California Proposition 65 Info
We want to be sure that you feel good about our products! You may have noticed that warning labels have been added to some of our products and invoices to ensure compliance with Proposition 65, so that we can continue serving our herbal products to customers in California. We realize you may have concerns about the California Proposition 65 and what it means. Rest assured that our products are safe.
California Proposition 65 is specifically about lead, an element that can be found commonly or naturally in soil, plants, and water. Sun God Medicinals manufactures products made from dried whole herbs grown in nature. Sun God Medicinals does not intentionally add any lead to any of its products.
The State of California requires a warning for products sold in California that would result in a consumer ingesting more than 0.5 micrograms of lead in a day. This is an exceedingly low level that is, by law, 1000 times lower than the level of exposure that has been shown to have no observable effect on humans or animals. Therefore, the law sets an extremely stringent warning threshold.
Many herbs often contain very low levels of lead that may trigger the requirement to warn. Rather than limiting our customers’ access to whole herb products in California, we have chosen to issue the warning specified under Proposition 65.
All of our herbs and products test well within the internationally accepted safety standards for dietary supplements (ANSI 173). If you would like to read more please see the FAQs below.
Proposition 65 FAQs
Yes, our products are well within the safety levels set by the internationally recognized standard for dietary supplements—ANSI 173.
Yes, our herbs are harvested in small batches to ensure they are tested for heavy metal levels, impurities, and potency. Only if the herbs pass ANSI 173 specifications are they released into inventory to be made into Sun God Medicinals products.
The State of California has a law called Proposition 65 (also known as the Safe Drinking Water and Toxic Enforcement Act of 1986), which requires the state to publish and maintain a list of 800+ chemicals, including heavy metals, known to cause cancer, or birth defects or other reproductive harm. Prop 65 also requires businesses to notify Californians about the presence of these chemicals in their products if the chemicals exceed certain levels.
The levels set by Prop 65 at which a warning must be provided are very stringent. For chemicals that are reproductive toxicants, such as lead, the level triggering a warning is, by law, 1000 times lower than the highest level of lead known by California NOT to cause reproductive harm. In other words, the Prop 65 warning threshold for lead incorporates a 1000-fold safety factor below the level found to have no observable effect on humans or animals. For lead, a warning is required at levels above 0.5 mcg/day, which is very stringent.
At Sun God Medicinals, our products follow the ANSI 173 safety standards, which require that products have less than 20 mcg/day; so all of our products, even when taken at the maximum amount suggested on our label, are below 20 mcg/day. Rather than limiting our valued customers’ access to whole herb products in California, we have chosen to issue the warning specified under Proposition 65. Again, Sun God Medicinals products are nowhere near the no observable effect level as established by the very science on which Prop 65 is based.
Various countries and safety organizations have reviewed known studies and science to produce safety guidelines. The Prop 65 levels are among the most stringent. For comparison, Prop 65 allows for 0.5 mcg / day of lead, according to the AHPA, Canada’s Natural Health Directorate allows for 2 0 mcg / day, the FAO/WHO and EU allow for 2 5 0 mcg / day, the US FDA Tolerable Daily intake is 7 5 mcg / day, and the ANSI 173 standard (which Sun God Medicinals follows) is 2 0 mcg / day.
No. Sun God Medicinals does not intentionally add lead to any products.
Lead is an element that exists in nature. It is found in varying degrees across the globe. Lead is widely distributed in the environment and may be found naturally in the earth, soil, and water as a result of geologic deposits of lead. Plants grown in soils containing lead can uptake lead into parts of the plants.
Hundreds of companies have received Prop 65 notices regarding lead in nutritional supplements, including reputable big name brands. Many of the legal battles are ongoing.
Some companies are pulling products from the shelves, some are reformulating where possible, some are moving to extracts, some are decreasing the suggested usage, and some are negotiating settlements that allow for higher levels of lead without the warning. Some companies are also providing Prop 65 warnings for their products.
The Prop 65 law has allowed for some exemptions:
Companies with less than 10 employees do not have to warn, regardless of levels of chemicals.
Companies that can prove that heavy metals are “naturally occurring” do not need to warn for exposures to those naturally occurring levels. Proving that lead is naturally occurring can require litigation.
Some companies have negotiated Court-approved settlements that provide additional, “naturally occurring” allowances for lead in dietary supplements. Those companies do not need to provide warnings if their products do not exceed those allowances.
Prescription drugs are exempt from the Prop 65 warning requirements.
Our aim is to provide you with the safest herb products available. We decided to place the warning on the bottle because the alternatives did not seem to serve you, our customer.
Making changes to our formulas or lowering the amount to be taken daily would make our products less effective.We did not want to remove our products from California as an alternative. Our mission is to make available the healing properties of whole herbs to all those who choose to use them in their health care, and making our products unavailable to Californians runs contrary to our mission of service. We believe it is the right of every person, including Californians, to be able to take safe herbal medicines in the form of their choosing.