California passed a law in 1986 that is officially known as the Safe Drinking Water and Toxic Enforcement Act, or State Proposition 65 (Prop 65 for short). While it remains politically controversial, this law was enacted as a ballot initiative and is intended to protect the State’s drinking water from chemicals known to cause cancer, birth defects or reproductive harm, and requires business to inform Californians about exposures to such chemicals.
With over 800 chemicals listed under the California Prop 65 ruling, these chemicals include anything from heavy metals to pesticides. One of the listed substances within Prop 65 concerns trace amounts of lead, which is a naturally occurring element that is often found in soil, plants, and water. Every plant, water and soil sample contains, and has likely always contained, trace amounts of lead. Therefore, the law sets an extremely stringent warning and it is safe to conclude that a Prop 65 warning does not automatically mean that a product is unsafe.
No. Absolutely not. The safe harbor limits under the statute are much lower than any level sufficient to cause consumer concern. The State requires a warning for any product sold in California that would result in a consumer ingesting more than 0.5 micrograms of lead per day. It is important to note, that this is an exceedingly low level and is found to be 1,000 times lower than the lowest level at which human and animal studies reported “no observable effect level.”
To compare California’s levels with federal standards, the Prop 65 Maximum Allowable Level (MADL) for lead is 0.5mcg/per day. The U.S. Environmental Agency (EPA), however, provides that the safe harbor limit for lead in drinking water is 15 mcg/day, and the Food and Drug Administration (FDA) allows up to 10ppm of lead in dietary supplements.
Because California requirements are not the same as federal and international safety requirements, it is easy to understand why this causes a lot of confusion between warnings on products sold in California and what is required elsewhere in the U.S.A.
This explains why you will see certain products on the market with warnings, and virtually identical products without warnings. However, it is important to note that just because another brand does not have the warning, this does not automatically mean that the other brand is free of the substance or has lower levels.
With a mission to manufacture and distribute premium quality, natural health food supplements, we assure you, that in order to maintain our strict Quality Control and Quality Assurance safety standards, each material ingredient and completed product of ours is tested by independent labs that follow both ethical lab practices and scientifically valid methods. No amount of lead is ever introduced into our products during processing or production and we confirm that the trace amount of lead present in our products is naturally occurring.
In summary, the Proposition 65 warning has been added to the all of the VITRATOX labels to ensure compliance with the law so that we can continue serving our customers in California. A Proposition 65 warning label does not mean that our products are in violation of any product-safety standards or requirements. It is simply because of the unavoidable trace element of lead that is naturally occurring within the plant and volcanic based products, that we are required to apply the California Proposition 65 warning label.
V.E. Irons, Inc. VITRATOX products always have, and always will meet or exceed all domestic and internationally accepted standards for dietary supplements. Our products remain the most pure and effective, naturally derived and chemically unaltered dietary supplements on the market today.
If you have any further questions, please feel free to contact our corporate office at: 1(800)544-8147 or you may email us at: [email protected]