Tuesday, October 04, 2016

IN MY VIEW: FDA is Partly to Blame for Explosion that Injured Teen on the Hogwarts Express

For several years, the FDA has been nagging us about how important it is that the agency claim jurisdiction over electronic cigarettes because of their safety hazards. Now that the FDA has that jurisdiction, it is the public health agency that is ultimately responsible for ensuring the safety of electronic cigarettes. And so far, it is doing a terrible job.

This past weekend, a teenager suffered burns after an e-cigarette exploded on the Hogwarts Express at the Universal Orlando theme park, sending a fireball in her direction. Since the FDA is responsible, upon its own insistence, for the safety of electronic cigarettes and this explosion occurred on its watch, the agency bears some responsibility for the girl's injuries.

After all, the agency has failed to set any standards, or even to issue a guidance or advisory, for electronic cigarette battery safety. Moreover, the FDA's Center for Tobacco Products has actually institutionalized the problem of exploding batteries because it promulgated regulations that prohibit e-cigarette companies from repairing the defects that are causing these explosions. Since August 8, companies have been prohibited from making any safety improvements on their products, including fixing the problem of exploding batteries. To correct such problems would amount to selling a new "tobacco product," something that is not allowed under the FDA's regulations.

Imagine being the president of the company that manufactured the product which injured this girl and having to explain to the girl's family that although a safety defect has been identified in your product, the FDA has prohibited you from fixing it. The idiocy of these regulations would be comical if they weren't causing so much human damage.

The Rest of the Story

The FDA regulations are so detrimental to the public's health that vape shops are interpreting the rules to mean that they cannot even fix defective e-cigarette devices of their customers: "In addition to talking about health benefits, the regulations now prohibit vape shops from working on customers' devices, which is something that shops charged money for as a service. "It's almost like going to a mechanic and the mechanic tells you what's wrong and how to fix it, but telling you that you have to do it yourself," said Jonathan Golin, a manager at Gorilla Vapes in East Brunswick."

So if a customer has a device that is overheating, leading to the release of formaldehyde, many vape shops apparently believe there is nothing they can do to fix these devices, which is going to harm the health of these customers unless they can fix the devices themselves, which is not something most people are able to do.

Suppose, for example, that a company or a vape shop discovered that it could prevent overheating, and therefore the formation of formaldehyde, by adding a second coil. Thanks to the FDA, the company or vape shop cannot do this because it would result in a "new" tobacco product, whose sale would be unlawful. While one might argue that if a customer already bought a device and then brought it back, the store could fix it; however, it would still essentially be selling a "new tobacco product."

As the official regulator of e-cigarette devices, including batteries, the FDA should be held responsible for its failed regulatory approach. Instead of regulating the safety of these products, the agency chose instead to take a prohibition approach -- wiping out 99% of the industry.

In the meantime, people riding the Hogwarts Express may want to practice their extinguishing spells, as the problem of exploding batteries is not going to be fixed any time soon, thanks to the FDA's Center for Tobacco Products shirking its responsibility for ensuring the safety of the products under its jurisdiction.

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