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Warning: This product contains lead, a chemical known to the State of California to cause birth defects and other reproductive harm. For more information, visit https://www.p65warnings.ca.gov/
Safe Drinking Water and Toxic Enforcement Act also known as Proposition 65 or Prop 65 is a law that applicable only to California. Prop 65 law requires a warning label placed on every product which you see in our label.
When it comes to Green Regimen Products the amount of naturally occurring lead in our servings is lower compared to plant foods, fruits, and vegetables. It is recommended by the USDA to have 3-5 servings of vegetables daily which could contain up to ten times (10x) more lead the maximum allowed by Prop 65.
A 1-cup serving of Natural Green Beans contains 28.75 micrograms of lead which is around 50 times (50x) the allowed Prop 65 levels.
A typical full grown Natural spinach serving size contains 5.2 micrograms of lead which is 10 times (10x) higher that Prop 65 levels.
Certificate of Analysis
IEH Laboratories & Consulting Group
Almost all foods we see and consume every day has a higher amount of lead compared to the Prop 65 limit.
Apple 2.5 mcg, Honey 4.5 mcg, Cucumber 3.4 mcg, milk fat 3.4 mcg, avocado 4.5 mcg
Spinach 7.0 mcg, Sweet Potato 7.2 mcg, Brussels Sprouts 7.9 mcg
Beef and Liver 9.0 mcg. Mixed Nuts 10.2 mcg. Italian Salad Dressing 12.2 mcg
States outside California are not required to follow Prop 65 law which require products sold in California to put a warning about the potential exposure to any substance. This gives our customers peace of mind that our products have a low naturally occurring lead levels compared to plants growing in non-contaminated soils. If you are following the recommended 3-5 servings of vegetables, you might be consuming more than the maximum recommendation from Prop 65.
Almost all the foods we consume nowadays contain some level of one or more of the substance recognized by the state of California. The Proposition 65 exposure standards are so strict that certain natural foods such as corn, yams, potatoes, turnips, spinach, tomatoes, lettuce, artichokes, green beans, carrots, and cucumber provide exposures in excess of Prop 65 limits. But food producers are not required to give prop 65 notices.
Any amount of chemicals listed by the State of California found in Green Regimen occur as a result of the natural state of the ingredients in the products.
There is some exception when it comes to Prop 65 and it’s when a listed substance occurs naturally in a food product, and not as the result of “known human activity.” But the issue is the State of California has never stated any clear guidelines on how this exception applies to the health supplement industry. So whether the ingredient is natural, or placed into a supplement, we are still required to follow Prop 65 requirements.
We must follow and put a warning on our labels even if lead and other substances occur naturally in the environment and are found in trace amounts in naturally occurring ingredients, including those ingredients used to make dietary supplements.
Plant, minerals, and protein all are known to contain substances that surpass those allowed exposures on the Prop 65 list. Naturally grown plants absorb metals and other trace chemicals from the soil in which they are grown. For example, Prop 65 sets a safe harbor limit of 0.5 mcg of lead per serving, but this limit is far below the amount of lead naturally found in many fruits and vegetables grown on clean, non-contaminated soils. In 2009 the State of California conducted its own food crop soil-lead-uptake analysis (Agriculture, Ecosystems and Environment 129:212-220), and California’s experts found that the most commonly consumed vegetables (from 70 different locations), averaged nearly four times the Prop 65 lead limit per serving.
And if we think about it if we follow the Prop 65 standards, each serving of carrots, wheat, lettuce, potatoes and many other vegetables would require a lead warning.
We must remember that Prop 65 regulates exposures, not concentrations nor actual harm or injury. Natural proteins, for example, naturally have high levels of lead. Any process to remove the lead would destroy the protein. All Green Regimen products fall within FDA suggested guidelines for any/all of the chemicals listed by Prop 65 and can be safely consumed.
Green Regimen prefers to comply with the Prop 65 warning label requirements, as a business decision, in order to avoid expensive, time-consuming, and business destroying litigation over Prop 65 compliance. We firmly believe that all of our products should be exempted under the “naturally occurring allowance” exception and 100% safe. However, as we mentioned to avoid any problems all Green Regimen products will comply with the notice requirements until this exception is more clearly delineated by the Courts and the State of California.
Green Regimen believes that the limit for lead mandated by California Proposition 65 as reproductive toxicant is unduly strict when taking into consideration lead limits of other recognized government agencies such as FDA, EPA, USDA etc. The California Agency responsible for administering Proposition 65, Office of Environmental Health Hazard Assessment (“OEHHA”) has developed safe harbor levels. A business has “safe harbor” from Proposition 65 warning requirements if exposure to a chemical occurs at or below these levels. These safe harbor level, Maximum Allowable Dose Level (“MADL”) for lead as causing birth defects or other reproductive harm is 5 parts per million.
According to OEHHA (www.oehha.ca.gov) the criteria used by the State of California to determine the MADL for reproductive toxicants:
“For chemicals that are listed as causing birth defects or reproductive harm, the “no observable effect level” is determined by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. Proposition 65 then requires this “no observable effect level” to be divided by 1,000 in order to provide an ample margin of safety. Businesses subject to Proposition 65 are required to provide a warning if they cause exposures to chemicals listed as causing birth defects or reproductive harm that exceed 1/lOOOth of the “no observable effect level.”
Green Regimen’s understanding is that the use of a factor of 1/1,000th is no longer, if it ever was, scientifically defensible. According to many knowledgeable experts the factor should be much higher than 1/1OOth. The required use of the 1/1,000th factor is a provision in California’s Proposition 65. Many experts believe that the 1/1OOOth factor is no longer defensible in view of advancing science on the subject. However, because Proposition 65 was passed by the voters in California, the 1/1OOOth factor can only be changed by a two-thirds vote of the California legislature and such a vote is extremely unlikely.
Green Regimen believes that the lead in its products is “naturally occurring.” Proposition 65 allows for subtracting out natural background levels of lead from the total level of lead but only that portion that is not added by “human activity.” The problem is the cost and feasibility of scientifically determining what is naturally occurring and what is added by human activity. To make that determination for any product, including Green Regimen's Elite Protein Chocolate/ Vanilla containing 10 or more ingredients, is very costly and beyond the ability of Green Regimen to bear.
We comply with the law, and until any legislative changes occur, we will continue to place Prop 65 Warnings on relevant products sold to or in the State of California.
Certificate of Analysis
IEH Laboratories & Consulting Group