The FDA Releases Long-Awaited Regulation Details
The vaping community has been anxiously waiting for months to find out how the Food and Drug Administration would deal with electronic cigarettes. We’ve seen speculations ranging from mild regulation to a full force strike down that would completely kill the ecig industry in an instant. This week, the long awaited FDA proposal was finally released and surprisingly, it wasn’t quite as harsh as most were expecting. The FDA plans to regulate e-cigs under their authority for tobacco control, but they aren’t going to take a severe approach. In fact, it seems almost balanced. Of course, there are still a few areas that cause concern.
FDA Proposal Highlights
The full proposal is 241 pages long, so let’s look at the major highlights to get a better understanding of what the FDA plans to change and how it could impact you as a vaper. First, the FDA will do a complete review of all e-cig products that were released or updated since February 2007. All ecig manufacturers will be required to disclose the chemicals used in each product on a visible label. In addition to the ingredient listing, health warnings must include a disclaimer that the ecig contains nicotine and it can be addictive.
If any ecig companies make health claims, they must have actual evidence to prove the claims as truthful. For instance, if an ecig brand claims that vaping is healthier than smoking, they need to have actual clinical research to back it up. The FDA also proposed a ban on ecig sales to anyone under age 18 as well as a total ban on distribution of free ecig samples. In a surprising twist, the FDA has decided not to ban advertising or Internet sales. Both of these areas were major concerns for ecig companies and vapers. There will also be no ban on e-liquid flavors so you can continue vaping your fruity flavored e-liquids without worry.
Overall, the FDA proposal seems balanced, but there are a few areas that cause concern. Most worrisome is the requirement for ecig companies to submit applications and undergo review of all products released or updated since February 2007. The FDA intends to review each of these products individually to determine what devices should be allowed to remain on the market. The 2007 date will basically include all electronic cigarettes in use today. Companies have to submit their applications within two years and the FDA will then conduct reviews, but there is not time limit on how long the review process might take.
Basically, this review is going to create a lot of red tape for ecig manufacturers and it will be a frustrating process as the FDA will likely move very slowly through the reviews process. At this point, it looks the ecigs can remain on the market during the review process and waiting period for approval, but it still adds a new element of risk for ecig manufacturers. Each company will have to make some tough choices. Should they continue to invest in new technology, new marketing, and new distribution channels when there is a chance that the FDA could eventually reject the product and require that it be pulled from the market? Unfortunately, ecig companies will have to make some difficult decisions during the review waiting period.
The FDA is notorious for taking months or even years to review applications. In 2009, The FDA was given authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act. However, it was only in January 2013 that the FDA finally released their first round of processed tobacco applications. Over a four-year period, they managed to accept two new products and deny four others. They also rejected 20 exemption requests. This was barely a drop in the bucket as hundreds of other applications were still pending review.
The Good News
Even though the FDA’s proposed regulations will create some inconvenience for ecig manufacturers, there is definitely a bright spot that deserves some attention. The proposal requires that ecig companies must have scientific evidence to back any health claims they make about their electronic cigarettes. However, on the flip side, that means that ecig companies can make health claims! While the FDA could potentially insist on ridiculous standards for research, there is a window of opportunity here that many ecig companies can seize. For the first time, ecig companies will be free to openly promote their products as safer than smoking. There is already bountiful research to prove this claim and more research is currently underway.
Overall, the FDA regulation proposal is certainly not perfect, but it could have been much worse in the long run. We’ll continue to follow the situation in the coming months and provide total coverage of the FDA regulations as they progress to the approval stage.
What do you think of the FDA ecig regulation proposal? Is it better than you expected? What concerns you most?