November 28, 2021

Volume XI, Number 332

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California Announces Revised Proposition 65 Labeling & Marketing Regulations

On January 8, 2021, California’s Environmental Protection Agency, Office of Environmental Health Hazard Assessment (OEHHA) issued proposed amendments to Article 6 of the regulations implementing the state’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65.  These changes will require any company using short-form warnings to revise their labeling and marketing compliance plans.

Compliance with California’s Proposition 65 is a familiar hurdle for businesses selling consumer products into that state.  Proposition 65 requires that consumers be provided with a “clear and reasonable warning” of exposures to certain chemicals determined by California’s Office of Environmental Health Hazard Assessment (OEHHA) to cause cancer, birth defects, or other reproductive harm. Manufacturers, distributors, and retailers who fail to provide such a warning are at risk for enforcement lawsuits from California’s Attorney General or the public at large, which place the burden of proof on the defendant business to demonstrate compliance.  Substantial fees, as high as $2,500 per violation per day, can be incurred.

The warning for a product that can cause exposure to a carcinogen typically requires disclosure of one or more such chemicals.  For example:

Warning signWARNING: This product can expose you to chemicals including [name of one or more chemicals], which [is/are] known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.”

Currently, under changes made in 2016, Prop 65 regulations (27 CCR § 25603) permit companies to use abbreviated “short form” warnings when the warnings are placed “on-product.” Many businesses gravitated towards these short-form warnings on both their products and websites, because the abbreviated warnings do not require disclosure of a listed chemical.  For example, for a listed carcinogen:

Warning sign WARNING: Cancer - www.P65Warnings.ca.gov.”

The rulemaking proposed on Jan. 8 would modify the existing short-form warning provisions as follows:

  • Only allowing use of the short-form warning (a) on products with 5 square inches or less of label space, or (b) when the standard warning will not fit;

  • Eliminating use of short-form warnings for internet and catalog warnings, even if a compliant short-form warning is used on the product itself;

  • Clarifying how short-form warnings can be used for food products;

  • Requiring that the name of at least one chemical be included in the short-form warning; and

  • Requiring the words “risk” and “exposure” in the warning.

These changes are not surprising, given that OEHHA has previously expressed concern about the use of short-form warnings prophylactically even when businesses do not have actual knowledge of exposures to a listed chemical.

Amendments to the California Code of Regulations must be made in accordance with the California Administrative Procedures Act, which allows for a period of public comment on the proposed changes.  Comments can be submitted online at https://oehha.ca.gov/comments until Mar. 8, 2021.

Once the comment period on the proposed regulations closes, OEHHA will issue a final regulation.  The changes to the short-form warnings would take effect one year after issue of those final regulations.  The amendments also include a “sell-through” provision, whereby the warning changes would not apply to products manufactured prior to the effective date.

Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume XI, Number 20
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About this Author

Michael J. Sullivan, Womble Carlyle, risk management attorney, cost control lawyer
Managing Partner

Michael Sullivan is Managing Partner in the Atlanta office of Womble Carlyle, a full-service business law firm with more than 530 lawyers in 14 offices throughout the Southeast and Mid-Atlantic United States and in Silicon Valley. Michael is a mass tort and complex commercial litigation attorney with over 30 years of experience representing clients in bet-the-company litigation.  His practice today includes acting as trusted advisor to senior level executives on risk management, cost control and litigation management issues.  In addition to his leadership role in the...

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Mark J. Vaders FDA Litigation Attorney Womble Bond Dickinson Winston-Salem, NC
Associate

Mark Vaders provides cost-effective scientific and legal solutions to clients whose branded products are regulated by the FDA and state agencies. He has assisted in drafting many submissions to FDA’s Center for Tobacco Products, and serves as an in-house resource on vapor product science. His practice also focuses on developing legal- and science-based defenses to product liability lawsuits. Mark has provided counsel to RJ Reynolds Tobacco Company, RJ Reynolds Vapor Company, a leading national supplier of scientific and medical equipment, a global reinsurance provider, and other clients....

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Patrick Spaugh, Womble Carlyle Law Firm, Commercial Dispute Litigation Attorney

Patrick focuses his practice on assisting clients in complex commercial disputes.  He adds value to clients by scrutinizing the facts during discovery, delving into case law to perfect dispositive motions, and leaving no stone unturned to ensure that cases are exhaustively prepped at each stage of litigation.

Patrick has helped defend a Fortune 500 company in a putative ERISA class action; a commercial bank in a putative civil RICO class action; businesses in general commercial disputes often involving claims for Unfair and...

704-331-4962
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