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Proposition 65 Defense

California established Proposition 65, also known as “Prop 65” or the Safe Drinking Water and Toxic Enforcement Act of 1986. Prop 65 requires businesses to publish clear and reasonable warning on any significant amount of chemicals in their products known to cause cancer or birth defects or other reproductive harm. These chemicals are regulated by a list of potentially harmful chemicals, published the State of California’s Office of Environmental Health and Hazard Assessment, which is updated annually.

Since companies with 10 or more employees are subject under the Prop 65 warning requirements, many companies selling FDA regulated products such as foods, cosmetics, drugs, medical devices and tobacco should be aware of the laws applicable to them. The following phrases are an example of “clear and reasonable warning” on product labels, labeling or display as required by Prop 65:

  • "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm."

  • "WARNING: This product contains a chemical known to the State of California to cause cancer."

Companies that fail to comply

with these warning requirements may encounter expensive losses including lawsuits by either the State of California or private attorneys that can be fatal to a business. The penalties for these kinds of lawsuits can amount to $2,500 per day, per violation.


Furthermore, private attorneys involved in these lawsuits can claim for 25% of the penalties in addition to attorney’s fees that often exceed the penalties itself. According to the California’s Prop 65 Enforcement Report, in 2011 alone, private attorneys and environmental activist groups were awarded over $15.8 million in Prop 65 settlements. Of this $15.8 million, 75% of the settlement was awarded due to attorney’s fees.

Let us help your company enter into the California market successfully by minimizing the chance of a Prop 65 violation and allowing us to protect your business from potential issues that may arise from Prop 65.  At FDAeasy.com, our experts have extensive experience with California Proposition 65 and related regulations, including product development, Prop 65 litigation and label review. We will work with you through the whole process to make a smooth and successful transition entering into the California market.