Carlson products meet or exceed strict federal safety standards; however, Proposition 65 (Prop 65) requires that a limited number of our nutritional supplements include the following notice when sold in California:
For more information, visit www.p65Warnings.ca.gov. Similar warnings are posted throughout the state in almost every hotel, restaurant, retail store, airport, and gas station, and can even be found throughout the Disneyland theme park.
What is Proposition 65 (Prop 65)?
In 1986, California voters approved an initiative commonly referred to as Prop 65. When it was created, it was designed to prevent toxic chemicals from being dumped into California waters. It also required warnings on products that contained certain hazardous chemicals. Prop 65 is enforced only by civil lawsuits brought on by either public authorities or private parties. Originally there was good reason for the law, but it has since resulted in unanticipated complications. Unfortunately, since Prop 65 was passed by a ballot initiative and not the standard legislative procedure, it’s extremely difficult to change.
Which chemicals are included in Prop 65?
Prop 65 applies to chemicals that the state of California identifies as carcinogens and reproductive toxins. The extent of exposure level and toxicology of the chemicals that might actually cause cancer, birth defects, and/or reproductive harm are heavily debated. And although the list originally included about 30 chemicals, it has since grown to include more than 800 different chemicals.
What levels of chemicals require this warning?
Prop 65 does not set limits on the amount of any one chemical a product can contain, but it does set Safe Harbor exposure levels to identify when label warnings are required. These levels are often 1,000 times lower than the No Observable Adverse Effect Levels (NOAELs) recognized by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), European Union (EU), and World Health Organization (WHO). These Safe Harbor levels are defined by their potential risk:
- Safe Harbor Levels for Carcinogens are called “No Significant Risk Levels” (NSRLs). They are based on the most sensitive study meeting certain requirements and calculations described in regulations for an exposure level that results in one excess cancer in an exposed human population of 100,000.
- Safe Harbor Levels for Reproductive Toxins are called “Maximum Allowable Dose Levels” (MADLs). They are based on the most sensitive study meeting certain requirements at a level that is 1,000 fold below the NOAEL of the study.
Here’s an example: Lead is a heavy metal found naturally in soil. The EPA requires that soil in children’s play areas contain less than 400 mcg of lead per gram of soil, while the Consumer Product Safety Commission (CPSC) requires that children’s toys contain less than 100 mcg of lead per gram of toy weight. In 1993, The U.S. Food and Drug Administration (FDA) set a Provisional Tolerable Total Intake level (PTTIL) in micrograms/day of 6 mcg for children under 6, 15 mcg for children 7 and up, 25 mcg for pregnant women, and 75 mcg for adults.
The Prop 65 MADL standard for all age groups is 0.5 mcg per day. Unfortunately, it’s virtually impossible to manufacture nutritional supplements that don’t contain trace amounts of lead which sometimes approach this limit. In fact, many fresh fruits and vegetables we eat daily naturally have higher amounts of lead than California’s Safe Harbor standard.
At Carlson, we are dedicated to ensuring our labels have full disclosure and transparency—even with requirements such as the Prop 65 warning. You can rest assured knowing that our full line of nutritional supplements meets or exceeds the requirements of the federal government and are considered extremely safe in all other 49 states across the nation. If you have any questions or concerns, please don’t hesitate to contact us. You can reach us by email at email@example.com or by calling (888) 234-5656.