Like most people in the industry, I was living in a constant state of fear of what FDA regulations might mean to the industry. Would the regulations ban e-liquid flavoring? Advertising? The ability to purchase cool vaping doodads online?
Now that the FDA has released its regulation for public comment we can breathe a little easier. Sort of.
First of all, it is important to remember these are proposed regulations, so until they are finalized, they are subject to change.
If you have a spare afternoon to read through the proposed regulation, you can find it here. Fortunately, I read it for you. None of the doomsday scenarios are in this document. Specifically, the document says the FDA doesn’t plan on doing these things yet.
Top officials of the agency also stated that anything like flavor bans and the such will require separate regulations. Incidentally, this enraged our favorite goon squad of politicians.
But, I’ll remind you that they didn’t say they’d never do them, they just didn’t plan on doing it right now. And you can bet your bottom that opponents will continue to rabble rouse to get harsh restrictions.
So what did we get?
There are a few things this regulation will do. First of all, it will bring e-cigarettes, cigars, pipes and anything that is derived from the tobacco plant under the FDA’s watch via the Family Tobacco Control and Prevention Act.
Some of the regulations that specifically apply are labeling requirements. Age restriction for sales, vending machine prohibitions and premarket authorization.
A lot of these things are not big surprises. Some of these like consistent labeling requirements will actually potentially be good for consumers. There will also be a requirement for a label that reads something about nicotine being addictive, not terribly helpful.
This is also the first time the Agency has levied age control at this level. Specifically, they cited the lack of age restrictions on a state-to-state basis. It appears that despite the best efforts of some so-called health advocacy groups, minimal age restrictions will indeed become a reality. Once again, a fairly good thing.
In its report, the FDA also noted that there would be a “significant financial impact” to small businesses. This will come in the form of premarket approvals, which I will get into shortly. What they are currently proposing is a long window between the regulation being finalized and when these rules would be enforced. The most onerous and expensive of which won’t take effect for two years.
For the short term, it appears that e-cigarette consumers dodged a fairly large bullet. We did not end up seeing EU-style arbitrary and punitive regulation with the FDA.
Down the road
Potential problems come down the road. For one, this set of regulations is very open-ended. During the comment period, vapers and the e-cigarette industry won’t be the only ones trying persuade the agency to alter some of the things we don’t like. Prohibition groups will likely be trying to somehow to prove the gateway theory. The Agency even encourages people to submit data supporting claims that e-cigarette companies market to kids, or flavors make it easier for people to transition to more dangerous tobacco products.
The real elephant in the room, however, comes in the form of premarket authorizations. Essentially, the original Tobacco Act law hardcodes the date of February 2007 for grandfathering any product. That means products can’t be put through the substantial equivalence application process which is considerably cheaper than the pre-market authorizations process.
Premarket authorization is kind of where the whole house comes crumbling down. Granted, these are early days, so perhaps things won’t be so dark as I’m imagining.
Still looking at the FDA’s own estimates in the report (page 189 or so for those of you playing along at home), they expect one pre-market authorization to take about 5000 labor hours to complete. Most of that is dedicated to the time it will take to conduct and submit scientific studies of the products.
Now, the agency said it’s likely not all submissions will require this, but since it’s a new process nobody knows for sure what that means. Think about it, the typical work year consists of 2080 hours. So, ignoring the fact you need high-dollar science types for this, how many small businesses can afford 2.5 full-time employees just to submit stuff to the FDA.
Did I mention each product needs to be submitted before it could be marketed? Each flavor and variation of e-liquid counts as a product. You can see where this is headed for your average small e-liquid manufacturer for example.
Incidentally, all parts that make up an e-cigarette will count as tobacco products. The FDA seems a little vague on how this will play out, at one point saying they aren’t going to explicitly define that. But, elsewhere they say that anything used to actually consume nicotine is part of the device, so that would include your batteries, cartomizers etc. But relax, those hand-crocheted eGo lanyards are accessories and not covered.
Also not covered is products not marketed for use with nicotine. But, there appears to be some question that companies who produce some things with nicotine would have to submit all products even the 0MG stuff.
I’ll be honest, there’s a lot of unknowns here. A lot of things that need to be translated and discussed. The FDA hasn’t even opened public comments, which is expected to go on for 75 days.
The good news is short-term, there’s not a big looming cloud over the industry. Businesses will have some time to work out how they will deal with the new landscape. Be prepared, however, to be an active participant to ensure your ability to vape will be maintained for years to come.
What’s your take on this whole thing? I’d love to hear from you.
