California Prop 65 Warning and Information
Though we meet or exceed all applicable Federal safety standards, California law requires that our natural herbal products, like many other natural products, be sold with a Proposition 65 notice in California.
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 the dumping of toxic chemicals into 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. [1]
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—such as global soil, water, and air pollution, pesticide over-spray, or chemical leaks—and those that are intentionally applied, such as synthetic fertilizers, pesticides, or processing agents used during drying or manufacturing. For example, lead is a naturally occurring heavy metal that can be found in soil due to both natural presence and decades of industrial activity. Plants can absorb lead from contaminated soils, even if grown organically and without any synthetic inputs. [2] [3] [5]
Although the intent behind Prop 65 was consumer safety, it has also led to significant legal and labeling complications. Critics, including California’s own Attorney General, have acknowledged concerns about how the law has been used in practice. [4]
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. [Source 3] 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.
For comparison
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 [Source 5] 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 Starwest applies the appropriate Prop 65 warning to its labels.
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.
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2. Lead at Superfund Sites: Human Health United States Environmental Protection Agency. Accessed 15 October 2014. Web.
3. M. Gaweda. Changes in the Contents of Some Carbohydrates in Vegetables Cumulating Lead. Polish Journal of Environmental Studies, 4 Aug. 2006. Web.
4. L. L. Halko. California’s Attorney General Acknowledges Prop 65 Abuse. Washington Legal Foundation: Legal Backgrounder, Vol. 22 No. 9. 27 July 2007. Web.
5. Lead dietary exposure in the European population. European Food Safety Authority, 11 July 2012. Web.