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About the California Proposition 65 Warning


Macrolife Naturals products labels now have a statement on their label to comply with California's Proposition 65 requirement to give notice of lead. In the case of Macrolife products, the notice is specifically limited "birth defects or other reproductive harm."


Proposition 65 is a California law and only applies to California consumers. It requires warning labels pertaining to a variety of different chemicals and substances only for products sold in the State of California. Although it is well meaning it sometimes causes confusion or is unduly strict as is the case of the required warming about lead for reproductive toxicants.


Lead is an element which occurs in nature. As the American Cancer Society notes on its website

Lead is a common presence in the environment from both man-made and natural sources, so it is not possible to completely eliminate your exposure to it. But because lead can cause health problems, even aside from its possible link to cancer, it is important to limit your exposure whenever possible.


And this is what the World Health Organization says in part on its website

People are exposed to lead through the air they breathe, through water and through food/ingestion. Toxic 

effects are usually due to long term exposure. The population groups at greatest risk of exposure are young children and workers. A recent report suggests that even a blood level of 10 micrograms per deciliter can have harmful effects on children's learning and behavior.


Macrolife Naturals believe 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 ( 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 toprovide 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 1/1,OOOth 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 1/1,OOOth 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 asthe 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 powers contain 30 or more 40 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.