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Scott Gottleib FDA Press Conference On E-Cig Regulations

By Tyler McCanus

Monday August 7, 2017
dr scott gottlieb fda press conference on vaping regulations
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New Dood and Drug Administration boss Dr. Scott Gottlieb held an FDA press conference on e-cig regulations and the results were mixed for vapers. The press conference actually covered a range of tobacco products including electronic cigarettes and cigars. As far as vapers were concerned, we were waiting to hear what was next in store for the industry. We got some good news.

The good news is a 5-year postponement of the full implementation of the FDA e-cig regulations. There was more good news regarding Dr. Gottlieb’s views on potentially harm reducing products. He said that less harmful products could be part of the solution. He said that less harmful products, a category that one would assume included electronic cigarettes, might possess benefits that we must consider.

We have found a video of the press conference that you can watch for yourself. It is 27 minutes long. We will cover the main points below so you can get the idea without watching as well.

Watch Scott Gottlieb FDA Press Conference


Main Takeaways:

  • FDA postpones due date for submission of PTMAs for vapor products by 5 years
  • Harm reduction products may be an asset to reducing tobacco harm
  • Open to the possibility that harm reduction products can help smokers
  • The focus on reducing cigarette addiction by regulating nicotine
  • FDA will be taking a hard look at flavors

The vaping community and industry was looking at a deadline of August 2018 to submit PMTA applications for product approval. That deadline has now changed. The August 2018 deadline was pushed back until 2022. That is a 5-year reprieve. That means that all of the products that are currently on the market can stay on the market. One PMTA application for one product could cost an e-cig company $1 million. Most companies will not be able to pay those costs. Even if they exceed all standards, it won’t matter. If you can’t pay, you can’t stay in business. Hopefully, given the additional time, that can change. The FDA has expanded the time frame as they more fully evaluate.

FDA Focussing On Regulating Nicotine

Dr Gottlieb is seemingly open to a new category of products that may be able to deliver nicotine without burning tobacco. He wants to focus on harm reduction by focussing on nicotine. Gottlieb referenced reducing the nicotine content of tobacco products to help reduce smoking. He suggested that reduced nicotine will make cigarettes less addictive.

The fight is far from over. The restrictions that limit the ability to bring new products to market are still in place. There has been no change announced regarding the PMTA FDA approval process for new tobacco products.

There was a hint of bad news that we kind of saw coming. At Dr. Gottlieb’s FDA confirmation hearing he mentioned that there needs to be a balance in the variety of e-liquid flavors. The concern is that kids are attracted to certain fruit and dessert flavors. As it stands, the FDA will be taking a deep look into flavors. It is possible that the variety of e-liquid flavors could face future regulation.

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