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Forbes accuses FDA of assigning ‘zero value’ to smoke-related deaths

Forbes Magazine has been an active and vocal opponent of the newly announced FDA deeming regulations that threaten to wipe out the entire vaping and e-cig industry. However, a recently published article seems to indicate that the nearly 100-year old news organization is kicking things up a notch by accusing the federal government of placing zero value on the lives of smokers and e-cig users.

The FDA deeming regulations officially went into effect on August 8, 2016, and the vaping community immediately began witnessing the nasty side effects.  Free samples from vape shops are now illegal, and employees can no longer help customers rebuild or repair technology.  Selling to minors can also result in legal ramifications, but Forbes makes note of another, often unnoticed, repercussion that is just downright deadly.

FDA:  Sharing of potentially lifesaving information is prohibited.

In the article, FDA Assigns Zero Value to Smokers Who Die Because of Its E-Cigarette Regulations, Forbes journalist Jacob Sullum states that the FDA deeming regulations prohibit retailers from discussing any of health benefits of electronic cigarettes with its customers. Manufacturers are also immediately banned from making their products more convenient, easier to manage, or even safer to use.


 “Nicopure, one of the companies that is challenging the FDA’s regulations in federal court, used to tell consumers that in vaping ‘nothing is burned,’ ‘no smoke is released,’ and ‘no ash’ is generated. It also noted that the aerosol produced by e-cigarettes contains ‘no tar’ and only ‘a fraction of the 4000 chemicals currently found in standard tobacco cigarettes.’ Although all of these statements are indisputably true, they are illegal under the FDA’s reading of the Family Smoking Prevention and Tobacco Control Act.”

Thanks to the FDA, innovation in the vaping industry will also systematically stall to a snail’s pace unless retailers and manufacturers can afford the million-dollar Pre-Market Tobacco Application (PMTA) process previously reserved for Big Tobacco.  As a result, this ban on innovation and prohibition of even sharing public health information on the benefits of vaping is essentially encouraging the American Public to switch back to conventional cigarettes.

“The FDA’s censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA’s requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety.”

Forbes Magazine goes on the offensive.

According to Nicopure CEO Jeff Stamler, the company “introduced approximately 288 new e-liquid products, 6 new vaporizer products, and 23 new vaporizer components” in 2015 alone.  Based on this current rate of yearly production, Nicopure would theoretically be forced to pay nearly $317 million in PMTA fees for each new product in the coming years, all of which would conveniently find its way into the very deep pockets of the FDA.


However, the more alarming point is that the PMTA process is not clearly defined.  No one seems to know how long it will take to gain PMTA approval, not even the FDA itself.  Estimates range from 6-months to two years, and approval is not guaranteed, even if the million-dollar fees are indeed paid. What happens to technological innovation in the meantime?

Even if Nicopure Labs and others like them can afford $317 million dollars in PMTA fees per year, the time gap between submission and approval of the application almost guarantees the death of the vaping industry.  Forbes Magazine is clearly taking a stand against the FDA when it states, “All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account“  when writing and implementing the FDA deeming regulations of 2015.


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