1. What is Proposition 65?

In 1986, California voters enacted Proposition 65 (officially called the California Safe Drinking Water and Toxic Enforcement Act) in response to consumer concerns about the introduction of certain chemical substances into the environment, including drinking water.

Prop 65 requires businesses selling products in California to provide certain warnings to consumers if their products contain a chemical substance “determined by the State of California” to cause cancer or reproductive toxicity. Because this is a California-specific law, it does not matter that federal or other states make the same or opposite determinations as California. Prop 65 warnings can be triggered even when levels of a listed chemical may be next to zero and the product is perfectly safe.

Prop 65 is what is commonly referred to as a “right to know” statute that may require disclosures, but the use of a warning does not necessarily mean a product is unsafe. In fact, Prop 65 does not ban the sale or use of any product for health or safety reasons nor does it determine that a product is safe or unsafe.

While we applaud California’s efforts to alert consumers, Prop 65 is one of the most stringent product labeling laws in the country. Many commentators have criticized the law as ineffective and unnecessary. The U.S. Food and Drug Administration has even warned the State of California about the potential for consumer confusion and deceptive labeling due to Prop 65’s overreaching. Nevertheless, Isagenix is committed to complying with Prop 65 and will provide warnings as deemed appropriate. Isagenix is confident in the safety of its products, which meet all applicable U.S. federal safety standards and are manufactured according to current Good Manufacturing Practices.

2. What does Prop 65 apply to?

Prop 65 applies to consumer products distributed or sold to consumers in California and to environmental and workplace exposures in California.

Prop 65 warnings are very common in California, and customers living in or visiting California see them in many places and on many products. Prop 65 warnings can even be found scattered around Disneyland.

3. What does a Prop 65 warning say?

The State of California has identified several versions of appropriate Prop 65 warnings. The following is an example of an approved food product warning:

“WARNING: Consuming this product can expose you to chemicals including [list chemical or chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.”

4. What substances are on the Prop 65 List?

The State of California maintains a list of Prop 65 chemicals. The list currently contains over 800 chemicals and can be found at oehha.org/prop65.html. Unfortunately, Prop 65 does not make a distinction between substances that are man-made and those that are naturally found in the environment (like in soil and crops). For example, lead is on the Prop 65 list, even though it is a naturally occurring element in products like produce and cocoa.

5. Where do the 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 such metals, which are found in soil, water, air, and rocks, are naturally and commonly present in foods and food ingredients. 

6. What levels trigger the requirement to warn?

Warnings are not required if a business can prove that exposure does not exceed certain astronomically low threshold limits. These limits can be nearly impossible to prove, particularly when a Prop 65 material is naturally occurring and variable.  

• For carcinogens, the threshold is called the No Significant Risk Level (NSRL), which is the level of exposure that would result in no more than one excess case of cancer in 100,000 individuals exposed to the chemical every day for 70 years. In other words, a person exposed to the chemical at the NSRL for 70 years would not have more than a one in 100,000 chance of developing cancer as a result of that exposure.

   

• For reproductive toxicants, the No Observable Effect Level (NOEL) is determined by identifying the highest level of exposure that has been shown to pose no harm to humans or laboratory animals and dividing the NOEL by 1,000. A warning is required for exposures that exceed 1/1000th of the NOEL. In other words, California sets a 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. 

7. Is Isagenix in compliance with federal safety guidelines?

Yes, 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. Isagenix has built its reputation on exceeding all standards commonly used in the nutraceutical industry. Our no-compromise commitment to the quality and safety of our products and ingredients will never change. Product quality – and our Customers’ health – is our highest priority.

8. Where can I get more information about Prop 65?

More information is available from California’s Prop 65 website at oehh.ca.gov/prop65.html. 

9. Proposition 65 Lawsuits

Several privately run public-interest groups, including the Environmental Research Center (ERC), have filed hundreds of lawsuits against nutritional companies, including some of the largest nutrition and dietary supplement companies in the world. These lawsuits generally allege that lead is present in nutritional products such as shakes, capsules, herbal supplements, and bars and that Prop 65 warnings are required. (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.) ERC also filed a suit against Isagenix in 2012.  ERC did not claim that any consumer was hurt and did not seek to recall or ban the sale of any Isagenix product to California consumers. Instead, ERC alleged that Isagenix must provide Prop 65 warnings on some products (which Isagenix had voluntarily elected to do well before the lawsuit was filed, despite its belief that it was and is not required to do so).

Isagenix denied the allegations made by ERC and denied that it must provide Prop 65 warnings. However, to avoid prolonged and extremely expensive litigation (some cases can reach multiple millions of dollars in attorney fees and costs), Isagenix agreed to continue using warnings when processing and shipping orders to California Customers and settled the lawsuit without any admissions or court findings that it violated Prop 65.