California's Proposition 65 FAQs

You may have seen warning labels on some of our products sold in California. These labels were added to ensure compliance with California’s Proposition 65 and to continue providing high quality botanical and nutritional supplements to our California customers. Please read below for more information about Prop 65 and the testing and safety of our products.

What is Prop 65?

In 1986, California voters approved an initiative called the Safe Drinking Water and Toxic Enforcement Act - better known as Proposition 65. This proposition requires companies to place warning labels on products containing certain levels of substances. Each year a list of these substances is updated and published. The list has grown to include over 800 substances and includes additives or ingredients in pesticides, common household products, food, drugs, dyes, solvents, heavy metals, and even Vitamin A at particular levels. 

 

Why is there a Prop 65 warning label on your product?

 

You will see a warning label on one of our products because it contains more than 0.5 micrograms of lead per serving or recommended daily dose. This is an exceedingly low level that is 1000 times lower than the level of exposure that has been shown to have no observable effect on humans or animals.

 

Another product is labeled due to the naturally occuring trace amounts of lovastatin (monacolin K) in red yeast rice. This is not a drug that has been added to the product and is a naturally occuring compound that appears in oyster mushrooms and red yeast rice. 

 

Do you intentionally add lead to your products?

 

No. Natura does not add lead in any of our products. Lead is an element that exists in nature and can commonly be found in the soil, plants and water. It is widely distributed through the environment, therefore, is commonly eaten in foods and found throughout the food supply. It is not intentionally added to naturally grown foods or ingredients contained in our nutritional supplements. Natura’s products are formulated with botanicals grown in nature, which contain very low levels of lead.

 

Here are some examples of lead content found in common foods. The food listed below is a small example of common foods that would require a prop 65 warning if the law was applied to food as it is to supplements:

 

Food	Median mcg/serving	Highest found   mcg/serving	Serving Size
Spinach, fresh/frozen	1.47	7.03	4 oz. serving
Sweet Potatoes, fresh/baked	1.59	7.26	4 oz. serving
Lettuce, leaf, raw	0.57	1.59	4 oz. serving
Fruit juice blend (100% juice)	0.85	2.38	6 oz. serving
Bread, cracked wheat	0.68	2.38	6 oz. serving

 

Data from US Food & Drug Administration, Total Diet Study – Elements Results Summary Statistics, Market Baskets 2006-2011 http://www.fda.gov/downloads/food/foodscienceresearch/totaldietstudy/ucm184301.pdf

 

The law governing Prop 65 is not uniformly enforced. The same law that applies to supplements does not apply to food.  If Prop 65 applied to common foods, the majority of produce purchased at the grocery store would require a warning label.

 

How do you test for heavy metals?

 

Each ingredient contained in our formulas is tested for potency and purity, utilizing the most advanced laboratory equipment and scientifically validated methods, such as High Performance Liquid Chromatography (HPLC). This ensures that our products are free of dangerous microbes and heavy metals, and that active ingredients are at optimum therapeutic levels.

 

How do Prop 65 levels compare with other safety standards?

 

Other countries and safety organizations have reviewed known studies and scientific evidence to produce safety guidelines, which determine the levels of heavy metals that can be consumed on a daily basis without causing harm. The Prop 65 levels are among the most stringent. In comparison, as Prop 65 allows for 0.5 micrograms of lead per day, the United States FDA allows 75 micrograms per day, the FAO/WHO and EU allow for 250 micrograms per day.

 

Does the Prop 65 label mean your products are unsafe?

 

No. Our products are very safe. We have stringent specifications for each of our products. From the way the plants are grown and harvested, to the way the ingredients are processed, our botanical ingredients are sustainably sourced and are free of pesticides and harmful chemicals.

 

We also choose manufacturers who are compliant with the FDA’s current Good Manufacturing Practices (cGMPs) and who have demonstrated their ability to properly prepare a distinct formulation to our stringent specifications. Our finished products are once again tested for purity, and are issued a Certificate of Analysis (C of A) to confirm composition.

 

Do I have any reason to be concerned?

 

You should always be aware of product warnings and your exposure to toxic chemicals and their impact on your health. As the State of California’s own Prop 65 website states ”A Proposition 65 warning does not necessarily mean a product is in violation of any product-safety standards and requirements.”

 

The FDA’s “Recommended Safe and Tolerable Daily Diet Lead intake” for adults is 75 mcg. This is 150 times higher than the tolerable Prop 65 amount and yet the FDA considers it safe.

 

Keep in mind that a warning label does not automatically mean the product is unsafe for consumption.

 

Why did you decide to put the warning label on certain products?

 

• Natura is committed to complying with all federal and state laws, including Prop 65.
• We strive to produce the highest quality and most potent and effective products on the market. If changes were made to our formulas to adhere to Prop 65’s stringent standards, our products would be less effective. We will not compromise the quality of our products and ingredients under any circumstance; therefore, we have made the choice to place the warning labels on particular products.
• We want to maintain and protect your access to whole herbs contained in our formulas.

 

We hope this information is helpful. If you have any questions regarding Proposition 65 or our formulas, please contact our Customer Service team using the contact form or by calling 541.488.0210 and pressing 1.