California recently finalized changes to its Proposition 65 (Prop 65) warning rules that included significant changes to short-form warning statements for product labels. These changes directly affect nicotine‑containing products — including e‑cigarettes, e‑liquids, oral nicotine products, and other consumer goods that can expose consumers to nicotine.
The following are four things that nicotine product sellers should know about the Prop 65 regulation changes.
1. What is Prop 65 and how does it affect nicotine products?
In general, Prop 65 prohibits any “person in the course of doing business” from “knowingly and intentionally expos[ing] any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving a clear and reasonable warning.” Cal. Health & Safety Code § 25249.6.
California’s current list of chemicals known to cause cancer, birth defects, or other reproductive harm that require a Prop 65 warning has approximately 900 chemicals. Nicotine was added as a reproductive toxicant for developmental toxicity in 1990.
Thus, when a product exposes consumers to a listed chemical, the manufacturer, producer, packager, importer, supplier, distributor, or retailer generally must provide a “clear and reasonable” warning regarding the exposure unless an exemption applies.
To fall within a “safe harbor” for a “clear and reasonable” warning, California regulations provide that the warning must meet specific (1) formatting requirements depending on the selected “method of transmission” (e.g., posted sign, shelf tag, label, electronic device, webpage) and (2) content requirements that generally consist of a Prop 65 warning symbol and warning statement. See Cal. Code Regs. tit. 27, §§ 25601–25603. For product labels, the regulations outline alternative, short-form statements.
2. What are the warning statements and what has changed?
Effective January 1, 2025, California’s Office of Environmental Health Hazard Assessment (OEHHA) made several key changes to the content of the safe harbor warning statements.
First, rather than requiring the warning statement to begin with “WARNING:“, the regulations allow sellers to use the alternative words, “CA WARNING:” or “CALIFORNIA WARNING:” to make clear to consumers that the warning is a California-specific requirement.
Second, the alternative short-form warning statements for product labels are now markedly longer. Previously, the warning statement read “WARNING: Cancer – www.P65Warnings.ca.gov.” for exposures to listed carcinogens and “WARNING: Reproductive Harm – www.P65Warnings.ca.gov” for exposures to listed reproductive toxicants. Now the warning statements must identify at least one listed chemical after the words “WARNING:,” “CA WARNING:“, or “CALIFORNIA WARNING:“, including:
- For exposures to listed carcinogens, the words:
- “Cancer risk from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or
- “Can expose you to [name of chemical], a carcinogen. See www.P65Warnings.ca.gov.”
- For exposures to listed reproductive toxicants, the words:
- “Risk of reproductive harm from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or
- “Can expose you to [name of chemical], a reproductive toxicant. See www.P65Warnings.ca.gov.”
- For exposures to both listed carcinogens and reproductive toxicants, the words:
- “Risk of cancer from exposure to [name of chemical] and reproductive harm from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or
- “Can expose you to [name of chemical], a carcinogen, and [name of chemical], a reproductive toxicant. See www.P65Warnings.ca.gov.”
- For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words:
- “Risk of cancer and reproductive harm from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”; or
- “Can expose you to [name of chemical], a carcinogen and reproductive toxicant. See www.P65Warnings.ca.gov.”
Third, the regulations provide for a transition period for the short-form statements. Specifically, products manufactured and labeled prior to January 1, 2028 may continue to use the original short-form warning content.
Fourth, the regulation changes provided additional information regarding safe harbor warning requirements for internet purchases with two notable clarifications: (1) internet webpages must display the required Prop 65 warning on the product display page, provide a clearly marked hyperlink using the word “WARNING” or the words “CA WARNING” or “CALIFORNIA WARNING” on the product display page that links to the warning, or otherwise prominently displays the warning to the purchaser prior to completing the purchase; and (2) if the on‑product label uses a new short‑form warning, the online warning may use the same, short-form content.
3. What does the new short-form warning look like for nicotine products?
Under the amended regulations, a short‑form warning on a label for a product containing nicotine must generally include:
- The Prop 65 warning symbol. This consists of a black exclamation point in a yellow triangle, unless the label is not printed using yellow, in which case the symbol may be black-and-white.
- The words “WARNING:”, “CA WARNING:”, or “CALIFORNIA WARNING:” in bold and all caps.
- The exposure statement. Because nicotine is listed for reproductive toxicity (developmental), a typical nicotine product will use a reproductive‑harm short-form statement. This would either be “WARNING: Risk of reproductive harm from exposure to nicotine. See www.P65Warnings.ca.gov.” or “WARNING: Can expose you to nicotine, a reproductive toxicant. See www.P65Warnings.ca.gov.”
If the nicotine product also exposes consumers to other Prop 65 chemicals, additional warnings may be required. Businesses need to evaluate their full chemical exposure profile — not just nicotine — to select the correct wording and chemical names.
4. Are California’s Prop 65 warning requirements, as applied to nicotine products, preempted by federal law?
Yes and no.
At least one federal court has ruled that Prop 65’s labeling requirements are preempted by the Federal Food, Drug, and Cosmetic Act, which expressly states that no State can impose “any requirement which is different from, or in addition to” the FDA’s labeling requirements. See In re Fontem US, Inc., Nos. SACV 15-01026, SACV 15-02018 (C.D. Cal. Nov. 1, 2016); 21 U.S.C. § 387p(a)(2)(A). Nevertheless, the same court found that the other non-labeling methods of satisfying Prop 65’s requirements, such as point-of-sale signage, were not preempted.
Thus, nicotine product companies likely must still provide the Prop 65 warning statement in some fashion—even if they elect not to do so through product labeling.
Takeaways
Sellers of nicotine products in California should assess their compliance with Prop 65 in California and develop plans to update any short-form labels ahead of the transition to the new requirements on January 1, 2028.
Our team has extensive experience advising companies in this area. If you have any questions or concerns regarding how these requirements might apply to your products, please do not hesitate to contact us.
(This post is for informational purposes only and does not constitute legal advice. You should consult counsel about how these rules apply to your specific products and distribution channels.)