What is Proposition 65?
The Safe Drinking Water and Toxic Enforcement Act of 1986, or Proposition 65, requires businesses to notify Californians about potential harmful exposures to certain chemicals in the products they purchase, or exposures that may occur in certain environments. By providing this information, Proposition 65 provides Californians a ‘right to know’ in order to make informed decisions about protecting themselves from exposure to these chemicals. Proposition 65 also prohibits California businesses from knowingly discharging significant amounts of listed chemicals into sources of drinking water.
What types of chemicals are on the Proposition 65 list?
The list contains a wide range of naturally occurring and synthetic chemicals that are known to the State of California to cause cancer, birth defects and/or other reproductive harm. These chemicals include many additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes.
Why does the company provide the Prop 65 warning?
Proposition 65 requires all companies whose products contain certain low levels of listed chemicals to label those products with a warning. The State of California determines which chemicals are included in the Proposition 65 list. The mere presence of a listed chemical may require that the warning be placed on the product. By law, a warning must be given for listed chemicals unless the exposure is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. Through civil litigation, Proposition 65 imposes significant penalties for failing to provide a warning unless the company can prove that the presence of the listed chemical presents “no significant risk”, which is defined in a way that renders definitive proof difficult, costly, and uncertain. Companies are often faced with the expense of having to defend civil litigation merely due to the presence of a listed chemical in a product without a warning, regardless of whether the chemical results in exposure levels sufficient to trigger a warning or presents any actual risk to humans. Out of an abundance of caution, providing a warning is a practical way to avoid the uncertainty and financial risk of Proposition 65 litigation.
Does the Prop 65 warning mean that our products are not safe?
The Proposition 65 warning does not mean that our products are unsafe. The Proposition 65 regulation requires that the warning appear on the product label when the product contains certain extremely low levels of listed chemicals. Our products contain chemical concentration levels below the limit values set out in ISO 10993, ICH Guidelines for residual solvents Q3C(R5) (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, where the Food & Drug Administration (FDA) is a founding regulatory member). Our products have been tested for biocompatibility according to ISO 10993 and are considered biologically safe. The California government states: “The fact that a product bears a Proposition 65 warning does not mean by itself that the product is unsafe. You could think of Proposition 65 more as a ‘right to know’ law than a pure product safety law” - April 2012, CA Office of Environmental Health Hazard Assessment.
Does the warning have to be included on products sold outside of California?
We are a global company and sell our products at an international level. Therefore, it is difficult to determine which specific products are sold or used in California. We have decided to place the warning on all of our products regardless of the states in which they are being sold.
LoFric catheters and Proposition 65 cancer warning
Thorough search of available scientific literature gives no indication of any possible correlation between the LoFric catheters and any form of cancer. The note on the label is due to a very low amount of substances indicated on the Prop 65 list. All catheters are thoroughly tested. The LoFric products have been tested for biocompatibility according to ISO 10993 and are considered to be biologically safe. This has been audited by FDA.
Among the studies found when searching in PubMed and Google scholar with relevant key words are mainly studies focusing on:
- Patients already suffering from cancer or other types of afflictions, and thus need intermittent self catheterization to assess the bladder outflow problems
(Rijal et. al 2013; Nesbakken et al. 2002; Roberts et al. 2013; Zare 2018; KJÆRGAARD et al 1994).
- Comparisons between hydrophilic coated intermittent catheters and uncoated catheters in terms of performance and/or cost-effectiveness as well as to elucidate the risks of urinary tract infections in a post-operative setting.
(Welk et al. 2018; Han CS et al. 2017; Vapnek et al. 2003; Pereira et al. 2001; Cindolo et al. 2004; Chartier-Kastler et al. 2011 Review).