1. What is Proposition 65 (Prop 65)?
Prop 65 is what is known as a "right to know" statute. The California voters enacted Prop 65 in 1986 as the Safe Drinking Water and Toxic Enforcement Act. Prop 65 requires companies to provide "clear and reasonable" warnings to consumers if their products contain a chemical determined by the State of California to cause cancer or reproductive toxicity. Prop 65 was enacted in response to consumer concern about the introduction of chemicals into the environment, including drinking water. The law governs extremely low levels of chemicals and is among one of the most stringent reporting laws in the country. The presence of these low levels of chemicals necessitates warnings only. Prop 65 does not ban the sale or use of any product for health or safety reasons. Over 800 chemicals are currently listed under Prop 65, many of which may be naturally present in the environment.
2. What is the Prop 65 warning?
The State of California has identified the following Prop 65 warning as clear and reasonable for consumer products: "WARNING: This product contains chemicals known to the State of California to cause cancer, birth defects or other reproductive harm."
3. What products require the Prop 65 warning?
The law governs warnings for consumer products distributed or sold in California to consumers. Naturally occurring levels of chemicals in foods do not require warnings. Furthermore, warnings are only required for amounts that exceed daily exposure thresholds based on average consumption. In addition to consumer products, the law covers warnings for environmental and workplace exposures to listed chemicals.
4. What chemicals are subject to Prop 65 warnings?
Prop 65 requires the State of California to maintain a list of chemicals that it identifies as carcinogens or reproductive toxicants. This list is routinely updated to add or delete chemicals. The current list contains over 800 chemicals and can be found at www.oehha.org/prop65.html.
5. Where do these chemicals come from?
Many commonly used ingredients, including cocoa, calcium, and magnesium can contain naturally occurring levels of Prop 65-listed chemicals. For example, lead and other heavy metals, which are widely distributed in soil, water, air, and rocks, can be naturally -- and commonly --present in foods and food ingredients. Isagenix does not intentionally add any lead or heavy metals as ingredients to any of its products.
6. What levels trigger the requirement to warn?
A company that sells a product in the State of California does not need to provide a warning for any exposures if it can show that the exposures do not exceed regulatory threshold limits, which are very stringent. For carcinogens, this is the “No Significant Risk Level,” which is the level of exposure that would result in no more than one case of cancer in 100,000 individuals exposed to the chemical every day for 70 years. For reproductive toxicants, it is the “Maximum Allowable Daily Level,” which is level at which no reproductive toxicity effects are observed in laboratory animals, divided by an extremely conservative 1000-fold safety factor.
7. Is Isagenix in compliance with Federal safety guidelines?
The warning thresholds identified by Prop 65 are often significantly lower than safety levels identified by the Federal government. Isagenix products are in full compliance with all federal guidelines for product safety including those manufacturing and safety guidelines established by the Food and Drug Administration.
8. Where can I get more information about Prop 65?
For more information on Prop 65 please see the Prop 65 web site maintained by the State of California at www.oehh.ca.gov/prop65.html or by calling (916) 445 - 6900.
9. Isagenix Statement – Environmental Research Center Proposition 65 Lawsuit
Environmental Research Center (ERC), a privately run “public interest” group, recently filed a lawsuit against Isagenix alleging a violation of California’s Proposition 65. ERC claims that Isagenix is required to provide warnings for lead for several products under California’s Proposition 65. This is not a class action complaint and does not allege that any California consumer has been hurt; ERC is the only plaintiff making these Proposition 65 claims. The lawsuit also does not seek to recall or ban the sale of any Isagenix product to California consumers. Instead, ERC is alleging only that Isagenix is required to provide warnings (which Isagenix voluntarily elected to do well before the lawsuit was filed) and seeks payment of certain civil penalties and reimbursement of ERC’s attorneys’ fees and costs.
Isagenix denies the allegations made by ERC and does not believe its products require California Proposition 65 warnings. Isagenix does not intentionally add lead to its products, an element that can be found commonly or naturally in soil, water, and ingredients such as chocolate, calcium, and other dairy products. Isagenix stands behind the safety of its products, which meet all applicable U.S. federal safety standards and are manufactured according to current U.S. Good Manufacturing Practices. While Isagenix supports Proposition 65, it is important to note that Proposition 65 is a “right to know” statute that requires companies to provide warnings and that inclusion of a warning does not automatically mean that the product is unsafe.
Despite its belief that it was not required to do so, Isagenix voluntarily elected to provide Proposition 65 warnings to California customers well before the lawsuit was filed. Given this decision and our belief in the safety of our products, we do not believe that Proposition 65 requires us to make any changes to our product formulas. Isagenix has always prided itself on providing the highest quality no compromise products. Rest assured the safety and efficacy of our products is and will always remain our number one priority.
ERC’s lawsuit is part of a broader campaign targeting the nutritional supplement industry. Since 2010 (around the time that ERC was formed), ERC has issued over 300 Proposition 65 claims concerning other companies, including a number of our competitors and some of the largest dietary supplement companies in the world, alleging exposures to lead in a wide range of nutritional products such as shakes, capsules, herbal supplements, and bars. While many of ERC’s cases have resulted in settlements and many are still pending, to our knowledge, none of ERC's lawsuits have yet gone to trial.
California Proposition 65 has some of the most stringent warning standards in the world. There are over 800 chemicals currently listed under Proposition 65. For certain chemicals that are listed as reproductive toxicants, such as lead, California Proposition 65 warnings are required at extremely low levels that incorporate a 1,000-fold safety factor. In other words, for those chemicals, California sets a warning trigger level that is 1,000 times lower than the level of exposure that has been shown to have no observable effect on humans or animals.