The Horrifying Reality of FDA Paperwork and e-Cigarettes

The comment period is over.  Members of the industry, consumers, Big Tobacco, prohibitionists and other stakeholders have all submitted our comments to the FDA about the fate of e-cigarettes.

FDA Logo

Now we wait.  Wondering what the FDA will come back with. Will they loosen things up, or cave into the prohibitionists and busybodies who want more restrictions?  Maybe Big Tobacco’s gambit to nuke the rest of the industry will get considered?

What will things look like once the regulations come online?  Possibly the biggest point of concern is one that was included in the draft regulations already: the insane paperwork burden.

Much has already been said about this part.  We know that as it stands, none of the small businesses will be able to keep pace with the paperwork. There’s three kinds of applications that could be submitted under the deeming regulation.

buried under paperworkThe first one is a general equivalence application.  This one isn’t really going to apply since there’s probably not much on the market that has been hanging around since 2009. The FDA is also notoriously bad at keeping up with the thousands of applications it already has from cigarette companies.

Second, and the one everyone is worried about is the pre-market application.  This is where all the studies and user fees and everything else comes in.  According to the FDA itself, you can expect to spend about 5000 man hours compiling and untold thousands of dollars per product. Just to hope the FDA will let you sell the stuff.

Finally, there’s the modified risk application.  I’m not sure if this will even come into play. This is essentially the paperwork you have to file just to be able to say that your product is safer than smoking.

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While it may not be as important to the overall survival of the industry under regulations, it just so happens we have an example of that paperwork. This might be a preview of what to expect when submitting products to the FDA for any kind of approval.

Swedish Match recently submitted an application to the FDA for being classified as a modified risk product. Since it’s a government thing, you can view their submission right here.

I’ll give you a moment to recover from the shock.  In case you didn’t feel like hitting that link, it would have taken you to the FDA’s site where you can access all of the documents.  I lost count after about 125 documents.  You can download all of the documents in a convenient 1.7GB zip file.

And remember, this is just the application to say that Snus isn’t as bad for you as smoking.  It’s not trying to prove it will cure cancer or anything crazy like that. It’s just so they don’t have to put untrue disclaimers on the product packaging.

Now, it might be that the FDA comes up with a more simplified path for small companies to get approval to market their products in the market.  In particular, the SBA has taken the FDA to task for regulations that place an undue burden on small businesses. Perhaps, the paperwork won’t be as over the top as this.

Maybe I’m just being alarmist (again).  Or maybe that application is a glimpse into the future of running any sort of vaping manufacturing operation in the next couple years.  What do you think?

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Steve K

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