In 2009, broad new authority for FDA over tobacco products didn't include e-cigarettes because they were just a blip. Later, they took off in popularity. The free market is always mysterious but I liken it to Wi-fi and Bluetooth. While a centralized committee drawn from large companies came up with Bluetooth for the wireless future, then were years late in rolling out a product that didn't work very well, Wi-fi took off thanks to small players and public uptake in the free market.
So it goes with smoking cessation and harm reduction. Gums and patches were created by Big Pharma and then handed to the people as the only choice, but people did have a choice. Vaping was a grass roots movement. Before Juul, no company had even 2% of the market. It was all small players. But just like with supplements sold by sketchy companies, it was not great to have some numbskull buying a 50 gallon drum of diluted nicotine and opening up a vape shop near schools. It was only a matter of time before FDA took it on and they did, but under the Obama administration it was pretty Draconian. With a wave of the pen, and with no voter accountability, they were going to create 10 million casual criminals by declaring that any product made from before FDA even got authority over tobacco had to go through FDA approval.
Johnson & Johnson was giddy. That money they gave to Stan Glantz of UC San Francisco, who suddenly turned on smoking cessation and harm reduction, paid off. Cigarette companies were giddy, because they had time to catch up and use all that tobacco. The biggest threat to their revenue was being eliminated by government fiat.
In 2015, I sent an employee to the White House to argue that we should push back the date (which did not happen) but the Trump administration came in and FDA Commissioner Dr. Scott Gottlieb saw reason and did postpone it to give companies more time to prepare. Then it got postponed again. Let's face it, this is going to be an expensive process and we don't want the only companies that can endure it to be cigarette makers and drug companies, who will buy up bankrupt groups for peanuts and then go through approval. An extra year or two was not putting anyone in peril.
Anti-smoking groups who were subsidized by the cigarette settlement of the 1990s (Tobacco Free Kids, etc.) have deftly swiched to being anti-nicotine despite any evidence it is any more harmful than caffeine or sports for developing brains. They have engaged in "Reefer Madness" techniques, with commercials showing kids breaking TVs and yelling at their parents because of that Demon Weed. Kids rebel, and old people are sometimes clueless, so those goofy ads probably added to kids experimenting, but there is no vaping epidemic any more than there is a Red Bull one. CDC may claim so, but as we have seen with gun injuries and opioids and prediabetes claims, there is no scientific methodology they use. They use surveys with rather suspect motivation.
However, anti-vaping groups took it to federal court and won, so the date was set back to May, 2020. Now, the hundreds of companies in the Vapor Technology Association are suing in the Kentucky U.S. District Court (a friendlier court for business, which is why ban groups always go for California, New York, or DC) to block review, arguing it will wipe out small companies who've done nothing wrong.
FDA did not appeal last time so they may not believe it needs to be delayed any further this time either. Companies should get ready.
