What is Proposition 65 (also called “Prop 65”)?
In 1986, California voters approved an initiative to address concerns about unintended exposure to toxic chemicals. Prop 65 (formally 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 or birth defects or other reproductive harm when repeated exposure to toxic substances above certain thresholds occur. The governor of California is required to have the list updated yearly; currently, there are over 800 chemicals on this list.
The American Herbal Products Association has a webpage that addresses many consumer questions about Prop 65 and to help companies selling products into California explain to their customers why a product includes a Prop 65 warning and what that warning language means.
What types of substances exist in dietary supplements that fall under Prop 65?
Prop 65 regulates chemicals officially listed by California as having a 1 in 100,000 chance of causing cancer over a 70-year period or 1,000 times below the lowest level at which measurable reproductive harm may be detected, in two ways:
- The first statutory requirement of Prop 65 prohibits businesses from knowingly discharging listed chemicals into drinking water sources, or onto land where the substances can pass into drinking water sources.
- The second prohibits businesses from knowingly exposing individuals to listed chemicals without providing a clear and reasonable warning.
The list contains a wide range of naturally occurring and synthetic substances that are known by the State of California to cause cancer or birth defects or other reproductive harm when certain exposure thresholds are met. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust or roasting coffee beans.
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 Prop 65 listed chemicals exist in dietary supplements?
One example of a nutrient possibly requiring labeling if above a certain dosage is vitamin A (retinol/retinyl esters). Additionally, many plant-based foods, even when grown organically, can contain lead, mercury, or other heavy metals due to the absorption of 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. Prop 65 endeavors to make Californian consumers aware of potential exposures so that they may make informed choices that have the potential to affect their health.
Are products 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 is for each different chemical. An example, for listed reproductive toxins, the stated level requiring a warning label is 1,000 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 products would still require Prop 65 warnings.
Another example of this debate is lead. The Prop 65 notice limit for lead is 0.5 mcg per day. The U.S. Environmental Protection Agency’s safe limit for lead in drinking water is 15 mcg/L per day. To help with perspective on how some of the standards set by Prop 65 are extremely low, and how many foods contain naturally-occurring lead from the soil they were grown in, 1 oz. of dark chocolate can contain about 0.6 mcg of lead, which would exceed the safe limit of lead by Prop 65 standards.
Good quality suppliers take every precaution possible to ensure their products are safe. At Emerson, we are confident that the suppliers we carry care deeply 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 the company is compliant with the law – which is really a very good sign.
What is the required warning?
The State of California requires companies to label products containing Prop 65 listed chemicals above certain amounts with clear and reasonable warnings. There is no single required warning statement, and different manufacturers may use different warning statements. For dietary supplements, these warnings may look like one of the following:
- WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.
- WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov.
How does Prop 65 affect the products I purchase?
If you provide a ship-to address within California, and you are purchasing a product with a Prop 65 warning statement on the label, you will also receive a Prop 65 warning statement for that product on your Review Order page.
For some products, suppliers manufacture specific versions for sale only in California with reduced levels of Prop 65 listed substances below notice requirements. If you provide a ship-to address within California, you will automatically receive California formulated versions of these products.
As a healthcare provider, am I responsible to inform patients of exposure to harmful chemicals?
California businesses with 10 or more employees are responsible to inform consumers of potential exposure to chemicals on the Prop 65 list. This includes cleaning products, office supplies, and may include recommended dietary supplements.
If you have questions about Prop 65 or how it affects the products you purchase, please contact us to schedule an appointment with our Medical Education team at (800) 654-4432.