The Safe Drinking Water and Toxic Enforcement Act, more commonly known as Prop 65, was an initiative approved by California voters in 1986 to hold manufacturers and industrial entities accountable for pollution being dumped or otherwise secreted into California water sources. It requires businesses to notify Californians about certain chemicals located in their homes or workplaces or that are released into the environment, and that are contained in the products they buy, or that are utilized as a part of the products’ manufacturing process. This allows Californians to make informed decisions about protecting themselves from exposure to these chemicals.
Prop 65 is a unique, California-only “right to know” law that requires products sold to California residents California to bear warning notices about potential exposure to any of the over 900 substances listed by the state. You can find those substances listed here.
Prop 65’s warning standards are uniquely low. Although originally intended to monitor chemical exposure in water as a result of industrial waste, the practical application of Prop 65 has changed dramatically. For practical purposes, Prop 65 warnings are required for any product (food or non-food) that exposes an individual in California to virtually any detectable amount of a listed chemical. However, Prop 65 does not ban any products from sale in California; it simply requires warnings about the listed chemical contained in the product or as a part of the product’s, or a product component’s, manufacturing process.
InBody takes our customers’ and clients’ safety very seriously. All our products are approved by the United States Food and Drug Administration (“FDA”), most as Class II medical devices, and have undergone rigorous safety testing protocols.
There is no other state or federal law or regulation, even under the FDA, similar to Prop 65, which requires warnings for listed chemicals contained in products at levels that are far below levels known to cause any actual harm. For example, Prop 65 regulates substances officially listed by California as having a 1 in 100,000 chance of causing cancer or birth defects over a 70-year period, whereas the FDA and other health authorities have determined that tiny traces of certain chemicals, such as those found in plastic or which are part of the manufacturing process of plastic, are unavoidable and, yet, do not present a public health risk, the threat of injury, or need for warnings.
Furthermore, lawsuits to enforce Prop 65 against manufacturers may be instituted by the State of California, or much more frequently by private attorneys. Unfortunately, such private “enforcers” have turned more into “bounty hunters”, making it their life’s work on profiting from lawsuits against non-compliant companies.
You may have noticed your product has a Prop 65 warning label. Like many other companies, InBody has made a business decision to preemptively comply with Prop 65. Rather than engaging in a long, expensive, and protracted legal battle to prove in court that our products do not expose any listed chemicals in any meaningful way, we have chosen to simply place a sticker.
We understand that you may be concerned, but we want to reiterate that our products have been tested thoroughly throughout the supply chain, have been approved as Class II medical devices by the FDA, and have never, in over 20-years of sales, use, and benefit to many satisfied customers across the United States, been the cause of any serious injury, illness, disorder, or death. Our customers trust our products, and we trust that you understand why we have made our business decision regarding Prop 65.
For more information, go to www.P65warnings.ca.gov.