California Proposition 65
To protect its sourcing partners and business interests, Earthotic, LLC will include the California Proposition 65 WARNING on our product packaging. This WARNING only applies to consumers that live in the state of California.
If your shipping address is within the state of California, you must agree and consent to the following, which applies to products we ship to California:
California Proposition 65 WARNING: Cancer and Reproductive Harm – http://www.P65Warnings.ca.gov/food.
California Proposition 65 WARNING: Consuming this product can expose you to chemicals, including lead, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to http://www.P65Warnings.ca.gov/food.
If you would like more information on Proposition 65, please see https://oehha.ca.gov/proposition-65.
What is Proposition 65?
In 1986, California voters approved an initiative called the Safe Drinking Water and Toxic Enforcement Act due to their concerns of overexposure to toxins. This act is now known as Proposition 65. The state law only applies to California (or any products shipped/sold to California). Propsition 65 requires the state to publish two lists of chemicals: one list of chemicals known to cause cancer and another list known to cause birth defects or other reproductive harm. The state updates these lists once a year. Now, the list has grown to include well over 950 chemicals since it was published in 1987.
Proposition 65 warnings can be found all over California, including restaurants, amusement parks (including Disney Land), work environments, parking lots, hospitals, rental properties and dental offices. You can find the warning label on many consumer products, including products that are 100% natural and have been certified organic.
The list includes all chemicals shown to be a reproductive toxin or carcinogen in laboratory animals. Proposition 65 even includes chemicals that have not been tested on humans or occur naturally in very low quantities (such as lead, which is in soil).
You can find more about Proposition 65 on California’s OEHHA website.
Who does Proposition 65 Apply to?
Proposition 65 applies to all companies doing business in California and requires them to notify consumers of the presence of any chemical on the Proposition 65 list. The list contains a wide range of naturally occurring as well as synthetic chemicals. These chemicals include ingredients in pesticides, food, drugs, household products and the list go on and includes most products that people use every day.
Please note that Proposition 65 does not ban the sale of a product. It only requires that a warning be added to the product that contains a listed chemical. If products sold in California could expose a resident to one or more of the chemicals on the list, then a “clear and reasonable” warning notice must be on the products label. A note for non-California residents, if a law similar to Proposition 65 could be enforced in the other 49 states, the majority of the products you buy would have a warning label.
The Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program. OEHHA is part of the California EPA, which evaluates scientific information on substances considered for placement on the Proposition 65 list. For more information please visit OEHHA’s website https://oehha.ca.gov/proposition-65.
Should I be concerned about a Proposition 65 warning notice?
It’s understandable that consumers are concerned about these product warnings. However, it’s important to understand that just because a product has a warning notice does not necessarily mean it’s harmful. California sets strict threshold limits far below the “safe” limits set by the US Food and Drug Administration (FDA), World Health Organization, Environmental Protection Agency, and various European Health Agencies. Proposition 65 guidelines vary quite a bit from federal labeling guidelines. Under federal law, if a consumable product contains excessive levels of toxins, it’s banned completely.
Proposition 65 can be very confusing to consumers, so it’s important to keep in mind that a warning on a product is a “right to know” and not a ban. For instance, some substances on the list, like lead, are naturally occurring in low levels within the soil, even with organic farming.
All ingredients in Earthotic products are natural and certified organic. Our facilities follow strict FDA guidelines and Good Manufacturing Practices (GMP) — we do not add any synthetic chemicals or ingredients.
Can Proposition 65 be enforced outside of California?
Proposition 65 is a California state law and cannot be enforced with companies that do businesses outside of the state of California. Furthermore, California can only enforce the law were companies ship and/or sell their products in California.
In addition, companies required to display Proposition 65 warnings on their products sold in California are not required to do the same when they sell in other states. While companies that do not do business in California are not required to add the warning notices on their products, many do anyway to avoid possible litigation (in the instance that their product ends up being shipped or sold to California).
If a product that is intended for sale outside of California makes it into the state of California without a warning label, it becomes subject to Proposition 65 litigation.
Why does Earthotic include the Proposition 65 warning label on its products?
To avoid potential litigation, Earthotic labels its products with the Proposition 65 warning to protect the company and its sourcing partners. All herbal fruits and vegetables, even those that are certified organic, will contain some “naturally occurring” contaminants such as heavy metals that are listed on the Proposition 65 list.
Under Proposition 65 these substances require a warning at the strictest levels, much lower than limits set by the FDA. Lead is one of the heavy metals that occur naturally in soil. While the FDA standards for lead is 75 micrograms per day for adults, the Proposition 65 maximum is 0.5 micrograms, which makes it almost impossible to produce supplements that meet the strict Proposition 65 “safe harbor’ limits.
Since these heavy metals occur naturally, this means they are not added by Earthotic’s sourcing partners who are FDA approved and follow Good Manufacturing Practices (GMP) to minimize or completely eliminate heavy metal contamination.
Some argue that Proposition 65 warnings on food conflict with federal law, but California stands firm on their decision that supplements and food will not be removed from the list, even for naturally occurring substances. Since the burden of proof falls on the business, Earthotic has chosen not to invoke the “naturally occurring allowance” due to the complex nature of the law and substantial costs it would incur defending itself in a lawsuit.
*This label is not required for states other than California. We provide this label for instances when we ship products to California.
- American Herbal Products Association (AHPA). (2020). Proposition 65 and the Food We Eat. Answers to frequently asked questions about California Proposition 65.
- Center for Food Safety and Applied Nutrition. Lead in Food, Foodwares, and Dietary Supplements. U.S. Food and Drug Administration.
- Lee, R. M., Smith, C. W., & Elliott, M. E. (2020, November 6). The Evolving Argument Surrounding Federal Preemption of Proposition 65. Pillsbury Law.
Do all products sold in California include the Proposition 65 warning labels?
Not all companies that sell products in California include the Proposition 65 warning labels on their products. For example, small businesses with 9 or fewer employees may be exempt from Prop 65 requirements.
Alternatively, a company may not know that they are required to add the warning to their products and are at risk of being sued. Products that do not display the label may still contain toxins on the Proposition 65 list. You can find updated lists here.
Where can I find more information regarding Proposition 65?
You can find more information about California’s Proposition 65 on the State of California Department of Justice website.
For an in-depth yet easy-to-read article, read Wellness Mama‘s Prop 65 explanation.
In addition, “Why This Warning” will help answer some of the most common questions regarding Prop 65 (like why we have the label even if we aren’t in California).
For more questions, contact us here.