What is the California Proposition 65 “Warning”?
In California it’s a law known as the Safe Drinking Water and Toxic Enforcement Act. It’s also referred to as Proposition 65 and for short: Prop 65.
California’s Proposition 65 requires the warning you now see on our label. This notice applies only to California consumers and not to customers in any other states.
To put this in perspective: the amount of lead contained in a serving of a MacroLife product is below the naturally occurring lead found in plant foods, vegetables, and fruits. The USDA recommended 3-5 servings of vegetables daily could contain up to ten times more lead than the maximum allowed by California prop 65. Here are two examples:
Natural green beans contain 28.75 micrograms of lead in a one cup serving, which is an exposure of approximately 50 times the allowed Prop 65 levels.
Natural spinach contains approximately 5.2 micrograms of lead in a typical adult serving size which is an exposure that exceeds Prop 65 levels by 10 times.
Proposition 65: Good Intentions, Bad Law
Prop 65 limits for for lead are so low, almost all foods contain amounts higher than allowed:
24 Times Higher:
Italian salad dressing 12.2 mcg , Mixed nuts, no peanuts, roasted 10.2 mcg, Liver, beef, fried 9.0 mcg
16 Times Higher:
Brussels sprouts, fresh, boiled 7.9 mcg, Sweet potato, fresh, baked 7.2 mcg ,Spinach, boiled 7.0 mcg, Dry table wine 6.8 mcg
8 Times Higher:
Avocado, raw 4.5 mcg , Honey 4.5 mcg, Watermelon, raw 4.5 mcg, Raisin bran cereal 4.1 mcg, Raisins, dried 3.5 mcg, Cottage cheese 4% milk fat 3.4 mcg, Cucumber, Raw 3.4 mcg, Peach, raw 3.4 mcg, Granola cereal 3.0 mcg , Apple, red, raw 2.6 mcg
More about the California Proposition 65 warning:
Prop 65 requires products sold in California to bear warnings about potential exposure to any of the substances listed by the state of California. This notice does not apply to any other state in the Union. To put this notice in perspective, the value of lead contained in Macrolife products is well within the range and below the mean value of naturally occurring lead levels found in plants growing in non-contaminated soils. A person eating the USDA recommended 3-5 servings of vegetables daily could consume up to ten time more lead than the stringent maximum recommended by California.
Frequently Asked Questions
What kinds of food are affected?
Almost all foods contain some level of one or more of the substances recognized by the State of California. In most cases, the exposure levels established by Prop 65 are less than what occurs naturally in fruits, vegetables, grains, and even drinking water. The Proposition 65 exposure standards are so strict that certain natural foods such as yams, turnips, apples, tomatoes, artichokes, carrots, cucumbers, green beans, lettuce, spinach, potatoes, and corn provide exposures in excess of Prop 65 limits. However, food producers are not required to provide Prop 65 notices.
How does this affect MacroLife Naturals Products?
Any amount of chemicals listed by the State of California found in Macro Greens, Miracle Reds, Macro Coco Greens, Macro Berri Reds or any MacroLife Naturals Superfood Bar occur as a result of the natural state of the ingredients in the products. Prop 65 states that no warning is required when the listed substance occurs naturally in a food product, and not as the result of “known human activity.” However, the State of California has never issued clear guidelines on how this exception applies to the health supplement industry. It is generally understood that 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. However, to claim this naturally occurring exception to Prop 65 (i.e.: to not post the labels on products) usually lands the claimant in an expensive, time consuming, and business destroying legal proceeding.
Does this apply to all naturally occurring substances?
Should I be worried about eating MacroLife or other natural products?
Proteins, plants, and minerals all are well-known to contain substances that exceed 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 harbour 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. When compared with the Prop 65 standards, each serving of potatoes, lettuce, wheat, carrots and many other vegetables would require a lead warning.
Remember that Prop 65 regulates exposures, not concentrations and not 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 MacroLife Naturals products fall within FDA suggested guidelines for any/all of the chemicals listed by Prop 65 and can be safely consumed.
Why does MacroLife Naturals put warnings on their labels?
MacroLife Naturals 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 believe all our products should be exempted under the “naturally occurring allowance” exception. However, until this exception is more clearly delineated by the Courts and the State of California, all MacroLife Naturals products will comply with the notice requirements.
Macrolife Naturals 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 the website of the 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.”
Macrolife’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 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.
Another concern is that Proposition 65 focuses on the presence of individual chemicals in food products and does not focus on the safety and benefits of the whole product and does not focus on real harm to people. Proposition 65 allows for the use of citizens (as private attorneys general) to enforce its provisions. As a result, an industry of so-called bounty hunters has developed. These persons threaten to file suit against any business which has a product that they claim requires a Proposition 65 notice. When Macrolife was confronted by one of these bounty hunters it quickly learned the litigation facts of life. First and foremost is the issue of burden of proof. The plaintiff only has to show that the chemical in question is in the product and no warning label was provided. The plaintiff is not required to show actual or threatened harm. However, Macrolife as the defendant has the burden of proving that the average consumer’s exposure to lead is below the MADL.
Macrolife 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 and, in particular Macrolife products which in the case of its powders contain 30 or more ingredients, is very costly and beyond the ability of Macrolife to bear. In a California case, Environmental Law Foundation v. Beech-Nut Corporation, et al. in the Alameda County California Superior Court, Case No. RG 11 597384, the Plaintiff sought to require the Defendants to place a Proposition 65 warning of lead on their fruit, vegetable and grape drink products. Although the Defendants did prevail at trial, the Court found that the Defendants did not show that the lead in their products was solely naturally occurring and not resulting from human activity. Thus, even very large Defendant corporations with their litigation and scientific expert budgets could not show to the satisfaction of the trial court what portion of the lead in their products was naturally occurring.
Macrolife strongly believes in the efficacy and safety of its products. However, because Macrolife as a small company could not bear the cost of litigation, it reluctantly decided to enter into a settlement which required placing the warning level on its products. The founders of Macrolife are very health conscious and believe in both consuming and selling foods and products which they believe are not harmful. This includes the Macrolife products.
The information contained on the Web Site is for informational purposes only. It is not intended to provide legal, accounting, tax, investment, financial, medical or other advice to you, and you should not rely upon the information to provide any such advice.
Cautions/warning for Macro Greens & Reds (Europe ONLY):
If you are on any medication or have a pre-existing medical conditions please consult your doctor before use. This product may not be suitable in combination with medication for high blood pressure, heart disease, diabetes or seizures, stimulant laxatives or steroids. Do not take this product if you have the following medical conditions: High Blood pressure, cardiovascular disease, diabetes, kidney or liver disease, hypokalemia, Immunosuppressive conditions, iron deficiency, gastro-intestinal disorders, stomach lesions or ulcers.