‍What is proposition 65?

In November 1986, a ballot initiative, commonly referred toas Proposition 65 (aka. Prop 65) and formally titled The Safe Drinking Waterand Toxic Enforcement Act, was passed in the state of California. The goal ofProp 65 is to protect the drinking water from toxic substances as well as toaddress public concern regarding consumer exposure to both naturally-occurringand synthetic chemicals.

Who regulates prop 65?

Proposition 65 is implemented by the California Office ofEnvironmental Health Hazard Assessment (OEHHA), a department within theCalifornia Environmental Protection Agency (CalEPA). The OEHHA utilizesscientific data regarding the health risks posed by environmental contaminantsto compile and maintain the list of substances subject enforcement under Prop65.

Businesses are required to provide a “clear and reasonable”warning to Californian consumers if their product could cause exposure to anyof the over 900 listed chemicals, thus enabling Californians to make informeddecisions regarding their health. Any business selling a consumer good toCalifornia, whether directly or indirectly, is subject to Proposition 65 lawand the warning requirement.

What products need a prop 65 warning?

Proposition 65 warnings can be found on a variety ofconsumer products such as insecticides, building materials, household cleaningsupplies, food, elevators and cars and in a variety of settings like hospitals,grocery stores and restaurants.

Which chemicals are included under prop 65?

Known carcinogens such as asbestos and nicotine are includedon the list, but also naturally-occurring environmental substances like heavymetals, such as lead and cadmium. The published list even contains substancessuch as aloe vera extract and gentian violet, plants commonly used as analternative to traditional therapies as well as commonly prescribed medicines,such as doxycycline, an antibiotic and lovastatin, a cholesterol-lowering drug.

The chemicals on the Prop 65 list have been evaluated by theOEHHA and have been determined that exposure through breathing, swallowing ortouching may cause cancer, reproductive toxicity and birth defects.

What types of warnings are required under prop 65?

Proposition 65 differentiates between two different types oftoxicities: cancer and reproductive. If the product can potentially poseconsumer exposure to a published chemical, the chemical and associated toxicitytype should be identified in a warning following the format below:

WARNING: Consuming this product can expose youto chemicals including [name of one or more chemicals], which is [are] known tothe State of California to cause cancer and birth defects or other reproductiveharm. For more information go to www.P65Warnings.cs.gov/food.

Many Prop 65 chemicals have a safe harbor level, developedby the OEHHA. Safe harbor levels can vary depending on the type of toxicity; NoSignificant Risk Levels (NSRLs) are for those chemicals with a cancer risk andMaximum Allowable Dose Levels (MADLs) are for those chemicals with areproductive harm or birth defect risk. The Safe Harbor Level identifiesthe highest daily level of exposure to a listed chemical where businesses donot need to provide a Prop 65 warning.

NSRLs are defined by the OEHHA as “the level of exposurethat would result in not more than one excess case of cancer in 100,000individuals exposed to the chemical over a 70-year lifetime.” Take lead forexample, a naturally-occurring heavy metal that OEHHA lists as both a cancerand reproductive toxicity Prop 65 chemical. Lead has an NSRL of 15 micrograms(mcg) / day, meaning that if a person was exposed to 15 mcg of lead per day for70 years, they would have a 1/100,000 chance of developing cancer as a resultof that level of daily lead exposure. To put this into perspective,according to information released in 2018 by the AmericanCancer Society, both women and men have a 1/3 risk of developing cancer inher or his lifetime.

MADLs are calculated in a highly conservative method by theOEHHA, based on identifying the level of exposure shown to cause reproductiveharm and dividing the number by 1,000. Any product with 1/1000th of the amountshown to cause harm would be subject to Prop 65 requirements. Lead has an MADLwhich is listed at 0.5 mcg / day. Therefore, any product exposing the consumerto 0.5 mcg or more of lead daily must provide a reproductive toxicity warningto the consumer, even though this level is 1/1000th of the amount shown tocause harm.

What chemicals could be in dietary supplements?

Chemical elements such as lead, arsenic and mercury areabundant throughout the world. These heavy metals occur naturally in the air,water and soil and levels can vary depending on region and season. Ingredientssuch as botanicals and minerals, since they originate from the earth, naturallycontain trace amounts of these and other elemental metals.

At MotherWit Wellness, we source many botanical and mineralingredients for use in our high-quality formulas. We strive to keep ourcustomers informed and our products contain only the purest and most potentingredients. Our goal is to use the most natural ingredients possible, whichmeans there are naturally occurring miniscule traces of common environmentalheavy metals in our products.

How do proposition 65 limits compare to federal chemicallimits?

Proposition 65 limits are based on the evaluations performedby the OEHHA. Other federal regulating bodies such as the Food and Drug Administration,Occupational Safety and Health Administration and Environmental ProtectionAgency all have a different set of limits for certain contaminants.

Lead is a chemical listed on the Proposition 65 list and anyproduct that exceeds a daily exposure of 0.5 mcg requires notice to theconsumer for a reproductive toxicity warning. To put this level intoperspective, 0.5 mcg is the amount of lead that can be found in about ½ cup offresh spinach. The World Health Organization established a limit for lead consumptionof 250 mcg per day for the average adult. This variation in levels shows thedifferent perspectives that agencies have.

Are products labeled with a Prop 65 warning dangerous?

The guidelines developed by Prop 65 are much more stringent thanmany of the Environmental Protection Agency’s (EPA) and the U.S. Food and DrugAdministration’s (FDA) guidelines for exposure to chemicals. As an example, thelimit for lead in drinking water set by the EPA is 15 mcg/L, whereas the Prop65 threshold for any product containing lead is 0.5 mcg. The FDA’s limit fordaily lead exposure, also known as the Interim Reference Level (IRL), is 12.5mcg per day.

For additional reference, many foods naturally containlevels of heavy metals and are exempt from Prop 65 regulations. For example, darkchocolate contains an average of 0.92 mcg of lead per ounce, which exceeds Prop65 guidelines. Additionally, grape juice contains around 2.6 mcg of lead perserving, which is over five times the limit advised by Prop 65.

What does a Prop 65 warning on supplements mean?

Unlike food, supplements containing certain chemicals arerequired to carry a Prop 65 label even if all ingredients in a dietarysupplement are naturally occurring. Heavy metals, including arsenic, cadmium,lead, and mercury, are prevalent in the soil and water. These metals can thenaccumulate in plants commonly used in the production of dietary supplements.

Most vegetable, fruit, and herbal matter is likely tocontain some level of contaminants—whether it be from pesticides, herbicides,or heavy metals. It is helpful to note that the level of exposure to thesesubstances is minimal and average daily intake is well below the tolerablelimits determined by the EPA and FDA.

MotherWit Wellness takes precautions to ensure the safety ofour products. If you live in California, you may notice some of yoursupplements carry a Prop 65 warning label on the packaging. This is a clearsign that our company is compliant with California law. This warning labelsimply means that the supplement contains trace amounts of certain chemicalsthat may pose a small risk. 

In Summary

While receiving a product with a Prop 65 warning label maycause, chemical exposure is generally low when products are used as directed.Prop 65 regulations are particularly strict and more rigorous than theguidelines set by the EPA and FDA. Use supplements as directed and speak toyour healthcare practitioner if you have any concerns.

Where can i learn more?

For more information about Prop 65 law or to see thecomplete chemical list visit the OEHHA Prop 65 website.