Tuesday, September 13, 2016

Unlike Samsung Galaxy, FDA Regulations Don't Allow E-Cigarette Companies to Fix their Exploding Batteries

Last week, Samsung temporarily took its Galaxy Note 7 smartphone off the market while it works to solve the problem of exploding batteries, which occurred while the devices were charging. A Samsung investigation found that the problem was a battery cell made by one of its two battery suppliers. The problem stemmed from a defect in the manufacturing process, which is now being corrected.

At the same time, a number of e-cigarette companies have noted a similar problem with batteries in their devices, possibly related to a similar manufacturing defect. However, in contrast to Samsung, these companies are actually not allowed to fix the problem.


Because the FDA has prohibited e-cigarette companies from fixing exploding batteries - or any other manufacturing defect - in their products.

This unprecedented consumer "safety" regulation actually puts the public at great risk. No matter how many manufacturing defects are discovered, no matter how severe they are, no matter how easy they are to fix, and no matter how much the companies want to fix the problem to ensure the safety of their products, these safety improvements are simply not allowed, due to the stupidity of the FDA's e-cigarette deeming regulations.

The only thing worse than the FDA issuing such inane regulations is the fact that the major anti-tobacco groups supported this absurd approach to tobacco and nicotine product regulation.

The Rest of the Story

The FDA is completely butchering the intent of Congress in including new product applications as part of its Family Smoking Prevention and Tobacco Control Act of 2009. The only reason the requirement for pre-market tobacco applications was included in the law is that tobacco companies had a history of altering their products in a way that increased public health harm. For example, they might increase nicotine delivery by adding ammonia to change the pH, market low-nicotine cigarettes which don't actually reduce risk, or alter the blend of tobacco types which might increase the level of certain carcinogens. From the perspective of Congress (a perspective with which I don't happen to agree but that is irrelevant to this commentary), the tobacco companies simply couldn't be trusted. Any changes they made to their products could potentially place the public at increased risk while at the same time giving them the false impression that the products were safer.

This justification does not hold for applying the same requirement to electronic cigarettes and vaping products. There is absolutely no history of the companies making product changes designed to make the products more dangerous while giving consumers the impression that the product is safer. In fact, the opposite is the case. There is a long history of product improvements over time, such that the safety of vaping devices has substantially improved from when they were first introduced into the market.

One example of this is the problem of diethylene glycol contamination. In 2009, the FDA found diethylene glycol contamination in two brands of electronic cigarettes. This problem probably resulted from the use of non-pharmaceutical grade propylene glycol. Apparently, the problem was corrected because since that time, I am not aware of any further testing that has revealed diethylene glycol in e-liquids of any manufacturer.

The companies have also consistently made quality improvements over time, resulting in more effective products. More effective products have a greater public health impact because the better these devices are in helping smokers quit, the greater their contribution to improving the public's health.

Therefore, it makes absolutely no sense to prevent the e-cigarette companies from making safety and quality improvements to their products.

The rest of the story is that in its application of the law to e-cigarettes, the FDA has completely run afoul of the intent of Congress in enacting the Family Smoking Prevention and Tobacco Control Act. The result is a set of regulations that not only fail to protect the public's health, but which place the public at imminent and substantial risk.

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