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.
If you are interested in obtaining additional guidance on this topic, contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com). For more information on our Tobacco and E-Vapor Practice, visit www.khlaw.com/evapor. For more information on our Proposition 65 Practice, visit www.khlaw.com/Proposition_65. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.