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Dramatic Increase in Proposition 65 Actions Against E-Vapor Products; New Warning Requirements Start August 30, 2018

Electronic cigarette and e-liquid (collectively "e-vapor") manufacturers are increasingly the targets of California Proposition 65 enforcement actions brought by private plaintiffs.  Of the 168 private enforcement actions brought against e-vapor manufacturers, 150 of these have been filed since 2016.  We provide background on Proposition 65 below, followed by specifics regarding how the e-vapor industry has been targeted.

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity. See Cal. Health & Safety Code §§ 25249 et seq.  Among other things, the law prohibits the knowing exposure of any individual to a significant amount of a listed chemical without first providing a "clear and reasonable warning" to such individual. Cal. Health & Safety Code § 25249.6. The law requires these warnings to be provided for consumer product, workplace, and environmental exposures unless "the person responsible can show that the exposure [to a listed carcinogen] poses no significant risk assuming lifetime exposure at the level in question," or, for a listed reproductive toxin, that the substance "will have no observable effect assuming exposure at 1,000 times the level in question." Cal. Health & Safety Code § 25249.10(c).

Proposition 65 Enforcement Against E-Vapor Products

The 60-day notices sent to e-vapor manufacturers have focused on four listed chemicals:  acetaldehyde (listed as a carcinogen), formaldehyde (listed as a carcinogen), nicotine (listed as a reproductive toxicant), and tobacco smoke (listed as a carcinogen).  We have identified approximately 150 60-day notices sent to e-vapor companies.  Almost all of these notices have been filed by the Center for Environmental Health (CEH).  CEH has either detected listed chemicals in the products by analytical testing (e.g., testing the e-liquid) or has alleged that the intended use of the product (e.g., the e-vapor device) will result in exposure to the listed chemical(s).   

Out of the enforcement actions since 2015, there have been nearly 100 settlements that have amounted to approximately $3.9 million in combined fees and penalties.  The highest settlements amounted to $355,000, with the average settlement amount being in the range of $42,000. 

E-Vapor manufacturers should be aware of their rights and responsibilities under Proposition 65, particularly in light of new warning requirements, which differ from the current Proposition 65 warnings in terms of presentation and content, that become mandatory on August 30, 2018 - around the same time the nicotine addiction warning required by the FDA's Deeming Regulation goes into effect for e-vapor products.  

© 2017 Keller and Heckman LLP

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About this Author

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 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...

202.434.4230
Mitzi Ng Clark, Food, Drug Law, Keller Heckman Law Firm
Partner

Mitzi Ng Clark practices in the area of food and drug law, with an emphasis on food packaging.

Ms. Clark advises domestic and international corporations on a wide range of regulatory issues, ranging from FDA premarket clearance requirements for food-contact materials and local and state regulations concerning plastics and chemicals, to good manufacturing issues and regulatory requirements for food, cosmetics, and animal feed.  Ms. Clark’s practice extends to the international arena, where she counsels clients on regulatory matters in jurisdictions such as Canada, the European Union, the Pacific Rim, Latin America, and the Middle East.  She has made food-contact submissions in countries such as China, India, South Korea, and Indonesia. 

202-434-4238