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CPSC Likely to Gain New Authority Over Some Nicotine-Containing E-Liquid Packages

With the passage of the Child Nicotine Poisoning Prevention Act (S. 142) by both houses of Congress, the U.S. Consumer Product Safety Commission (CPSC) will likely soon get new authority to require child-resistant (CR) packaging ("special packaging") over certain packages of nicotine-containing "e-liquid." Assuming the President signs the bill, as expected, covered products will be subject to the same requirements that CPSC already enforces on packaging of prescription drugs, some over-the-counter (OTC) drugs, and other potentially hazardous products found in the home.

Specifically, the law applies to "liquid nicotine containers," defined to include "package[s] from which nicotine in a solution or other form is accessible through normal and foreseeable use by a consumer and that is used to hold soluble nicotine in any concentration." Thus, bottles of refillable nicotine-containing e-liquid sold directly to consumers for use in "open-system" electronic vaping devices are covered, but packaging for zero-nicotine e-liquid - a growing segment of the e-liquid market - is not covered by the definition.

The new law also creates another important exception. Special packaging requirements would not apply to "sealed, pre-filled, and disposable" nicotine containers that are "inserted directly into an electronic cigarette, electronic nicotine delivery system, or other similar product," so long as the nicotine is not accessible to consumers "through customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion or other contact by children." In other words, "closed-system" electronic cigarettes (cigalikes) where the e-liquid is not intended to come into contact with or be handled by the consumer are not required to use CR packaging.

CPSC already implements the Poison Packaging Prevention Act of 1970 (PPPA), Pub. L. 91-601, 84 Stat. 1,670 (Dec. 30, 1970). That law requires certain household substances to have packaging that makes it significantly difficult for children under five years old to open within a reasonable amount of time. The PPPA is regarded as one of the CPSC's biggest successes. For example, CPSC estimates a 45% reduction in deaths of children under 5 due to the unintentional ingestion of aspirin or oral prescriptions.

To meet PPPA requirements, 80% of children should not be able to open the special packaging after 10 minutes of attempting to open it. The CPSC has adopted specifically prescribed testing. Additionally, 90% of adults must be able to open the packages. A minimum of one panel of 50 children must be tested, along with 100 adults aged 50 to 70 years old. Manufacturers or importers of products that require special packaging must issue certificates of conformity indicating that their products comply with the special packaging requirements, and must issue/furnish them to distributors and retailers, and make them available to the CPSC or U.S. Customs and Border Protection (CBP) upon request, under provisions of the Consumer Product Safety Improvement Act (CPSIA).

The bill - formally presented to the President for his signature or veto on January 19, 2015 - was originally introduced by Sen. Bill Nelson (D-FL) in summer 2014 in part because of the increase in Poison Control Center-reported incidents involving possible e-liquid ingestions, which can cause death or severe illness in large enough quantities. Indeed, in one case - although the facts are controversial, as apparently the consumer mixed e-liquid at home with very high concentrations of nicotine rather than using a commercially available product - one child death has been associated with access to an open bottle of e-liquid. Several states, including New York, Massachusetts, North Carolina, Texas, and Minnesota, have passed laws requiring CR packaging for e-liquid products.

Vaping advocates agree that CR packaging is necessary and note that most responsible manufacturers have been using such packaging for some time. The American E-Liquid Manufacturing Standards Association (AEMSA), a trade association of e-liquid manufacturers dedicated to the safe and responsible production and handling of these products, has required CR packaging for its members since 2012.

The new bill, which would take effect 180 days after it is signed into law, does not limit or pre-empt the Food and Drug Administration's (FDA) authority to regulate e-cigarettes, and FDA would still be empowered to impose its own packaging requirements. Specifically, the Act mandates that FDA consult with the CPSC if the FDA "adopts, maintains, enforces, or imposes or continues in effect any packaging requirement for liquid nicotine containers, including a child-resistant packaging requirement ... taking into consideration the expertise of the Commission in implementing and enforcing this Act and the ... [PPPA]."

Electronic cigarettes and e-liquids that contain nicotine derived from tobacco fall within meaning of "tobacco product" under the Food, Drug and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (FSPTCA). While the FSPTCA only gave FDA the immediate regulatory authority over cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco products, it also gave FDA the authority to promulgate a regulation to "deem" other, currently unregulated tobacco products (including nicotine-containing e-cigarettes and e-liquid) to be regulated products subject to the FSPTCA. The so-called "Deeming Regulation" is currently in the final stages of review at the Office of Management and Budget (OMB) and is expected to be published in 2016.

Regardless of any new authority it obtains over e-cigarettes, as it has with certain drugs, it seems likely that FDA would defer to CPSC's relatively successful approach to safeguarding children from ingesting easily openable dangerous products. Manufacturers and importers of liquid nicotine refill containers should begin planning to implement this new requirement, and expect enforcement by the CPSC down the road if packaging does not comply.

© 2019 Keller and Heckman LLP


About this Author

Sheila Millar, Keller Heckman, advertising lawyer, privacy attorney

Sheila A. Millar counsels corporate and association clients on advertising, privacy, product safety, and other public policy and regulatory compliance issues.

Ms. Millar advises clients on an array of advertising and marketing issues.  She represents clients in legislative, rulemaking and self-regulatory actions, advises on claims, and assists in developing and evaluating substantiation for claims. She also has extensive experience in privacy, data security and cybersecurity matters.  She helps clients develop website and app privacy policies,...

Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the FDA Tobacco and Electronic Cigarette practice at Keller and Heckman.  Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance.

Mr. Chowdhury is also a frequent contributor to the Food and Drug Law Institute's (FDLI) Update Magazine, has served on the Editorial Advisory Board of the Food and Drug Law Journal, and has authored and edited numerous articles and publications, including Tobacco Regulation and Compliance: An Essential Resource, FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer and Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. He frequently speaks at industry conferences and events, was featured in U.S. News and World Reports Best Lawyers Edition(2016) and was named one of “10 Names to Know in the Vape World” in the October 2015 issue of Vape Magazine

Mr. Chowdhury also has an active pro bono practice through Keller and Heckman’s Pro Bono Program and has been featured in the Baltimore Sun for successfully obtaining asylum in the United States for a family who fled their home country of El Salvador because of violence they faced from an international gang.