The Prop 65 Supplement Warning: What You Need to Know

In this article, we will discuss the California law Prop 65, its impact on the supplement industry, and what it means to the consumer.

What is Prop 65?

Prop 65 is a law passed by California voters in 1986. Formerly known as The Safe Drinking Water and Toxic Enforcement Act of 1986, the goal of the law was to protect drinking water and other products such as health supplements from toxins believed to cause cancer and birth defects.

Prop 65 has two statutes:

• Statute 1. Prohibits businesses from knowingly discharging substances on the list into drinking water sources or onto land where they can eventually reach drinking water sources.
• Statute 2. Prohibits businesses from knowingly exposing individuals to substances on the list without providing a clear warning.

Warning Labels

Prop 65 was specifically designed to allow consumers the opportunity to decrease their exposure to harmful substances or avoid them altogether via easily identifiable cautionary labels.

As a result, all products sold in California containing chemicals listed in Prop 65 come with a warning:

WARNING: This product contains chemicals known to the State of California to cause birth defects, cancer, or other forms of reproductive harm.

The wording can be modified to fit each specific product, as long as consumers are alerted to its dangers per California law.

Prop 65 List

Currently, there are over 800 items listed on the Prop 65 list, including the following:

To see the complete list, click HERE.

Understanding Prop 65

It is important for consumers to understand what is in their food and supplements. While Prop 65 is designed to protect individuals from harm, understanding the labeling process is critical as well. For example, not all substances on the list are intentionally added to products. Lead, cadmium, and mercury occur naturally, and can be found in some soil and water samples. Another product made in a factory where car exhaust is present may have a warning label as well.

Unfortunately, the labels won’t identify which substance is in the product, how much is in the product, if it was purposely added, or the consumer’s level of exposure.

Safe or Unsafe?

Prop 65, the FDA, and its European counterpart (European Food Safety Authority) each have their own regulations for deeming products as safe or unsafe. Labeling criteria are based on exposure levels for each individual substance. Prop 65 follows a more stringent listing, with some substances up to 1000 times below FDA standards for safety.

Prop 65 labeling criteria include the following:

• Carcinogens. A lifetime exposure of amounts that present 1 person in 100,000 risk of having cancer.
• Reproductive toxins. A lifetime exposure of 1 person in 1,000 of the “no observable effect level.”

A ”carcinogen” is defined as a substance or radiation that promotes the formation of cancer cells. The “no observable adverse effect level” (NOAEL) highlights an organism’s level of exposure via observation or experiment, where there is no biologically or statistically significant rise in the frequency or severity of any adverse effects of the tested protocol.

Based on FDA standards, exposure at Prop 65 levels in either category would have shown no adverse effects in animal studies and not deemed hazardous.

Enforcement of Prop 65

Enforcement of Prop 65 is conducted via civil lawsuits. These lawsuits are carried out in cities with populations of over 750,000 and brought by private parties, city attorneys, district attorneys, or the California Attorney General. Businesses in violation of Prop 65 are subject to civil penalties up to $2500 per day for each violation they have committed. The business may be ordered to stop committing the violation as well as be subjected to penalties from unfair business practices violations.

To avoid potential lawsuits, many companies opt to put warning labels on their products, even if the products don’t exceed the limits mandated by Prop 65. This can increase the possibility of one product having a warning label, while another product with identical ingredients is label-free.

Prop 65 Pros and Cons

As a result of Prop 65, California has seen the following benefits:

• Companies removing toxic ingredients from their products
• Reduction of emissions of toxic chemicals into the air
• Increased communication and cooperation between industry and government to remove toxic materials

The law is believed to have increased efforts of companies to comply with laws and making it easier to enforce penalties.

Not everyone is happy with Prop 65. Critics of the California law point out the following:

• Increased prevalence of “over-warning” or “meaningless warnings”
• Lack of communication clarity, or increased confusion for the consumer
• An excessive number of lawsuits filed by private attorneys, or firms focusing exclusively on Prop 65 claims
• Majority of monies received in lawsuits has been applied to attorney’s fees
• Cases have been won without any benefit to the citizens of California

In an effort to protect small businesses from frivolous lawsuits, a reform of Prop 65 (AB 227) was passed in 2013. The bill provided small businesses with a streamlined procedure for compliance, along with a limit on penalties assessed.

Additional Information

Warning labels won’t disclose which toxic substances are in their products or the amounts. To avoid confusion, consumers should contact the product manufacturer directly for additional information.

Revelation Health uses all-natural ingredients in its supplements. Trace amounts of substances listed on Prop 65 may be found in its products, primarily due to natural occurrences. In an effort to provide the best supplements for consumers, no additives, GMO, preservatives or other harmful ingredients have been added. Contact Revelation Health HERE for additional questions about its products.

Conclusion

Prop 65 was specifically designed to alert consumers about hazardous substances in various products and supplements they may use. While beneficial, many may find the warnings too vague or confusing. By gaining a better understanding of Prop 65, a person is one step closer to avoiding hazardous substances and reaching their health goals.