What is a Proposition 65 warning?
You may have seen the following warning associated with our products, as well as on other products purchased from other manufacturers:
WARNING: This product contains chemicals known to the State of California to cause cancer, birth defects or other reproductive harm.
Prop 65 is a CA regulation that requires warnings for any products that contain one of the chemicals listed in the proposition. In our case, it's heavy metals that are found in the soil, water and occur in nature. Everything that is grown from the earth will not meet the standards, including a bowl of salad. However, food does not require this label. Only dietary supplements.
The warning does not mean that our products will necessarily cause cancer or reproductive harm. A Proposition 65 warning also does not mean a product is in violation of any product-safety standards or requirements. In fact, the California government has clarified that “the fact that a product bears a Proposition 65 warning does not mean by itself that the product is unsafe.” The government has also explained, “You could think of Proposition 65 more as a ‘right to know’ law than a pure product safety law.” See http://oehha.ca.gov/prop65/background/p65plain.html.
While we believe our products are not harmful when used as designed, we provide the warning as a result of this California law.
What is Proposition 65?
Proposition 65 is a broad law that applies to any company operating in California, selling products in California, or manufacturing products that may be sold in or brought into California. It mandates that the Governor of California maintain and publish a list of chemicals that are known to cause cancer, birth defects and/or other reproductive harm. The list, which must be updated annually, includes a wide variety of chemicals that can be found in many everyday items, such as dyes, solvents, drugs, food-additives, by-products of certain processes, pesticides and tobacco products. The purpose of Proposition 65 is to ensure that people are informed about exposure to these chemicals.
Proposition 65 also requires warnings to be placed on any product, product packaging, or literature accompanying a product that contains or may contain any of the 800-plus chemicals that the California Air Resources Board considers harmful. As noted above, many of the elements listed under Proposition 65 have been routinely used in everyday consumer items for years without documented harm.
A warning must be given if the listed chemical is merely present in a product unless a business demonstrates that the exposure it causes poses "no significant risk." With respect to carcinogens, the "no significant risk" level is defined as the level which is calculated to result in not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime. In other words, if you are exposed to the chemical in question at this level every day for 70 years, theoretically, it will increase your chances of getting cancer by at least 1 case in 100,000 individuals so exposed.
With respect to reproductive toxicants, the "no significant risk" level is defined as the level of exposure which, even if multiplied by 1,000, will not produce birth defects or other reproductive harm. In other words, the level of exposure is below the "no observable effect level," divided by 1,000. (The "no observable effect level" is the highest dose level which has not been associated with observable reproductive harm in humans or test animals.)
A Proposition 65 warning generally means one of two things: (1) the business has evaluated the exposure and has concluded that it exceeds the "no significant risk level"; or (2) the business has chosen to provide a warning simply based on its knowledge about the presence of a listed chemical without attempting to evaluate the exposure. Qualia has chosen to provide a warning based on its knowledge about the presence of one or more listed chemicals without attempting to evaluate the level of exposure, as not all of the listed chemicals provide exposure limit requirements. With Qualia products, the exposure may be negligible or well within the “no significant risk” range. However, out of an abundance of caution, Qualia has elected to provide the Proposition 65 warnings.
Why does Qualia include this warning?
The penalties for not complying with Proposition 65 are high. As a result of the potential penalties and because there is no penalty for providing an unnecessary warning, Qualia, as well as many other manufacturers, have elected to provide the Proposition 65 notice out of an abundance of caution in order to avoid the potential for liability.
I purchased this product outside of California; why is it included?
Our products are sold nationwide. It would be extremely difficult and costly to determine which products will be ultimately sold or brought into California. Therefore, to ensure compliance with Proposition 65 requirements, we have decided to include these warnings on all of our products, regardless of origin.
For more information about Proposition 65 visit: http://www.oehha.ca.gov/prop65/getNSRLs.html
If you have specific questions pertaining to this warning, please contact our customer experience team at (855) 281-2328.
Qualia nootropics were designed to promote a sustained improvement across the whole pallet of objective capacities and subjective states that contribute to optimized, creative, productive flow states, including:
We are committed to going above and beyond industry standards and FDA requirements for safety and quality.
Our manufacturing facilities are certified by GMP/ ISO 9000 quality management standards, using the industry best for our airtight seals, desiccants, and equipment. We receive and review a COA (certificate of Analysis) for each batch of every raw ingredient coming in, conducted using HPLC (high performance liquid chromatography) and MS (mass spectrometry).
Because of the complexity and importance of human neurology, we have taken a whole systems approach that takes into consideration end to end pathways, multiple pathways, and the complicated interactions of many different supplements with one another, and applies a variety of ethical principles that are sorely needed in this space.