California Prop 65 Warning & Info
- What is Prop 65 about?
- What kinds of chemicals require this warning?
- Comparison of the Prop 65 Standards vs National Standards
- Should I be concerned about Remedy's products?
- What if I'm still concerned about lead or other heavy metals in herbs?
- Why do some herbal products have a warning and others don’t?
- I do not live in California. Why am I receiving this warning?
- Who enforces Prop 65?
What is Prop 65 about?
In 1986, the people of California passed a ballot initiative proposition called the Safe Drinking Water and Toxic Enforcement Act of 1986, now commonly known as “Prop 65”, primarily designed to prevent dumping of toxic chemicals in California waters. However, it also required warnings on products that contain certain chemicals. While we certainly agree that keeping industrial chemicals out of food products is a good idea, that is not what Prop 65 does.
Prop 65 applies to any product or service received or used in California. As applied to foods, Prop 65 makes no distinction between natural and artificial products. And although it excludes “naturally occurring” chemicals in foods, that term does not include man-made pollutants that may end up in natural products through means outside of the manufacturer’s control. Prop 65 does not distinguish between chemicals resulting from external sources like worldwide soil, water, and air pollution, pesticide over-spray or chemical leaks, which are then absorbed by plants, and those that are intentionally applied like synthetic fertilizers and pesticides or chemicals introduced later in drying, processing or manufacturing.
What kinds of chemicals require this warning?
Prop 65 applies to over 800 chemicals identified by the State of California as carcinogens and reproductive toxins. 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, and solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes such as motor vehicle exhaust.
Prop 65 does not limit in any way, nor requires the disclosure of, the types or amounts of chemicals that can be put into a product as long as the warning is given. It does set a “safe harbor” exposure level for many of the governed chemicals, below which no warning is required. Safe Harbor Levels are often much lower than those set by the FDA, EPA and WHO.
Comparison of the Prop 65 Standards vs National Standards
Let’s use lead as an example. Lead is a naturally occurring element that is found in the environment, including soil. According to the EPA, natural levels of lead in soil can range between 50 parts per million (ppm) and 400 ppm. Human-spread lead contamination widens this range, of course, with reports of over 10,000 ppm in certain types of areas, such as industrial facilities.
International standards for lead in dietary supplements and food are often set at no more than 5 ppm. The Prop 65 Safe Harbor Maximum Allowable Dose Level for lead is 0.5 micrograms per day, meaning that a person may not be exposed to lead above this amount, by any product, without a Prop 65 warning. Setting aside the difficulties of translating this exposure level to a concentration level in a specific product, applying this standard to herbs and supplements means that lead content levels would need to be many times lower than federal levels in order for a product to be sold without a Prop 65 warning. Above the Safe Harbor Levels, a Prop 65 warning must be given to avoid lawsuits and potential liability.
When grown in soil with a relatively “low” lead content (500 ppm), spinach and radishes can have lead levels that exceed 3 ppm, while beets and carrots can exceed 6 ppm. Also, herbs may contain over 90% water by weight, so lead levels in dried herbs can be up to 10 times higher than their fresh counterparts. In addition, it is difficult to get root crops entirely free of the soil they are grown in. Under these circumstances, it is easy to see how it might be difficult to keep lead levels low in natural herbal products and especially in herbal root products.
Lead Prop 65 warning required at 0.5 micrograms/serving and higher
FDA tolerable daily intake level
Adults: 75 micrograms
Children: 6 micrograms
A 4oz. serving of nuts, Brussel sprouts, or spinach can deliver up to 10 micrograms of naturally occurring lead. Indeed, virtually all foods contain lead and other heavy metals. In a study by the European Food Safety Authority the estimated mean lifetime dietary exposure from all sources to lead was estimated to be almost 50 micrograms per day in the overall European adult population. This is 100 times the Prop 65 limit. As you can see the potential amount of lead exposure from herbs and spices is at most a small amount of the total exposure to lead for the average person.
When manufacturing herbal products, it is often impossible to meet Safe Harbor levels. When Safe Harbor levels cannot be met Remedy's applies the appropriate Prop 65 warning to its labels.
Should I be concerned about Remedy's products?
A Prop 65 warning does not necessarily mean the product is dangerous.
Remedy's tests all its ingestible products for Lead, Cadmium, Mercury and Arsenic. Used properly, we believe our products pose no health risk. We apply the warning to protect our company from lawsuits by individuals and groups looking for businesses that allegedly do not comply with Prop 65.
For many herb and other food and supplement products it is impossible to both meet the Safe Harbor Levels and provide a realistic serving size, so the choice is to either put the warning on the label or discontinue selling many of our products.
What if I'm still concerned about lead or other heavy metals in herbs?
You can consider taking herbs in tea or extract form. Our testing of a variety of teas and liquid extracts indicates that heavy metals are not soluble or only slightly soluble in alcohol and water and the exposure to heavy metals is even less when using herbs in these forms.
Why do some herbal products have a warning and others don’t?
While unlikely, it could be that the supplier has determined that their product falls within safe harbor rules. More likely, the supplier may not yet have implemented the warnings for their products yet, or they are not aware of the potential legal liability.
I do not live in California. Why am I receiving this warning?
The law applies to all products sold in California whether or not the manufacturer sells the product in California or intends for the product to be sold in California. We sell our products through distributors who may sell the product into California, so we cannot limit the labeling only to products/orders we ship directly to California.
Who enforces Prop 65?
Prop 65 actions can be brought by the California Attorney General or certain other public authorities, or by anyone who chooses to bring suit “in the public interest”. Any plaintiff, including the State of California, who prevails or settles in a lawsuit is entitled to 25% of any civil penalties paid by the Prop 65 defendant. Over the years, a number of individuals, groups, and professional plaintiffs, often referred to as “bounty hunters”, have brought Prop 65 lawsuits, the vast majority of which are settled. In 2010 private plaintiffs settled 187 lawsuits for amounts totaling nearly $14 million.
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