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FDA Won’t Enforce Pre-Market Review Requirement for E-Liquid Packaging Modified to Incorporate “Flow Restrictors”

In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new interpretation, sending out dozens of Notices of Violations to manufacturers of e-liquids, demanding immediate stop sale, withdrawal, destruction of products from distributors and retailers, and transition to new packaging incorporating flow restrictors. However, CPSC’s demands that manufacturers change their packaging put them at risk of enforcement actions by the Food and Drug Administration (FDA) for introducing “new products” without premarket approval.

The E-Vapor Coalition, a group of national and state vapor trade associations, came together to advocate for the industry and sent a detailed letter to CPSC detailing the flaws in the Commission’s new interpretation of the CNPPA. The letter, which was also sent to FDA, outlined how CPSC’s actions, which apparently did not involve coordination with FDA, potentially conflict with FDA’s rules prohibiting changes to e-liquid packaging without FDA premarket approval. Thereafter, the E-Vapor Coalition, and many individual companies, repeatedly requested that FDA clarify whether it would enforce premarket review requirements for products that were modified to include flow restrictors. Until now, FDA refused to provide such clarification.

Finally, on November 25, 2019, the FDA published a notice in the Federal Register announcing a new “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.” The guidance states that FDA will not enforce violations of the premarket review requirements where modifications to packaging have been made to protect children from ingesting liquid nicotine by adding flow restrictors. The new guidance removes significant regulatory uncertainty faced by companies that acceded to CPSC’s demands.

The guidance also states that FDA will not enforce premarket review requirements for companies modifying their battery-operated delivery systems to meet the safety standards of UL 8139 (Standard for Safety for Electrical Systems of Electronic Cigarettes and Vaping Devices). This means that companies can finally adopt product features that will make their devices safer without risking enforcement actions that would take them off the market.

While FDA has taken steps to help manufacturers improve safety by removing regulatory uncertainty, CPSC has continued its aggressive enforcement of its new interpretation of the CNPPA. Last week, CPSC published an open letter to e-liquid retailers, warning them that, in its interpretation, sale of nicotine-containing e-liquids in packages without flow restrictors is a violation of federal law that can subject the seller to civil monetary penalties. The letter instructs retailers to remove the products from sale and quarantine them. The letter specifically warns retailers against selling these products at a discount, an action that CPSC views as an implicit acknowledgment that the retailers are “engaged in selling illegal products.” The letter is the first time that CPSC openly directed its enforcement actions to retailers. It was published as CPSC continues to face increasing pressure from advocates, legislators, and the media over its perceived lack of enforcement of the CPSC’s interpretation of the CNPPA. Since CPSC issued this new interpretation, members of the e-liquid industry have sought to work cooperatively with both FDA and CPSC in the interest of protecting consumers and clarifying the legal rules of the road. The industry, however, remains confident that CPSC’s novel interpretation of the CNPPA is not supported by the statutory language or legislative history.

© 2020 Keller and Heckman LLP

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About this Author

Sheila Millar, Keller Heckman, advertising lawyer, privacy attorney
Partner

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,...

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

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.

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Boaz Green Product Safety Attorney Keller and Heckman Law Firm
Counsel

Boaz Green practices in the areas of product safety and consumer protection, assisting on regulatory compliance, enforcement and policy questions. In his product safety practice, Mr. Green counsels clients on risk management and product safety strategies, responses to allegations of incidents or unsafe products, as well as on compliance with Consumer Product Safety Commission (CPSC) requirements, including those of the Consumer Product Safety Act, the Consumer Product Safety Improvement Act, the Federal Hazardous Substances Act, the Poison Prevention Packaging Act, and CPSC regulations and...

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