What is the California Proposition 65 “Warning”?

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

Green Regimen - Elite Protein - Heavy Metal Test Results

Prop 65: INTENTIONS

Almost all foods we see and consume every day has a higher amount of lead compared to the Prop 65 limit.

Examples:

8 Times Higher

Apple 2.5 mcg, Honey 4.5 mcg, Cucumber 3.4 mcg, milk fat 3.4 mcg, avocado 4.5 mcg

16 Times Higher

Spinach 7.0 mcg, Sweet Potato 7.2 mcg, Brussels Sprouts 7.9 mcg

24 Times Higher

Beef and Liver 9.0 mcg. Mixed Nuts 10.2 mcg. Italian Salad Dressing 12.2 mcg

More about Prop 65 Warning:

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.

Frequently Asked Questions

Which foods are affected?

Today, the vast majority of our diet includes at least a small amount of substances identified by California's Proposition 65. The exposure guidelines set by Prop 65 are so stringent that various naturally occurring foods like corn, yams, potatoes, turnips, spinach, tomatoes, lettuce, artichokes, green beans, carrots, and cucumbers result in exposures surpassing the Prop 65 thresholds. However, it's not mandatory for food manufacturers to issue Prop 65 warnings.

How does this impact Green Regimen Products?

Green Regimen's products may contain trace amounts of chemicals listed by the State of California, but these are only present due to the natural state of the ingredients used.

An important caveat in Prop 65 applies when a listed chemical is inherently present in a food item, not introduced through "known human activity." However, the State of California hasn't provided clear guidance on how this exception is applicable to the health supplement sector. Therefore, regardless of whether an ingredient is naturally occurring or added to a supplement, adherence to Prop 65 regulations is still obligatory.

This means that even if substances like lead are naturally present in the environment and found in minute quantities in natural ingredients, including those used in dietary supplements, we are obliged to include a warning on our product labels.

Is it safe to consume Green Regimen or other natural products?

Plants, minerals, and proteins are known to contain levels of substances that exceed the exposure limits set by Prop 65. Naturally grown plants absorb metals and other trace elements from their soil. For instance, Prop 65's safe harbor limit for lead is 0.5 mcg per serving, yet this threshold is significantly lower than the lead levels naturally occurring in many fruits and vegetables cultivated in clean, uncontaminated soil. A study conducted by the State of California in 2009 (Agriculture, Ecosystems and Environment 129:212-220) on soil-lead-uptake in food crops found that commonly consumed vegetables from 70 different locations had nearly four times the Prop 65 limit for lead per serving.

Considering Prop 65 standards, common vegetables like carrots, wheat, lettuce, and potatoes would all necessitate a lead warning on each serving.

It's crucial to understand that Prop 65 governs exposure levels, not concentrations or actual risk of harm or injury. Natural proteins, as an example, inherently contain high levels of lead, and any attempt to remove the lead would compromise the protein itself. All Green Regimen products comply with the FDA's recommended guidelines for the chemicals listed under Prop 65, ensuring their safe consumption.

Why are there warnings on Green Regimen labels?

Green Regimen opts to adhere to the warning label requirements of Prop 65 as a strategic business choice. This decision aims to circumvent the risk of costly, lengthy, and potentially devastating litigation surrounding Prop 65 compliance. We believe that our products should be classified under the "naturally occurring allowance" exemption and are 100% safe. However, to avoid potential issues, all Green Regimen products will carry the required notices until this exemption is more explicitly defined by the Courts and the State of California.

Green Regimen contends that California's Prop 65 mandated lead limit, identified as a reproductive toxicant, is excessively stringent compared to the lead limits set by other reputable government bodies like the FDA, EPA, USDA, etc. The California Office of Environmental Health Hazard Assessment (“OEHHA”), which administers Proposition 65, has established safe harbor levels. A business is given "safe harbor" from Prop 65 warning mandates if the exposure to a chemical does not exceed these levels. The Maximum Allowable Dose Level (“MADL”) for lead, in terms of birth defects or reproductive harm, is 5 parts per million.

According to OEHHA (www.oehha.ca.gov), the criteria set by the State of California to determine the MADL for reproductive toxicants are based on the “no observable effect level,” identified as the exposure level proven to be harmless to humans or laboratory animals. Proposition 65 mandates dividing this “no observable effect level” by 1,000 to ensure a significant margin of safety. Businesses subject to Prop 65 must provide a warning if they cause exposures to chemicals listed as causing birth defects or reproductive harm that exceed 1/1,000th of the “no observable effect level.”

Green Regimen believes that the application of a 1/1,000th factor is scientifically unjustifiable. Many experts argue that this factor should be significantly higher, above 1/100th. This 1/1,000th factor, a stipulation of California’s Prop 65, is considered outdated by many, but changing it requires a two-thirds vote of the California legislature, which is highly improbable.

Green Regimen maintains that the lead present in its products is “naturally occurring.” While Proposition 65 permits the deduction of natural background lead levels from the total lead content, only the portion not added through “human activity” can be subtracted. Determining the naturally occurring versus human-added lead in a product, especially for products like Green Regimen's Elite Protein Chocolate/Vanilla with multiple ingredients, is expensive and beyond the company's capacity.

We comply with current laws and will continue to include Prop 65 Warnings on applicable products sold in or to the State of California, pending any legislative changes.