Tuesday, July 5, 2016

FDA standards on e-cigs are reasonable -- Ron Johnson, however, is not

Safeguards are meant to prevent long-term health issues, especially for children; other measures are equally proper

Christian Berkey, CEO of Johnson Creek Enterprises (an electronic cigarette liquid manufacturer), is fearful that federal Food and Drug Administration regulations could do substantial harm to the e-cigarette industry.

image via Wikipedia
“Close to a million jobs could vanish and nearly 30,000 businesses could close because of federal regulations on vaping,” he wrote in an op-ed appearing on Madison.com this week.

Those overbearing rules that Berkey talks about, however, aren’t going to do as much damage as he says they are. And they serve a real purpose, especially given how little we know about the long-term effects of e-cigarette use.

The regulations primarily limit individuals under the age of 18 from being able to purchase vaping equipment, accessories or liquid. Other regulations require that companies that are mixing vaping liquids register with and get permission from the FDA before doing so for commercial purposes.

In that sense, the regulations could feasibly affect sales. Many e-cigarette shops mix their own liquids in the back of their stores, and these regulations would halt that practice.

Yet, these shops would be allowed plenty of time to “do right” by the FDA standards, and to continue their practice of mixing liquids without real action taken against them in that time:
...federal health officials countered that the industry would have ample time to respond to the rules. Companies with products on the market now, including vape shops that mix their own liquids, will have two years to submit an application to the F.D.A. for approval of a product. It can stay on the market for another year while the agency reviews the application.
Emphases in bold added.

The standards that the FDA are calling for are not too imposing -- requiring age restrictions on e-cigs and their accessories should make sense even to the most cynical of vapers out there, and regulating who is mixing what chemicals together should similarly be a no-brainer. And the time-frame that the FDA is giving to small businesses is fair.

The way that Berkey is making it out to be, however, you’d think that e-cigs have been banned completely by the FDA.

“[W]e will have to close down if FDA regulations move forward,” he wrote.

That’s extreme hyperbole that shouldn’t be taken seriously. Yet U.S. Sen. Ron Johnson (R-Wisconsin), unfortunately, is taking the e-cigarette regulations on as his latest pet project in Washington DC, even in the face of evidence that the health effects of vaping demonstrate we should show concern over continued usage over time:
Last year, a Journal Sentinel investigation, "Gasping for Action," found high levels of harmful chemicals in locally made e-liquids. It also exposed inadequate testing that allowed manufacturers to make false claims that their products were free of these lung-destroying chemicals, such as diacetyl. A Harvard University study found similar results late last year.
Sen. Johnson, however, is undeterred in his opposition, despite these health concerns. His critiques echo those of Christian Berkey: “[E-cig businesses] fear that the FDA’s e-cigarette rule will force them out of business by requiring them to complete costly and time-consuming premarket applications for each e-cigarette product,” he wrote last month.

But again, those regulations give ample time to businesses to apply with the FDA. And they don’t prevent them from continuing their practices in the meantime.

The FDA regulations are more than fair, and provide guidelines for how we should handle the industry in a time of uncertainty. They don’t prevent businesses from prospering, but merely limit the sale to minors and keep those who are mixing different “juices” accountable.

A reasonable person would see these regulations as common sense measures to prevent or limit health problems in the immediate future, especially for children. Ron Johnson, however, isn’t a reasonable senator.


  1. You are a clown sir, and clearly uninformed. Taking up the flag for a cause you know nothing about is foolhardy at best. The FDA approval costs millions, per individual product and nicotine level, and they reserve the right to deny them on false premises. This is an effort to keep money in the hands of Big Tobacco and Pharma. Try some critical thinking here.

  2. Did you review the reports on diacetyl? Cigarettes have far higher levels with no problem of being on the market. Those high levels in cigarettes have never once resulted in popcorn lung. Seems like a scare tactic to me.

  3. You appear to know little or nothing on the subject of this article. Why write it?