California Proposition 65 Disclosures

Proteins, plants, and minerals all are well-known to naturally contain chemicals and substances that exceed the allowed exposures set by the California Proposition 65 (“Prop 65”) rules and regulations. Naturally grown plants absorb metals and other trace chemicals from the soil in which the plants grow. Prop 65 sets a safe harbor limit of 0.5 micrograms of lead per serving to prevent birth defects or other reproductive harm, but this limit is substantially below the amount of lead naturally occurring in many fruits and vegetables grown in clean, non-contaminated soils.

In fact, in 2009, the State of California conducted a soil-lead-uptake analysis of its own food products regularly consumed from grocery stores (See: Agriculture, Ecosystems and Environment 129:212-220), and the researchers found that the most commonly consumed vegetables (from 70 different locations), averaged lead exposures nearly four times the Prop 65 lead limit per serving to prevent birth defects or other reproductive harm.

As an example, when compared with the Prop 65 standard described above, each serving of potatoes, lettuce, wheat, carrots, and certain other vegetables would require a lead warning for birth defects or other reproductive harm.

Kroma tests all of its products as a whole for compliance with California Proposition 65 (“Prop 65”) and federal Food and Drug Agency ("FDA") requirements. Prop 65, as amended, was formerly known as the Safe Drinking Water and Toxic Enforcement Act of 1986. Prop 65 regulates exposures, not concentrations and not actual harm or injury.

Many natural proteins, for example, naturally have high levels of lead. Any processes to remove the lead from the protein would destroy the protein. All Kroma Wellness, PBC (“Kroma”) products are within FDA-suggested guidelines for any/all of the chemicals listed by Prop 65 and can be safely consumed.

Prop 65 states that no warning is required when the substance listed in the Prop 65 rules and regulations naturally occurs in a food product, and not as the result of “known human activity.” However, the State of California has never issued clear guidelines on how this exception applies to the health supplement industry. Even when the ingredient is natural, and placed into a supplement, Kroma complies with the Prop 65 warning requirement.

It is generally understood that lead and other substances and chemicals listed in the Prop 65 rules and regulations naturally occur in the environment and are found in trace amounts in many naturally occurring ingredients, including those ingredients commonly used to make dietary supplements like those offered by Kroma. However, claiming any exception to Prop 65 and determining not to publish a Prop 65 warning may result in expensive and time-consuming legal proceedings.

Almost all foods contain some level of one or more of the chemicals and substances recognized by the State of California to cause cancer and birth defects or other reproductive harm. In some cases, the exposure levels established by Prop 65 are less than what naturally occurs in certain fruits, vegetables, and drinking water. Although many fruits and vegetables naturally exceed the limits set under Prop 65 rules and regulations, food producers are not required to provide Prop 65 notices.

Kroma strives to comply with Prop 65 and will continue to place Prop 65 Warnings as appropriate until there is legislation to better align Prop 65 standards and limits to the exposure levels of the Prop 65 recognized chemicals and substances naturally occurring in fruits and vegetables.