California's Proposition 65: When the law makes criminals of everyone.
If you spend much time in California, you're probably used to seeing warning signs about Proposition 65 (Prop 65). They're on display at restaurants, banks, gas stations, grocery stores, and even at Disney Land.
Prop 65 was introduced in 1986 and requires companies to give clear warning if their product exposes an individual in the state of California to any detectable amount of more than 800 listed chemicals and chemical families and compounds known to the state to cause cancer or reproductive toxicity. Many of these chemicals are naturally occurring at some level in all food products, and thus also in nutritional supplements derived from food products.
It should be noted that in virtually every instance the threshold amounts of these chemicals set by Prop 65 are 1/10th to 1/15th the levels set by international organizations and the US FDA. In many instances the amounts are so low that many healthy fruits and vegetables such as yams, turnips, apples, tomatoes, carrots, cucumbers, green beans, lettuce, spinach, potatoes, corn and many other fruits and vegetables would not pass the Prop 65 guidelines. Since foods are exempted from Prop 65, they needn't carry a warning label. However once a food or herb leaves its natural state (such as when encapsulated) it become subject to Prop 65.
There has been considerable abuse. Because the law allows private citizens to sue and collect damages from any business violating the law, there have been cases of lawyers and law firms using Proposition 65 to force monetary settlements out of California businesses. Most of the Prop 65 complaints are filed on behalf of straw man plaintiffs by private attorneys, some of whose businesses are built entirely on filing Proposition 65 lawsuits. Many top-drawer supplement companies, including Vitamin Shoppe, Solgar, Rainbow Light, Enzymatic Therapy, Carlson, Metagenics, Nature's Secret, Designs For Health, New Chapter and Kyolic Garlic have been subject to Prop 65 lawsuits.
D'Adamo Personalized Nutrition, and all other food and supplement companies who sell their products in the state of California, are subject to Prop 65. We pride ourselves on the quality of our products and our adherence to Good Manufacturing Ethics and their imaginative design. Quite frankly, although 70% of our formulations actually pass Prop 65 standards, some by their very nature can never pass the Prop 65 mandated maximum levels in any way, shape or form. These include products that contain seafood, green leafy vegetables, nuts, seaweeds, and some leafy herbs. We try to do all we can to keep the levels as low as possible but these products feature living systems that are natural accumulators of very low levels of these chemicals.
What does Dr. Peter D'Adamo have to say about Prop 65?
What does an extension cord, a trip to Disneyland, and serving of spinach have in common?
Apparently, they can give you cancer. At least in California.
California’s Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act, was enacted in 1986. It is intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm. As part of the law, the state is required to publish a list of chemicals that are “known to the State of California to cause cancer or reproductive toxicity.” Products that contain amounts of these chemicals above the limits set by the state must have an attached warning label, the infamous ‘this product contains an chemical known to the state of California cause cancer.‘
One of the interesting aspects of Prop 65 is how different it is from all of the other national standards set by organizations such as the FDA and EPA. Prop 65 is significantly more strict. Although well intentioned, there are serious problems with this statute. Let’s take a look at just two of the chemicals singled out for required warning labels.
Our first chemical is acrylamide, which a rodent study pinned as a possible carcinogen. It’s found in almost everything that’s cooked at a high temperature. And because a particularly litigious law firm recently sued the state for not properly warning residents about acrylamide in coffee, California is now on the verge of requiring all coffee shops and manufacturers to include a warning on the beverage that it may cause cancer, despite the fact that many of the newer studies link coffee drinking to a lowered risk of some types of cancer, including prostate cancer, liver cancer, endometrial cancer, and some cancers of the mouth and throat.
The Prop 65 Safe Harbor maximum allowable dose level for lead is 0.5 micrograms per day, but the FDA daily limits are set at 75 micrograms for adults and 6 micrograms for children.
According to the EPA, natural levels of lead in soil can range from 50 parts per million (ppm) to 400 ppm. These levels naturally get incorporated into any vegetation that grows in them. Green beans contain 28.75 micrograms of lead in a one cup serving, which is an exposure of approximately 50 times the allowed Prop 65 levels. Spinach contains approximately 5.2 micrograms of lead in a typical adult serving size which is an exposure that exceeds Prop 65 levels by 10 times.
So why don’t we see Prop 65 warnings on our vegetables? That’s because of the ‘naturally occurring exemption’ under Prop 65 that provides that “human consumption of a food shall not constitute an ‘exposure’ for purposes of [Proposition 65] to the extent that the person responsible for the exposure can show that the chemical is naturally occurring in the food.” The 0.5 micrograms per day safe harbor limit applies uniformly to products sold in California, whether the product is a extension cord, a leather handbag or a nutritional supplement.
So, a bowl of spinach does not require a Prop 65 warning, but as soon as you make a supplement or market a smoothie containing it, you’re selling a product that contains a carcinogen.
Risks and consequences
This regulation disproportionately impacts sections of the economy, such as food and supplement manufacturers. For example, while an extension cord manufacturer can source a parts supplier who uses no lead in their wiring, nutritional supplement makers can at best only reduce lead, but cannot completely eliminate lead given its natural occurrence in the ecosystem.
Finally, and perhaps most significantly there is the risk of ‘warning fatigue’ due too the incredible overreach of Prop 65: The more ubiquitous and generalized disclosures become, the less effective they are. Thus while it is critically important to warn consumers about serious health risks, we should not extend this campaign to hypothetical ones. Proposition 65 is not accomplishing that, and by anesthetizing people to the real threats, it may in fact be doing more harm than good.
- California Code of Regulations, Title 27, Section 25501(a).