What is California’s Prop. 65 Initiative?
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. There are over 800 chemicals on this list including lead and mercury . Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products that they purchase. Prop 65 also prevents businesses from knowingly discharging toxic compounds into drinking water or onto land where they can pass into drinking water. The intent is that this information enables California residents to make informed decisions about protecting themselves from exposure to these chemicals.
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?
One example of a nutrient possibly requiring labeling is vitamin A, if it is above a certain level in a supplement. Additionally, 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 exposure to toxic chemicals and their impact on our health. Proposition 65 ensures that Californians are aware of all exposures that have the potential to impact their health.
Are dietary supplements labeled with the Prop 65 warning unsafe?
A Prop 65 warning does not mean that a product will cause cancer or reproductive harm when used as directed. For example, for reproductive toxins, the level for warnings is 1000 times lower than the lowest level at which animal studies reported no reproductive health effect. At this dose, the risk of harm may be very low, yet a product still requires the Prop 65 warning.
One 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. This means that about 1/4 cup of the water considered safe by the EPA would bring you beyond the safe daily limit according to Prop 65. Additionally, many foods contain naturally-occurring lead from soil, but are not subject to be labeled with the Prop 65 warning. One ounce of dark chocolate contains about 0.6 mcg of lead, which would also exceed the safe limit of lead by Prop 65 standards. We raise this comparison not to scare you, but to put into perspective how the standard set by Proposition 65 is extremely low. Good quality supplement manufacturers take every precaution possible to ensure a safe product. At Ayush Herbs/RUved, we are confident that the brands we carry care very much about delivering products that are not only safe, but beneficial to patient health. 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.
What is the required warning?
The State of California requires dietary supplement companies to label products containing ingredients on their list with the following warnings: WARNING: THIS PRODUCT [MAY] CONTAIN[S] CHEMICALS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.
How does Proposition 65 affect dietary supplements?
Dietary supplement manufacturers address Proposition 65 in several different ways: Specific products for sale in California may by reformulated to meet the requirements of Proposition 65.
We do carry products with a different California-specific formulation. 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” limit according to 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. As a healthcare provider, am I responsible to inform patients of exposure to harmful chemicals? All businesses with 10 or more employees are responsible to inform consumers of exposure to chemicals on the Proposition 65 list. This includes cleaning products, office supplies, and may include recommended dietary supplements they may come into contact with. If your practice has 10 or more employees, you should reach out to the State of California to ensure you are compliant with the law.