ParaStat – 60 capsules

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.AHPA has launched a new webpage to answer consumers’ questions about California Proposition 65 (Prop 65) and to help companies selling products in California explain to their customers why a product includes a Prop 65 warning and what that warning really means. For more information click here or read more information below.What types of substances exist in dietary supplements that fall under Prop 65?

Proposition 65 regulates substances officially listed by California as having a 1 in 100,000 chance of causing cancer over a 70-year period or birth defects or other reproductive harm in two ways.

1)     The first statutory requirement of Proposition 65 prohibits businesses from knowingly discharging listed substances into drinking water sources, or onto land where the substances can pass into drinking water sources.

2)     The second prohibits businesses from knowingly exposing individuals to listed substances without providing a clear and reasonable warning.

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 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.

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.

For more information about proposition 65, please visit the State of California’s website by clicking here.

What types of substances exist in dietary supplements that fall under Prop 65?
One example of a nutrient possibly requiring labeling if above a certain dosage is vitamin A(retinol/retintyl esters).  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.

For the complete list of substances which fall under Proposition 65, please click here.

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.  Proposition 65 endeavors to make Californians aware of 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 the use of an individual product will cause cancer or reproductive harm when used as directed. There continues to be much debate over what a toxic level or a cumulative toxic level of each different substance is.  As an example, for reproductive toxins the stated level requiring a warning label is 1000 times slower 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.

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.  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.

Good quality supplement manufacturers take every precaution possible to ensure a safe product.  At BioPure Healing Products®, we are confident that the brands 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 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:

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” 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.

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 Proposition 65 list.  This includes cleaning products, office supplies, and may include recommended dietary supplements.