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.