Child-Resistant Packaging for Liquid Nicotine:
Are Current State and Federal Policy Responses Adequate?

Vol. 6, Issue 2 // March 2, 2016
By Mena Alsaraf and Tim K. Mackey, University of California—San Diego

I. Introduction

Electronic cigarettes (e-cigarettes), also known as Electronic Nicotine Delivery Systems (ENDS) or personal vaporizers (PV), are battery-powered devices that deliver nicotine in the form of vapor. In 1965, Herbert Gilbert, a scrapyard worker in Pennsylvania, was granted a patent for smokeless cigarettes that never saw production due to lack of technology at that time.¹ Later, the modern e-cigarette was invented by pharmacist Hon Lik in Beijing, China in 2003 and was introduced to the European markets and the U.S. market in 2006 and 2007.² In September 2008, the World Health Organization (WHO) declared that e-cigarettes were not a smoking cessation device and did not deem them as safe or effective.³ However, since that time, the e-cigarette industry has rapidly grown in global sales, product offerings, and different markets now representing a multi-billion dollar industry for recreational nicotine use.⁴

E-cigarettes are filled with e-liquids—liquid nicotine mixed with other ingredients and flavors. E-liquids are advertised in a number of flavors, including chocolate, bubblegum, or fruit and at varying levels of nicotine concentration. In the U.S., sales of e-cigarettes to minors under the age of 18 are banned in the majority of states.⁵ However, despite these legal limitations, studies have documented the ease of accessing e-cigarettes by youth and adolescents. Research has also shown that e-cigarette use is becoming increasingly common among adolescents with no smoking history.⁶ According to data published by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products, there has been a significant increase in high school students consuming e-cigarettes, jumping from 660,000 in 2013 to two million students in 2014.⁷ The increased use of e-cigarettes can be a gateway to nicotine addiction, with chronic nicotine use causing histone acetylation changes of a specific gene in the corpus striatum of the brain that is important for establishing addiction to most drugs.⁸

Currently, the U.S. does not regulate the production, distribution, sale, packaging, and labeling of e-cigarettes (other than those marketed for therapeutic use), as it waits to finalize a set of proposed regulations. This lack of regulation raises several public health concerns regarding e-cigarette uptake, the health impact of nicotine exposure, and consumer safety. One of these issues includes the controversy of liquid nicotine poisoning in children via exposure to e-cigarettes and e-liquids. According to data from the National Poison Data System (NPDS) reported by the American Association of Poison Control Centers (AAPCC), there were 271 cases of exposures in 2011, 460 cases in 2012, 1,543 cases in 2013, 3,783 cases in 2014 and 2,890 cases as of November 30, 2015.⁹ Notably, liquid nicotine exposures can occur through ingestion, inhalation, or absorption through the skin or eyes, and can lead to poisonings and overdose. The AAPCC has reported that more than half of reported poisoning cases have occurred in children under the age of six.¹⁰

Many consumers are not fully aware of the potential side effects or health harms of e-cigarettes due to lack of adequate warnings. Therefore, parents may leave e-liquids containers accessible to children; there are documented cases of children under six that have been able to easily open containers. Complicating issues further is the fact that currently FDA does not regulate the contents of e-liquids effectively, giving manufacturers discretion on concentrations of nicotine and use of other ingredients in their composition.

Additionally, e-liquid containers do not require mandatory labeling of their constituents, leaving consumers often unaware of the exact ingredients contained in the wide variety of e-liquids marketed directly to the consumer. Also, given that e-liquids are marketed in a variety of different flavors, such as chocolate and strawberry, young children may be attracted to their packaging and odors.

Hence, in order to ensure appropriate protection of children who may be exposed to the health hazards of e-liquids and their potential for poisoning, several states, and recently, the federal government have adopted child-resistant packaging laws. This article explores how state jurisdictions and the federal government have responded to calls to enact e-cigarette child-resistant packaging, identifies potential barriers to additional legislation/regulation, and describes the critical elements needed in future proposed rulemaking on the issue.

II. Actions by State Governments to Enact Child Resistant Packaging

As of November 2015, there are a total of 29 states that are attempting to address child-resistant packaging for e-cigarette products. This includes 15 states (Arkansas, Illinois, Indiana, Minnesota, Missouri, New Mexico, New York, North Carolina, North Dakota, Oregon, Tennessee, Utah, Vermont, Virginia, and Wyoming) that have adopted laws that require child-resistant packaging for e-cigarette products. The remaining 14 states (Arizona, California, Maine, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, Ohio, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin) have proposed bills that would require e-cigarette products to be in child-resistant packaging. Though many of the state laws share certain commonalities, several variations in approaches in requiring child-resistant packaging exist, resulting in a patchwork of state laws that may make it difficult for manufacturers to achieve compliance and raising questions about consistency in ensuring consumer and child safety.

The legislative intent of enacting e-cigarette packaging laws primarily focuses on protecting vulnerable populations, such as children, and enhancing safety and welfare. However, a review of the specific requirements of the subset of 15 states that have enacted laws reveals clear variance in the level of detail contained in these regulations. The stated purpose for enacting such laws often differs, indicating disparate political priorities that may impact the completeness and ability to implement legislation. As an example, five of the states with the most robust regulation (Arkansas, Indiana, New Mexico, New York, and North Carolina) explicitly include protecting children under five as the primary purpose of the law. In New York, Governor Andrew Cuomo signed a bill requiring child-resistant packaging on all liquid nicotine sold in the state after an 18-month old boy accidentally ingested e-liquids and became the first child in the country to die from e-liquid poisioning.¹¹

Additionally, different laws ban different products; some state laws explicitly require child-resistant packaging on e-liquids containers, others focus on e-cigarette products, and still other states focus on the broader category of liquid nicotine containers. Requirements to include child-resistant packaging clearly differ based on the type of product or e-liquids container. In Illinois, Indiana, New Mexico, New York, and North Carolina packaging is required only on e-liquids themselves while in Arkansas, Minnesota, Missouri, North Dakota, Oregon, Tennessee, Utah, Vermont, Virginia, and Wyoming, packaging is required on either liquid nicotine containers or e-cigarette products. Complications also arise because liquid nicotine is present in consumer products (e.g., pesticides and insecticides) other than e-liquids, making it hard to apply uniform packaging standards to products with different intended uses.

States also employ different exceptions to which products are subject to regulations/bans. For example, Illinois, Missouri, New Mexico, North Dakota, and Utah exclude child-resistant packaging on sealed and prefilled cartridges shipped by manufacturers that are not intended to be used by the consumer. Indiana, New Mexico, Oregon, and Wyoming, include an exemption for all FDA approved e-cigarette products that are used as drugs, tobacco cessation products, or for any other therapeutic purposes. In Tennessee, an exemption is available for any liquid nicotine container that is specifically preempted by federal law. Virginia extends an exemption to products manufactured before the law’s effective date and the state provides a three-month grace period to sell or discontinue remaining inventory.

For the 29 states with both enacted and proposed legislation, the majority define “Child-Resistant Packaging” as packaging that is designed or constructed to meet the child-resistant effectiveness standards set forth in the Poison Prevention Packaging Act of 1970 (PPPA).¹² The PPPA is a federal regulation that requires the use of child-resistant packaging for prescription drugs, over-the-counter drugs, household chemicals, and other hazardous materials that are considered dangerous for children.¹³ However, packaging standards may differ depending on the scope of products covered under the law, and whether products are intended for wholesale, distribution, or retail sale to the end-user consumer. Some states require trained specialists with knowledge of the occupational health risks of hazardous substances to oversee the production and packaging of covered products. However, if the product is intended for consumer use, legislation instead focuses on consumer safety and limiting accidental exposure.

The remaining 21 states that have yet to adopt or propose child-resistant packaging are likely to use existing state legislation as a model when addressing this important public health and consumer safety issue. Though no current model legislation exists, certain states address the issue more comprehensively and outline a set of specific requirements covering the entire scope of the issue from manufacturing, distribution, consumption, and education. For instance, Indiana Senate Bill, SB 463 enacted on May 7, 2015, includes a set of 19 requirements that manufacturing facilities need to comply with. The requirements target areas such as the necessity of child-resistant packaging that meets the PPPA’s standards, the use of tamper evident packages, and the importance of labeling the container with all active ingredients (including nicotine) and banning the use of unauthorized ingredients in preparations. It also requires the containers to have a batch number (with a response code), manufacturing date, and a scannable code. Moreover, e-liquids containers must be distributed by manufacturers or sold by manufacturers, wholesalers, or retailers before either the expiration date on the container or two years following the manufacturing date. Further, the manufacturing and packaging of the e-liquids should take place in a clean room with access limited to authorized personnel (including a secure environment that is subject to 24-hour video recording). In addition, the manufacturing facilities are required to maintain sample bottles from each production batch in a secure area for at least three years where they will be subject to random audits as well as site visits by the alcohol and tobacco commission. Manufacturers and their subcontractors must meet all of these requirements and cannot have been convicted of a felony or offense that involves controlled substances.

Collectively, varying applicability of regulations/bans, different exemptions, and divergent standards, raise concerns regarding consistency in applying child-resistant packaging across the entire industry given that many manufacturers operate in multiple states. Further, enforcement of laws appears to be uneven, with some states penalizing retail sales violations with civil penalties and/or misdemeanors, while other states have no enforcement mechanisms.

III.   Federal Responses to E-cigarette Packaging

Currently, there are no federal laws regulating non-therapeutic e-cigarette products despite the fact that these nicotine delivery devices were introduced to the U.S. market almost eight years ago. In April 2014, FDA proposed a deeming rule aimed at extending its authorities for “additional tobacco products” including, but not limited to, e-cigarette products.¹⁴ This rule is known as the “Deeming Tobacco Products To Be Subject to the Federal Food, Drug & Cosmetic Act, as Amended by the Family Smoking Prevention and Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Proposed Rule” (Proposed Rule) and has yet to be finalized.¹⁵ Once finalized, FDA will have at its disposal powerful regulatory tools that it can use to regulate various aspects of e-cigarettes such as manufacturing, packaging, labeling, marketing, distribution, and sale.¹⁶

In January 2016, the U.S. Congress approved legislation, known as the “Child Nicotine Poisoning Prevention Act” (CNPPA) that requires child safety packaging for liquid nicotine containers.¹⁷ This law requires any container used to hold liquid nicotine in any concentration (whether naturally or synthetically derived) that has an opening and/or is accessible by a consumer (i.e., does not include sealed, prefilled, and disposable containers that are inaccessible) to have special packaging similar to the one described in the PPPA and consistent with Consumer Product Safety Commission standards.¹⁸ The requirements of the legislation are similar to some of the proposed and enacted state laws. However, it lacks the specificity of state laws, instead focusing on simply requiring PPPA-compliant child-resistant for all liquid nicotine containers.

In June 2015, FDA issued an advance notice of proposed rulemaking (ANPRM).¹⁹ This notice is in regards to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and other tobacco products.²⁰ FDA opened the ANPRM for public opinion requesting all interested parties to provide responses to a set of questions addressing certain important regulatory concerns by October 31, 2015 (90-day comment period). However, significant pressure by e-cigarette and vaping industry trade groups raises the question of whether the proposed rulemaking will successfully be enacted or amended due to political pressure. As an example, Gregory Conley, the President of the American Vaping Association (AVA), a leading advocate for the benefits of vapor products (such as e-cigarettes) and the vaping community,²¹ reacted to the ANPRM by stating that the AVA supports child resistant packaging but also noted, “Child-resistant packaging is already in use by the vast majority of e-liquid manufacturers.”²²

Conley’s statement likely refers to e-cigarette manufacturers, distributors, and vendors complying with state laws associated with child-resistant packaging. However, even in New York where a law requiring child resistant packages for liquid nicotine is in place, e-cigarette manufacturing companies appear to be in violation of applicable requirements. In June 2015, four liquid nicotine companies in New York violated the liquid nicotine packages restrictions and sold liquid nicotine in non-child resistant packages.²³ Two of these companies are retailers Henley Vaporium and Beyond Vape, companies with retail outlets in New York City, while the other two companies sell their products online or through local retailers.²⁴ A settlement agreement reached in these cases now requires the four companies to remove all noncompliant packages from all their distributors and retail outlets, to train their staff on the requirements of the New York legislation, to provide proof of testing of containers, to demonstrate adherence to poison prevention packaging, and to pay penalties.²⁵ Despite this legal action, questions regarding the scope and effectiveness of state laws in ensuring adequate child resistant packaging requirements in the absence of federal law remain.

Upon further examination, the purpose behind federal actions on e-cigarette packaging appears to differ significantly. Though the CNPPA is similar to the recent ANPRM in regards to nicotine exposure warnings and child-resistant packaging for liquid nicotine, the CNPPA is brief and narrowly focuses on child-resistant container packaging without addressing specifics about the structure of the container or disclosure of ingredients. Conversely, the ANPRM focuses on broader details including the structure and design of the container as well as other factors that should be considered when designing the proposed rule. Finally, the Proposed Rule is much broader in scope than child-resistant packaging and considers regulation of manufacturing, packaging, labeling, marketing, distribution, and retail settings.²⁶ In brief, the Proposed Rule is targeted towards the e-cigarette industry as a whole while the CNPPA and ANPRM are targeted towards a specific regulatory aspect of the industry, packaging e-cigarette products. Hence, given that the ANPRM is likely the most viable federal regulatory tool to address this issue, we examine a set of questions raised by the ANPRM in the next section that may influence future policymaking.

IV. ANPRM’s Questions

Of the nine questions in the ANPRM, six directly address issues specific to the future use of child-resistant packaging for liquid nicotine containers.²⁷ We list these questions below. Questions are followed by summarized hypothetical responses based upon the review conducted in this article, focusing on state and federal responses to the public health and consumer safety concerns of liquid nicotine exposure:

1. Should FDA require child-resistant packaging for liquid nicotine? If so, why?

Response: Liquid nicotine containers are accessible to children whose parents are using e-cigarettes. Liquid nicotine is found in the e-liquids that are used to refill e-cigarettes and is casually found in consumers’ houses. The current packaging of these e-liquids is not universally child safe given the varying responses of state laws and the absence of federal requirements. Also, e-liquids come in flavors such as chocolate and strawberry; young children may be attracted to these odors and may attempt to ingest the e-liquids, leading to an increased risk of poisoning.

2. Should FDA require child-resistant packaging for liquid nicotine if the liquid nicotine product is not intended to be opened by the consumer (e.g., liquid nicotine in permanently sealed, prefilled, and/or disposable cartridges)? Please provide the reason for your response.

Response: If the product will not be opened or accessible by the consumer at any time during the life of the product, then there will be little risk of liquid nicotine exposure in children. This must be accompanied by requirements that products be handled by subject-matter experts who know how to protect themselves and others from being exposed to liquid nicotine due to occupational health safety risks.

3. If FDA were to require child-resistant packaging for liquid nicotine (including for those products that are not intended to be opened by the consumer), what type of exposure risks (e.g., oral, ocular, dermal) should FDA seek to mitigate with the requirement?

Response: The AAPCC defined exposures as contact with the substance through ingestion (oral exposure risk), inhalation, absorption through skin (dermal exposure risk) or eyes (ocular exposure risk), poisonings, overdoses, and so on.²⁸ Therefore, all types of direct exposure risks should be mitigated in order to protect young children. Once the liquid nicotine containers are in child-resistant packaging, then even if a child gains access to an e-liquid container, they should be protected from these exposure risks with appropriate controls/ technology.

4. If FDA were to require child-resistant packaging for liquid nicotine, how should the requirement be articulated? Please consider: (a) Whether the requirement should be based on mandated physical characteristics 6 of the packaging (e.g., must have a squeeze-to-turn lid, flow restrictor); (b) whether the requirement should be performance based (e.g., unable to be opened by 80 percent or more of 5-year-olds who try to open the package, and more than 90 percent of adults on average between the ages of 50-70 can successfully open the package); or (c) whether the requirement should be based on a combination of (a) and (b), or is there some other basis for the requirement that FDA should consider? Is your proposal technically feasible? Please submit data or evidence to support your position.

Response: In order to achieve greater policy coherence with existing state law, child-resistant packaging should meet the standards of the PPPA of 1970.²⁹ The PPPA requires that packaging must be designed to be significantly difficult for children under five years of age to open but not difficult for normal adults to open.³⁰ Therefore, a combination of both (a) and (b) will be a proper articulation such that packaging requirements should be based on physical characteristics that require two dissimilar motions for opening and are not readily accessible/openable by children. This will protect children under five from gaining access to the substance and accidently ingesting or harming themselves due to improper handling.

5. Are there other factors FDA should consider to further prevent or discourage people (especially infants and children) from inadvertently consuming or being exposed to liquid nicotine? If so, please explain. Examples of other factors may include: attractiveness of the product or packaging (e.g., appealing images, fragrance, flavors), resemblance of packaging to food and drink items (e.g., candy, fruit), color of the product (e.g., resemblance to beverages such as juice), resemblance of packaging to that of medications (e.g., eye drops).

Response: Current e-liquids come in a variety of packaging and flavors. The majority of the packaging resembles eye drop packages that are easy for a child to open and gain access to the contents. Other packaging looks like small juice boxes, giving the impression to young children that they are juices rather than liquid nicotine. Also, e-liquids come in a wide range of flavors. This results in a product appearance with a variety of colors and odors that make them more attractive to young children. Hence, FDA should take these factors into account when constructing the new packaging requirements and align these requirements with the Proposed Rule.

V. Model Rulemaking

Model Requirements:

Based upon the analysis carried out above and current regulatory gaps in state and federal rulemaking, we believe that certain additional minimum requirements are needed in any future FDA proposed rulemaking on e-cigarette packaging to adequately protect consumers and children. Below we describe a set of model regulations that includes specific packaging standards, manufacturing quality and safety requirements, necessary exemptions, and establishes penalties for violations. FDA should also directly engage with manufacturing facilities to ensure adequate oversight of the packaging process of all liquid nicotine containers, specifically e-liquid containers.

Age Requirements: In alignment with FDA’s Proposed Rule and consistent with section 906(d) of the Federal Food, Drug, and Cosmetic Act, and the age requirements enacted in the Family Smoking Prevention and Tobacco Control Act for combustible and smokeless tobacco products, e-cigarettes and e-liquids should not be sold to individuals under the age of 18. A driver’s license or other validated age verification process should be required at the time of purchase whether in person or online. E-cigarettes, specifically e-liquids, must be packaged in child-resistant packaging in order to prevent direct exposures such as oral, ocular, and dermal to young children.

Specific Packaging Requirements: Packaging needs to comply with the following set of requirements.

1. In alignment with the recently enacted CNPPA, e-liquids and liquid nicotine must be sold in child-resistant packaging. Child-resistant packaging is defined as a container with a child-proof cap that can only be opened by applying special physical characteristics that require two dissimilar motions (e.g., push down and twist). This will protect children under five from gaining access to the substance and accidently ingesting or harming themselves. Specifically, e-liquids and liquid nicotine containers should follow the PPPA packaging requirement that requires packages to be designed or constructed to be difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use properly.³² E-liquid and liquid nicotine containers must not be packaged in clear or transparent bottles / containers.
2. E-liquid and liquid nicotine containers must not be designed to look like mini-juice bottles or other containers that mask the appearance of a potentially harmful substance. Children will assume these are juices and will be more likely to seek access to such products. Therefore, containers should have a solid white color so that the contents are not visible to the consumer. This will assure children will not be attracted to the colors of the containers.
3. 3. Ideally, e-liquids and liquid nicotine packaging should not include marketing for tempting flavors similar to the ones currently on the market that range from chocolate and bubblegum to various fruit flavors such as strawberry, peach, and cherry. These flavors attract children to try the products unaware of their danger. Additionally, recent studies indicate that e-liquid flavoring chemicals (e.g., aldehydes) may be harmful to human health.33 However, the current construction of the Proposed Rule does not extend FDA regulatory authority over characterizing flavors beyond cigarettes. In the absence of a product or marketing ban on e-liquid flavors, manufacturers should be required to add additional packaging that includes a smell-proof container / bag to ensure children are not exposed to a potential poison hazard.
4. E-liquids and liquid nicotine containers must be made of a flexible and unbreakable material to prevent the substance from being spilled if the container is accidentally dropped.
5. Retailers and distributors must package the containers in a locked box with slots for each container to avoid accidental damage and improper access.
6. E-liquids containers must be labeled with all ingredients and adequate and visible health warnings. A standardized label should include mandated disclosure of all active ingredients as well as the manufacturing date and the expiration date. E-liquid containers must have a special warning label in bold on the principal display area of the container (i.e., on the face of the container) stating: Nicotine is an addictive substance. Keep out of reach of children due to risk of poisoning and death. This will ensure that consumers are aware of the dangerous contents of this product and risks to children.

Online Sellers and Distributors: Additionally, e-cigarette and e-liquids manufacturers that sell, distribute, package, or wholesale products online to U.S. consumers or through other forms of digital technology (e.g., mobile applications, social media, etc.) are required to meet requirements for child-resistant packaging, even if they are not physically located/domiciled within the United States.

Manufacturing Safety and Quality: All e-liquids and liquid nicotine manufacturer’s facilities must take reasonable safety and quality measures, including ensuring: (a) clean packaging areas; (b) authorized personnel trained to handle packaging and manufacturing; (c) proper mixing of ingredients; (d) proper storage of ingredients and finished product; (e) proper identification of e-liquids and liquid nicotine containers by batch number and scannable code for tracking, safety, and recall-related issues; and (f ) distribution and sale of products is limited to vendors appropriately licensed per applicable laws, rules, and regulations.

Exemptions to this rule:

(1) All sealed and prefilled e-liquids or liquid nicotine containers that are not intended to be handled or used by consumers (no risk of liquid nicotine exposures in children). Manufacturers and traders represent and warrant that these products will only be handled by subject-matter experts with appropriate training who know how to protect themselves from possible nicotine exposure. Manufacturers will implement an identification and tracking system to ensure compliance with this requirement.

(2) All FDA certified and approved products for sale as tobacco cessation products or for another approved therapeutic purpose. These products go through the FDA approval process for manufacturing and labeling that considers child-resistant packaging.

Penalties for Violations:

All parties subject to the rule must sell e-liquids and liquid nicotine containers in child-resistant packaging. Therefore, any violation of this rule is subject to civil and administrative penalties. Specifically, parties will be subject to a civil penalty for a first violation and possible seizure and destruction of non-complying products. For a second violation, a civil penalty, possible license suspension (by state authorities), and product seizure and destruction are potential penalties. For a third violation, parties will have their licenses revoked in 9 addition to the remedies described previously.

Federal Preemption:

States must meet the minimum requirements set forth in this rule, including in regards to age requirements, packaging standards, manufacturing safety and quality, and penalties for non-compliance. States however, are not subject to federal preemption for state laws / regulations / ordinances that extend additional requirements or penalties not included in this rule.

VI. Conclusion

Currently, even after the recent passage of the CNPPA, there is lack of sufficient regulation of the packaging of e-liquids and liquid nicotine. CNPPA provisions requiring child-resistant packaging for liquid nicotine is a critical first step. However, e-liquids themselves remain under-regulated and constituents are not currently disclosed, nor are their attendant health risks, leaving children at further risk of exposure to this toxic substance. Though federal legislation, state laws, and FDA regulations are attempting to implement child-resistant packaging standards, the current patchwork of regulation needs to be more robust. Hence, in this article, we propose a policy solution that takes advantage of lessons learned from existing state and federal attempts to protect consumers. Our model policy is comprehensive, addressing standards for consumers, manufacturers, and sellers including requiring age verification, specific packaging and design standards, manufacturing safety and quality requirements, use of health warnings, disclosure of ingredients, and penalties for violations. In response, we call for FDA and policymakers to act in haste to incorporate these recommendations into existing policy efforts in order to appropriately address and harmonize packaging requirements for liquid nicotine in order to ensure consumer safety for this generation’s children and the next.

Endnotes

1. See A Case of the Vapers, The Economist, Mar. 17, 2014, available at http://www.economist.com/ blogs/schumpeter/2014/03/e-cigarette-patent-wars.

2. See The Consumer Advocates for Smoke-free Alternatives Association, E-cigarette History (casaa 2009), http://casaa.org/E-cigarette_History.html.

3. Id.

4. See Coral Springs and PR Newswire, Global E-Cigarette Market Trends Points to Significant Growth in Coming Years – Company Enters JV Partnership to Bring E-Cig Products to Native American Gaming Industry Casinos, Mar. 17, 2015, http://www.prnewswire.com/news-releases/global-e-cigarette-market-trends-points-to-significant-growth-in-coming-years—company-enters-jv-partnership-to-bring-e-cig-products-to-native-american-gaming-industry-casinos-296552551.html.
5. See Karmen Hanson et al., Alternative Nicotine Products | Electronic Cigarettes, National Conference of State Legislatures (Oct. 9, 2015), http://www.ncsl.org/research/health/alternative-nicotine- products-e-cigarettes.aspx.
6. See Adam M. Leventhal et al., Association of e-cigarette use with smoking during early adolescence, 314 JAMA 700 (American Medical Association Aug. 18, 2015), http://jama.jamanetwork.com/ article.aspx?articleid=2428954.
7. See CDC, E-cigarette use triples among middle and high school students in just one year Hookah use doubles; no decline seen in overall tobacco use among middle or high school students, Centers of Disease Control and Prevention (CDC Apr. 16, 2015), http://www.cdc.gov/media/releases/2015/ p0416-e-cigarette-use.html.
8. See Dean E. Schraufnagel, Electronic Cigarettes: Vulnerability of Youth, 28 Pediatric Allergy, Immunology, and Pulmonology (2015), available at http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC4359356/.
9. See American Association of Poison Control Centers, E-Cigarettes and Liquid Nicotine, AAPCC, http://www.aapcc.org/alerts/e-cigarettes/.
10. Id.
11. See Keshia Clukey, Case Closed in Fort Plain Liquid Nicotine Death, Times Union, April 13, 2015, available at http://www.timesunion.com/news/article/Case-closed-in-Fort-Plain-liquid-nicotine-death-6195411.php.
12. See Consumer Product Safety Commission, Poison Prevention Packaging Act, S. Consumer Product Safety Commission (Oct. 28, 2015), http://www.cpsc.gov/en/Regulations-Laws– Standards/Statutes/Poison-Prevention-Packaging-Act/.
13. Id.
14. See S. Food and Drug Administration, Products, Guidance & Regulations – Deeming – Extending Authorities to Additional Tobacco Products, Center for Tobacco Products (2014), http://www.fda. gov/TobaccoProducts/Labeling/ucm388395.htm.
15. See AAPCC, supra note 9.
16. See Center for Tobacco Products (2014), supra note 14.
17. See Bill Nelson, Text – S.2581 – 113th congress (2013-2014): Child nicotine poisoning prevention act of 2014, gov (Dec. 12, 2014), https://www.congress.gov/bill/113th-congress/senate-bill/2581/text.
18. Id.
19. See U.S. Food and Drug Administration, FDA Issues Nicotine Exposure Warnings and Child-Resistant Packaging ANPRM (Jun. 30, 2015), http://www.fda.gov/TobaccoProducts/NewsEvents/ ucm453196.htm.
20. Id.
21. See Gregory Conley, News – The American Vaping Association, The American Vaping Association (Sept. 17, 2015), http://vaping.info/news.
22. Id.
23. See A.G. Schneiderman Cracks Down on E-Cigarette Industry, Announces Settlements with Liquid Nicotine Retailers and Manufacturer to Keep Poisonous Substance out of Children’s Hands, New York State Office of the Attorney General (Jun. 23, 2015), http://www.ag.ny.gov/press-release/ ag-schneiderman-cracks-down-e-cigarette-industry-announces-settlements-liquid-nicoti-0.
24. Id.
25. Id.
26. See Center for Tobacco Products (2014) , supra note 14.
27. See FDA ANPRM (Jun. 30, 2015), supra note 19.
28. See AAPCC, supra note 9.
29. See S. Consumer Product Safety Commission (Oct. 28, 2015), supra note 12.
30. Id.
31. See Charlotta Pisinger and Martin Døssing, A Systematic Review of Health Effects of Electronic Cigarettes, 69 Preventive Medicine 248 (2014), available at http://www.sciencedirect.com/science/ article/pii/S0091743514003739.
32. See S. Consumer Product Safety Commission (Oct. 28, 2015), supra note 12.
33. See Peyton A. Tierney et al., Flavor Chemicals in Electronic Cigarette Fluids, Tobacco Control (Apr. 15, 2015), available at http://tobaccocontrol.bmj.com/content/early/2015/03/27/ tobaccocontrol-2014-052175.

About the Authors

Mena Alsaraf is a current Masters student in the joint Masters Degree Program in Health Policy and Law, at the University of California – San Diego, School of Medicine and California Western School of Law.

Tim K. Mackey is an Assistant Professor in the department of Anesthesiology and Division of Global Public Health at the University of California – San Diego, School of Medicine. He is also the Associate Director for the UC San Diego – California Western School of Law Joint Masters Degree Program in Health Policy and Law and the Director of the Global Health Policy Institute. He has worked as a consultant for the World Health Organization, and acted as an expert speaker for the U.S. Department of State in addition to working with other organizations. His work focuses on global health policy, regulatory science, and health governance.

Acknowledgment

The authors would like to thank Joanna Sax, Professor of Law at California Western School of Law, for her helpful comments and suggestions on an earlier version of this manuscript.

The views, opinions, and statements expressed in this article are those of the author(s). FDLI neither contributes to nor endorses Forum articles.