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The FDA Finalizes Its New E-Cigarette Regulations

After two long years of debate, the FDA has finally decided upon the new vaping laws it wants to apply for the e-cigarette industry. First impressions suggest they could be seriously damaging to what is a multi-million dollar sector.

The FDA first tried to introduce its regulations two years ago but after much pressure from the large vaping community it was forced to withdraw and rethink its proposals. Some parts of the new 2016 vaping laws are unlikely to cause much consternation but other elements are expected to lead to expensive headaches for manufacturers, sellers and consumers.

FDA Regulations on Ecigs and Tobacco Sales

FDA E-Cig Regulations

The real contentious issue with these regulations is the part that requires all manufacturers to go through the Pre-Market Tobacco Application process (PMTA). This process is very expensive – current estimates suggest it can cost over a million dollars to submit an application. It takes around 1,700 hours to complete the rigorous paperwork that goes with it. PMTA will not only apply to new products, it has also been backdated to February 17 2007, meaning pretty much all products currently on the market will have to go through this testing procedure.

There is no guarantee that the application will be successful of course, which means some companies may pay out millions of dollars to comply with the law only to lose out because no product they sell meets the FDA guidelines. This will cost smaller manufacturers dearly and could lead to a huge contraction in the availability of certain e-cigarette products.

There is some hope that this unreasonable regulation will not be passed into law. Rep. Tom Cole and Rep. Sandford Bishop, have sponsored an amendment that will mean the predication date is changed and anything currently on the market will not have to go through the expensive and time consuming PMTA process. This could help manufacturers stay afloat because it means that their products will not be removed from sale. The amendment has already passed the House Appropriations Committee but will still need to pass through the House of Representatives in order to become law. It is well worth writing to your representative and asking them to support this amendment that will give some protection to the e-cigarette market.

As well as the PMTA the e-cigarette regulations will give manufacturers several other responsibilities. Manufacturing establishments need to be registered, product listings need to be provided, ingredients need to be reported, health warnings need to be placed on packaging and words like ‘light’, ‘low’ or ‘mild’ need to be removed. These bring e-cigarettes in line with regulation on regular tobacco. Many feel this is unfair because Mitch Zeller the head of the FDA’s Center for Tobacco Products was interviewed by Vox in which he endorsed the idea that e-cigarettes are less harmful than tobacco. These regulations fail to account for this and instead put e-cigarettes on a par with tobacco.

Following these complex and controlling regulations there will for the first time be an age restriction on the sale of e-cigarettes and e-liquid. No one under the age of 18 will be able to purchase e-cigarettes or e-liquid either in person or online. Photo ID will be required for age verification, sales in vending machines will be stopped and there will be no free samples. These measures limit access to e-cigarettes for minors which is definitely important. According to USA Today 16% of high school students are using e-cigarettes. Age restrictions will hopefully limit these numbers and will encourage more responsible behavior from vapers.

Some critics are arguing that this is a big victory for the tobacco lobby. No matter what happens these e-cigarette regulations will cause the price of e-liquids and e-cigarettes to rise which could potentially push vapers back towards smoking. It also makes the market more accessible to large tobacco companies because of the money involved in regulation, which again would harm the smaller manufacturers.

We all want a smoke free America but that dream has been pushed back even further by these regressive regulations.

You can read the entirety of the FDA’s final vaping regulations 2016 here. What do you think about these regulations? Share your thoughts with us in the comments and on our social media pages. 

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