The warning is included on certain products to ensure compliance with Prop 65 and is in response to what Scivation believes are frivolous lawsuits that have been filed against companies that may have naturally-occurring lead or other heavy metals in their nutritional supplements. Any consumer product, including many household and grocery items, with naturally-occurring levels of heavy metals (Lead, Arsenic, Mercury, Cadmium) or other elements must bear this warning statement on its label if they are to be sold in California, unless the levels are beneath the threshold set by the Act.To sell products in this state, companies must abide by the rules and regulations set forth in this Act, including a warning statement such as: “This product contains chemicals known to the State of California to cause cancer or reproductive harm”. Many companies may provide this warning on their websites, product labels, or in magazines. It is important to note that Proposition 65 does not ban the sale of any products containing these chemicals; it only requires a warning. (*Note – nutritional supplements are considered a food in the State of California under this Act.)Does this law apply everywhere?
The “Prop 65” warnings are only required under California law. Prop 65 standards are among the most stringent standards currently in place. The standards and regulations set forth in this proposition are more rigorous than standards set even by federal regulatory agencies.
Should I be concerned?
Generally, one should always take heed of product warnings. While such warnings may sound confusing, it is important to note the following: Scivation products are manufactured at NSF certified cGMP facilities with superb attention to quality, purity and safety. The inclusion of the Proposition 65 warning on Scivation dietary supplements does not mean that a single serving of a Scivation product contains dangerous levels of heavy metals. Certain ingredients included in our products, at suggested daily serving size, have naturally occurring heavy metals in them, and it is because of this, Scivation products necessitate a warning.
Although the warning language required by the Act may be frightening, many of the chemicals considered carcinogenic by this act are naturally present in the environment because of human activity, industry, and natural bioaccumulation in materials such as bodies of water or items grown in natural soils.
How are these warnings determined?
The State of California adds chemicals to its Prop 65 list through a prescribed protocol. Prop 65 allows chemicals to qualify to be listed for various reasons, including based on the results of animal testing. Oftentimes, these animal studies involve extremely high doses of the chemical in question.
What types of dietary supplements require a warning?
Any dietary supplement that exceeds the threshold set but Prop 65. For instance, any dietary supplement that contains more than .5 mcg of lead per daily serving requires a warning.
Why don’t all similar products carry the warning? Who is exempt and how is it enforced?
A lack of warnings for a product does not necessarily mean that the product is free of the same substances at similar levels. Inconsistent enforcement of Prop 65 often explains why certain products on the market will carry the warning, and other, virtually identical products, do not disclose the warning. Businesses with less than 10 employees and government agencies are the two most notable exceptions to this proposition as both are exempt. Chemicals may be listed as having “no significant risk level”, known as Safe Harbor Limits, and may also exempt businesses from using a clear and reasonable warning statement on their products or premises. In addition, products that are not sold to the state of California are not subject to this requirement and must not bear the warning.
Litigation may result when a public or private party initiates a lawsuit against a specific company on behalf of public interest or through the California Attorney General’s Office. The Office of Environmental Health Hazard Assessment OEHAA under the California EPA umbrella oversees Prop 65. The State California Department of Justice Attorney General’s Office enforces reporting and non-compliance litigation concerning this proposition to California Health and Safety Code, Section 25249.7.
What steps are taken by Scivation to assure product quality?
Each Scivation product goes through comprehensive quality assurance procedures, at both the manufacturing laboratory and in-house at Scivation HQ. Analytical testing is conducted at the conclusion of each batch produced to guarantee product uniformity, compliance, and quality. In addition to employing industry-leading product testing protocols, Scivation products are tested by a third-party laboratory on a rotational basis.