The clock is ticking and tomorrow will be the final day to leave a comment for the FDA about their proposed electronic cigarette regulations. The opportunity to give your opinion is really important and we shouldn’t take it lightly as a community of vapers. If you haven’t weighed in yet, make sure you do it today! Thousands of people have already took a stand for ecigs, including some heavy weights like NATO executive Thomas Briant. He recently spoke out in support of the ecig industry, urging regulators to rethink their current proposal and make some crucial changes.
Briant pointed out that the FDA’s proposed regulations would not be easy to implement and it could spell disaster for a vast number of businesses. He is specifically worried that the FDA will require companies to submit a premarket tobacco application (PMTA) on any product that was released after February 15, 2007. Most ecig companies were started after that date so many companies will need to submit a PMTA for every single product and perhaps even individual flavors.
The application process will be gruesome and the FDA estimated that a single PMTA would require an estimated 5,000 hours of labor. Companies might be asked to provide product studies, clinical trials, or ingredient testing. With the average company offering multiple ecig models and dozens of flavors, submitting applications for the existing products would be a monumental task. “This may result in newer products being removed from the market if a manufacturer is unable to afford the time and cost of compiling PMTAs,” said Briant.
For those businesses that can afford the time and money involved in the PMTAs, the next issue will be waiting for approval. The FDA is notorious for taking years to process paperwork, as we have seen with previously filed substantial equivalent applications. At recent count, the FDA had approved 17, denied 17, and a total of 4,177 were still awaiting an answer after months of “pending” status reports.
So what is the best solution? Briant said that NATO was urging to FDA to change the guidelines to reduce the number of pre-existing products that would require approval. “In the comments being filed by NATO and other industry members, we are urging the FDA to more recent date than February 15, 2007, so that such products as e-cigarettes would not need to have a PMTA submitted,” he said.
Now it’s your turn to offer potential solutions for ecig regulation. If you haven’t left a comment to share your perspective with the FDA, this is your final opportunity. Take time today to comment in support of ecigs and then start asking your friends on social media to do the same!