The FDA's Proposed Rules are Unworkable

[Plastic Shaman]

So, I’ve been reading over the rules proposed in the federal register:

Deeming tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and tobacco Control Act; Regulations on the Sale and Distribution of tobacco Products and Required Warning Statements for Tobacco Products

I’m currently trying to figure out how the FDA plans to argue this when it eventually gets to Court. The proposed rules derive their statutory authority from 21 USC 387, the Tobacco Control Act. This means that the FDA has chosen to take one of two routes to enforce regulation that were described in the Sottera, Inc. v. Food & Drug Admin. In other words, the FDA could have attempted to regulate under the Tobacco Control Act or under the FDCA’s drug/device provisions as a therapeutic device.

By choosing to go with the Tobacco Control Act, the FDA has limited itself to the scope described in 21 USC 387(a). Because of this, the FDA can only regulate tobacco products. The term tobacco products is defined in 21 USC 321 as:

(rr)(1) The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

(2) The term “tobacco product” does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353(g) of this title.

This all begs the question, are e-cigarettes tobacco products, or rather what parts of e-cigarettes are tobacco products? Obviously, the nicotine that is contained in e-liquid is derived from tobacco would fall under this definition. However, there is still a question that about whether the rest of the additives and the devices themselves are tobacco products. As the concurrence in Sottera, inc. points out, absent agency interpretation entitled to Chevron deference, it is impossible to know what the extent of a tobacco product is from the statute (the concurrence demonstrates a problematic line of reasoning from this statute, stating that if the plastic components of an e-cigarette are tobacco products, then so is a syringe with nicotine liquid in it).

So, the FDA needed to issue an interpretation on this. They did this in the proposed rules, which reads:

Products that meet the statutory definition of “tobacco products” can include currently marketed products such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco. Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes.

Now, this definition can be challenged as to whether the FDA has Chevron deference. I think that the first part of Chevron is obviously met. So, the question is whether the FDA’s interpretation is permissible based on statutory construction. I would argue that this interpretation would fail the arbitrary and capricious standard articulated in Chevron for two reasons.

First, the problem with this interpretation relates back to the course the FDA would have had to take had it tried to regulate under the FDCA. If the FDA had attempted to do this, the rule would be subject to the provisions of 21 USC 353(g)(1). So, under the FDCA, the agency has to make a further determination of jurisdiction if the product is a device or combination product. Also, To me, it seems that this interpretation is contrary to the statute in that the same item which is a device or combination could be subject to two different levels of scrutiny not because of their different components, but because one is claimed to be used for therapeutic purposes. Additionally, it is unclear to me how the proposed rules circumvent the exception for devices and combination products that is stated in 21 USC 321. This is all my just my interpretation and I could very well be wrong about it all.

Second, and more importantly, as Chevron, citing United States v. Shimer, states:

... If this choice represents a reasonable accommodation of conflicting policies that were committed to the agency's care by the statute, we should not disturb it unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned.

Here, I would argue that the interpretation made by the FDA violates this fundamental principle stated in Chevron. While I have not read the legislative history, I think there is solid footing to argue that Congress did not intend to allow the FDA the broad authority they are attempting to exercise here and this interpretation is contrary to public policy. The FDA’s definition currently includes filters, papers, tubes, pouches, and flavors as something that falls under the definition of a tobacco product. Did Congress really feel that items like food flavoring, such as those sold at stores, pouches and papers should be deemed tobacco products? Furthermore, it is contrary to public policy to allow the FDA to regulate such a potentially broad category of items, especially ones that are intended for a wide range of consumer use. While it is clear that the statute allows for regulation of components, parts, and accessories, it is unclear what these are. To further complicate things, the proposed rules make exceptions for certain accessories:

FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product, and we expect that they will not have a significant impact on the public health. In addition, FDA considers accessories to be those items that may be used in the storage or personal possession of a proposed deemed product. Therefore, items such as hookah tongs, bags, cases, charcoal burners and holders, as well as cigar foil cutters, humidors, carriers, and lighters would be considered accessories and would not fall within the scope of this proposed rule.

Why would papers, air filters, and pouches be considered tobacco products that might harm public health, but bags, tongs, and lighters not be?

Zero nic e-juice further bolsters my argument. Zero nic juice has all of the components of e-liquid, minus the nic. Under this definition, this juice falls under the definition of tobacco products since its components are used to make cartridges for e-cigarettes. However, zero nic juice contains no nicotine and therefore no tobacco derivatives. How could Congress have intended to define something that plainly contains no tobacco as a tobacco product? This also raises questions about when an item becomes an accessory or component. Take your mod and atty. they are components of an e-cigarette in the sense that they can be used for e-juice with nicotine, but they can also be used with zero nic juice. Are they simply components because they can be used for juice with nic in it? if that's the case, we can extrapolate this logic to all vg, pg, kanthal, cotton, and food flavorings on the market since they can potentially become components of juice with nic in it.

Anyways, it seems to me like the FDA’s proposed rules could fail if challenged on a number of grounds that were left open in Sottera, Inc. The more I read over what I've written and the definitions, as well as the proposed rules, the more I begin to think that FDA might have to really limit it's definition or the spectrum of items that might be included in its proposed rules, or else face constant challenges. This is assuming that the proposed rules aren't shot down by a court.

These are just my opinions. I’m just a student of law, not an expert of it, especially administrative law. Also, this is all off the cuff, so I might be totally wrong about this whole thing and Court's could be fine with it. I may also just be spinning my wheels and focusing on something totally irrelevant, but I don't think these rules take into account the workings and parts of e-cigarettes as a whole and will create a world of ambiguity. So, if anyone knows more than me, see obvious flaws in my logic or interpretation, I’d love to hear them, as well as any other comments!

 

[Nate5700]

Wow. I just skimmed over your post, I might read it more deeply later, but it looks like you've put a lot of thought into this. I have a very good friend who is a lawyer and I'm sure he'd just love diving into this, I may forward it to him.

Maybe if/when the FDA issues it's rules on e-cigarettes you should lawyer up and see if you can challenge it yourself, you've obviously done the research. That is if you've got the money, as a student that can be tough...

 

[Plastic Shaman]

I'll be out of law school soon, but I probably wouldn't have standing to challenge these rule. You would probably need someone with economic interests involved.

 

[FlamingoTutu]

Shaman, Very nice post! This will likely be moved to the FDA section where you’ll get better feedback. You’ve raised some questions we’ve wondered about too. The FDA did try to make it a prescription/drug thing and the court shot it down so they can’t try that again. This is their second effort. I believe it was Njoy (soley) that challenged them the first time around in court.

CASAA wrote a fantastic letter to the FDA and here’s a link to the page. The link to the document is at the bottom. CASAA: CASAA Submits Comment to FDA on Behalf of Consumers Regarding FDA Proposed Deeming Regulation

We need more people like you.

 

[Plastic Shaman]

Well, the concurrence in Sottera shows how it could go about regulating under the FDCA. What the FDA lost on was their claim that the Brown case only affected statutes past before it. The Court clarified that it could regulate if it was regulated as a therapeutic device. Regardless, the FDA chose not to go further with the whole thing and just proposed rules under the Tobacco Control Act. The issue I have with this is that it seems to me that e-cigs could be considered as one of the exceptions under the definition of tobacco under title 21. However, that's probably unimportant and wouldn't pass muster in a court. I'll have to read through all the proposed comments.

 

[FlamingoTutu]

The first case was before my time and I haven't gone in a scrutinized it. Wouldn't do me any good if I did. I'm just trying to get you up to speed, as it were, on what is happening now because it sounds like you have a deep interest and would enjoy the FDA sub-forum FDA Regulations , among others. We can always use another good brain in there.

 

[Plastic Shaman]

So, I've gone through the comments that CASAA sent into the FDA. This is just my opinion, but there is a lot in there that I don't really find too useful. This is probably an unpopular thing to say, but I've always felt that their statements read less like an advocacy group and more like an ideological group. Frankly, a lot of these comments read like a paranoid rant. I don't really see how telling the FDA that it's lying or intentionally misrepresenting data is very productive in the comments process of rule making under the APA. I doubt the FDA is going to pay much attention to most of that stuff. There's a time and a place for those things, but I doubt this is it. Just my opinion.

Additionally, CASAA doesn't seem to understand the arbitrary and capricious standard. They claim making an exception for cigars is arbitrary and capricious, as well as a number of other agency actions. However, in State Farm and many other cases, the Supreme Court has said, in the context of rule making, that an agency has acted in an arbitrary and capricious manner when:

the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.

Claiming that the FDA is acting with favoritism towards wealthy cigar smokers isn't really addressing the question of whether the expansion of the FDA's jurisdiction is proper under statute, or how that should work such expansion should work.

I think it's a good thing that they talked a lot about the economic impacts, but I have a hard time swallowing their numbers. I'm looking through the FDA's economic analysis, but I don't see where the FDA says that it's action will cause %99.9 of all e-cig businesses to close. I wish they had included some references. Likewise, the question of scientific validity isn't really at issue at this point, as the FDA said it needs to get e-cigs under its jurisdiction and then conduct some research. Still, I doubt it's bad to start addressing it.

The thing that saddened me the most is that the FDA asked for comments on the regulation of e-cig and on parts and accessories. While I saw a lot of criticisms and policy concerns, which are fine, I didn't see many proposed alternatives, other than CASAA asking that the FDA just drop the issue. The FDA even asked for comments about whether there should be more definition of what parts, components, and accessories are. It seems to me that this might have been a good opportunity to mention the differences in regulation of normal tobacco products and all the different components of e-cigs. I think it's possible that this might have clarified some things, especially as far as hardware is concerned.

As far as comments about the actually regulation, I think that they missed some opportunities to propose some alternative solutions, such as differentiating between the nicotine in e-liquid and the other parts of the liquid. Since there is a major concern about the feasibility of retailers being able to complete the application process, this idea could alleviate some of the problems. What I'm saying is that if you could convince the FDA that the tobacco portion is the only really important thing to look at, then only those who are actually manufacturing the nicotine would need to apply for this process. Once again, I think that the FDA does not understand how the market works. From my reading of the proposed rules, I don't see anything where they acknowledge the fact that most e-liquid is made by small business who are simply combing products that they are buying from manufacturers. It seems superfluous to make them all apply for approval for all these mixtures when the statutory concern is based around the tobacco product itself. As a side note, I don't know how this application process works on a basic level. Does every retailer have to submit an application for each liquid they are making? Not only would this be an insurmountable amount of work for the FDA, but it would open the door for some arguments against the proposed rules. For example, if this is the case, the FDA has failed to recognize that it would be making multiple parties apply for approval for the same exact thing. In other words, if B&M x and B&M y both order nic from the same company and their blueberry flavor as well as vg and pg from the same places, the FDA is double counting if it makes them both apply for approval. Since the FDA has not discussed any of this, as far as I can tell, I think that it has failed to consider an important aspect of problem under the arbitrary and capricious standard.

Anyways, these are just my opinions. What do I know? Any thoughts or counter arguments would be appreciated as well as any other information I might be missing. Does anyone happen to know of any other organizations that commented in opposition to the proposed rule? I would love to read some other comments.

 

[TyPie]

While I have not had sufficient time to digest all of the points (legal or otherwise) raised here, my first reaction is, that it seems to me that the FDA's approach to ecigs over the years has been extremely heavy-handed, based on misconception, and from a perspective that strongly suggests a 'guilty-until-proven innocent' / 'bad until proven good' perspective.

The fact that tobacco products (e.g., cigarettes) are still perfectly legal and sold over-the-counter presents a dichotomy of standards (so-to-speak) that makes the FDA deeming regulations and their approach to ecigs extremely difficult to justify or comprehend. (Not all that many months ago I would have argued relentlessly for my right to smoke cigarettes. Now I could not care less if they were outlawed completely. It's funny how that works.....)

It appears to me that from the very beginning, the FDA did not understand what e-cigs are, what they do, what they are made of, and why people are flocking to them. They appeared to act / attempt to act and continue to act (regulate / classify) without having sufficient and necessary facts. They seemed to have 'jumped the gun' on e-cigs, revealed certain intentions, played their hand, and I can therefore understand CASAA's stance and approach as a logical reaction to the FDA. Many are naturally curious, suspicious, un-trusting, and even fearful of a large government agency, apparently bent on protecting us......from WHAT(?), with what motives, all seemingly with the help and encouragement of BT and Big Pharma.

I'm all for safety, and the ingesting of safe products with safe accessories, but they want to analyze and define accessories (hardware) to determine if they should be regulated as tobacco products? It all seems very curious to me.

 

[Plastic Shaman]

Well, they don't want to. They are including that in the proposed rules. The big question I'm asking is what the definitions of all these terms are and how they will apply to what we are using considering the complexity of e-cigs and liquid. I doubt the FDA knows much about rebuildables or how a person can make diy juice and juice with no nicotine. I also doubt they understand the manufacturing market. Sure, they can say that the plastic cartridge that contains the liquid in a blu is subject to regulating, but does that mean a dripper made by a small manufacturer is also subject to FDA regulation?

The FDA, and Congress, need to consider these things or they will destroy the market, not through any insidious banning of flavors or taxation, but through the benign application process. If anyone has any answers to these issues, I'd love to know!

 

[Woofer]

The FDA, and Congress, need to consider these things or they will destroy the market

Many believe that is exactly what the FDA wants to do so perhaps they are right on track.