The BARS Program Blog

FDA and Vaping Lawsuit – A Review

As many of you know, FDA’s “deeming” rule as generated much discussion at retail industry events and a court case challenging its validity.  Once FDA released their official stance on regulation earlier this year, the Right to Be Tobacco-Free Coalition and Nicopure Labs (large producers of vaping products), officially filed a lawsuit challenging these regulations. Here is a brief timeline of events thus far.

• May 2016:  The FDA officially ruled that vaping products need to be regulated similar to tobacco products, meaning that each product will need to pass a rigorous application process, and will be considered “tobacco products” when sold. Like other tobacco products, the sale of vaping products would be prohibited to those under 18, and all adults under the age of 27 should be properly carded.  In addition, each vaping product sold would need to be approved, which could take up to 1700 hours and $1,000,000 (click here to read the full New York Times article).
• July 2016:  Nicopure Labs & the Right to Be Tobacco-Free Group each file a motion for summary judgment against the FDA, stating that the deeming regulations are unconstitutional.  These regulations include the predicated date of February 15, 2007, the requirement that all manufacturers of vaping products undergo the application process, that vaping products are considered “tobacco products” since they contain no tobacco, and that innovation will be stifled for the industry, and could possibly destroy vaping.  The judge in the case, Amy B. Jackson, decided to combine the motions into one.
• August 2016:  The FDA filed a brief opposing the vaping industry’s claim, and asked that their deeming regulations be upheld as constitutional.  Nicopure and the Right to Be Tobacco-Free filed another brief in response.
• October 2016:  Judge Jackson heard oral arguments from both sides earlier this month.  The decision from the judge could take up to six months. The judge could rule in favor of either the FDA or Nicopure & the Coalition. It is also possible that the judge will rule that neither party will be granted a summary judgement and a trial date will be set for later in 2017.

Essentially, the process is on hold for the moment. The BARS Program will continue to keep an eye on this entire process, and update our customers when the judgement has been made, or a trial date has been set.  The results of the case will affect how vaping products are regulated and sold. If you have more questions, please don’t ever hesitate to reach out with questions.  Email us at www.barsprogram.com/contact or call us directly at 1-877-540-5500.