Because of California’s Proposition 65, some products we sell will have the following warning attached to the bottle, such as:
WARNING: Cancer and Reproductive Harm - www.p65warnings.ca.gov
What is California’s Proposition 65?
Prop 65 is the common name for the Safe Drinking Water and Toxic Enforcement Act of 1986 passed in California.
The idea was to increase the transparency around the presence of naturally occurring and synthetic chemicals in products, foods, and more that could cause cancer, birth defects, or reproductive harm. The Proposition 65 list is currently over 900 items long and includes things like herbicides & pesticides, common household products, drugs, dyes, solvents, chemically stuff, and heavy metals.
Companies are required to warn consumers if their products or services could expose them to one of the ingredients on the list.
Prop 65 is only a labeling regulation for California consumers and is not an FDA or national standard related to health or safety. No other state has such a labeling regulation.
The amount of the particular substance in dietary supplements that triggers the label warning is very low and includes a very large margin of safety.
In an effort to protect themselves from potential lawsuits in California for not displaying a required warning, some companies may affix the Prop 65 warning labels to products -- as well as to website pages about products -- regardless of whether or not the specific products exceed Prop 65 limits.
Exactly what triggers this warning for these products?
A microscopic amount of lead can trigger this warning. Lead exists in our air, soil, water, and food crops. The level that triggers this warning is far below the level associated with actual reproductive harm. Because Prop 65 warning levels are stringently low, it is common to find such warnings posted in California restaurants, hotels, schools, grocery stores, and hospitals.
How is the warning level for lead determined?
The California Office of Environmental Health and Hazard Assessment (OEHHA) sets the warning level for lead by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals and then adds a very large margin of safety. This “no observable effect level” defined above is divided by 1,000 to get the margin of safety. This margin of safety requires companies to provide a warning if there may be an exposure that exceeds 1/1000th of the “no observable effect level” (NOEL). Based on its NOEL, the warning level for lead is set by default at 0.5 micrograms (one-half of a microgram). A microgram is one-millionth of a gram. However, there are certain allowances for “naturally occurring” amounts and different levels are also set in court-ordered agreements.
Why is lead found in foods, vitamins and minerals?
Widespread in nature and in soil, low levels of lead are found in many foods and botanical products. Small amounts of lead are found in many foods and supplements even though they are not added during the manufacturing process. All products we sell are tested for heavy metals and never exceed the levels set by the USP (United States Pharmacopeia) and International and FDA guidance documents.
How does Proposition 65 work?
Proposition 65 was designed to provide a market-based incentive for manufacturers to remove listed chemicals from their products. Initially Proposition 65 provided a means for reducing certain exposure that may not have been adequately controlled under existing laws. Despite its successes, this initiative has become problematic.
What are the problems with Proposition 65?
One of the more obvious problems with Proposition 65 is that it does not directly affect the levels of listed chemicals in a product or require products to be safe; it merely requires that the product carry a warning. Additionally, it does not create safety standards for individual industries. Perhaps the most problematic element of Proposition 65 relates to the way in which it is enforced; it allows private individuals and entities to act as enforcers by bringing lawsuits against violators.
Private enforcers and their lawyers collect huge settlement sums through this process. This has encouraged an industry of “enforcers” in California, some with serious concerns for health and environment and others who are little more than vigilante bounty hunters. As a result, many California businesses have had hyper-technical enforcement efforts brought against them that are motivated by profits rather than to seek consumer protection.
What does a Proposition 65 warning really mean?
It is important to remember that it is not illegal in California to sell products with heavy metals above the Proposition 65 levels, but it is illegal to sell them without a Proposition 65 warning. Proposition 65 does not set new regulations for the manufacturing of products, nor does it require that businesses improve their products. It merely requires that those products not in compliance with its strict standards provide a warning. When a warning is given by a business, it means one of two things:
1) The business has evaluated the exposure and has concluded that it exceeds the “no significant risk” level as defined by Proposition 65; or
2) The business has chosen to provide a warning simply based on its knowledge of the presence of a listed chemical without attempting to evaluate the exposure. The exposure in this instance could be below the Proposition 65 levels, could be none at all, or could be exceedingly high.
It is also important to note that many industries have succeeded in getting their own industry wide standards, making them exempt from Proposition 65.