On 24 April 2014 the United States Food and Drug Administration released their regulatory proposal for electronic cigarettes. Most of the documents should be available via regulations.gov at Regulations.gov: Docket FDA-2014-N-0189. This includes the proposed regulations and the environmental assessment of the regulations. Presently, it lacks the Regulatory Impact Analysis document (RIA), available at FDA: About FDA: Reports: Economic Impact Analysis of FDA Regulations.
The very first thing to note about the proposal is the comment deadline. The regulations are given a 75-day comment period for all stakeholders (including the public) to comment on the proposal. That places the deadline at midnight on 9 July 2014. This may be extended (it seems likely; the typical comment period is 90 days), but until it is, if you plan to comment you should plan to get your comment in by the current deadline (not much sooner).
The second thing to note is the rest of the timeline here. After 75 days (or whenever the comment period ultimately ends) the FDA must read the comments, formulate, and release their final rules. That process may take between six months and two years. 30 days after they release their final rule, the regulations will go into effect.
Litigation will not be possible until the final rules come out, but there very likely be some regulation, with injunctions that delay the effect of some of the rules, possibly for the duration of the suits. And only after the smoke has cleared (ho ho) will we really know what the rules are. That’s years away.
There are two primary documents to be aware of:
- The Family Smoking Prevention and Tobacco Control Act (FSPTCA)
This is the statutory basis for the regulations. It is available: FDA: Downloads: PDF: Family Smoking Prevention and Tobacco Control Act.
- The proposed regulations (available above at docket on regulations.gov)
These are the primary sources for understanding and commenting on the regulations themselves. They are the subject matter. The current proposal is the clay to be sculpted into a final rule. The FSPTCA is the workshop where the sculpting is taking place.
There are currently two main sources of support for the documents:
- The Regulatory Impact Analysis (also linked above)
- The Environmental Assessment (in the docket at regulations.gov; there is an accompanying document for it, put out by the EPA, also available in the docket)
These supporting documents helped guide the current proposal and commenting on them may help to further shape the proposal.
There are existing regulations under the FSPTCA, available at FDA: Tobacco Products: Rules & Regulations (note that the current proposal is linked there as well, but those with a
Proposed Rule are not yet in effect). These may have some bearing in comments, but will be most useful in understanding the current regulations on tobacco products. They are also important as the proposed regulations modify some of the existing rules, so they fit together like a jigsaw puzzle.
In a similar manner, the FSPTCA has some interactions with other parts of the United States Code (USC). Most notably, some definitions refer to other parts of the Food, Drug, and Cosmetic Act (21 USC).
Okay, enough background. What’s in the regs?
Note: this is parody, please take your FDA-approved grain of salt now.
You: [To me] I saw you with the regs! What was in the regs‽
Aww, what’s in the regs‽
What’s in the fucking regs!
[To FDA] You lie! You’re a fucking liar! Shut up!
[To me] No! No!! You tell me: that’s not true. That’s not true.
No, it’s all right, you tell me.
Tell me it’s alright!
So you may have heard some bad things about the deeming regulations. Sure, you heard some okay things, like:
- Ban on sales to minors (including limiting vending machines)
- Addition of warning labels
But then you heard that every whit of vaping kit you’ve ever imagined using will now be required to be anointed in blood as part of an elaborate sacrifice ritual taking place on the third day of the harvest in the moonlight.
Maybe. But that’s what the comment period is about. If the FDA receives high quality comments that convince them to put away the dagger, they will do so. It’s really that simple. Government agencies are not Brazil-esque bureaucracies, torturous serial killers, or fanatical cultists. What they are, like any other large organization, is risk averse.
They do not want egg or mud on their face. They do not want to be responsible for pissing off major corporations, but they don’t want to piss off the public either (nor aid the death of millions who might stay on cigarettes if ham-fisted regulations stifle the vaping market). They are open to sane compromises that protect the public health (their primary goal, by statute), and that protect them from undue scrutiny and lots of litigation.
The most important things to know right now are:
- You have some time now to start understanding the regulations and making some notes for eventual comments.
- The proposal is not the final word, and we have a chance to shape the regulations, a chance we must take advantage of.
- We must be patient. Use the time we have to build your comments brick by brick. The comments made of brick will protect the little pigs from the big bad wolf. Those made of sticks and straw will be blown down.
I will be detailing the regulations in future posts. There are a lot of angles, and I’ve got a lot of notes, but until a major organization like CASAA has released a more detailed analysis, it would be premature for me to delve into too much detail.