Proposition 65 (Prop 65)
What is Proposition 65?
In November 1986, a ballot initiative, commonly referred to as Proposition 65 (Prop 65) and formally titled The Safe Drinking Water and Toxic Enforcement Act, was passed in the state of California. The primary goal of Prop 65 is to protect drinking water sources from toxic substances and to address public concern regarding exposure to a wide range of naturally-occurring and synthetic chemicals in consumer products.
Who regulates Prop 65?
Proposition 65 is implemented by the California Office of Environmental Health Hazard Assessment (OEHHA), a department within the California Environmental Protection Agency (CalEPA). OEHHA uses scientific data regarding potential health risks to compile and maintain a list of substances subject to Prop 65.
Businesses are required to provide a “clear and reasonable” warning to California consumers if their product could cause exposure to any of the over 900 listed chemicals. This enables Californians to make informed decisions regarding their purchases and health. Any business selling consumer goods to California, whether directly or indirectly, is subject to Proposition 65 law and its warning requirements.
What products might need a Prop 65 warning?
Proposition 65 warnings can be found on a wide variety of consumer products, including insecticides, building materials, household cleaning supplies, food, and even in settings like elevators, cars, hospitals, grocery stores, and restaurants.
Which chemicals are included under Prop 65?
The Prop 65 list includes known carcinogens such as asbestos and nicotine, but also naturally-occurring environmental substances like heavy metals (e.g., lead, cadmium). The list even contains substances such as aloe vera extract and gentian violet (plants sometimes used in alternative therapies) as well as commonly prescribed medicines like doxycycline (an antibiotic) and lovastatin (a cholesterol-lowering drug).
The chemicals on the Prop 65 list have been evaluated by OEHHA, which has determined that exposure (through breathing, swallowing, or touching) may pose risks of cancer, reproductive toxicity, or birth defects.
What types of warnings are required under Prop 65?
Proposition 65 distinguishes between two main types of toxicities: cancer and reproductive harm. If a product could potentially expose a consumer to a listed chemical, the chemical and its associated toxicity type should be identified in a warning,
typically following this format:
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.
Many chemicals listed under Proposition 65 have “safe harbor levels” developed by OEHHA. These levels can vary depending on the type of toxicity: No Significant Risk Levels (NSRLs) are for chemicals with a cancer risk, and Maximum Allowable Dose Levels (MADLs) are for chemicals with a reproductive harm or birth defect risk. The Safe Harbor Level identifies the highest daily level of exposure to a listed chemical where businesses are generally not required to provide a Prop 65 warning.
NSRLs are defined by OEHHA as “the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime.” For example, lead, a naturally-occurring heavy metal listed by OEHHA as both a cancer and reproductive toxicity chemical, has an NSRL of 15 micrograms (mcg) per day. This means if a person was exposed to 15 mcg of lead daily for 70 years, they would have an estimated 1/100,000 chance of developing cancer due to that specific exposure. (To put this into perspective, according to 2018 information from the American Cancer Society, both women and men have approximately a 1/3 lifetime risk of developing cancer from all causes.)
MADLs are calculated by OEHHA using a highly conservative method, typically by identifying the level of exposure shown to cause no observable reproductive harm and then dividing that number by 1,000. Any product exposing a consumer to 1/1000th of the amount shown to cause harm (or more) would be subject to Prop 65 warning requirements for reproductive toxicity. Lead, for instance, has an MADL of 0.5 mcg per day. Therefore, any product potentially exposing a consumer to 0.5 mcg or more of lead daily must provide a reproductive toxicity warning, even though this level is 1/1000th of an amount demonstrated to cause no observable harm.
What chemicals could be in dietary supplements like those from Nutropx?
Elements such as lead, arsenic, and mercury are naturally present throughout our environment – in the air, water, and soil. Their levels can vary by region and season. Ingredients commonly used in dietary supplements, such as botanicals (plants and herbs) and minerals, originate from the earth and can therefore naturally contain trace amounts of these and other elemental metals.
At Nutropx, we are deeply committed to sourcing the highest quality ingredients for our premium, science-backed formulas. We believe in transparency and aim to provide our customers with products that are both pure and potent. Because we prioritize natural ingredients where possible, and because these ingredients come from the earth, it is possible that our products may contain minuscule, trace levels of common environmental heavy metals. We conduct rigorous testing and strive to ensure these levels are as low as feasibly possible while delivering effective products. We encourage our customers to understand that these elements are naturally occurring and widely present in many foods and natural products.
How do Proposition 65 limits compare to federal chemical limits?
Proposition 65 limits are based on evaluations performed by OEHHA and are specific to California. Other federal regulatory bodies, such as the U.S. Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA), all have their own sets of limits and guidelines for certain contaminants, which may differ from Prop 65 levels.
For example, lead is listed on Prop 65, and any product exceeding a potential daily exposure of 0.5 mcg requires a reproductive toxicity warning for California consumers. To put this into perspective, 0.5 mcg is an amount of lead that can be found in common healthy foods, such as approximately ½ cup of fresh spinach. The World Health Organization (WHO) has established a provisional tolerable weekly intake for lead, which translates to a much higher daily guideline for adults (e.g., around 250 mcg per day for an average adult, though this is a general guideline and not a strict regulatory limit for all contexts). This variation in levels illustrates the different methodologies and focuses of various agencies.
How is Proposition 65 enforced, and are there penalties for non-compliance?
Proposition 65 is enforced by the California Attorney General’s office, as well as by district attorneys and certain city attorneys. Additionally, any individual acting in the public interest can file a lawsuit against a business alleged to be in violation of Prop 65. Civil lawsuits are a common enforcement mechanism.
Monetary penalties for failing to provide warnings can be as high as $2,500 per day, per violation. Many businesses have faced lawsuits for non-compliance. Proving compliance or defending against a lawsuit can be costly, leading many companies to settle such litigations out of court.
Where can I learn more?
For more detailed information about Proposition 65 law or to see the complete chemical list, please visit the official OEHHA Prop 65 website: www.P65Warnings.ca.gov. For food-specific information, you can visit www.P65Warnings.ca.gov/food.
