The FDA tried to regulate electronic cigarettes as a medical device back in 2010, but NJOY fought them with a lawsuit and won (see Sottera Inc. v. U.S. Food and Drug Administration). This forced the FDA to change strategies and try to regulate e-cigs as tobacco instead. The FDA won the battle to regulate e-cigs as tobacco and now they’re circling back around to regulate them as a drug and medical device again.
According to TheHill.com, the White House’ Office of Management and Budget is reviewing a rule from the FDA that was originally proposed back in September of 2015 and sent to the White House on Monday of last week. This rule states that the FDA can regulate tobacco products as a drug, device, or combination product if it’s used to diagnose or treat a disease.
This rule also gives the FDA the authority to regulate a tobacco product as a drug if it has nicotine that affects the body differently than combustible cigarettes, and in the case of electronic cigarettes and smokeless tobacco, it does.
So what does this mean?
Well, according to Vapes.com, retailers would be required to undergo a clinical trial process for all products, which would be prohibitively expensive and time-consuming.
The PreMarket Tobacco Application (PMTA) process already requires submission of nonclinical and clinical studies relevant to the PMTA. If those studies don’t exist, a manufacturer will need to conduct and submit their own research.
No vape company has completed a PMTA yet and has a product approved by the FDA, which means there are no research studies available for any other manufacturer to use to submit their own PMTA.
But if the FDA is able to get vape products classified as a drug, having available studies might not even matter. If vaping products are classified as a drug, every manufacturer may need to do their own clinical trials for every single product they sell.
I’m just thinking out loud here. I don’t know how true or accurate this might be. I haven’t seen anyone else talking about the possible repercussions of this law. But if any of my thoughts are true, this rule could put an end to the vaping industry. The majority of the vape industry is operated by small business, most of which who could not afford a clinical trial for every product they sell, much less even one product.
Vapes.com also stated was that if e-cigs are classified as a drug, that would mean the average consumer would need a doctor’s prescription to get them. That’s another scary thought.
I don’t know when the Office of Management and Budget will make a decision on this ruling, but this seems pretty big. I worry what might happen to the vape industry if this is approved by the White House.