California Prop 65 Warning

United States of America, State of California “Safe Drinking Water and Toxic Enforcement Act of 1986” more commonly known as Proposition “Prop” 65, explained

In 1986, California voters approved an initiative to address their growing concerns about exposure to toxic chemicals. That initiative became the Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65. Proposition 65 requires the State to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 900 chemicals since it was first published in 1987 (oehha.ca.gov).

In 1986, California voters approved Proposition “Prop” 65, the “Safe Drinking Water and Toxic Enforcement Act of 1986”.

Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment. By providing this information, Proposition 65’s intent was to enable Californians to make informed decisions about protecting themselves from exposure to these chemicals (oehha.ca.gov).

Businesses are required to provide a “clear and reasonable warning” before knowingly and intentionally exposing anyone to a listed chemical. This warning can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or other published notices. The warning is required even if the listed substances are naturally occurring and even if the amount of the chemical in the product falls far below Food and Drug Administration (FDA), Environmental Protection Agency, and World Health Organization safe levels (oehha.ca.gov).

However, it is possible for a business to be exempt from this legislation if it is determined that there is “no significant risk” of exposure to the ~900 chemicals currently on “Proposition 65 List of Chemicals”.  The “no significant risk level” is defined as the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime. In other words, a person exposed to the chemical at the “no significant risk level” for 70 years would not have more than a “one in 100,000 chance” (0.001%) of developing cancer as a result of that exposure (oehha.ca.gov).

Many corporations that do business in California, including USANA Health Sciences, find the above legal definition of “no significant risk level” to be unjustly burdensome and difficult, if not impossible, to defend in a court of law. As such, many corporations—including USANA Health Sciences—prophylactically include or attach the Proposition 65 warning with/to their products sold in California.

“Many businesses have opted to include [Proposition or ‘Prop’] 65 warnings out of an abundance of caution to avoid liability under the statute without evaluating whether exposures to their products or facilities would be required under the statute.”

– prop65news.com

In the case of USANA, and specifically in the case of lead in USANA products, we believe the allowable lower limit of 0.5 micrograms, which would trigger the need to include a warning to be unduly and erroneously low for two major reasons. First, lead is a naturally occurring atom that can be found in some degree in nearly all food products that humans consume including fruits, vegetables, and cereal crops.

Lead is a naturally occurring atom found throughout the world’s food supply

At the bottom of this entry you will find a selected list of approximately 400 food items that the United States Department of Agriculture found to contain lead. Additionally, a study analyzing lead concentrations in fruits, vegetables, and cereal crops found in some cases lead to be present at levels greater than 1000 micrograms—over 2000-fold the Proposition 65 allowable level (Szymczak, J. et al. 1993).

One study analyzing lead concentrations in fruits, vegetables, and cereal crops found lead to be present at levels greater than 1000 micrograms—over 2000-fold the Proposition 65 allowable level—in some crops!

-Szymczak, J. et al. 1993

Second, the pharmacology (how lead is circulated and distributed throughout the body), toxicology (potential to cause acute/chronic poisoning), carcinogenicity (potential to cause cancer), mutagenicity (potential to mutate DNA), and teratogenicity (potential for birth defects) data for lead is equivocal at best. In toxicology studies the lowest observed toxic dose was between ~3000- to ~22,000-fold the Proposition 65 level. Regarding carcinogenicity, mutagenicity and teratogenicity, according to INCHEM a coalition of intergovernmental organizations including International Programme on Chemical Safety (IPCS), World Health Organization (WHO), Canadian Centre for Occupational Health and Safety (CCOHS), Inter-Organization Programme for the Sound Management of Chemicals, (IOMC), FAO, ILO, UNEP, UNIDO, UNITAR, OECD, and the World Bank states that:

1. “The lowest reported lethal dose in man (LDL0) is 1470 µg/kg”. (INCHEM.org)
2. “…evidence for carcinogenicity in humans is inadequate (IARC, 1987). Alkyl lead compounds have not been tested adequately: the evidence for carcinogenicity of organolead compounds in animals is inadequate (IARC, 1987)”. (INCHEM.org)
3. “TEL [tetraethyl lead] and TML [tetramethyl lead] did not induce mutation in bacteria (IARC, 1987)”. (INCHEM.org)
4. “No adequate animal studies exist of the possible teratogenic effects of lead (WHO, 1977)”. (INCHEM.org)

USANA understands that its customers want their products to be as “clean” as humanly possible and we strive to deliver on that promise.  That is why USANA has—and will continue to—regularly test and monitor products to safeguard against potentially harmful contaminants including rejecting raw materials, vendors, or finished products when levels are found to be unacceptably high. This includes lead, other chemicals on the Proposition 65 list, other harmful substances not on the Proposition 65 list, biological contaminants such as yeast, mold, and bacteria, and many, many other chemicals and contaminants. USANA complies with all laws and regulations governing product safety. These laws and regulations have always been, and will continue to be, of paramount importance to ensure USANA is providing its customers with safe, healthy, and beneficial health products.

Dr. Myron Wentz’ vision: “The USANA family will be the healthiest family on earth. Love life and live it to its fullest in happiness and health.”

                                  -Myron Wentz, Ph.D. Founder and Chairman USANA Health Sciences, Inc.

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