If you’re an Adapt Naturals customer that lives in California, you may have the following California Prop 65 warning on Bio-Avail Organ’s label or on our website:

WARNING: Consuming this product can expose you to lead, which is known to the state of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.

What is Proposition 65?

Proposition 65 is a California “right to know” law requiring companies to display a warning label on any product that contains specific chemicals above a certain threshold. 

If you live in California, you’ve likely seen this warning on everything from chocolate, coffee, protein powders, and supplements and on just about every building you’ve walked into.

Over 900 chemicals have been listed under California Prop 65 as carcinogens, reproductive toxicants, or both. These include compounds that naturally occur in trace amounts in soils, like lead, mercury, cadmium, and arsenic.

Because these compounds occur in soil, they are often found in commonly eaten foods—or supplements made from foods, like Bio-Avail Organ—even though these chemicals are not intentionally added.

How do Prop 65 limits compare to those set by federal and international agencies?

It’s important to note that the limits established by Prop 65 are far more stringent than those set by the EPA (Environmental Protection Agency), FDA (Food and Drug Administration), and EFSA (European Food Safety Authority). 

Chemicals are known to cause birth defects or other reproductive harm undergo rigorous research to determine the level at which they pose no threat to humans or animals. This is known as the “no observable effect” level. 

Prop 65 divides this level by 1,000 to ensure a large margin of safety. In other words, a warning label is required if a product contains more than 1/1000th of the “no observable effect” level for a chemical known to cause reproductive harm or birth defects.

How does Prop 65 affect commonly eaten foods? 

As noted above, heavy metals like lead and arsenic are unavoidable in the environment and commonly occur in soil. This means fruits, vegetables, botanicals, and animal products like meat and milk have the potential to contain trace amounts of these compounds.

For example, in the FDA’s Total Diet Study, a max concentration of lead was found to be 18 ppb (parts per billion), which means that an 85g serving of fresh spinach would result in an exposure of lead of roughly 1.5 mcg. This is 3 times higher than the “safe harbor” limit for lead under Proposition 65 (0.5 mcg/d). 

Dark chocolate contains 0.92 mcg of lead per ounce. A typical serving size for chocolate is 1.5 ounces. So, consuming a serving of chocolate would also exceed the Prop 65 safe harbor limit by three-fold. 

In fact, consuming the USDA-recommended 3-5 servings of vegetables daily could easily result in exposures of lead that are multiples higher than the safe harbor established under California Prop 65.

Despite this, neither fresh spinach, dark chocolate, nor any other fruit or vegetable carries a Proposition 65 warning because many foods are exempt from Prop 65 regulations. 

What does a Prop 65 warning label on a supplement mean?

Like foods, dietary supplements often contain trace amounts of naturally occurring heavy metals. Yet, unlike foods, supplements are required to carry Prop 65 warnings.

We comply with California law by displaying the warning, but this does not mean our product is unsafe to consume. 

The warning label simply means that Bio-Avail Organ contains trace amounts of lead—just like many fruits, vegetables, botanicals, animal products, and other foods may also have.

Each batch of Bio-Avail Organ is tested for heavy metals by a third-party lab to ensure the levels are below the federal and international thresholds. 

Ultimately, each individual must decide—in consultation with their healthcare provider—what level of exposure to substances covered by Prop 65 is safe for them. We hope this article helps you to make an informed decision.