Proposition 65, officially the Safe Drinking Water and Toxic Enforcement Act of 1986, is a law that requires warnings be provided to California consumers when they might be exposed to chemicals identified by California as causing cancer or reproductive toxicity. The warnings are intended to help California consumers make informed decisions about their exposures to these chemicals from the products they use. The California Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program and publishes the listed chemicals, which includes more that 850 chemicals. In August 2016, OEHHA adopted new regulations, effective on August 30, 2018, which change the information required in Proposition 65 warnings.
You may have seen the following warning associated with certain Elite Gourmet® brand products, as well as on other products purchased from other manufacturers:
WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.
What is this warning about?
This warning is the result of a unique law passed in California in 1986 called “Proposition 65.” Proposition 65 requires a warning to be included with any product sold in California that may contain any of the 900-plus chemicals that State of California regulators (as opposed to federal and other state regulators) consider harmful. These chemicals appear naturally in many of the foods we eat and are also present in many of the modern conveniences we take for granted. As explained below, failure to provide a warning can result in significant costs and penalties in California.
Is this product safe to use?
Yes, it is safe to use as instructed. All Elite Gourmet® products and Americana brand products meet federal and state laws (including California’s) for safety and restricted substances. A Proposition 65 warning is a notification that a product may include a substance on California’s Proposition 65 list. The list is broad and encompasses products purchased in California that are used or consumed in everyday living. For example, warnings have been required for coffee, vinegar, and fish. The Proposition 65 warning will also be found on vitamins, antacid tablets, kitty litter, china ware and crystal decanters, diesel exhaust, nail polish, spot remover, and even sand. The warnings posted on Amazon's website warn against exposure from consuming fresh fruits, nuts, vegetables, beer, wine, canned goods, baked goods, and snack foods such as chips, as well as exposure from wearing jewelry, driving a car, using a power tool or touching an electric cord. As explained in the Wall Street Journal article, "If You Drink Coffee In California, be Warned it May Cause Cancer" warnings in California have become the rule rather than the exception and are largely ignored.
I purchased this product outside of California. Why are you providing the Proposition 65 warning to me?
Elite Gourmet® products are sold throughout the U.S. to retailers with national distribution. Each distribution warehouse can and does serve multiple states, including California. To avoid the potential Proposition 65 costs and penalties if a product without a warning is brought into California, we decided to include these warnings, regardless of origin of purchase. A California judge recently ruled that coffee must contain the Prop 65 warning for cancer. Starbucks and other coffee sellers will be facing potentially millions of dollars in fines for a failure to warn.
If the product is safe, why does Elite Gourmet® include this warning?
For purposes of Proposition 65, the fact that the product meets federal and state safety standards is irrelevant. If there is even a trace amount of a Proposition 65 chemical in the product, it is up to the manufacturer to prove that the amount falls below California’s minimum exposure level. What constitutes “exposure” is poorly defined and the decision is left to the courts. For a manufacturer, the legal fees to contest a Proposition 65 case are significant. Because providing a warning removes all of these potential costs and litigation risks, Elite Gourmet® and many other manufacturers have opted to provide the Proposition 65 warning.
Doesn’t the State of California require evidence of harm to humans prior to placing a chemical on the Proposition 65 list?
No. In fact, California regulators require no evidence of harm or even likelihood of harm to humans prior to placing a chemical on the Proposition 65 list. Instead, evidence from animal testing has been deemed sufficient, even when those tests on animals are conducted with outlandish dosages. As an example, California’s initial decision to add BPA (Bisphenol A) to its Proposition 65 list is based on a 2008 study of high dose BPA testing on rodents. The dosage on rodents in that study was equivalent to a human consuming 264,000 cans PER DAY of food lined with BPA for a lifetime. Although that very same study concluded that there was insufficient evidence to treat BPA as a developmental toxicant to humans, California has used it as a basis for adding BPA to its Proposition 65 list.
What is BPA?
BPA (Bisphenol A) is a chemical first approved by FDA in the early 1960s. The resins are used to protect foods from microbial (botulism) and other contamination by coating the inside of metal products, such as some food cans. It is also used in the production of polycarbonate plastics and epoxy resins. These hard, clear, heat-resistant plastics are found in clear popcorn popper covers. They are also used on light switch covers and internal motor parts.
Can a chemical be on the Proposition 65 list even though it is considered safe by the FDA and the EPA?
Yes. BPA once again provides an excellent example. In August 2008, the FDA released a draft report finding that BPA remains safe in food contact materials. Thereafter, $30 million was appropriated under the 2009 stimulus budget to perform more studies on BPA. The EPA commissioned a study that was released in 2011. That study used humans rather than animals as its test subjects. Each subject was asked to ingest high doses of BPA. By monitoring blood and urine, the scientists found that the BPA was detoxified and eliminated from the body and was undetectable.
In the fall of 2014, FDA experts from across the agency, specializing in toxicology, analytical chemistry, endocrinology, epidemiology, and other fields, completed a four-year review of more than 300 scientific studies on BPA. The FDA review has found no information to prompt a revision of FDA’s safety assessment of BPA. FDA scientists have also recently determined that exposure to BPA through foods for infants is much less than had been previously believed and that the trace amounts of the chemical that enter the body, whether it’s an adult or a child, are rapidly metabolized and eliminated.
In summary, the FDA and EPA have each performed extensive research on BPA. Despite this overwhelming scientific evidence that BPA is safe, California has chosen to ignore these findings and placed BPA on its Proposition 65 list.