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California Prop 65

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Food safety is a priority concern at Naturally occurring elements such as lead and cadmium are found in the earth’s crust. Plants grown in the soil absorb nutrients, minerals and elements from the soil. Therefore, there will be trace amounts of naturally occurring elements in grains, vegetables and fruit. Additionally, these elements can also be found in fish and meats.

The Food and Drug Administration and various other health authorities monitor the amount of cadmium and lead found in food. These agencies have determined that negligible amounts of unavoidable naturally occurring minerals are not a public health risk nor do they pose any threat of injury. Therefore, these agencies do not feel it is necessary for there to be any type of warning related to these naturally occurring elements. The FDA consistently monitors the amount of lead and cadmium in food. Germack takes this matter so seriously, that we have a third party SQF audit certification in place. You can be assured that our products are safe and have passed FDA regulations.

In 1986, California voted Proposition 65 into place. This proposition is also known as the Safe Drinking Water and Toxic Enforcement Act. Prop 65 is a law that is unique to the state of California. It requires products sold in California to include warning information regarding potential exposure to specific chemicals. The list of chemicals exceeds over 800 and the number of chemicals on the list continues to increase. The warning must accompany any product, food or non-food, that contains any detectable amount of any of the chemicals on the list.

Prop 65 doesn’t ban the sale of products containing any of the potentially problematic chemicals found on their list. The Proposition does require that the products have a warning label on them even when the amount of the chemical found in the product is significantly below a level that could cause harm. These warnings must be placed on products sold in California even when the amount of the chemical is a level that would be acceptable to FDA regulations or other federal laws. Prop 65 regulates substances listed by California as having a 1 in 100,000 chance of causing cancer of birth defects over a 70 -year period. Lawsuits against manufacturers regarding Prop 65 may be instituted by the state of California or by private watchdogs and their attorneys whose goal is to sue companies to profit from this law.

The organic food industry and dietary supplement industries have recently been targeted by Prop 65 “bounty hunters.” The basis for this attack connects directly to naturally occurring elements such as lead that is in the soil the plants used in their products were grown in. The exposure level set by Prop 65 is often less than what occurs naturally in organically grown food and in products used in the dietary supplement industry. At Germack, we have implemented manufacturing practices that minimize or eliminate the risk of contamination.

At Germack, we feel that negligible amounts of the chemicals Prop 65 has listed should be provided with exemption status under the “naturally occurring allowance.” However, to avoid lengthy legal battles involving products containing chemicals on the Prop 65 list, we have chosen to comply with Prop 65 requirement. One way we do this is by providing warnings on our products that indicate there are detectable levels of trace amount of the chemicals that appear on the potentially problematic chemicals list. Another option we use for complying with Prop 65 regulations is that we limit the serving size for California residents to an amount that doesn’t require a warning.

You might find it interesting to note that the Governor of California has recently proposed reforms to end abusive Prop 65 lawsuits. You can acquire more information regarding these reforms at Governor Brown proposes to reform Proposition 65.