CALIFORNIA: PROPOSITION 65
In 1986, the people of California passed a proposition, now commonly known as “Prop 65″, that was primarily designed to prevent dumping of toxic chemicals in California waters.
That initiative became the Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65 / Prop 65.
Prop 65 requires the State to publish a list of chemicals known to cause cancer or birth defects orother reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 800 chemicals since it was first published in 1987.
The list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm. These chemicals include 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 by-products of chemical processes, such as motor vehicle exhaust.
Prop 65 warnings are seen throughout California in a wide range of settings – in restaurants, grocery stores, hotels, schools, hospitals, and on a wide variety of consumer products including dietary supplements and herbal supplements.
Practically all foods contain certain levels of one or more of the substances listed by the State of California. In many cases, the exposure levels established by Prop 65 are less than what occurs naturally in fruits, vegetables, grains, and even drinking water.
Proteins, plants, and minerals all are well-known to contain substances that exceed those allowed exposures on the Prop 65 list.
Prop 65 makes no distinction between natural and artificial products.
Prop 65 requires warning labels be applied to products which contain chemicals on the list.
Lead is one element that is on the list.
Lead is an element that exists in nature. It is found in varying degrees across the globe. Lead is widely distributed in the environment.
Prop 65 has inadvertently affected dietary supplements and herbal ingredients which naturally contain very low levels of certain elements commonly found in soil, plants, and water – a common example is lead.
The Prop 65 limit of 0.5 mcg / day for lead is far below the amount of lead naturally found in many fruits, vegetables and herbs grown on clean, non-contaminated soils.
Various countries and safety organizations have reviewed known studies and science to produce safety guidelines on the levels of heavy metals that can be consumed on a daily basis without causing harm. The Prop 65 levels are among the most stringent and build in a 1000-fold safety factor below the no observable effect level for chemicals listed as “reproductive toxicants” – such as lead.
The lead in herb products is not more or less risky than lead found in the American diet, which is reported to provide about 15–25 mcg of lead per day or more – the lead comes mainly from plant foods.
The State of California requires a warning for any product sold in California that would result in a consumer ingesting more than 0.5 mcg of lead in a day. This is an exceedingly low level that is, by law, 1000 times lower than the highest level of lead known by California NOT to cause reproductive harm. In other words, the Prop 65 warning threshold for lead incorporates a 1000-fold safety factor below the level found to have NO observable effect on humans or animals. Therefore Prop 65 sets an extremely stringent warning threshold.
For comparison, where Prop 65 allows for 0.5 mcg/day of lead the following limits are:
- 250 mcg / day European Union / FAO / WHO
- 75 mcg / day US FDA
- 20 mcg / day AHPA – Canada’s Natural Health Directorate
To put this into perspective:
- 1 capsule of HP8 may typically contain 0.3 mcg of lead
- A daily dosage of 2 capsules may typically contain 0.6 mcg of lead
- A daily dose of 4 capsules may typically contain 1.2 mcg of lead
All of the ingredients in HP8 test well below the international and federal accepted safety standards for lead in dietary supplements.
So, the Prop 65 standard is set far below the lead levels allowed anywhere else and is not based on scientific analysis of actual risks, but on a regulatory system contained within the Proposition.
The warning labels required by Prop 65 do not present information about the safety or the risk of any product.
It is important to note Prop 65 does not ban any products; it simply requires warnings on products that contain certain chemicals.
Rather than limiting our customers’ access to HP8 in California, we have chosen to apply the warning on the HP8 label as specified under Prop 65.
The warning has been added to our HP8 label to comply with Prop 65 so we may continue to serve our customers in California.
Although Prop 65 was well-intentioned, it has caused many unforeseen consequences, and because it was passed by a ballot initiative, avoiding the usual legislative process, it is difficult to change.
American Biosciences Inc. does not object to compliance with Prop 65, despite its position that the required labels are misleading rather than informative.
If you would like to read more about Prop 65, please see the link below: