Vapes in Violation: The Case for an FDCA-Based Negligence Per Se Claim Against E-Cigarette Manufacturers

I.  Introduction

E‑cigarette use, particularly among adolescents, has significantly increased over the last decade.1 In 2024, 1.63 million students (5.9%) used e‑cigarettes, including 410,000 students (3.5%) still in middle school.2 This onslaught of youth nicotine consumption has been deemed a “youth vaping epidemic”3 and has resulted in thousands of cases of acute respiratory illness,4 exposure to toxic metals,5 and serious burn injuries.6 Throughout this crisis, public and private actors have struggled to work within the boundaries of the law to rein in e‑cigarette manufacturers who continue to produce and push their products despite the risks.

The United States Food and Drug Administration (FDA) has had the authority to regulate all tobacco products, including e‑cigarettes, vaporizers (“vapes”), and other electronic nicotine delivery systems (ENDS) since 2016,7 through the Family Smoking Prevention and Tobacco Control Act (TCA)8 as incorporated into the Federal Food, Drug, and Cosmetic Act (FDCA).9 The FDA has used this authority to issue marketing denial orders for over 6,500 e-liquid and e‑cigarette products.10 As of September 2025, the FDA has authorized only four brands of e‑cigarettes (Logic, NJOY, JUUL, and Vuse) and twenty total e‑cigarette products and devices.11 Despite this, hundreds of unauthorized products still appear on the market,12 and the FDA has taken limited enforcement action against their manufacturers.13

In the absence of FDA enforcement, a growing number of private parties have filed litigation against e-cigarette manufacturers, with claims including “products liability, fraudulent misrepresentation for deceptive advertising, failure-to-warn, breach of warranty, negligence, and public nuisance.”14 Such litigation primarily stems from “common allegations that manufacturers failed to provide adequate warnings of the dangers associated with their products and marketed their products to young adults and children.”15 In at least one recent decision, however, it has become clear that e‑cigarette suits may face federal preemption issues under the TCA,16 just as many other suits have faced preemption issues under other FDCA provisions.17 As private litigation against e‑cigarette manufacturers increases, these preemption concerns grow pressing.

One yet unexplored route for holding e‑cigarette manufacturers liable is through FDCA-based negligence per se claims. Typically, negligence claims inquire into whether the defendant has exercised the standard of care that a reasonably prudent person in a similar situation would exercise under comparable circumstances.18 Under the negligence per se doctrine, however, the applicable law or regulation itself is used as the standard of care, and accordingly, negligence is found when a defendant violates said law or regulation.19 While many courts have rejected the FDCA as a basis for negligence per se claims based on its lack of a private right of action,20 several courts have sustained such claims, separating the statute’s right of action from the standard of care it imposes.21 FDCA-based negligence per se litigation may therefore appeal to private e‑cigarette plaintiffs not only for its reduced burden,22 but also because such claims can avoid the FDCA’s preemption clause.23 Accordingly, this Comment argues that using the FDCA to establish a standard of care for private negligence per se claims against e‑cigarette manufacturers is both legally feasible and an effective solution to the current e‑cigarette crisis.

This Comment will first detail the statutory history of FDA regulation of tobacco and nicotine products, before delving into an examination of the negligence per se doctrine and its application to the FDCA. While examining FDCA-based negligence per se actions, it will take particular notice of the preemption risks that have curtailed FDCA-based claims in the past and the specific instances in which such claims have been allowed to proceed. This Comment will then argue that FDCA-based negligence per se actions are not inherently foreclosed and that such actions are feasible if a plaintiff divorces the standard of care found in the FDCA from the right of action under which they are bringing suit. Finally, this Comment will propose that FDCA-based negligence per se actions could be successful against e‑cigarette manufacturers, as the provisions of the FDCA that regulate tobacco products are specific and, having been enacted in response to a public health crisis, contain uniquely protective provisions that more easily support a standard of care.

II.  Background

A.  The Federal Food, Drug, and Cosmetic Act

The FDCA was enacted in 1938 and authorizes the FDA to “oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics.”24 The FDCA was passed largely in response to the Elixir of Sulfanilamide Disaster, a mass poisoning event in which over 100 patients died due to a lack of safety testing of a drug’s solvent.25 Previous federal legislation, namely the Food and Drugs Act of 1906, proved woefully inadequate to handle the rise of adulterated and misbranded food and drug products.26  The sulfanilamide disaster, in conjunction with the 1938 Wheeler-Lea Act, provided the push the House needed to pass the FDCA.27

Since its enactment, the FDCA has undergone a multitude of amendments in response to the changing needs of federal regulation in the field of public health.28 Many of these amendments have been in response to public health disasters; the 1962 Kefauver-Harris Amendment, for example, came after thousands of children were born with congenital disabilities resulting from defective morning sickness medication.29 The amendment enabling the FDA to regulate tobacco products was no exception.

In April of 1994, following years of increasingly grave surgeon general’s warnings about the risks of smoking, all seven of the CEOs of America’s largest tobacco companies testified under oath before the House Committee on Energy and Commerce’s Subcommittee on Health and the Environment that they did not believe nicotine was addictive and that their advertising did not intentionally target children.30 Mere weeks after this testimony, the subcommittee received internal documents from one of these major tobacco companies directly contradicting the given testimony.31 All seven CEOs resigned soon after.32 Two years later, in August 1996, the FDA issued a final rule aiming to reduce underage use of cigarettes and smokeless tobacco.33

The FDA’s first attempt at regulating tobacco did not last long. Tobacco manufacturers filed suit, and by March of 2000 the Supreme Court declared in FDA v. Brown & Williamson Tobacco Corp.34 that the FDA lacked the statutory authority to regulate tobacco products. This decision was premised upon the FDA’s finding that “‘tobacco products are unsafe,’ ‘dangerous,’ and ‘cause great pain and suffering from illness.’”35 The Court concluded that, due to their inherently dangerous nature, “if tobacco products were ‘devices’ under the FDCA, the FDA would be required to remove them from the market” entirely in order to protect consumers, rather than to merely regulate them.36 The Court then found that an FDA ban would contravene congressional intent; banning tobacco products would have a large adverse effect on the national economy, and Congress had adopted an express policy of “protecting ‘commerce and the national economy . . . to the maximum extent’” when regulating tobacco product labeling and advertising. 37 Throughout the opinion, the Court grappled with the FDA’s conception of safety and the FDA’s role to provide a “reasonable assurance of the safety and effectiveness” of the devices it regulates.38

In 1998, following dozens of state-brought lawsuits, the attorneys general of fifty-two states and territories, alongside the four largest tobacco companies in the U.S., signed the Master Settlement Agreement (MSA), a landmark settlement that restricts the behavior of tobacco manufacturers and obligates such manufacturers to make continuing payments to the signing states and territories.39 Among other things, the MSA strictly limits tobacco companies’ ability to market, advertise, promote, and merchandise their products.40 Despite this significant advancement in enforcement, legislation giving the FDA statutory authority to regulate tobacco was not passed until the Family Smoking Prevention and Tobacco Control Act (TCA)41 was enacted in 2009 as an amendment to the FDCA.42 The TCA added a chapter to the FDCA solely for the purpose of regulating tobacco, and imposed a series of restrictions on tobacco manufacturers. Among the enacted language of the TCA are congressional findings that specifically reference the concerns of youth nicotine addictions and sanction the provisions of the 1996 FDA Tobacco Rule as consistent with the TCA.43 For the purposes of this Comment, it is important to note that while the TCA continuously refers to tobacco products and tobacco manufacturers, the term “tobacco products” was extended to cover e‑cigarettes and e‑cigarette manufacturers in 2016.44 As such, any references to tobacco can be taken as including e‑cigarettes, despite such products not actually including tobacco.

B.  Tort, Negligence, and the Negligence Per Se Doctrine

1.  Tort law and ordinary negligence

In order to best understand both the negligence per se doctrine and the current claims being brought against tobacco manufacturers, it is first necessary to provide a brief introduction to tort law and ordinary negligence claims. A tort, while notoriously “indefinable,” has been classically described as “a wrong which consists in the infliction of temporal damage by a responsible person under circumstances of such nature that the person afflicting the damage knows, or in common experience, ought to know, that his conduct is likely to result in harm.”45 While tort law is historically a state common law matter,46 both states and Congress have enacted tort law statutes, and typical tort claims include those for negligence, products liability, battery, and defamation.47

Negligence claims are brought against persons alleged to have acted without the reasonable care required of them.48 There are four “classic elements” comprising a cause of action for negligence: duty, breach of duty, causation, and damages.49 To satisfy these elements, the plaintiff must prove the defendant owed them a duty to behave in a certain manner, but did not behave in such a manner, which actually and proximately caused the resulting injury.50 “Determination of negligence,” and breach of duty in particular, “tends to be a fact-intensive inquiry highly dependent upon the given circumstances.”51

2.  The negligence per se doctrine

The negligence per se doctrine is a tool by which litigants can establish that a defendant’s conduct was negligent merely by proving that the defendant acted in violation of an applicable statute.52 If the doctrine is applied by the court, the specific acts proscribed under the statute at issue are taken as the “minimum standard of care as a matter of law,” and by proving statutory breach, a plaintiff establishes both duty and breach of duty for their negligence claim.53 This doctrine thus proves extremely useful for a plaintiff, as it reduces the complex legal inquiry of negligence into clear-cut factual determinations.

The exact contours of what elements are needed to establish a negligence per se claim vary between jurisdictions,54 and courts decide whether negligence per se is appropriate under a particular statute.55 Typically, however, a statute may be adopted as a standard of conduct when the statute’s purpose is, exclusively or in part, “to protect a class of persons,” which includes the plaintiff, against the “kind of harm which has resulted” by the defendant’s conduct, caused by “the particular hazard” the harm stemmed from.56 In other words, negligence per se is appropriate when a defendant caused an injury “of the type the statute . . . was intended to protect against.”57 A statute’s purpose may be surmised from its “title, preamble, detailed provisions, history, or other reasons.”58  After negligence per se is found appropriate by the court, the plaintiff must still establish that the defendant violated the statute and that the statutory violation proximately caused the injury.59

In addition to analyzing a statute’s purpose, a court determining whether a statute is appropriate to form the basis of a negligence per se claim must also analyze how specific a statute’s requirements are.60 If a statute’s requirements are too broad, a court will generally find that its breach constitutes evidence of negligence, but not negligence per se.61 Exactly where the line is for specificity varies. Some courts have held that a statute should impose a requirement “which is fixed and absolute, the same under all circumstances and is imposed upon all [class members].”62 Others have stated it should contain “a positive and definite standard of care . . . whereby a jury may determine whether there has been a violation thereof by finding a single issue of fact.”63

This is not to say that a statute with discretionary aspects cannot sustain a negligence per se claim. In Ohio, for example, the state Supreme Court found a sufficiently specific standard of care in a housing statute that required landlords to comply with “the requirements of all applicable building, housing, health, and safety codes that materially affect health and safety.”64 Nevertheless, a statute must have concrete enough standards such that a court can determine when it is breached without risking misinterpretation of the statute’s provisions.65

C.  FDCA-Based Negligence Per Se

FDCA-based negligence per se claims have, to date, experienced limited success in court.66 For decades, both federal and state courts have grappled with such claims’ preemption issues at trial and on appeal, with some courts, including the Tenth Circuit, holding that provisions of the FDCA seemingly cannot sustain a negligence per se claim at all.67 While it may be tempting to conclude from this precedent that the FDCA is a poor vehicle for any negligence per se claim, this conclusion would ignore the delicate lines the Supreme Court has drawn concerning preemption by the FDCA.

As this Comment will examine, the Court only allows plaintiffs to bring claims that parallel, but do not arise from, federal requirements.68 As such, the lower courts’ decisions on FDCA-based negligence per se claims have been quite sensitive to what specific provision of the FDCA is at issue, comparing that provision’s requirements to existing common law.69 This sensitivity has created a range of drastically different holdings.70 Since, as this Comment will establish, courts have not yet examined TCA-based negligence per se claims, their viability is still an open question. Moreover, as this Comment will argue, the TCA is uniquely suited to bringing negligence per se claims that are able to exist within the boundaries the Court has drawn.

1.  The FDCA’s preemption problems

a.  Implied preemption—the FDCA’s lack of a private right of action

The first hurdle for any FDCA-based private claim is the well-established fact that the FDCA does not contain a private right of action for civil damages.71 Section 337 of the FDCA expressly restricts its enforcement to the federal government, stating that “all such proceedings for the enforcement, or to restrain violations . . . shall be by and in the name of the United States.”72 This statutory language by itself is not necessarily conclusive, as even when a statute expressly limits its enforcement authority, courts have used a four-factor test to read in an implied right of action which allows private individuals to enforce the statute’s provisions.73 In the case of the FDCA, however, courts have summarily rejected arguments for an implied private right of action, concluding that “[n]either the legislative intent nor the statutory purpose of [the FDCA] justif[ies] a reading that a private cause of action . . . exists or should exist.”74 The Supreme Court affirmed this conclusion in Buckman Co. v. Plaintiffs’ Legal Committee,75 holding that claims that exist “solely from the violation of the FDCA” were impliedly preempted.76 As such, it is settled law that only the federal government can bring suit to enforce the FDCA’s requirements.

Some courts have proceeded to extend Buckman’s holding to surmise that the FDCA cannot serve as the basis for any negligence per se action.77 This conclusion, however, does not necessarily follow. While Buckman did indeed find that private actions brought to enforce the FDCA were federally preempted, it specifically acknowledged that its holding did not extend to claims which “arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.”78 In other words, while Buckman foreclosed claims that would not exist without the FDCA, it left open the opportunity for claims brought because a manufacturer caused the type of harm that would be otherwise actionable under the common law, including torts.

Lower court decisions illustrate the distinction made in Buckman. While some courts found the lack of a private right of action under the FDCA to be a death knell for negligence per se claims,79 others separated the notion of a private right of action from the doctrine of negligence per se, acknowledging that plaintiffs can use the FDCA to establish a duty or standard of care while still originating the basis of their claim outside of the statute.80 As the Third Circuit explained, these decisions are premised on the understanding that “the doctrine of per se liability does not create an independent basis of tort liability but rather establishes, by reference to a statutory scheme, the standard of care appropriate to the underlying tort.”81 Thus, cases that separate the concept of a private right of action from the negligence per se doctrine distinguish between FDCA-based negligence per se claims that are based on the violation of an “administrative requirement” such as “regulatory approval, or a license, or a report for the administration of a more general underlying standard,” and claims that indicate a “breach of a tort duty” or other independent basis for action.82 While claims based solely on an administrative requirement cannot proceed even when the regulatory scheme “as a whole is designed to protect the public or to promote safety,” those with an independent basis in tort or otherwise can proceed.83
            Other decisions aid in demonstrating what FDCA provisions can support a negligence per se claim. In Talley v. Danek,84 the Fourth Circuit held that merely failing to obtain FDA approval was an administrative requirement that could not sustain a claim.85 They contrasted this type of claim against an allegation that a defendant failed to meet a requirement to label a surgical nail with the correct size, which the court said established a standard of care “because the mislabeling created an unreasonable risk for patients.”86 In Allen v. Delchamps,87 the Supreme Court of Alabama upheld a negligence per se claim based on an FDCA provision “indicating that sodium bisulfite is not safe when ‘used on fruits or vegetables intended to be served raw’”88 because the regulation was adopted to address “the potential hazards to sulfite-sensitive individuals” and the plaintiffs were using this standard of care to support a negligence claim they could have brought without the existence of the statute.89 Finally, in Grove Fresh Distributors v. Flavor Fresh Foods,90  the Northern District of Illinois sustained a Lanham Act claim that used the FDCA definition of orange juice from concentrate to establish a statutory standard for misbranding because “[e]ven without the FDA regulation . . . [plaintiffs] could attempt to establish a violation” of the Lanham Act but “would simply need to provide other evidence establishing the proper market definition.”91 Essentially, a plaintiff may legitimately use the FDCA as a shortcut to establish a standard of care as long as they otherwise would have “an independent basis for [their] claim.”92

b.  Explicit preemption—the FDCA’s express preemption provisions

Some may examine this line of precedent and conclude that bringing an FDCA-based negligence per se claim is too much of a gamble for a plaintiff, given the complex lines that courts have drawn around importing standards of care depending on the specific provision at issue. Such a person might then be inclined to wonder why a plaintiff doesn’t simply pursue the underlying state common law action under which their claim arises instead. The answer to this inquiry lies within another statutory provision of the FDCA. In addition to the implied preemption issues created by the FDCA’s general enforcement restrictions, subchapters of the FDCA, such as the Medical Device Amendments of 1976 (MDA),93 contain express preemption provisions. The preemption provision of the MDA, which has received the most treatment in court in comparison to other express preemption provisions in the statute, reads:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.94

For the purposes of this Comment, it is important to note that the TCA contains an almost identical provision to the MDA, stating that:

No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this subchapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products.95

In Riegel v. Medtronic,96 the Supreme Court interpreted the MDA’s express preemption provision as preempting plaintiffs from bringing state common law claims of strict liability, breach of implied warranty, and negligence against medical device manufacturers, because such claims “‘would, if successful, impose state requirements that differed from, or added to,’ the device-specific federal requirements.”97 In the e‑cigarette context, TCA provisions have similarly preempted some insufficient labeling and failure-to-warn claims.98

The interaction of this express preemption with the aforementioned implied preemption thus creates a “narrow gap” of feasible FDCA claims.99 As stated in McGee v. Johnson & Johnson,100 “a plaintiff ‘must be suing for conduct that violatesthe FDCA (or else his claim is expressly preempted by § 360k(a)),’ and ‘must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted by Buckman).’”101 Riegel, however, explicitly cautioned that its holding “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations” as “the state duties in such a case ‘parallel,’ rather than add to, federal requirements.”102 This conclusion was then reaffirmed in Buckman.103 A negligence per se claim that imports a federal standard is by nature a parallel claim, because it exactly enforces the requirements of the statute, rather than “some new or higher requirement not anticipated by federal law.”104 As such, if an FDCA-based negligence per se claim was able to provide a sufficient independent cause of action such that it survived implied preemption under Buckman, it would be able to subsist in this narrow gap of feasible claims.105

In this way, as this Comment will later examine, a carefully drawn negligence per se claim brought in the right jurisdiction can impute more straightforward liability onto e‑cigarette manufacturers for negligent actions that have otherwise been unenforceable by private parties, as long as it invokes a portion of the TCA that can cognizably be said to establish a standard of care.

2.  Current state of the law

To date, only the Northern District of California, in Colgate v. JUUL Labs,106 has directly addressed the question of private negligence per se claims brought against e‑cigarette manufacturers. In Colgate, private plaintiffs alleged (among other claims) that the e‑cigarette manufacturer JUUL was per se negligent because it failed to obtain state licenses to sell its products.107 The court dismissed such claims, holding that state licensing requirements were a mere administrative requirement rather than a defined standard of care suitable to support a negligence per se claim.108 Additionally, prior to this ruling in a separate motion to dismiss, the court addressed preemption.109 They found that several failure-to-warn labeling claims were preempted by the FDCA as amended by the TCA, but sustained claims for design defect, manufacturing defect, breach of implied warranty, and negligent misrepresentation.110

While the negligence per se claim at issue in Colgate did not premise itself on the TCA, the decision can still provide insight as to how hesitant courts still are to sustain negligence per se claims on statutes that do not lay out a clear standard of care. As of the date of this Comment’s authoring, no prior precedent exists for negligence per se claims brought by private actors against e‑cigarette companies using the TCA. As such, it is still an open question whether the TCA can serve as a standard of care for negligence per se claims, and, if so, whether such claims are preempted.

III.  Private Negligence Per Se Claims Under the TCA Are Feasible

A.  TCA-Based Negligence Per Se Claims Are Not Inherently Preempted

Having assessed the breadth and development of the law surrounding FDCA-based negligence per se claims, this Comment argues that TCA-based claims are not inherently preempted by the statute’s lack of a private right of action.111 To find all claims that use an FDCA provision as a standard of care preempted would be to disregard Buckman’s explicit distinction between claims that “exist solely from the violation of the FDCA” and claims that “ar[i]se from the manufacturer’s alleged failure to use reasonable care.”112 If all private claims that utilized a device manufacturer’s violation of the FDCA were preempted, there would be no need for the Court to specify “solely” in its distinction. Instead, Buckman merely foreclosed claims that relied exclusively on asserting a violation of one of the FDCA’s purely administrative provisions (such as licensing) without incorporating common law tort or any other separate right of action.

This understanding of Buckman makes intuitive sense and is supported by precedent. To illustrate this point, one must only look at the FDCA from a practical perspective. If a drug manufacturer fails to file a required document with the FDA but otherwise produces a properly labeled drug fit for human consumption, it is a fundamentally different act than if a manufacturer produces a drug with improper labeling that leads the public to consume and become addicted to such a drug under a mistaken assumption of safety. Despite this, both actions are violations of the FDCA.113 The difference is that in the latter instance, the alleged act would also constitute a tort and would therefore have a separate right of action.114 This distinction was acknowledged in Riegel when the Court specifically cautioned that its holding did not bar suits under state duties that “‘parallel,’ rather than add to, federal requirements.”115

Negligence per se claims that are brought under state statutes but use provisions of the TCA to establish a standard of care can fit within the “narrow gap” of permissible private claims set by Buckman and Riegel.116 Not all TCA provisions, however, establish a standard of care that can support such actions, as evidenced by courts’ rejections of claims brought simply because the defendant marketed their product for a purpose for which it did not have FDA approval.117 Therefore, to avoid preemption, TCA-based negligence per se claims must allege violations of statutory provisions that actually have “independent substantive content,” like the requirement that a medical device be safe, controlling behavior that could otherwise give rise to a common law claim.118

B.  Several TCA Provisions Contain a Standard of Care

Having established the availability of and guidelines for a successful TCA-based negligence per se action, this Comment now argues that several of the TCA’s provisions are not mere “administrative requirement[s],” but rather create a cognizable standard of care that can sustain a negligence per se action against e‑cigarette manufacturers.119 A statutory provision contains a standard of care when its purpose is “to protect a class of persons,” which includes the plaintiff, against the “kind of harm which has resulted” by the defendant’s conduct, caused by “the particular hazard” the harm stemmed from.120 In addition, these requirements must be sufficiently specific as to create a “fixed and absolute” standard easily analyzed by a jury.121 The TCA’s provisions meet both the purpose and specificity requirements, creating a standard of care from which a jury might find per se negligence.

1.  The purpose of the TCA is to protect a class of persons from a type of injury

The TCA has a clear purpose evident from both its title, the Family Smoking Prevention and Tobacco Control Act,122 and the congressional findings and purpose laid out in the Act itself.123 Relevantly, the Act finds that “[t]he use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults,” and that “[b]ecause past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion and distribution of such products are needed.”124 The Act then continues to emphasize the particular sensitivity of youth to the smoking and tobacco industry, before stating that the Act’s purposes are, among other things, to “ensure that the Food and Drug Administration has the authority to address issues of particular concern . . . especially the use of tobacco by young people,” to “provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce and promote less harmful tobacco products,” to “ensure that consumers are better informed” and to “impose appropriate regulatory controls on the tobacco industry.”125 These findings and statements of purpose incorporated in the TCA make it clear that the Act is meant to protect the public from manufacturers of tobacco and smoking products and the illnesses they cause; moreover, the statute clearly identifies adolescents as a particularly vulnerable class of persons whom the Act is meant to protect.

This impression is supported by the history of the TCA and its enactment. The TCA’s language originated in, and endorses,126 the 1996 FDA Tobacco Regulations. As established, these regulations were promulgated as a direct response to tobacco manufacturers not only concealing the harmful effects of cigarettes and marketing cigarettes in a way that would appeal to children, but then lying about their knowledge under oath.127 In other words, the TCA’s provisions arose out of tobacco manufacturers breaching their duty to consumers. Given that history, it seems altogether appropriate to assume that the TCA was designed to combat these harms by creating an affirmative standard of care for manufacturers.

Moreover, the TCA is distinctly different from the other provisions of the FDCA. Whereas the other dangerous drugs and devices that the FDCA regulates have some therapeutic benefit that outweighs their risk of harm, tobacco products are “an unsafe means to obtaining any pharmacological effect.”128 This distinct nature of tobacco products, in fact, grounded the Supreme Court’s holding in FDA v. Brown & Williamson Tobacco Corp.129 There, the Court found that the danger of tobacco was so “incompatible with the FDCA’s core objective” of safety that the FDA did not have the authority to regulate tobacco without a congressional amendment.130 A level of additional import and nuance can thus be attributed to the congressional findings and purposes incorporated in the TCA––not only are its provisions protecting the youth, but they are meaningfully different from the rest of the FDCA because they regulate a uniquely dangerous product whose harms cannot be extinguished or outweighed.

a.  The TCA does not solely consist of administrative requirements

Critics of this argument may counter that, even if the TCA’s general purpose is to protect a class of persons from a specific harm, it is still unsuitable to establish a standard of care because its specific provisions are solely “administrative requirement[s].”131 If this were true, the TCA would be unable to sustain any negligence per se claim. This argument, however, does not take into account the full breadth of the TCA.

Certainly, there are many provisions of the TCA that are mere administrative requirements tobacco manufacturers must follow. For example, § 904 requires tobacco product manufacturers to submit certain information to the Secretary,132 § 905 requires owners and operators of tobacco manufacturing establishments to register themselves,133 and § 909 requires manufacturers and importers to maintain their records.134 These sections, while still working towards an underlying safety standard protecting public health, do not relate to a “breach of a tort duty” and it is difficult to imagine that any of them could be the proximate cause of a consumer’s injury.135

Other provisions of the TCA, however, govern the actual makeup, advertising, and branding of tobacco products and contain more than just administrative requirements. Namely, § 902 deems certain tobacco products adulterated,136 § 903 deems other tobacco products misbranded,137 § 102 restricts the distribution of free samples of tobacco products,138 and § 103 amends other provisions of the FDCA to, among other things, prohibit tobacco manufacturers from selling adulterated or misbranded products in interstate commerce139 or from making express or implied representations to consumers that their product is approved by the FDA.140 Additional TCA regulations prohibit the sale of tobacco products to individuals under the age of 21141 and require specific nicotine disclaimers on tobacco product packaging and advertisements.142 These statutory provisions do more than create procedure; they directly restrain acts of tobacco manufacturers that would pose an unreasonable risk of harm to consumers.

Comparing these regulations to the FDCA regulation held by the Fourth Circuit to contain a standard of care in Orthopedic Equipment Co. v. Eutsler143 emphasizes this point. The regulation in Eutsler deemed certain drugs and medical devices misbranded if they contained labeling that was “false or misleading in any particular.”144 Section 903 of the TCA, “Misbranded Tobacco Products,” contains the exact same language regarding tobacco products.145 The Fourth Circuit in Eutsler reasoned that prohibiting false or misleading labeling imposed “an absolute duty on manufacturers” and the violation of this requirement was a breach of that duty.146 The Fourth Circuit later reasserted this conclusion in Talley, noting that the mislabeling requirement was “substantive” and “established a standard of care because the mislabeling created an unreasonable risk for patients,” like how breaking a speed limit creates an unreasonable risk for others on the road.147 The court additionally noted that a distinguishing factor of acceptable statutes was that their breach could constitute the proximate cause of the injury alleged.148

The above-cited provisions of the TCA similarly contain a standard of care sufficient to support a claim of negligence per se, evidenced by their ability to proximately lead to injury. Adulterated e‑cigarettes contaminated by poisonous or deleterious substances could proximately harm smokers, just like false or misleading labeling. When manufacturers advertise and offer free samples of their products without explicitly stating that they contain nicotine, it may induce adolescents to smoke e‑cigarettes when they otherwise would have exercised caution. Similarly, false representations of FDA approval could lead consumers to overestimate the safety of the product.

The TCA thus contains statutory provisions that embody a standard of care. The TCA was enacted to protect adolescents and the general public from smoking-related illnesses and addiction, and while some of its provisions mandate administrative procedure in view of this general aim, others concretely strive to prevent particular hazards that could cause such illnesses and addiction.

2.  The TCA’s requirements are sufficiently specific to sustain a negligence per se claim

Having established that the TCA contains a standard of care, this Comment will now establish that the provisions embodying this standard are sufficiently specific as to create a “fixed and absolute” standard, and thus can form the basis of a negligence per se claim.149 In order to do so, this Comment will compare the provisions of the TCA identified above with other FDCAregulations that courts have found to be sufficient or insufficient to support a negligence per se claim, using two cases from different circuits as primary benchmarks.

a.  Howard v. Sulzer Orthopedics

There are several cases in which courts have affirmed an FDCA provision as being able to support a negligence per se claim, without directly addressing whether the provision was specific enough for the doctrine to apply. This includes Eutsler and Sellers v. Boehringer Ingelheim Pharmaceuticals, Inc.,150 which dealt with FDCA misbranding provisions closely resembling those of the TCA,151 and Mize v. Mentor Worldwide LLC,152 and Williams v. Bayer Corp,153 which concerned MDA pre-approval reporting requirements.154 These cases support the specificity of their TCA counterparts, insofar as the courts were willing to entertain negligence per se claims based on their language, but no concrete comparisons can be drawn from their holdings. The Sixth Circuit’s negligence per se holding in Howard v. Sulzer Orthopedics,155  however, provides an example of how courts have approached specificity.

In Howard, the court examined a plaintiff’s negligence per se claim that had been dismissed at the district court level on preemption grounds.156 The plaintiff’s claim was based on the allegation that the defendant failed to comply with the FDA manufacturing requirements that were incorporated in their pre-market approval application (PMA).157 On appeal, the defendant argued that the standards incorporated in their PMA were too generic to serve as the basis for the plaintiff’s claims and were “categorically unenforceable.”158 The Sixth Circuit disagreed, finding the claims enforceable because the plaintiff identified a specific standard he believed was violated.159 The standard read:

Where a manufacturing material could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device’s quality. The removal or reduction of such manufacturing material shall be documented.160

The court first analyzed the language of the statute using traditional tools of interpretation and found the statute to be ambiguous regarding whether it required the actual removal of a manufacturing material or just a specific process to attempt removal.161 Instead of declaring the requirement too vague to enforce, however, the court proceeded to examine the FDA’s comments in its final rulemaking and FDA guidance documents to attempt to determine what interpretation the FDA would adopt, ultimately concluding the provision required actual removal.162 When the defendant objected that interpreting this ambiguity could hold them liable for conduct the FDA might permit, the court responded: “The risk of a defective device must fall somewhere. We would not think it irrational for the FDA to assign that risk to that party that actually can do something to minimize it . . . rather than assign the risk to the party that cannot.”163 In sum, the Sixth Circuit resolutely held that the statute could sustain a negligence per se claim, even despite acknowledging potential conflicts with the FDA.

The Sixth Circuit’s analysis in Howard allows this Comment to provide several insights into how courts approach specificity in FDCA-based negligence per se claims. Firstly, it confirms that a requirement does not have to be completely unambiguous in order to sustain a claim––even the Sixth Circuit acknowledged that the provision could “reasonably be read either way.”164 Neither does a provision have to lay out the exact steps a manufacturer must take––here, the standard only called for “procedures” that would achieve a certain ambiguous result, and did not specify what such procedures should entail.165 Finally, FDA guidance and supplementary materials may be consulted to add specificity to regulations lacking on their face––the Sixth Circuit relied on such materials to predict the FDA’s interpretation and minimize the risk that the defendant would be held to conflicting standards.166

b.  Kubicki v. Medtronic

To solidify the boundaries of specificity, this Comment now turns to a case in which the FDCA regulations were deemed too vague. To do so, this analysis briefly steps outside of the boundaries of negligence per se cases to Kubicki ex rel Kubicki v. Medtronic, Inc.,167 a case attempting to establish a parallel state law claim through negligent design, manufacturing, labeling, and breach of warranty.168 In an opinion authored by then-Judge Ketanji Brown Jackson, the District Court for the District of Columbia examined product labeling and use instructions,169 including those requiring manufacturers to “establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications,”170 to ensure device labeling is “prominen[t]” and “conspicuous[ ],”171 and to “have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.”172

The district court found these requirements too vague to give rise to parallel state law claims, deeming them “overarching guidelines for manufacturers to follow when developing their own procedures, rather than specifically enforceable duties.”173 Examining each regulation in turn, the court noted they provided “no guidance on what is specifically required to achieve compliance, and thus cannot serve as a genuine comparator” for state law.174 For example, the court noted that the requirement to have “sufficient personnel with [ ] necessary education” did not “specify any ratio of employees to products” or define whether necessary education meant “a GED, high school diploma, bachelor’s degree, or otherwise.”175

While this holding may seem stricter than Howard, the D.D.C. actually acknowledged and affirmed Howard, stating that “[t]he Sixth Circuit’s decision in Howard . . . is not to the contrary.”176 The court distinguished its decision from Howard by noting that the plaintiff in Howardidentified a specific requirement he believed was violated (as opposed to the Kubicki plaintiff’s laundry list of regulations), and the requirement identified in Howard was not so vague as to prevent meaningful evaluation of whether its duties paralleled state law.177 Throughout both opinions, the crux of the inquiry turned on whether the regulation was detailed enough to minimize the risk of imposing duties on the defendant that are not required by the FDA.178

c.  The TCA’s provisions resemble those in Howard

Taking these examples as bookends, this Comment now turns to the TCA and argues that its provisions more resemble the regulations at issue in Howard than in Kubicki. The first provision of the TCA that bears examination is § 902, “Adulterated Tobacco Products.”179 Section 902 provides several ways in which a tobacco product may be deemed adulterated:

A tobacco product shall be deemed to be adulterated if—(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health; (2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; . . . .180

Like in Howard, there are still several ambiguities in the statute:181 namely, what substances qualify as “filthy, putrid, or decomposed,” “poisonous,” or “deleterious,” and what conditions qualify as “insanitary.” However, these definitional ambiguities are both minor enough that the regulation still provides guidance to a trier of fact and are necessary for the functioning of the regulation: it would be untenable to expect the FDA to specify every unsanitary condition or potential contaminant. If the regulation had simply decried adulterated tobacco products without further qualifications, it would resemble Kubicki, but, as written, it is clear about the standards manufacturers must meet.

The TCA’s misbranding provision has a similar structure, first providing a general term and then detailing actions that would constitute a violation:

A tobacco product shall be deemed to be misbranded—(1) if its labeling is false or misleading in any particular; (2) if in package form unless it bears a label containing—(A) the name and place of business of the tobacco product manufacturer, packer, or distributor; (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count [ ] . . . .182

Although omitted here for brevity, the provision additionally lists specific statements that must be included in labeling and advertising material, including the product’s name, uses, relevant warnings, precautions, side effects, and contraindications.183 The same analysis applies, strengthened in this instance by the increased specificity of the requirements at issue here and the endorsement of similar provisions in precedent.

The TCA’s other substantive requirements are no less specific. Section 1143.3 requires nicotine disclaimers on packaging and visual advertising and specifies not only the language of the disclaimers but the percent of the area of the package/advertisement they must occupy, the typography, and the color of the border.184 Section 102 forbids the distribution of free samples of tobacco products except in a “qualified adult-only facility” that meets a long list of qualifications and where a guard or officer “licensed by a governmental entity” checks identification.185 Finally, § 1140.14(b)(1) prohibits retailers from “sell[ing] covered tobacco products to any person younger than 21 years of age,”186 § 1140.14(b)(3) forbids selling covered tobacco products in a vending machine except in facilities where a retailer “ensures that no person younger than 21 years of age is present,”187 and § 103(b)(tt) prohibits making an “express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing . . . that the product is approved by the [FDA.]”188

Each of these requirements sets forth a clear standard for manufacturers and retailers of tobacco products, detailing conduct that would constitute a violation. Unlike Kubicki, these requirements are not “overarching guidelines” where manufacturers can develop their own regulations.189 Instead, these requirements plainly dictate what is needed to obtain compliance and therefore can be applied by courts in negligence per se actions with minimal risk of subjecting manufacturers to additional standards.

3.  There is an independent basis for bringing claims against e‑cigarette manufacturers under the TCA

Finally, having shown that there are provisions of the TCA that can sustain negligence per se claims, this Comment establishes that these claims are not solely based on the FDCA, and the behavior of e‑cigarette manufacturers could give rise to suit even if the FDCA did not exist, thus avoiding preemption under the reasoning set out in Buckman.190 In order to support this argument, this Comment examines several recent suits brought against e‑cigarette manufacturers that allege common law torts for behavior that would violate the TCA.

The first case that falls into this category is In re JUUL Labs, Inc., Marketing Sales Practices and Products Liability Litigation,191 a consolidated class action suit.192 In JUUL Labs, plaintiffs alleged (among other things) common law fraud on the basis of their reliance on JUUL’s “misrepresentations and/or omissions” including JUUL social media advertisements which “[in]adequately disclosed the nature or addiction risks of JUUL’s products, the actual amount of nicotine in or delivered by JUUL’s products . . . [and] that use of JUUL products poses significant health risks” or any similar warnings about the dangers of the product.193 The court denied JUUL’s motion to dismiss these fraud claims.194 The court also denied a motion to dismiss breach of implied warranty of merchantability claims against JUUL, stating that the plaintiffs’ claims that JUUL’s “products do not conform to statements made on their labels” and “are not merchantable for the purpose for which they are sold and are not fit for ordinary use” were adequately pleaded.195

Another recent e‑cigarette tort case is Lara v. Cool Clouds Distribution, Inc.196 In Lara, the plaintiff brought suit against Puff Bar, a e‑cigarette manufacturer, under the New Jersey Product Liability Act for defective design, for “deliver[ing] more nicotine than traditional cigarettes and other e‑cigarettes while stating that their individual nicotine levels are equivalent to one package of combustible cigarettes” and for otherwise not properly warning consumers about the addictiveness of their product.197 The court held that these allegations were sufficiently pleaded to survive Puff Bar’s motion to dismiss.198

The final e‑cigarette tort case this Comment will examine is Colgate v. JUUL Labs, Inc..199 In this consolidated class action, plaintiffs alleged “false advertising, fraud, unjust enrichment, several forms of product liability, several types of negligence, violation of Magnuson-Moss Warranty Act, breach of express and implied warranty, and violation of the unfair and unlawful prongs of various state consumer protection statutes.”200 The court held that the plaintiffs “sufficiently stated an omission claim and an affirmative misrepresentation with regards to JUUL’s claim that one pod has as much nicotine as a pack of cigarettes” and denied the motion to dismiss their false advertising, deceptive trade practices, fraud and negligent misrepresentation claims.201 The court noted that JUUL had a duty to warn consumers both that its nicotine formulation was stronger than what was stated on the label and that the liquid nicotine used in JUULs was more potent than the nicotine contained in cigarettes.202

All three of these cases deal with actions of a tobacco manufacturer that violated TCA regulations—namely, promulgating false or misleading labeling and advertising.203 And yet, all three cases were also found to allege sufficient common law claims to survive the pleading stage.204 Although not every provision of the TCA has been challenged and examined in court, it is easy to imagine how such cases would arise and what they might allege using other FDCA precedent. For example, plaintiffs could allege manufacturing defect claims for an e‑cigarette made unreasonably dangerous through the inclusion of a toxic chemical like diacetyl,205 conduct that could also violate the TCA’s prohibition on adulterated products,206 or negligence claims for being given free e‑cigarettes at a facility that was not age-restricted or out of a vending machine without age verification.207

The reason that these violations could give rise to suit even without the enactment of the FDCA is in large part the same reason that their prohibition in the FDCA could sustain a standard of care—they are actions that can proximately harm consumers. This argument would be unsustainable for the provisions of the TCA that created administrative requirements, because the requirement to register one’s company with the FDA was not a pre-existing duty that manufacturers had to consumers in order to avoid harm.

Not only does the TCA’s history and language emphasize its standard of care, and an analysis of its provisions evidence that they are sufficiently specific and substantive as to allow for a negligence per se claim, but there is additionally an existing market for negligence per se claims brought using these provisions, which is evidenced by similar actions already brought against e‑cigarette manufacturers. As such, TCA-based negligence per se claims, although untested, are uniquely positioned for success.

C.  Bringing Negligence Per Se Claims Under the TCA Accords with Legislative Intent

While this Comment’s proposed resolution offers an opportunity for litigants to bring suit against e‑cigarette companies under the TCA, this approach is likely to face criticism. Firstly, critics may assert that using negligence per se claims to enforce the provisions of the TCA is contrary to legislative intent. Since the TCA provides that the FDA and the federal government should be its only enforcers, one might argue that private negligence per se claims under the statute are subsequently merely “an attempt, by ingenious pleading, to escape one principle of law by making it appear that another not truly appropriate rule is applicable.”208

This pithy turn of phrase from Mylan Laboratories, Inc. v. Matkari,209 has been cited to oppose pleadings which courts have deemed to be private enforcements of the FDCA.210 The court’s reasoning in Mylan, and any such similar reasoning in other precedent, however, is not applicable to the above-identified provisions of the TCA. Mylan dealt with a Lanham Act claim for false advertising that alleged that the defendants had falsely represented obtaining FDA approval by placing their drug on the market with standard packaging inserts.211 Placing such packaging inserts in their product was not an act that would violate the Lanham Act if the FDCA did not exist—–the packaging inserts only implied FDA approval because they were often used for FDA-approved drugs.212 Thus, the court in Mylan was not condemning all claims that referenced the standards set in the FDCA, but condemning claims that used such standards to create causes of action while using what other courts have referred to as administrative requirements.213

Using the TCA’s language as a standard of care for a negligence per se claim does not create a cause of action that conflicts with the FDA’s enforcement role; it merely uses the FDCA to establish a legible standard for an otherwise cognizable claim. Any defendant that brings such a suit could alternatively sue for negligence without referencing the TCA, establishing a separate standard of care and risking preemption by subjecting manufacturers to differing standards from the TCA. Courts have indeed emphasized the independent nature of these claims’ cause of action when they found state-law duties parallel to FDCA requirements.214 Moreover, the FDA still retains primary responsibility for regulating tobacco products when plaintiffs use FDCA-based claims, since private negligence claims are distinct from the FDA’s regulatory enforcement.

The decisions of the Supreme Court support this permissive interpretation of congressional intent. Buckman specifically distinguished its holding from claims brought under “traditional state tort law” because its primary concern regarded claims that would “dramatically increase” the burdens of complying with the FDCA, against Congress’s intention.215 If the Court had felt that actions that arose separately and used the same standard of care as FDA regulations violated Congressional intent, Buckman would not have specifically distinguished “parallel” claims.216 Neither Congress nor the Supreme Court intended to foreclose private, injured plaintiffs from bringing suit against manufacturers for the proximate cause of their injuries, which is exactly what TCA-based negligence per se claims do.

D.  Bringing Negligence per se Claims Under the TCA Has Real Benefits for Plaintiffs

Another anticipated counterargument to this Comment focuses not on the sustainability of its premises, but on the necessity of pleading such relatively complex claims when plaintiffs are already alleging sustained causes of action under common law. Readers of this Comment, even if they believe that TCA-based negligence per se claims are feasible, may be unconvinced that such negligence per se claims are necessary if there are already cases being brought against e‑cigarette manufacturers by private actors, state actors, and the FDA itself.

This counterargument, however, is not persuasive. Firstly, while there has so far been success in some private suits alleging common law claims against e‑cigarette manufacturers, the Northern District of California’s preemption decisions in Colgate should serve as a warning to future plaintiffs that claims against e‑cigarette manufacturers are likely to face imminent preemption challenges.217 As such, regardless of current success it is important to preventatively identify and secure avenues for private e‑cigarette litigation that are less threatened by federal preemption.

Secondly, state and federal actors have not taken sufficient enforcement action to curb the behavior of e‑cigarette manufacturers, given the disastrous harm e‑cigarettes have inflicted on vulnerable populations. State litigation has resulted in valuable multi-state settlements,218 but such settlements are only feasible against the largest manufacturers, given their resource intensity, and are not personalized to address the harms of individual plaintiffs. Likewise, while new developments may arise after the recent Supreme Court decision regarding the FDA’s denial of e‑cigarette premarket authorizations,219 the FDA and Department of Justice have overall been so lacking in enforcement action against e‑cigarette companies that they have been called in front of the Senate Judiciary Committee.220 Meanwhile, youth continue not only to consume e‑cigarettes, but to suffer horrific injuries as a result of their consumption.221 Bringing TCA-based negligence per se claims is a legitimate, feasible solution to these problems, and as such serves a valuable purpose for potential plaintiffs.

IV.  Conclusion

FDCA-based negligence per se claims have experienced relatively little success in court as opposed to other products liability and common law manufacturing defect claims and are yet unexplored in the context of e‑cigarettes. However, such claims have the potential to be uniquely powerful against e‑cigarette product manufacturers due to the specificity of and standards of care contained within the Tobacco Control Act. Thus, pleading these claims could chart a way forward through preemption issues for private plaintiffs who may otherwise soon find it difficult to sufficiently allege a claim that does not step on the toes of the FDA. Given the abundance of unapproved e‑cigarette products on the market, and the documented harm they have caused to adolescents, the very body of persons the regulations governing them strove to protect, such claims may become increasingly relevant in the years to come as a method to curb the public health disaster that is adolescent vaping. 

• 1See generallyKristen Jones & Gary Salzman, The Vaping Epidemic in Adolescents, 117 Mo. Med. 56 (2020).
• 2E-Cigarette Use Among Youth, CDC, https://www.cdc.gov/tobacco/e-cigarettes/youth.html [perma.cc/6LQQ-YFKJ].
• 3End the Youth Vaping Epidemic, Am. Lung Ass’n., https://www.lung.org/quit-smoking/end-youth-vaping [perma.cc/TV9X-58GN].
• 4Sarah Schaffer et al., Adolescent E-Cigarette or Vaping Use-Associated Lung Injury in the Delaware Valley: A Review of Hospital-Based Presentation, Management, and Outcomes, 14 Cureus, no. 2, Feb. 7, 2022, at 1.
• 5Bo Ram Yang & Seung-Mi Lee, Electronic Cigarette Use and Heavy Metal Exposure, 103 Annals Epidemiology 1, 1–8 (2025).
• 6Vaibhav Sahni, E-Cigarette Explosion Injuries in the Oral and Maxillofacial Region and a Protocol for Their Management, 24 Evidence-Based Dentistry 176, 176–78 (2023).
• 7FDA’s Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products, FDA (Sept. 1, 2021), https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deem‌i‌n‌g‌-re‌g‌u‌l‌a‌t‌ions-e-cigarettes-cigars-and-all-other-tobacco-products [perma.cc/5BFU-5EYY].
• 821 U.S.C. § 387.
• 921 U.S.C. §§ 321–399.
• 10FDA Issues Marketing Denial Orders for Approximately 6,500 Flavored E-Cigarette Products, FDA (May 12, 2023), https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-denial-orders-approximately-6500-flavored-e-cigarette-products [perma.cc/Z247-3V24].
• 11E-Cigarettes, “Vapes” and Other Electronic Nicotine Delivery Systems (ENDS) Authorized by the FDA, FDA, https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends-authorized-fda ‌[‌p‌e‌r‌ma‌.‌‌c‌c‌/G‌‌B‌‌‌5‌Z‌-‌3‌FAZ] (last updated Sept. 17, 2025).
• 12See Matthew Perrone, FDA Warns Stores to Stop Selling Elf Bar, the Top Disposable E-Cigarette in the US, APNews (June 22, 2023), https://apnews.com/article/ecigarettes-elf-bar-vapes-4353becf747846b528ec2aea609ed2f9 [perma.cc/R7JY-W4L3].
• 13See Following the Two-Year Anniversary of FDA Failing to Regulate Unlawfully Marketed Vaping Products, Durbin Again Urges FDA, DOJ to Act, U.S. Senate Comm. on Judiciary (Sept. 11, 2023), https://www.judiciary.senate.gov/press/releases/following-the-two-year-anniversary-of-‌fd‌a‌-‌f‌ailing-to-regulate-unlawfully-marketed-vaping-products-durbin-again-urges-fda-doj-to-act [perma.cc/D43R-ST49].
• 14Lawrence G. Cetrulo, Toxic Torts Litigation Guide § 49:71 (2025).
• 15Id.
• 16SeeColgate v. JUUL Labs, Inc., 345 F. Supp. 3d 1178, 1187 (N.D. Cal. 2018).
• 17See, e.g., Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
• 18Gallick v. Balt. & Ohio R.R. Co., 372 U.S. 108, 118 n.6 (1963).
• 19Barry A. Lindahl, Modern Tort Law: Liability and Litigation § 3:79 (2d ed. 2024).
• 20See, e.g., Vanderwerf v. SmithKlineBeecham Corp., 414 F. Supp. 2d 1023, 1028 (D. Kan. 2006) (“Accordingly, a violation of the FDCA cannot give rise to a negligence per se claim.”); Rimbert v. Eli Lilly & Co., 577 F. Supp. 2d 1174, 1239–40 (D. N.M. 2008).
• 21See, e.g., Orthopedic Equipment Co. v. Eutsler, 276 F.2d 455, 461 (4th Cir. 1960) (“[W]e think that a violation of the Federal Food, Drug, and Cosmetic Act is negligence per se in Virginia . . . .”); Allen v. Delchamps, 624 So. 2d 1065, 1068 (Ala. 1993).
• 22Chambers v. St. Mary’s Sch., 697 N.E.2d 198, 201 (Ohio 1998) (“Thus, the application of negligence per se effectively reduces the elements that a plaintiff must prove in a negligence action.”).
• 23See, e.g., Hughes v. Bos. Sci. Corp., 631 F.3d 762, 772 (5th Cir. 2011) (“[I]nvoking the negligence per se doctrine to support a negligence claim that is otherwise parallel to federal requirements is not expressly preempted.”).
• 24Clinton Lam & Preeti Patel, Food, Drug and Cosmetic Act, Nat’l Libr. Med., ‌h‌t‌t‌p‌s‌:‌/‌/‌w‌w‌w‌.‌n‌cb‌i‌.‌n‌l‌m‌.nih.gov/books/NBK585046/ [perma.cc/LQ93-JJWA] (last‌ ‌u‌pdated July ‌3‌1‌,‌ ‌2‌0‌2‌3).
• 25Staff of House Comm. on Interstate and Foreign Com., 93d Cong., A Brief Legislative History of the Food, Drug, and Cosmetic Act 14, at 3 (Comm. Print 1974).
• 26Id.
• 27Id.
• 28Lam & Patel, supra note 24.
• 29Id.
• 30Portraits in Oversight: Henry Waxman and Big Tobacco, Levin Ctr., https://levin-center.org/what-is-oversight/portraits/henry-waxman-and-big-tobacco/ [perma.cc/7K6V-A‌8‌N‌H‌]‌.‌
• 31Id.
• 32Myron Levin, All 7 Tobacco Executives in Perjury Probe Have Quit the Industry, L.A. Times (June 1, 1996), https://www.latimes.com/archives/la-xpm-1996-06-01-fi-10679-story.html ‌[‌p‌‌e‌r‌m‌a.‌c‌c‌/‌9‌KKA-7X8R].
• 33C. Stephen Redhead & Vanessa Burrows, Cong. Rsch. Serv., FDA Regulation of Tobacco Products: A Policy and Legal Analysis CRS-3 (2007) (citing Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44396 (Aug 28, 1996); 21 C.F.R. §§ 801, 803, 804, 807, 820, 897).
• 34529 U.S. 120 (2000), superseded by statute, Family Smoking Prevention and Tobacco Control Act of 2009, Pub. L. No. 111–31, 123 Stat. 1776 (2009), as recognized in FDA v. Wages & White Lion Invs., L.L.C., 145 S. Ct. 898, 907–08 (2025).
• 35Id. at 134.
• 36Id. at 135.
• 37Id. at 139.
• 38Id. at 140 (citing 21 U.S.C. §§ 360c(a)(1)(A)(i), (B), (C) (Supp. III 1994)).
• 39The Master Settlement Agreement, NAAG, https://www.naag.org/our-work/naag-center-for-tobacco-and-public-health/the-master-settlement-agreement/ [perma.cc/3DCS-E46M].
• 40Id.
• 41Pub. L. No. 111–31, 123 Stat. 1776 (2009).
• 42Cong. Rsch. Serv., RL40475, FDA Tobacco Regulation: The Family Smoking Prevention and Tobacco Control Act of 2009 1 (2009). For another helpful depiction of the backdrop against which the TCA was enacted, see FDA v. Wages & White Lion Invs., L.L.C., 145 S. Ct. 898, 906–08 (2025).
• 43Pub. L. No. 111–31, div. A, § 2, 123 Stat. 1776 (2009).
• 44FDA’s Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products, supra note 7.
• 45Lindahl, supra note 19, § 2:1 (quoting 1 Thomas Atkins Street, Foundations of Legal Liability xxvii (1906)).
• 46Andreas Kuersten, Cong. Rsch. Serv., IF11291, Introduction to Tort Law (2023).
• 47Id.
• 48Lindahl, supra note 19, § 3:2.
• 49Id.
• 50Id.
• 51Souran v. Travelers Ins. Co., 982 F.2d 1497, 1506 (11th Cir. 1993).
• 52Lindahl, supra note 19, § 3:79.
• 53Id.
• 54See, e.g., Stepanek v. Kober Constr., 625 P.2d 51, 56 (Mont. 1981) (“Jurisdictions are divided on the application of a negligence per se rule for the violation of a regulation.”).
• 55See, e.g., Hunter v. District of Columbia, 64 F. Supp. 3d 158, 189 (D.D.C. 2014).
• 56Restatement (Second) of Torts § 286 (Am. L. Inst. 1965).
• 57Noyola v. Bd. of Educ., 688 N.E.2d 81, 85 (Ill. 1997).
• 58Restatement (Second) of Torts § 286 cmt. f (Am. L. Inst. 1965).
• 59Allen v. Delchamps, Inc., 624 So. 2d 1065, 1067 (Ala. 1993).
• 60See Sikora v. Wenzel, 727 N.E.2d 1277, 1280 (Ohio 2000).
• 61See id.
• 62Ornella v. Robertson, 237 N.E.2d 140, 143–44 (Ohio 1968).
• 63Chambers v. St. Mary’s Sch., 697 N.E.2d 198, 201 (Ohio 1998) (quoting Eisenhuth v. Moneyhon, 119 N.E.2d 440, 444 (Ohio 1954)).
• 64Sikora, 727 N.E.2d at 1281.
• 65Anthony Vale & James M. Beck, Drug and Medical Device Product Liability Deskbook § 4.02 (L. J. Press 2025) (“FDCA-based negligence per se claims based upon imprecise FDA requirements tailored for discretionary Agency administration can fail for lack of specificity.”).
• 66Id. (collecting cases and stating that there exists “a significant division of judicial opinion as to whether, and under what circumstances, FDCA-based negligence per se claims can be entertained in state law product liability litigation”).
• 67See, e.g., Brooks v. Mentor Worldwide LLC, 985 F.3d 1272, 1280 (10th Cir. 2021), cert. denied, 142 S. Ct. 477 (2021); Vanderwerf v. SmithKlineBeecham Corp., 414 F. Supp. 2d 1023, 1028 (D. Kan. 2006).
• 68Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)); id. at 513 (O’Connor, J., concurring in part and dissenting in part).
• 69See, e.g., Talley v. Danek Med., Inc., 179 F.3d 154, 158–59 (4th Cir. 1999).
• 70Compare Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128, 1152 (D. Minn. 2011) (concluding that all FDCA-based negligence per se claims were preempted by federal requirements), with Hughes v. Bos. Sci. Corp., 631 F.3d 762, 772 (5th Cir. 2011) (finding a negligence per se claim to be parallel to federal requirements and thus not preempted).
• 71See Medtronic, Inc. v. Lohr, 518 U.S. 470, 487 (1996) (“[T]here is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action.”).
• 7221 U.S.C. § 337(a).
• 73Cort v. Ash, 422 U.S. 66, 78 (1975).
• 74Pac. Trading Co. v. Wilson & Co., 547 F.2d 367, 371 (7th Cir. 1976).
• 75531 U.S. 341 (2001).
• 76Id. at 352.
• 77See, e.g., Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128, 1151 (D. Minn. 2011) (“Under Buckman Co. v. Plaintiffs’ Legal Committee, a private litigant may not sue a medical-device manufacturer for violating the FDCA.”).
• 78Buckman, 531 U.S. at 352.
• 79See, e.g., Brooks v. Mentor Worldwide LLC, 985 F.3d 1272, 1280 (10th Cir. 2021), cert. denied, 142 S. Ct. 477 (2021).
• 80See, e.g., Allen v. Delchamps, 624 So. 2d 1065, 1068 (Ala. 1993); Grove Fresh Distribs., Inc. v. Flavor Fresh Foods, Inc., 720 F. Supp. 714, 716 (N.D. Ill. 1989).
• 81In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781, 790 (3d Cir. 1999).
• 82Talley v. Danek Med., Inc., 179 F.3d 154, 159 (4th Cir. 1999).
• 83See id.
• 84179 F.3d 154 (4th Cir. 1999).
• 85Id. at 161.
• 86Id.
• 87624 So. 2d 1065 (Ala. 1993).
• 88Id. at 1067 (quoting 21 C.F.R. § 182.3739 (1997)).
• 89Id. (quoting Sulfiting Agents, 51 Fed. Reg. 25021, 25022 (July 9, 1986)).
• 90720 F. Supp. 714 (N.D. Ill. 1989).
• 91Id. at 716.
• 92Id.
• 9321 U.S.C. §§ 360c–360f (1976).
• 9421 U.S.C. § 360k.
• 9521 U.S.C. § 387p(a)(2)(A). Notably, this preemption provision does not affect product liability claims, which are exempted in 21 U.S.C. § 387p(b).
• 96552 U.S. 312 (2008).
• 97Id. at 321 (citing Riegel v. Medtronic, Inc., 451 F.3d 104, 120 (2d Cir. 2006)).
• 98See Colgate v. JUUL Labs, Inc., 345 F. Supp. 3d 1178, 1190 (N.D. Cal. 2018); cf. Lara v. Cool Clouds Distrib., Inc., No. 20-8030, 2021 WL 613842, at *9–10 (D.N.J. 2021) (declining to preempt a failure-to-warn claim).
• 99McGee v. Johnson & Johnson, 684 F. Supp. 3d 371, 378 (W.D. Pa. 2023).
• 100684 F. Supp. 3d 371 (W.D. Pa. 2023).
• 101Id. at 378 (quoting McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 815 (E.D. Pa. 2016)).
• 102Riegel, 552 U.S. at 330 (quoting Medtronic v. Lohr, 518 U.S. 470, 495, 513).
• 103See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001) (“Thus, although Medtronic can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.”) (emphasis added).
• 104Howard v. Zimmer, Inc., 299 P.3d 463, 470 (Okla. 2013).
• 105See Hughes v. Bos. Sci. Corp., 631 F.3d 762, 772 (5th Cir. 2011) (“[I]nvoking the negligence per se doctrine to support a negligence claim that is otherwise parallel to federal requirements is not expressly preempted.”); Coleman v. Medtronic, Inc., 167 Cal. Rptr. 3d 300, 315 (Cal. Ct. App. 2014) (“Medtronic does not present a persuasive argument as to why a negligence claim resting on a theory of negligence per se would be subject to preemption. Because Coleman’s negligence claim based on Medtronic’s failure to file adverse event reports is cognizable under California law and is parallel to federal requirements, he may proceed on this theory.”).
• 106402 F. Supp. 3d 728 (N.D. Cal. 2019).
• 107Id. at 755.
• 108Id.
• 109Colgate v. JUUL Labs, Inc., 345 F. Supp. 3d 1178, 1187, 1196 (N.D. Cal. 2018).
• 110Id. at 1193–94, 1196.
• 111Cf. Talley v. Danek Medical, Inc., 7 F. Supp. 2d 725, 731 n.4 (E.D. Va. 1998) (“To allow a state negligence per se action based upon alleged violations of the FDCA would defeat the purpose of that prohibition.”); Rimbert v. Eli Lilly and Co., 577 F. Supp. 2d 1174, 1239 (D. N.M. 2008) (“[T]he Tenth Circuit’s quotation from Braintree . . . seems, fairly read, to prohibit negligence per se claims based on the FDCA and its regulations.”).
• 112Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001).
• 113Compare 21 U.S.C. § 387d, with 21 U.S.C. § 387c.
• 114See Bayer Corporation v. Leach, 153 N.E.3d 1168, 1183 (Ind. Ct. App. 2020) (“The defendants argue that [the] claim that the medical device was ‘adulterated’ must be impliedly preempted because there is simply no state tort duty to manufacture a product that is not adulterated. We disagree.”).
• 115Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (citing Medtronic v. Lohr, 518 U.S. 470, 495 (1996)).
• 116McGee v. Johnson & Johnson, 684 F. Supp. 3d 371, 378 (W.D. Pa. 2023).
• 117Talley v. Danek Med., Inc., 179 F.3d 154, 160 (4th Cir. 1999).
• 118See id. at 161.
• 119Id. at 159.
• 120Restatement (Second) of Torts § 286 (Am. L. Inst. 1965).
• 121Ornella v. Robertson, 237 N.E.2d 140, 143–44 (Ohio 1968).
• 122Pub. L. No. 111–31, 123 Stat. 1776.
• 123Id. at §§ 2, 3.
• 124Id. at §§ 2(1), 2(6).
• 125Id. at §§ 3(2)–(8).
• 12621 U.S.C. § 387a-1(a)(2).
• 127Cong. Rsch. Serv., RL40475, FDA Tobacco Regulation: The Family Smoking Prevention and Tobacco Control Act of 2009 (2009); Portraits in Oversight: Henry Waxman and Big Tobacco, supra note 30.
• 128FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 142 (2000); id. at 178 (Breyer, J., joined by Stevens, Souter, & Ginsburg, J.J., dissenting) (comparing chemotherapy drugs’ therapeutic benefits of treating cancer with tobacco products).
• 129529 U.S. 120 (2000).
• 130Id. at 142, 161.
• 131Talley v. Danek Med., Inc., 179 F.3d 154, 159 (4th Cir. 1999).
• 13221 U.S.C. § 387d.
• 13321 U.S.C. § 387e.
• 13421 U.S.C. § 387i.
• 135Talley, 179 F.3d at 159. Note that even FDCA reporting requirements have been held to contain a standard of care when a sufficient causal link between the violation of such requirements and the injury at hand can be established. See, e.g., Mize v. Mentor Worldwide LLC, 265 Cal. Rptr. 3d 468, 480–81 (Cal. Ct. App. 2020) (finding the possibility of a sufficient causal link between failure to report to the FDCA and injury because the patient’s doctors allegedly had direct access to any information reported to the FDA).
• 13621 U.S.C. § 387b.
• 13721 U.S.C. § 387c.
• 13821 U.S.C. § 387a–1(2).
• 13921 U.S.C. § 331a.
• 14021 U.S.C. § 331tt.
• 14121 U.S.C. § 387f(d)(5). This federal minimum age was raised to 21 from 18 in 2019, following the passage of the “Tobacco 21” Act amending the FDCA. Pub. L. No. 116–94, § 603, 133 Stat. 2534, 3123 (2019).
• 14220 C.F.R. § 1143.
• 143276 F.2d 455 (4th Cir. 1960).
• 144Id. at 459 (citing 21 U.S.C.A. § 352).
• 14521 U.S.C. § 387c(a)(1).
• 146Eutsler, 276 F.2d at 460 (regarding the labeling of a surgical nail with misleading size dimensions).
• 147Talley v. Danek Med., Inc., 179 F.3d 154, 161 (4th Cir. 1999).
• 148Id. at 159 (“In our speed limit scenario, for example, the plaintiff would prevail if she could show that the speed limit statute was intended, as it surely was, to protect pedestrians and that the violation of the statute was a proximate cause of her injuries.”).
• 149Ornella v. Robertson, 237 N.E.2d 140, 143–44 (Ohio 1968); see also Sikora v. Wenzel, 727 N.E.2d 1277, 1282 (Ohio 2000).
• 150881 F. Supp. 2d 992 (S.D. Ill. 2012).
• 151Compare Complaint against All Defendants at 21, Sellers v. Boehringer Ingelheim Pharmaceuticals, Inc., 881 F. Supp. 2d 992 (S.D. Ill. 2012) (No. 3:12cv615) (using 21 U.S.C. § 352a in plaintiff’s negligence per se claim), and 21 U.S.C. § 352a (detailing what labeling constitutes misbranded drugs or devices), with21 U.S.C. § 387c (detailing misbranding labeling for tobacco products).
• 152265 Cal. Rptr. 3d 468 (Cal. Ct. App. 2020).
• 153541 S.W.3d 594 (Mo. Ct. App. 2017).
• 15421 U.S.C. § 360.
• 155382 F. App’x 437 (6th Cir. 2010).
• 156Id. at 437.
• 157Id. at 438.
• 158Id. at 440.
• 159Id.
• 160Id. (citing 21 C.F.R. § 820.70h).
• 161Howard, 382 F. App’x at 440.
• 162Id. at 441.
• 163Id.
• 164Id.
• 16521 C.F.R. § 820.70h.
• 166Howard, 382 F. App’x at 441.
• 167293 F. Supp. 3d 129 (D.D.C. 2018).
• 168Id. at 139–40.
• 169Id. at 178–79.
• 170Id. at 178 (quoting 21 C.F.R. § 820.70).
• 171Id. at 179 (quoting 21 C.F.R. § 801.15).
• 172Id. at 181 (quoting 21 C.F.R. § 820.25(a)).
• 173Kubicki, 293 F. Supp. 3d at 180.
• 174Id.at 181.
• 175Id. (citing 21 C.F.R. § 820.25(a)).
• 176Id. at 180 (citing Howard v. Sulzer Orthopedics, Inc., 382 F. App’x. 436, 440 (6th Cir. 2010)).
• 177Id.
• 178Id. at 185; Howard, 382 F. App’x at 440.
• 17921 U.S.C. § 387b.
• 180Id.
• 181See Howard, 382 F. App’x at 440.
• 18221 U.S.C. § 387c.
• 183Id.
• 18420 C.F.R. § 1143.3.
• 18521 U.S.C. § 387a-1.
• 18620 C.F.R. § 1140.14(b)(1).
• 18720 C.F.R. § 1140.14(b)(3).
• 18821 U.S.C. § 331tt.
• 189Kubicki ex rel. Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129, 180 (D.D.C. 2018).
• 190Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001).
• 191497 F. Supp. 3d 552 (N.D. Cal. 2020).
• 192Id. at 575.
• 193Id. at 612, 623.
• 194Id. at 630 (rejecting plaintiffs’ argument that damage allegations must have detailed disclosures).
• 195Id. at 631.
• 196No. 20-8030, 2021 WL 613842 (D.N.J. 2021).
• 197Id. at *12.
• 198Id. at *13.
• 199402 F. Supp. 3d 728 (N.D. Cal. 2019).
• 200Id.
• 201Id. at 748.
• 202Id.
• 203See 21 U.S.C. § 387c.
• 204Colgate, 402 F. Supp. 3d at 748; Lara v. Cool Clouds Distrib., Inc., No. 20-8030, 2021 WL 613842 at *13 (D.N.J. 2021); In re JUUL Labs, Inc., Mktg Sales Practices and Prod. Liab. Litig., 497 F. Supp. 3d 552, 630 (N.D. Cal. 2020).
• 205See Avian V. White et al., Risk Assessment of Inhaled Diacetyl from Electronic Cigarette Use Among Teens and Adults, Sci. Total Environ. (June 2021), https://pubmed.‌n‌c‌b‌i‌.‌n‌l‌m‌.‌n‌i‌h‌.‌g‌o‌v‌/‌33770882/ [perma.cc/4238-N6E5].
• 206See Bayer Corporation v. Leach, 153 N.E.3d 1168, 1184 (Ind. Ct. App. 2020) (stating that a tort claim in which an adulterated medical device was unreasonably dangerous to consumers “d[id] not exist ‘solely by virtue of the FDCA’”).
• 207See Evans v. Lorillard Tobacco Co., 990 N.E.2d 997, 1005 (Mass. 2013) (alleging negligent distribution by giving free samples of Newport cigarettes to minors).
• 208Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993).
• 2097 F.3d 1130 (4th Cir. 1993).
• 210See, e.g., Hoffman-La Roche Inc. v. Medisca, Inc., No. 99-CV-163, 1999 WL 123578, at *5 (N.D.N.Y. 1999); Braintree Laboratories, Inc. v. Nephro-Tech, Inc., No. 96-2459, 1997 WL 94237, at *4 (D. Kan. 1997).
• 211Mylan, 7 F.3d at 1137.
• 212Id. at 1139 (“In order to state a proper claim for relief under § 43(a) of the Lanham Act, Mylan was required to point to some claim or representation that is reasonably clear from the face of the defendants’ advertising or package inserts. That it did not do.”).
• 213See Talley v. Danek Med., Inc., 179 F.3d 154, 159 (4th Cir. 1999).
• 214See, e.g., Stengel v. Medtronic Inc., 704 F.3d 1224, 1233 (9th Cir. 2013) (“But we do hold, under Lohr, Buckman, and Riegel, that this claim is not preempted, either expressly or impliedly, by the MDA. It is a state-law claim that is independent of the FDA’s pre-market approval process that was at issue in Buckman. The claim rests on a state-law duty that parallels a federal-law duty under the MDA, as in Lohr.”).
• 215Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350, 353 (2001).
• 216Id. at 353.
• 217See Colgate v. JUUL Labs, Inc., 345 F. Supp. 3d 1178, 1187, 1196 (N.D. Cal. 2018).
• 218Christina Jewett & Julie Creswell, Juul Reaches $462 Million Settlement With New York, California and Other States, N.Y. Times (Apr. 12, 2023), https://www.nytimes.com‌/‌2‌0‌2‌3‌/‌0‌4‌/‌1‌2‌/‌h‌e‌a‌l‌t‌h‌/juul-vaping-settlement-new-york-california.html [perma.cc/9T2G-2TJX].
• 219FDA v. Wages & White Lion Invs., L.L.C., 145 S. Ct. 898 (2025).
• 220Diane Adam, Senate Judiciary Committee Grills FDA, DOJ on Lack of Enforcement Regarding Illegal E-Cigarettes, CSP Daily News (June 12, 2024), https://www.cspdailynews.com/to‌‌b‌a‌c‌c‌o‌/‌senate-judiciary-committee-grills-fda-doj-lack-enforcement-regarding-illegal-e [perma.cc/6UVQ-‌9‌L‌MG].
• 221See, e.g, Cassidy Morrison, California Boy, 15, Has Fingers Amputated and Horrific Facial Injuries After Vape Blew up in His Face, Daily Mail (Dec. 11, 2024), https://www.dail‌y‌m‌a‌i‌l‌.‌‌c‌o‌.‌u‌k‌/‌he‌‌a‌lth/article-14182271/california-teen-vape-explosion-amputated-fingers-injury.html ‌[‌p‌e‌r‌m‌a‌.‌‌cc‌/‌5‌F‌F‌‌P-2WRS].