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E-Vapor Industry Coalition Formally Opposes CPSC Novel Interpretation of CNPPA that Immediately Requires Flow-Restricted Packaging for E-Liquids

As previously reported on this blog, earlier this year, the U.S. Consumer Product Safety Commission (CPSC) announced that it was now reading the Child Nicotine Poisoning Prevention Act (CNPPA) to require nicotine e-liquid bottles to meet the “restricted flow requirement” in 16 C.F.R. § 1700.15(d), in addition to having child-resistant closures. A wave of enforcement actions soon followed. CPSC issued Notices of Violations to numerous e-liquid companies alleging that e-liquid bottles (specifically glass bottles) without flow restrictors rendered the e-liquid a “misbranded hazardous substance” pursuant to section 2(p) of the Federal Hazardous Substances Act (FHSA). CPSC ordered these companies to initiate a number of “corrective actions,” including to immediately stop sale and distribution, notify all known retailers and consumers, and destroy and dispose of returned units and any remaining inventory. Such actions may drive companies, including many small businesses that make up the backbone of the vapor industry, out of the market.

In response to CPSC’s demands for immediate action, a coalition of national and state vapor trade associations (the “E-Vapor Coalition”) came together to express their strong opposition to CPSC’s new reading of the CNPPA. In a letter to the CPSC Acting Chair and Commissioners, the E-Vapor Coalition lays out in detail the flaws in the CPSC’s new reading of the statute, which neither the plain language nor the legislative history support. Moreover, this recent interpretation is inconsistent with three years of previous guidance from the Commission. The E-Vapor Coalition letter also raises concerns about flaws in CPSC’s hastily drafted testing protocol for flow restrictors, which appear to be suitable only for testing plastic packaging. The letter also highlights the potential conflict with the Food and Drug Administration (FDA) rules prohibiting changes to e-liquid packaging without FDA premarket approval.

As the E-Vapor Coalition letter points out, while industry disagrees that the CNPPA requires flow restrictors as part of its special packaging requirements, or that packages without flow restrictors are “misbranded hazardous substances,” coalition members share CPSC’s desire to safeguard children from potential hazards of accidental ingestion of nicotine-containing e-liquids. While instances of accidental ingestion are fortunately extraordinarily rare, the E-Vapor Coalition does not object to an orderly transition to restricted flow packaging, in coordination with FDA. It is vital that this be done in a manner that will not unduly burden manufacturers, distributors and retailers, or deprive adult consumers of less risky alternatives to combustible tobacco by forcing existing producers who switch to flow-restricted packaging to seek pre-market authorization from FDA. Associations comprising the E-Vapor Coalition and their respective members look forward to working with both CPSC and FDA to achieve these goals.

To keep track of CPSC’s latest guidelines for liquid nicotine containers, see its Liquid Nicotine Packaging Business Guidance website.

© 2019 Keller and Heckman LLP

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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...

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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, data security and access procedures, manage trans-border data flows, respond to data breaches and create training programs. She assists clients on digital media issues, helping them develop social media, blogging and user-generated content policies, and to understand advertising technology and online behavioral advertising issues.  Ms. Millar also works with clients to navigate the array of federal and state requirements governing contests and sweepstakes, and advises on gift cards, coupons and rebates.  She represents clients on advertising and privacy matters before the Federal Trade Commission (FTC), the Children’s Advertising Review Unit (CARU), the National Advertising Division (NAD), as well as in connection with investigations by state regulatory bodies and Attorneys General.

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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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