In the spirit of Jonathan Swift's satirical essay from 1729 "A Modest Proposal," California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly referred to as Proposition 65) applies to almost everyone doing business in California, including companies that ship products into California. Whereas Swifts proposal of ridding Ireland of its poor children to ease the country's burdens was satirical, California's attempt to rid the state of dietary supplements is no joke. Although Proposition 65 (Prop 65) applies to all products sold in California, it is currently threatening the dietary supplement industry.
What is Prop 65?
Prop 65 requires products to bear warnings about exposure to any of a wide variety of chemicals that are deemed hazardous by the state of California. Prop 65’s warning provision is required for any product or compound that exposes an individual in California to any detectable amount of a chemical “known to the state” to cause cancer or reproductive toxicity; it allows consumers to sue companies, if their product(s) do not carry a “clear and reasonable warning ."
California’s Office of Environmental Health Hazard Assessment (OEHHA) has established a listing of chemicals that warrant such a consumer warning. There are currently over 900 chemicals listed under Prop 65, classified either as carcinogens or reproductive toxicants (or both). The list is located on the OEHHA website.
It is important to note Prop 65 does not ban any product; it simply requires warnings. Once a chemical is listed, businesses have 12 months to comply with these warning requirements.
When a warning is required
A warning statement must be provided to the California consumer if an exposure to any detectable amount of a listed chemical, unless the exposure is specifically exempted (see below). The method used to transmit the warning must be reasonably designed to make the warning available to an individual before exposure. Again, Prop 65 requires “clear and reasonable” warnings, meaning one cannot use a modifier in the statement (e.g. "may cause"). The language is fairly specific.
- For a carcinogen: WARNING: This product contains a chemical known to the State of California to cause cancer.
- For a reproductive toxin : WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.
- For a chemical that both a carcinogen and a reproductive toxin (like lead): WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.
Variations are allowed.
To emphasize the point, 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:
- On the consumer product (packaging, labeling, etc.)
- Posting signs in an area
- Distributing or publishing public notices
Failure to warn
If no warning is given, then anyone can sue, on behalf of the citizens of California, against the offending company. That offending company can be in based any of the 50 U.S. states, so Prop 65 is not just a problem for Calif.-based companies. A plaintiff bringing a Prop 65 lawsuit needs only to show detection of any amount of a listed chemical, no matter how minimal, provided that no warning was given or supplied. Once the plaintiff shows this detection, the burden shifts to the business to prove an exemption.
Exemptions
California law provides some exceptions to Prop 65’s warning requirement, where no warning is required:
- Safe Harbor Limits - OEHHA develops numerical guidance levels, known as “safe harbor numbers” for determining whether a warning is necessary (for nearly 300 chemicals to date). The OEHHA website has more information on safe harbor limits.
A business has “safe harbor” from Prop 65 warning requirements if exposure to a chemical occurs at or below these levels. The safe harbor levels are exposure levels quantified in micrograms per day (µg/d). These are expressed as: “No Significant Risk Level” (NSRL), for carcinogens; and "Maximum Allowable Dose Levels (MADLs), for reproductive toxicants. To avoid liability, a business must demonstrate—usually through a complex risk assessment—exposures will not exceed the NSRL or MADL. These numbers supposedly show that exposures will not exceed specified health risk thresholds, which are extremely conservative. For example, Prop 65 has maximum limits for some heavy metals; the maximum daily intake limits for these metals are as follows:
- Arsenic – Carcinogenic limit of 10 mcg day (0.01mg/day)
- Cadmium – Reproductive limit of 4.2 mcg day (0.0041mg/day)
- Lead – Reproductive limit of 0.5 mcg day (0.0005mg/day)
- Mercury – Reproductive limit of 0.3 mcg day (0.0003mg/day)
