Unintended consequences of the FDA’s e-cigarette regulations

Earlier this year, the Food and Drug Administration (FDA) finalized a rule that extended the agency’s authority to regulate electronic cigarettes and related vapor products as tobacco products. However, these products do not actually contain tobacco.

In so doing, FDA started the clock ticking toward August 8, 2018, the date on which e-cigarettes, e-liquids and other related newly deemed tobacco products that do not have FDA approval to remain on the market can no longer be legally sold.

E-cigarette products can only stay on the market after this ‘predicate date’ if a manufacturer undertakes a package of research that is required by FDA to consider granting approval for a product to stay on the market.

Experts have estimated that undertaking this research package to a good standard could cost a manufacturer at least $3 million per product it wishes to keep on the market. In other words, if an e-liquid manufacturer wants to sell four different flavors of e-liquid, the manufacturer would have to pay in the region of $12 million to conduct or commission research on those four products, none of which guarantees FDA will grant approval for any of the four liquids.

Some of the major companies will be able to shoulder this financial burden, but it is highly likely that the vast majority of small and independent manufacturers will not, and so, will be put out of business.

What, then, will people who currently use e-cigarettes do if, on August 8th 2018, their preferred products are no longer legally available to buy. My research team at the Centre for Substance Use Research (CSUR) recently asked this question to more than 9,000 US-based e-cigarette users, and the results should give FDA cause for alarm.

First, 8,451 current e-cigarette users who were also former cigarette smokers were asked what they would likely do if, as a consequence of the Deeming Rule, the e-cigarette products they use right now were taken off the market. Approximately 73 percent of the vaping former smokers indicated they would ‘bulk buy’/stock up on their preferred products before the rule was implemented.

Nearly 70 percent indicated they would start to source their e-cigarettes and e-liquids from a non-licensed vendor, and so fuel a black market trade in e-cigarettes. In addition, 66 percent of vaping former smokers said they would likely start to import e-cigarettes from overseas, and 65percent  said they would start making and mixing their own e-liquids at home — in other words, they would become not merely a consumer, but also a manufacturer of e-cigarette products.

It is very likely that each of these intended responses to FDA’s regulations would pose much greater risks to the health of consumers than are being posed by the e-cigarette products that are currently being sold in stores across the US. These unintended consequences — in particular, driving consumers to an underground ‘black market’ trade in e-cigarette products of dubious manufacturing standards and unknowable toxicity — would both undermine FDA’s ability to assess the population health impact of its own rule, and undermine the FDA’s stated mission of improving and protecting the health of Americans.

Full article: Unintended consequences of the FDA’s e-cigarette regulations | TheHill

There’s also a lot of folks who would return to traditional cigarettes.

But we all know that the government doesn’t seem to mind starting the roll of the black market on items they want to ban “for our own good.”

I vape. Personally, I would probably bulk buy and start mixing my own.

What a lot of people are missing in this entire thing is the large amount of big tobacco companies that have actually purchased companies like Blu e-cigarettes. The big tobacco companies are the ones that will be able to foot the bill for the FDA approval and meet their ridiculous demands. Big tobacco is behind all of this, because without the smaller manufacturers, people who vape – they assume – will be forced to buy and use the garbage they produce. And believe me… it’s all garbage. The taste is terrible and, frankly, most of them have a minimum nicotine content that is much higher than what smaller manufacturers are willing to go. I get 30-100 ml bottles that contain 3 mg of nicotine. Smaller guys also use propylene glycol, vegetable glycerine, and food grade flavoring (that’s literally it). Who the hell knows what’s in the juice from big tobacco… probably the same junk in the cigarettes.

Amazing. So, as with everything else, this isn’t for the good of the people. It’s for the good of big tobacco. Period.

Stop banning stuff!



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