US Senator Wants FDA To Clarify Consequences of Regulations
The new regulations for the vaping industry have been handed down by the FDA earlier this month. It has left many business and consumers wondering if they are set in stone and what it will mean for vapers.
But one thing is for certain — US legislators are not ready, or willing, to let the FDA go on with the regulations without some sort of clarification. And there is one in particular that is looking for answers.
An article from the Winston-Salem Journal that was released late last week states that Senator Ron Johnson, a Republican representing Wisconsin, sent a letter to FDA Commissioner, Dr. Robert Califf, requesting clarification on the new vaping regulations and the consequences of those regulations ahead of the August 8, 2016, implementation deadline. Among the requested information is a clarification of the regulatory burdens that these rules may have on the small business market in America.
Johnson, who is also chairman of the Committee on Homeland Security and Governmental Affairs, is thought to have questions in relation to how the new rules on vaping products will impact not just public health, but also the economy as well. These questions are meant to explore how and why the regulations could negatively impact the US economy as well as the potential to turn more people back to smoking traditional cigarettes.
In his letter, Johnson stated that “the costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for companies to continue to offer products that serve as an alternative to smoking.”
Johnson also went on to request that the FDA explain to him how “[it] determined how many e-cigarette businesses will be affected by the rule.” If the agency hadn’t made that determination, the senator then requested why it hadn’t been taken into consideration during categorization of vape products as tobacco products.
Vaping products are projected to hit over $1.5 billion in sales in 2016 alone. More importantly, there seems to be a direct correlation between the decline of traditional smokers and the rise of vapers, leading some scientists to consider the very real possibility that vaping is indeed a viable alternative to smoking.
But with the predicate date of February 15, 2007, hanging over many vape businesses — most of who would have to submit to a comprehensive review process for each product, totaling about $400,000 for each review — it is thought that entire businesses would be wiped out.
Although the regulatory review process is in place to create an understanding of the impact of the product on public health, many vape advocates argue that a predicate date that is more recent would give vape businesses a chance to breathe. It would also allow for more studies, such as the recent one from the Royal College of Physicians, to help bolster the understanding of vaping.
As it stands, there is hope for businesses, and it lies in the U.S. House of Representatives. The House is currently debating the Agriculture Appropriations Bill for the 2016-2017 year, a bill that contains an amendment that would see the predicate date moved from February 15, 2007, to August 8, 2016.
This bill and its amendment has sponsors from both sides of the aisle and is indeed co-sponsored by a Democrat — Representative Sanford Bishop Jr. of Georgia — and a Republican — Representative Tom Cole of Oklahoma. It is also widely supported by vape advocates and medical professionals alike, all of which agree that changes to the vaping regulations proposed by the FDA need to be changed.
For now, however, vaping businesses should brace for the August 8 implementation date.