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!