In 1986, the voters of California passed Proposition 65 (aka “Prop 65”), making The Safe Drinking Water Act of 1986 law. Prop 65 forbids businesses from knowingly exposing individuals to chemicals known by the State of California to cause cancer or reproductive harm, without giving clear and reasonable warning. The State of California’s Office of Environmental Health Hazard Assessment administers Prop 65 by determining and publishing the State’s list of chemicals (aka “Listed Chemicals”) known to cause cancer or reproductive harm.
With few exceptions, companies with 10 or more employees that sell products containing Listed Chemicals in California are subject to Prop 65 warning requirements. These requirements apply to many firms selling FDA regulated commodities such as food, cosmetics, drugs, tobacco and medical devices. The required warning must appear on the product label, labeling or display and must explicitly and conspicuously disclose the danger. California regulations require the following wording:
- “WARNING: This product contains a chemical known to the State of California to cause cancer."
- "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm."
These warnings can be very damaging to sales. Yet, failure to comply with Prop 65 can also be devastating. Subject companies that fail to include the required warnings potentially face expensive lawsuits by either the State of California or private firms, with penalties of $2,500 per day, per violation. Private attorneys can also sue for up to 25% of the penalties and frequently obtain attorney’s fees far in excess of the penalties. According to California’s Prop 65 Enforcement Report, in 2011 there were 338 Prop 65 Settlements, for a total of $16.2 million ($48k per Settlement). 327 of the Settlements were with private attorneys or environmental activist groups, for over $15.8 million, with 75% of this money going to attorney’s fees.
FDAImports.com applies its knowledge and experience of California Proposition 65, as well as California & federal law and regulations, to help your company penetrate the lucrative California market, while minimizing your exposure to Prop 65 lawsuits and other legal pitfalls. We assist established companies and startups into the California market, helping you to create successful brands for 38 million potential Californian customers. Contact us for product label reviews, new product development, litigation support, Internet and website claims review and consulting.