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What is Proposition 65 & How does it affect me?

What is Proposition 65 (also called “Prop 65”) & how does this effect me?

              In 1986, California voters approved an initiative to address concerns about unintended exposure to toxic chemicals. Proposition 65 (also known as the Safe Drinking Water and Toxic Enforcement Act of 1986) requires the State to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm when repeated exposure to toxic thresholds occur. The governor of California is required to have the list updated yearly; currently there are over 800 chemicals on this list.

 What is the required warning?

              The State of California requires dietary supplement companies to label products containing ingredients on their list with the following:


 What types of substances exist in dietary supplements that fall under Prop 65?

              Proposition 65 regulates substances officially listed by California as having an exposure threshold for causing cancer, birth defects or reproductive harm at 1 in 100,000 when taken over a 70 year period.

               The list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm when exposure thresholds are met.

              These may be chemicals, additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents, etc. They may also be used in manufacturing and construction. Californians are no stranger to these warnings, as they are posted in hotels, gas stations, and coffee shops and are found on many products they encounter on a daily basis.

 What types of substances exist in dietary supplements that fall under Prop 65?

              For supplements, the largest group of products that have a warning contain calcium or other minerals. Also, many plant-based foods, even when grown organically, can contain lead and mercury due to absorbing low amounts that are naturally occurring in soil.

 Should I be concerned?

              We should all be concerned about our cumulative exposure to toxic chemicals in our environment and their impact on our health.  Understanding the risk numbers (1 in 100,000 over 70 years of consumption) makes this a personal decision on what we choose to put in our bodies.

 Are dietary supplements labeled with the Prop 65 warning unsafe?

              A Prop 65 warning does not mean that the use of an individual product will cause cancer or reproductive harm when used as directed.   There continues much debate over what a toxic level or a cumulative toxic level of each different substance is.  No reproductive health effect was reported in animal studies when reproductive toxins were taken at 1000 times higher than the lowest level that require a warning label.  At this dose, the risk of harm may be very low, yet a product still requires the Prop 65 warning.

              Another example of this is lead.  The proposition 65 limit for lead is 0.5 mcg per day.  The US Environmental Protection Agency’s (EPA) safe limit for lead in drinking water is 15 mcg/L per day (30x more).  To help with perspective on how some of the standards set by Proposition 65 are extremely low, many foods contain naturally-occurring lead from the soil it was grown in.  One ounce of dark chocolate can contain about 0.6 mcg of lead, which would exceed the safe limit of lead by Prop 65 standards. After some legal discussions, the levels in dark chocolate are considered natural & products are exempt from having Prop 65 warnings.

              Good quality supplement manufacturers take every precaution possible to ensure a safe product.  If you see the Prop 65 warning on a product, it demonstrates that that company is compliant with the law—which is really a very good sign.

How does Proposition 65 affect dietary supplements?

              Dietary supplement manufacturers address Proposition 65 in several different ways:

  • Companies may formulate specific products for sale in California to meet the requirements of Proposition 65 and formulate products with a different formulation that is not California-specific.  Customers outside of California can purchase either of the formulations, but California residents will be restricted to only one.
  • Supplement manufacturers may test every lot of their products to demonstrate that they are within the allowable “safe harbor” limits of Proposition 65.  These limits are often about 1,000 times lower than federally established safe amounts.  If a company can demonstrate a product meets these stringent safe levels, a product does not need to carry the Proposition 65 warning.