Cal Proposition 65 & Dietary Supplements

What is Proposition 65?

In 1986 – almost 30 years ago – due to concern over exposure to toxic chemicals, California voters passed a citizen initiative, the Safe Drinking Water and Toxic Enforcement Act, or, as it’s now universally known, Proposition 65.  This citizen-based initiative, which is now the law in California, requires the State of California to publish two lists of chemicals – one list of chemicals that have been shown to have a risk of causing cancer in animals or humans, and a second list of chemicals that have been shown to have a risk of causing birth defects or other reproductive harm in animals or humans.

Even if a chemical has not been shown to cause these kinds of harm in humans, if the harm has been shown in animal testing, then the State of California is required to put the chemical on the appropriate Proposition 65 list.  The two lists, which are updated once a year, have grown to more than 800 chemicals since they were first published in 1987.

Proposition 65 also requires any company doing business in California to notify California consumers about the presence of a Proposition 65-listed chemical in any product the company is offering for sale in California.

If a product sold in California could expose a California resident to the specified minimum amount of one of these 800+ chemicals, then the product must include a warning notice.  Proposition 65 does not ban the sale of a product that contains a listed chemical; it simply requires that the product have a “clear and reasonable” warning notice on it.

What Kinds of Chemicals Are on the Proposition 65 Lists?

The two Proposition 65 lists encompass a wide range of both naturally-occurring and man-made chemicals.  Listed chemicals include ingredients found in pesticides, insecticides, and construction materials, as well as ingredients in common household products like foods, drugs, and alcoholic beverages.

Proposition 65 applies to all consumer goods sold in California, including food, although naturally occurring chemicals that are in food are not counted for purposes of determining if a warning notice is required.  Since 2013, as a result of litigation to determine their status, dietary supplements are categorized in California as foods for purposes of Proposition 65.

Some chemicals on the two Proposition 65 lists, such as lead, cadmium, and arsenic, are naturally found in the environment, literally all over the world.  Therefore, some products that naturally contain these chemicals can be required to carry a Proposition 65 warning notice, although, as noted above, not in the case of foods.

Are All States Affected by Proposition 65?

Proposition 65 only applies in California.  Manufacturers, distributors, and retailers who sell consumer goods in California are subject to Proposition 65’s warning notice requirement, whether or not the company is located in California.  However, it is certainly possible that a product originally intended for sale in California that has a Proposition 65 warning notice on it could find its way to another State and be offered for sale there, even though Proposition 65 doesn’t apply in that State.

Does Proposition 65 Apply to Dietary Supplements?

Proposition 65 does apply to dietary supplements sold in California.  If a dietary supplement contains a chemical on a Proposition 65 list, and the chemical is present in an amount above its Proposition 65 threshold – and the chemical is not naturally occurring in an ingredient in the dietary supplement – then a warning notice must be on the product to inform California consumers the chemical is present.

Are Products with a Proposition 65 Warning Notice Unsafe?

When a manufacturer includes a Proposition 65 warning notice on a product it does not mean the product is unsafe.  Rather, the notice is intended to inform California consumers of the presence of a listed chemical so the consumer can make an informed decision when purchasing the product.

How Concerned Should I Be about a Proposition 65 Warning Notice?

A bit of background information is needed to understand what Proposition 65 warning notices really mean.  It’s important to understand that a Proposition 65 warning notice does not mean a product is dangerous or harmful.  The threshold exposure limits that the State of California has set for many chemicals on the two Proposition 65 lists are far below the “safe” limits set by other regulatory agencies, such as the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, various European health agencies, and the World Health Organization.

For example, for lead, for children under the age of six, the U.S. Food and Drug Administration has established the “provisional total tolerable intake level” at six micrograms of lead per day.  Consuming less than this amount of lead daily is an amount the U.S. Food and Drug Administration deems to be safe for children in this age group.  By contrast, Proposition 65 requires a warning notice on any product that provides 0.5 micrograms of lead daily – an amount 12 times lower than the U.S. Food and Drug Administration’s “provisional total tolerable intake level” for daily lead consumption in a six-year-old.  For pregnant women, the U.S. Food and Drug Administration’s “provisional total tolerable intake level” for lead is 25 micrograms daily, which is 50 times greater than the amount requiring a Proposition 65 warning notice.  Finally, the U.S. Food and Drug Administration’s “provisional total tolerable intake level” for non-pregnant adults is set at 75 micrograms of lead daily, which is 150 times greater than the amount requiring a Proposition 65 warning notice in the State of California.

How Does Proposition 65 Determine the Threshold Levels for Which a Warning Notice Is Required?

Proposition 65 establishes two criteria to define the level of exposure risk.  One criterion applies to cancer risk and the other criterion applies to the risk for birth defects or other reproductive harm:

  • The maximum daily exposure threshold for a cancer-risk chemical is determined using the “no significant risk level.” The “no significant risk level” is defined as the maximum daily level of exposure that would result in not more than one additional case of cancer in 100,000 individuals exposed to that specific chemical every day for 70 years.  In other words, a person who was exposed for 70 years to the maximum daily limit of the chemical at the “no significant risk level” would have no more than a one-in-100,000 chance of developing cancer as a result of that 70-year exposure.

  • The maximum daily exposure threshold for a birth defect-risk chemical is determined using the “no observable effect level.”  The “no observable effect level” is defined as the maximum daily level of exposure that has been shown to not cause any birth defects or reproductive harm in laboratory animals or humans.  In addition, as a margin of safety, the “no observable effect level” is divided by 1,000 to establish the threshold for requiring a Proposition 65 warning notice for that chemical.

How Is California’s Proposition 65 Enforced?

Ultimately, the California Attorney General is responsible for enforcing Proposition 65.  In addition, the 53 district attorneys in the State of California can also enforce Proposition 65.  However, any private citizen who states that he or she is “acting in the public interest” can file a lawsuit against a company alleged to be violating Proposition 65 — this is the part of Proposition 65 commonly referred to as its “bounty hunter” provision.

Although Proposition 65 lawsuits have been filed by the California Attorney General and by California’s district attorneys, because the penalties for not including a Proposition 65 warning notice on a product are as high as $2,500 per violation per day, it is easy to understand why consumer advocacy groups, private citizens, and private plaintiff’s law firms have filed the vast majority of Proposition 65 lawsuits.  In fact, most lawsuits brought under Proposition 65 are filed by a very small number of consumer groups and law firms – some of these law firms do no other legal work but represent the plaintiffs who sue companies for allegedly violating Proposition 65.

How Can I Learn More about Proposition 65?

For information about the chemicals listed under Proposition 65 go to http://www.oehha.ca.gov/prop65.html or http://ag.ca.gov/prop65  

Or do an online search using “Proposition 65” as the search term

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