Q: What is Proposition 65?
Proposition 65 is officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986.
Proposition 65, commonly known as Prop 65, is a California ballot initiative that was voted into law in 1986. Prop 65 was designed to protect public health through strict regulations on the presence of toxic chemicals in California drinking water.
The California Office of Environmental Health Hazard Assessment (OEHHA) says Prop 65 “requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm.”
Each chemical is assessed separately to determine an acceptable daily level or amount and to establish restrictions. These chemicals may be found in consumer products that are purchased, in our homes and worksites, or released into the environment.
If your product contains more than the threshold, it’s required to have a Prop 65 warning label.
Prop 65 applies to any product or service received or used in California, though Prop 65 enforcement has spurred meaningful reform in ingredient standards, product testing, and manufacturing processes nationally.
Q: What Types of Products and Environmental Contaminants Are Regulated?
Prop 65 standards for Consumer Product Exposure include many common product categories including
- Drugs and nutritional supplements
- Medical devices
- Personal care products
Prop 65 standards for Environmental Exposure cover different types of possible environmental exposure, such as
- Exhaust from vehicles
- Possible construction or workplace exposure
- Toxins or chemicals present in buildings or homes
- Agricultural pesticides that may leach into groundwater
Q: What is the Prop 65 List?
The Prop 65 List is the current list of substances found to be harmful by the California Office of Environmental Health Hazard Assessment (OEHHA).
When Prop 65 went into effect in 1986, there were 30 chemicals on the list required to have this warning. By 2013, the Proposition 65 list had grown to over 900 chemicals, including ingredients like heavy metals, steroids, dyes, solvents, and pesticides.
It’s also worth noting that since 1999, over twenty chemicals have been removed from the list.
Examples of substances regulated by Prop 65:
- Aloe Vera Extract
- Citrus Red No. 2 (a dye)
- Diesel Engine Exhaust
Q: Why Do Some Products Have Prop 65 Warnings While Others with Similar Ingredients Do Not?
Prop 65 actions can be brought by the California Attorney General or other public or private entities, or anyone who chooses to bring suit “in the public interest”.
This means that, at any point, a company can be involved in a lawsuit that requires it to place a Prop 65 label on products OR come to a settlement.
As the Prop 65 list grows, previously unaffected companies are required to add warnings as new chemicals become a part of the list.
Additionally, many companies include a Prop 65 label proactively on products to avoid potential lawsuits.
Q: Are There Any Exceptions to Prop 65 Label Requirements?
There are TWO notable exceptions to Proposition 65 enforcement:
- If your company has under 10 employees, you are exempt from having to place the warning label, regardless of the levels of chemicals present in your product
- Prescription drugs are also exempt from providing a Prop 65 warning label.
Q: How Does Prop 65 Apply to Foods and Nutritional Supplements?
As applied to foods, Prop 65 makes no distinction between natural and artificial products. It DOES exclude “naturally occurring” chemicals in foods. But that definition DOES NOT make an exception for man-made pollutants that may end up in natural products through processes outside of the manufacturer’s control.
Examples of potential outside chemical contamination sources include
- Chemicals that result from natural phenomena (like volcanic activity or wildfires).
- Chemicals that are naturally absorbed by plants in the growth process due to national and worldwide soil, water, and air pollution.
- Chemicals present due to local/regional problems like pesticide overspray or chemical leaks. This includes substances that are intentionally applied—like synthetic fertilizers and pesticides—and those that may be introduced later in drying or processing.
Prop 65 also DOES NOT limit the types or amounts of chemicals that can be put into a product. Nor does the warning have to disclose the kinds or amounts of chemicals in the products.
As long as the regulatory “safe harbor” warning is given, then the seller is deemed to have complied with the law.
Q: Are Nutritional Supplements with a Prop65 Warning Label Unsafe?
Prop 65 is unique to the state of California, and its thresholds for allowable chemical levels tend to be MUCH more restricted than national standards.
As it relates to food, Prop 65 does not distinguish between natural and artificial products. Although it excludes “naturally occurring” chemicals in foods, what is NOT excluded are man-made pollutants that may end up in carefully-crafted natural products through processes that are completely outside of the manufacturer’s control.
So while Prop65 has made huge strides to protect public health, not all chemicals regulated by Prop65 are inherently unsafe OR unhealthy in small amounts.
You’ll need to do your own research to determine which toxins are present in products with a Prop 65 label and if the levels are truly unsafe in context.
For instance, levels that may be safe for healthy adults are not safe for children, the elderly, and the immunocompromised. And your daily exposure to chemicals can differ substantially based on factors like your location, diet, and daily habits!
Q: What About Proposition 65 and Lead in Supplements?
A great example of how Prop65 protects consumers is lead, a heavy metal that is known to cause cancer and birth defects in humans when we are exposed to large amounts.
The Proposition 65 lead limit for supplements is 0.5 mcg per day, which is quite low.
We can all agree that lead NEEDS to be regulated. But what levels of lead are truly dangerous? And with lead commonly found in our soils, fruits and vegetables, and drinking water, which sources are most likely to increase our daily consumption to unsafe levels?
For instance, we often get questions about the Prop 65 warning label on our best-selling Health Plus Colon Cleanse, a go-to natural fiber supplement for health-conscious consumers since 1981!
Although lead is inherent in Psyllium through the natural growth process and our supplement only contains a minuscule amount—0.5mcg— it is still required of us to put the prop 65 reproductive harm warning on the label in California.
It is important to understand that while these limits are set in place for consumer safety, the OEHHA (Office of Environmental Health Hazard Assessment) recognizes that the daily consumption or “safe harbor limit” on lead (0.5mcg) is 1,000 times lower than “safe exposure” amounts.
This means that when tested on humans and animals, by law it would take 1,000 times more lead than 0.5mcg to have any observable effects on the reproductive system.
For further context, the average one-ounce serving of dark chocolate contains about 0.6 mcg of lead. The safe lead limit for drinking water, according to EPA standards, is 15 mcg/L per day. So, if we follow Proposition 65 regulation, drinking only about one-fourth cup of water would bring you beyond the safe 0.5 mcg daily limit enforced for supplements
Q: Are Health Plus Products Tested Regularly for Leads and Other Contaminants?
Absolutely! Health Plus uses very extensive and thorough testing methods, along with multiple strict testing requirements for our vendors. The safety and health of our customers are our first priority.
Whether the ingredients are sourced overseas or domestically, we require them to be tested 3 times to ensure there is no harmful contamination.
- Each ingredient is required to be tested before it ships.
- Once received, the ingredient is quarantined and tested again. If it meets quality standards the product is then released for production.
- After the manufacturing process, the finished goods are put into quarantine and tested yet again before being sold.
Q: Does Health Plus Put Lead In Its Products?
No, Health Plus does not add or intentionally use lead in ANY of its products.
Lead is present in small amounts in many dietary supplements as a result of the natural growth process. Things such as soil fertilizers and irrigation water sources contain traces of lead, and these traces make their way into the plants they are nourishing.
While we are required to add a Prop 65 warning label to some of our products containing Psyllium Husk, the minuscule 0.5 mcg of lead is naturally present in the Psyllium Husk ingredient—NOT added through ingredient processing or manufacturing practices.
Q: So, Should I Worry When I See a Prop65 Warning Label?
It really depends! If you see a Prop65 warning label on a supplement, it isn’t always a call for alarm. In fact, it indicates that the brand is compliant with the law and respectful of your needs as a consumer.
It’s also important to note that the Prop 65 list DOES NOT reflect standards set by the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), or any other United States federal regulatory body.
While Prop65 has fast-tracked many important national regulatory changes that protect consumer health, its low thresholds have made it increasingly difficult for customers to distinguish which Prop65 Warnings they should truly heed.
Should you worry needlessly and lose sleep over Prop65 Warning labels? NO!
But, when discussing your health or any possible harm a product or environment may cause your body, it is always wise to be concerned and knowledgeable. Because of the broad scope of ingredients regulated by Prop65 and the low thresholds it enforces, you’ll need to do your own research into the safety of your favorite products.
We also suggest considering your daily consumption of potentially harmful substances, like lead, and how your diet and health habits can impact it. It’s all about assessing and eliminating the largest sources. Did you know that for many households, installing a high-quality water filtration system in your home can eliminate much of your daily intake of lead?
In our modern world, some contaminants are unavoidable! It’s all about being informed and maintaining balance.
Q: Where Can I Find Out More About California’s Proposition 65?
The Office of Environmental Health Hazard Assessment has a website full of helpful information on Proposition 65. It also includes an up-to-date list of regulated substances and “Safe Harbor” guidelines for each.
If you have any questions, comments, or concerns about Proposition 65, go to www.p65warnings.ca.gov