October 31, 2011
In the spirit of Jonathan Swift's satirical essay from 1729 "A Modest Proposal," Californias 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 65s 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 ."
Californias 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.
California law provides some exceptions to Prop 65s 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 demonstrateusually through a complex risk assessmentexposures 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)
Naturally occurring allowance
No warning is required when the listed chemical occurs naturally in a food product, and not as the result of "known human activity." However, OEHHA has never issued clear guidelines on this for the food/supplement industry. Most people generally understand that lead and other metals occur naturally in the environment and, thus, can be found in ingredients used to make dietary supplements. But there is big difference between a general understanding and the formal evidence required to support an allowance under Prop 65 in a given circumstance. The naturally occurring allowance can be a potential defense at trial, but it is only available on a ingredient-by-ingredient basis. The allowance is difficult, expensive, and time-consuming to utilize.
There are only a few successful consent judgments that quantify the naturally occurring allowance. The biggest example of this was when the California attorney general filed a lawsuit against three canned tuna companies (BumbleBee, Starkist and Chicken of the Sea) for not providing Prop 65 warnings about the presence of methylmercury in the their canned tuna. The tuna canners won, after a subsequent appeal by the Attorney General, with the appeals court affirming the trial courts ruling, which found the three tuna companies were not required to post Prop 65 warnings, related to the sale of canned tuna in California stores. The tuna companies win was based on a defense known as the naturally occurring allowance." The appeals court concluded there is substantial evidence that the methylmercury found in canned tuna occurs naturally and independent of human activity. The court found that methylmercury, is not emitted by pollution, and when a naturally occurring contaminant appears in a product, such as in tuna fish or dietary supplements, the Prop 65s warning requirement does not apply.
No warning is required when federal warning law preempts state law (e.g. Rx or drug products);
Small businesses with less than 10 employees, governmental agencies and public water systems are also exempt from the warning requirement.
Who can act to enforce Prop 65 requirements
Legal proceedings to enforce Prop 65 may be instituted by the State of California or private citizens. If a private citizen is successful in such an action, they can receive monetary awards and attorneys fees. It is important to note that Prop 65 does not require a plaintiff to allege that anyone has been harmed by the product in question; nor does it require the plaintiff to allege that the product is defective or that it violates an existing federal or state safety standard. They merely have to show no warning was given.
The process normally starts with a 60-Day Notice of Violation, a legal document served by a plaintiff to a defendant, alleging violations of Prop 65 warning requirements. During the 60-day notice time period, the California attorney generals office reviews the allegations and can take over the proceedings, if they choose. At the end of the 60-day period, either the private plaintiff or the State of California can initiate legal proceedings against the defendant. Only government prosecutors such as the attorney general and district attorney may file Prop 65 enforcement lawsuits without serving a 60-day notice. The notice must provide adequate information in regards to the violation, what product(s) are in violation, and chemical hazards present to allow the manufacturer to assess the nature of the alleged violation. If a notice is received, the client should contact their legal team. It is specifically recommended to seek advice from lawyers who specialize in CA Prop 65.
Issue for Dietary Supplement Products
Proteins, botanicals and many minerals all are well-known to contain heavy metals that exceed those on the Prop 65 list. Many plants absorb heavy metals from the soil in which they are grown, including those used in dietary supplements. For example, Prop 65 sets a safe harbor limit of 0.5 mcg of lead per serving, but this limit is far below the amount of lead naturally found in fruits and vegetables, even those 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 129:212220), and its own experts found that the most commonly consumed vegetables (from 70 different locations), averaged nearly four times the Prop 65 lead limit per serving. Using the Prop 65 own standard, each serving of potatoes, lettuce, wheat, carrots and most other vegetables would require a lead warning. But note, that no one (so far) has gone after the agriculture growers or dairy farms for failure to warn.
One major issue with such lawsuits is that many business insurers generally do not defend against Prop 65 violations, because "unlawful business practices" are normally not covered. Enforcement actions filed for violations of Prop 65 are almost always combined with an action for violation of Californias unfair business practices statutes any violation of Prop 65 is automatically deemed an unlawful business practice. Your company may be on its own in defending itself.
Currently, there is a rash of notices and lawsuits (which are increasing at an alarming rate) against the dietary supplement industry. Currently, these suits focus on heavy metals (primarily about lead content, so far), but this could change in the future to other chemicals on the list (other heavy metals, PCB, Pesticides, etc.). Remember that Prop 65 regulates exposures, not concentration.
Lately, many sellers of protein drink mixes and botanical products are being sued. Proteins, for example (such as soy and whey), naturally have high levels of lead. To make matters worse for these companies, removing the lead would destroy the protein.
In addition to the lead problem, there is an increase in lawsuits filed by so-called bounty hunters, who are deliberately focusing on the dietary supplement industry, a fragmented group of business, with little legislative or consumer clout to defend itself. Current litigation underway can be reviewed at California attorney general's website.
There have been very few actual trials in Prop 65 cases. The clear majority of cases are settled by consent judgments. These agreements provide for injunctive relief, civil penalties, contributions to public interest groups in lieu of disgorgement of profits, and attorneys fees and costs. The injunctive relief provisions of consent judgments usually stipulate some reformulation or labeling of product.
In the end, companies potentially facing Prop 65 challenges currently few options:
Provide a warning statement.
Stop selling/shipping in California.
Reformulate to make product compliant (remove the listed chemicals).
Robin Koon is senior vice-president at Best Formulations (www.BestFormulations.com), has more than 25 years of pharmaceutical experience in clinical pharmacy and as a drug chain executive overseeing operations, manufacturing, managed-care, and in retail.
Disclaimer: The information given is for discussion only, and not meant to be construed as legal advice. For that, please consult with your attorney.
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