Understanding Lead and PCB Warnings on Nutritional Supplements

Jul 18, 2014 8:44:18 AM

Written By:
DaVinci Healthcare Expert

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Unfortunately, due to a myriad of reasons, chemicals are found within the earth and oceans where many supplement ingredients are sourced from. DaVinci® Laboratories never adds harmful chemicals to our products, but since we formulate products with naturally-sourced ingredients, sometimes trace amounts of some chemicals may be found in our products. If you've ever bought DaVinci® Laboratories products, you may have noticed a warning on the label that reads, “This product contains [X], a chemical known to the State of California to cause birth defects and other reproductive harm.” These warnings are required due to a law passed in California in 1986, commonly known as Proposition 65. Read on to learn more about Proposition 65 and our products.

 

Learn more about quality ingredients in nutritional supplements

Formally titled, “The Safe Drinking Water and Toxic Enforcement Act of 1986,” Proposition 65 sought to prevent businesses from exposing consumers to certain toxins without providing a warning. Products distributed within the State of California intended for human consumption are tested for Lead, Arsenic, Mercury, Cadmium, and PCB's.

Many of these chemicals are naturally occurring (such as the heavy metals listed previously) and DaVinci® errs on the side of caution by testing for these heavy metals in our human products. Many chemicals on the Proposition 65 list are subject to "safe harbor limits," which means that there is a specified level of each individual chemical, subject to a "safe harbor" limit, which is permissible in a product without including the proposition 65 warning on a product.

PCBs are associated with marine-derived products, such as fish oil. For PCB warnings, there is no safe harbor level associated with reproductive health; in other words, any level of PCBs need bear a warning to this effect. The PCB warning is based on an established limit of 90 nanograms per day.

Two levels were also outlined for lead: Any foods or nutritional supplements that exceed 0.5 micrograms (a microgram is 1/1000 of a milligram) of lead per serving require warning labels that state. The document does not, however, specify "safe harbor" limits for other chemicals listed. Nor does it address that many of these chemicals are naturally occurring.

For example, almost all naturally occurring plant and food items contain some level of lead. A single sweet potato can include over 1 microgram per serving, and would therefore be required by California state law to bear a Proposition 65 warning. The World Health Organization (WHO) has established that it is permissible to allow 3.75 mcg of lead/kg of body weight per day, which multiplies the Proposition 65 limit 500 times over.

For all products to be completely free of proposition 65 chemicals would be impossible. Any claim that a product does not contain any chemical on that list regardless of the concentration would require that product to be tested for every single chemical listed (currently over 800 chemicals). The test results would have to indicate that all chemicals were below the minimum level of detection for the specified test method.

You will see that any formula that contains more than 0.5 mcg of lead per day has the Prop 65 warning on the label, and that any marine-derived product bears a similar PCB warning. While these warnings are not required for product sales in other states, we do sell products in California through large, national distributors. Therefore, you may see these warnings appear on our products even if you are not in California.

We hope this helps explain why we have included these warnings on select products. Feel free to contact us if you have further questions.

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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.