California Prop 65
What is California’s Proposition 65?
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, now universally known as Proposition 65, is a law that applies only in the State of California. Proposition 65 mandates the publication of a list of chemicals that the State of California determines causes cancer or birth defects, and requires companies that sell products that contain those chemicals to inform California residents about the risk of exposure to such chemicals by including a warning notice on the product label.
Since 1986, the two Proposition 65 lists have expanded to include more than 800 chemicals. Even if a chemical has not been shown to cause cancer or birth defects in humans, but has been shown to do so in animal testing, the chemical is still required to be placed on the applicable Proposition 65 list.
Proposition 65 warning notices can be seen throughout California, in various settings such as restaurants, grocery stores, hotels, bars, schools, hospitals, and theme parks.
What Chemicals Are on the Proposition 65 Lists?
The two Proposition 65 lists encompass a wide range of naturally-occurring and man-made chemicals. Listed chemicals not only include ingredients found in pesticides, insecticides, and construction materials, but also ingredients contained in common household products like foods, drugs, alcoholic beverages, and nutritional supplements.
Some chemicals on the Proposition 65 list – such as lead, cadmium, and arsenic – are found naturally in the environment all over the world. Therefore, some products that naturally contain these substances can be required to carry a Proposition 65 warning notice on their product label, such as mineral and botanical ingredients contained in nutritional supplements.
Are Other States Affected by Proposition 65?
Proposition 65 only applies in California. A company that sells consumer goods in California – whether or not the company is located in California – is subject to Proposition 65's warning notice requirement. Proposition 65 warning notices are not required to be included on the labels of products that are sold in other states.
Are Products with a Proposition 65 Warning Notice Unsafe?
When a manufacturer includes a Proposition 65 warning notice on a product, it does not mean the product is unsafe. Rather, the warning notice is intended to inform California consumers of the presence of a Proposition 65-listed chemical so the consumer can make an informed decision when purchasing the product.
How Does Proposition 65 Determine the Threshold Levels for Which a Warning Notice Is Required?
Proposition 65 establishes two criteria to define the level of exposure risk. The first criterion is cancer risk, and the second criterion is birth defect or other reproductive harm risk.
The maximum daily exposure threshold for a cancer-risk chemical is determined using the "no significant risk level." The "no significant risk level" is defined as the maximum daily level of exposure that would result in not more than one additional case of cancer in 100,000 individuals exposed to that specific chemical every day for 70 years. In other words, a person who was exposed for 70 years to the maximum daily limit of the chemical at the "no significant risk level" would have no more than a one-in-100,000 chance of developing cancer as a result of that 70-year exposure.
The maximum daily exposure threshold for a birth defect-risk chemical is determined using the "no observable effect level." The "no observable effect level" is defined as the maximum daily level of exposure that has been shown to not cause any birth defects or reproductive harm in laboratory animals or humans. In addition, as a margin of safety, the "no observable effect level" is divided by 1,000 to establish the threshold for requiring a Proposition 65 warning notice for that chemical.
What is NeonMind doing regarding Proposition 65?
NeonMind follows all the FDA regulations focused on Comprehensive GMP (Good Manufacturing Practices) to ensure the identity, purity, quality, strength and composition of dietary supplements. Each raw ingredient is tested for its identity, heavy metals, solvent residues and purity. For many botanicals we go through the HPLC-UV testing methods to ensure all the COAS and standard procedures submitted by the raw material companies for reagents, solvents procedures, calculation and standardization of chemicals meet the requirements as part of our due diligence for the suspected presence of chemicals listed by California Proposition 65. If at any stage a NeonMind product contains an amount of a naturally occurring chemical which is above a proposition 65 threshold, the company will use an appropriate warning notice on the product label. In many botanicals if the material is per gravity the results can differ using the HPLC methods. NeonMind follows a strict US Pharmacopeia guidelines for lead and other chemicals required by Proposition 65 for safe and daily intake. All final production batch is sent to a third party lab for final Microbial testing which is issued to enhance the homogeneity and stability of the final product for storage and shelf life. Neon mind products go through rigorous testing and label dosage requirements with proper directions for consumers.
How Can I Learn More about Proposition 65?