FDA Regulations May Come This Month
The day of reckoning that all vapers are anticipating may be here.
As reported by NACS Online, Washington insiders are reporting that the Food and Drug Administration could be releasing its final rule on the regulation of vape products as early as the end of this month. This is in contrast to the FDA’s spokesman, Michael Felberbaum, who said that he did not yet have a timeline for the ruling’s release.
The ruling has been in limbo since April 2014, when it was first proposed, giving many businesses in the vaping industry serious cause for concern. Because the FDA has not given the vaping industry any firm timeline, businesses are kept anxiously awaiting the news to see if they will have to submit to the particulars of the ruling, which could potentially put them out of business.
A major part of the FDA’s ruling would be the mandate that vaping products would be categorized as tobacco products. This means that any nicotine delivery device or product introduced into the market after February 15, 2007, would have to retroactively apply for approval by the FDA.
Why is this a big deal? Because as Forbes reported earlier this week, there were virtually no vaping products on the market as of the deadline of February 15, 2007, meaning most of the businesses now could not be grandfathered into the ruling. This would put all current vaping businesses in the position of having to submit to a pre-market review process, which could cost between $300,000 to $2 million after all is said and done.
The pre-market review process is a lengthy one and includes businesses paying for research and studies that the product would have a positive impact on not only the market but public health as a whole. Businesses would have to also show that the use of their products would not incite people to return to tobacco use, an effect that could only be measured by a product being on the market for years.
Because the process is lengthy and at times frustrating, not to mention expensive, the idea that this mandate could come through on the FDA ruling puts the entire vaping industry at risk. Most businesses just simply do not have the money needed to go through the process, which could see the end of an industry that is moving towards the mainstream.
So what’s with the deadline date, and why can’t the FDA change it? The date was part of the Family Smoking Prevention and Tobacco Control Act, which was made law in 2009. To change this date, allowing vaping businesses to be grandfathered into the act, would take action from Congress. To this end, the House Appropriations Committee’s agriculture subcommittee would have to consider an amendment to the law, allowing the FDA to use the date when the ruling takes effect, giving vaping businesses more space to breathe and plan for any upcoming review processes.
Even if the FDA rules on the mandate to go forward as planned, there is still a chance that vaping advocates and sitting Congressmen who could lobby for a change in the date. What remains to be seen is if the mandate, as written, will become law. Watch this space for more news as it becomes available.