FDA: New Tobacco Product Applications Will Take Roughly 5,000 Man Hours to Complete
vapemash August 6, 2014
The FDA proposed a new set of rules for tobacco products some time ago which, among other things, requires companies to apply for market approval of any tobacco product that wasn’t already on the market by February of 2007 or which has been updated since. Under said rules, all versions of electronic cigarettes used today would require a premarket tobacco application (PMTA for short) which many believe is nothing more than a red tape gateway designed to demolish innovation and protect tobacco and pharmaceutical companies.
The FDA received a massive heap of comments and complaints about the new rules and ultimately saw fit to extend the public comment period by a full month (which now ends Friday of this week). Concerns that the PMTA process would be virtually impossible for small businesses to complete now seem more justified than ever.
The FDA has said that the applications will likely take around 5,000 man hours to complete and may require companies to conduct studies, clinical trials, and chemical testing on the products for which they are applying. This is going to do just what many were worried about — hand the industry over to the companies that can afford to complete the application. In this case, those companies are Big Tobacco and Big Pharma. Small operations — the ones that got the industry going in the first place — won’t have much of a chance. The tobacco industry in particular is very used to jumping through hoops for the FDA and is well equipped for this kind of trouble.
Read more about the issue here.
So confident is the FDA, that they’ve even guesstimated that they will only receive 27 applications — one cigar, one pipe, and 25 electronic cigarette applications. Even if the FDA gets a lot more applications than that, they have almost no obligation to get to and resolve them in a reasonable amount of time. What few companies can complete applications are likely to be stuck waiting for approval for eternity.
vapemash August 6, 2014
The FDA proposed a new set of rules for tobacco products some time ago which, among other things, requires companies to apply for market approval of any tobacco product that wasn’t already on the market by February of 2007 or which has been updated since. Under said rules, all versions of electronic cigarettes used today would require a premarket tobacco application (PMTA for short) which many believe is nothing more than a red tape gateway designed to demolish innovation and protect tobacco and pharmaceutical companies.The FDA received a massive heap of comments and complaints about the new rules and ultimately saw fit to extend the public comment period by a full month (which now ends Friday of this week). Concerns that the PMTA process would be virtually impossible for small businesses to complete now seem more justified than ever.
The FDA has said that the applications will likely take around 5,000 man hours to complete and may require companies to conduct studies, clinical trials, and chemical testing on the products for which they are applying. This is going to do just what many were worried about — hand the industry over to the companies that can afford to complete the application. In this case, those companies are Big Tobacco and Big Pharma. Small operations — the ones that got the industry going in the first place — won’t have much of a chance. The tobacco industry in particular is very used to jumping through hoops for the FDA and is well equipped for this kind of trouble.
Read more about the issue here.
So confident is the FDA, that they’ve even guesstimated that they will only receive 27 applications — one cigar, one pipe, and 25 electronic cigarette applications. Even if the FDA gets a lot more applications than that, they have almost no obligation to get to and resolve them in a reasonable amount of time. What few companies can complete applications are likely to be stuck waiting for approval for eternity.
