the hold-up.


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Dave Coggin has a Master’s Degree in business and spent 35 years in corporate America. He is a co-founder and partner in DIYELS. He has spent the last five years actively researching and following the evolution of the e-cigarette industry. He is a strong proponent of e-cigarettes as the most promising option currently known for tobacco harm reduction. He may be contacted directly at dave@diyels.com .

The opinions presented here are exclusively those of the author. Vaper’s Vortex is offered as a service to our customers and followers. Anyone considering e-cigarettes as an alternative to tobacco cigarettes should seek qualified advice from a medical professional.

4 thoughts on “FDA Deeming on Electronic Cigarettes – What’s the Hold-Up?

  1. Over here in Europe the TPD, which contains what might be considered the worlds first draught at defacto bans of ecigs, will be making its first appearance in court on 1st October. I have no doubt that whichever way that coin lands that the FDA will be watching closely. As will many of the worlds 50M vapers.

  2. If we talk about the safety of electronic cigarette, it is not harmful for the people sitting around you. It is not possible with tobacco cigarettes and smoke produced by tobacco cigarettes is harmful for the other person sitting with a smoker.

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