Chipping Away at Prop 65

Litigators score a victory that has implications for the dietary supplement industry.

By Joanna Cosgrove

Online Editor

In November 1986, California voters passed The Safe Drinking Water and Toxic Enforcement Act of 1986, an initiative designed to protect California consumers from exposure to toxic chemicals. Dubbed Prop 65, the initiative zeroes in on an annually updated list of harmful carcinogens and toxicants that cause cancer, birth defects or other reproductive harm. While manufacturers stand to reap at-market benefits of Prop 65 compliance, they must first incur the expense of testing their products, developing alternatives, reducing manufacturing discharges, and providing warnings in compliance with the requirements of the Proposition. At present, scores of consumer product companies are embroiled in litigation with the state, charged with violating the tenets of Prop 65.

In late March, Boston legal firm Goodwin Procter LLP obtained a victory for its clients, the BumbleBee, Starkist and Chicken of the Sea tuna companies, when the California Court of Appeals affirmed a trial court finding that methylmercury warnings in connection with the sale of canned tuna are not required under Prop 65.

Specifically, the court found substantial evidence showing that virtually all the methylmercury found in canned tuna occurs naturally, independent of human activity. Methylmercury is the type of mercury found in fish and is not emitted by pollution. Naturally occurring substances are exempt from Prop 65.

According to Forrest Hainline III, partner in Goodwin Procter’s Litigation Department, and the lead trial counsel in the case in the Superior Court in San Francisco who also argued the appeal, the case has significant ramifications for the tuna industry and beyond. “The FDA has decided that consumers need to be informed in the appropriate way and that the Prop 65 warnings are unnecessary,” he stated. “Prop 65 has resulted in far-reaching consequences for the thousands of companies conducting business in California, including the dietary supplement industry. It is essential to point out that the appearance of naturally occurring contaminants, such as lead or methylmercury in products does not require a Prop 65 warning in California.”

In addition to proving that virtually all of the methylmercury was naturally occurring, Goodwin Procter also successfully illustrated in the trial court that the levels of methylmercury in tuna were below the baseline standard for Prop 65.

Mr. Hainline’s colleague, Joanne Gray, co-chair of the American Bar Association’s Food and Supplements Group and co-chair of Goodwin Procter’s Food/Supplement Industry practice, asserted that the decision sets a strong precedent for dietary supplement companies that may be facing similar lawsuits. “It demonstrates that the food and supplement companies targeted in Prop 65 lawsuits need to mount a strong defense when their products contain naturally occurring substances such as lead, thereby removing themselves from the unreasonable reach of so-called ‘Prop 65 claims’,” she said.

The state of California recently filed lawsuits against several leading dietary supplement companies, alleging violations of Prop 65 by claiming that the defendants sold supplements containing lead.

Regarding the lawsuits, Ms. Gray said, “It is a real threat to the entire industry, even though many of the claims are made regarding naturally occurring substances, which should be exempt from the reach of Prop 65. Some cases make claims regarding minute amount of substances that hold no real risk of harm—even if you ingest them daily.”

Ms. Gray said the court’s decision in the tuna industry case should make it easier for dietary supplement companies to defend Prop 65 claims. “They can point to the tuna industry precedent showing that naturally occurring substances present in their products (like the methylmercury in tuna, or lead in dietary supplements) should be and are exempt from the reach of Prop 65,” she said.

Despite the public stigma associated with lead consumption, Mr. Hainline said the minute amounts of lead in supplements essentially equate to nothing more than “trace amounts of naturally occurring elements—that in large quantities can cause harm—which have touched humans for thousands of years without harm.”

“There is no reason to warn the public of ‘harm’ when, in fact, no harm actually exists,” concurred Ms. Gray. “Warnings should focus on disclosing real harm, and the labeling should be appropriately worded and clear. Over-warning—that is, giving an excessive, inappropriate and unneeded warning—actually is a danger as it can make members of the public more likely to ignore truthful and useful warnings. It also can cause unnecessary anxiety to the public. And over-warning can hurt small businesses—even put them out of business—for no good reason.”

Looking Ahead

Mr. Hainline believes Proposition 65 is a well-intentioned law with three elemental flaws. For starters, he said, it conveys a message that is often fundamentally false. “The Prop 65 message (the core and mandatory language) is ‘WARNING: this product contains a chemical known to the State of California to cause cancer or reproductive harm,’ he said. “The takeaway from this message is that the State of California knows that the chemical in the product causes cancer or some reproductive harm in humans. For many chemicals, the State of California has no such knowledge. For example, in the acrylamide in French fries case, I asked Lauren Zeis, the chief cancer specialist for OEHHA if the State of California knows that acrylamide causes cancer in humans. After the Attorney General instructed her not to answer, and I obtained a court order requiring an answer, she said ‘No’.”

The second flaw, according to Mr. Hainline, is that unless the naturally occurring exemption is rigorously followed, Prop 65 does nothing to change a manufacturer’s behavior. “Prop 65 should exist to encourage manufacturers to remove questionable chemicals from their products where they can. Remember, Prop 65 is not a health statute. If we were talking about truly dangerous chemicals, then the State or federal government would ban them.”

His third criticism is that Prop 65 contributes to an atmosphere of over-warning. “When warnings are posted on everything (which is where Prop 65 is headed), consumers pay no attention to the warnings at all,” he explained. “This over-warning issue is at the core of FDA’s preemption letter in the tuna case. Warnings should be limited to the few very dangerous chemicals that for some reason are not banned altogether—like tobacco, for example.”

In the coming years, both Mr. Hainline and Ms. Gray hope there will be greater recognition of the limitations of Prop 65. “For the dietary supplement industry, my hope is that both the legal system and public understands that many companies are providing an often overfed and undernourished public with great products that help people live a healthy lifestyle. I hope courts will see that placing unnecessary and inappropriate warnings on these products will, in the long term, dissuade people from taking dietary supplements—which will ultimately hurt the public rather than help.”

Mr. Hainline took it one step further. “Prop 65 has no place on foods or supplements,” he declared. “It is critical that the people of our nation have confidence in the wholesomeness of the foods and supplements they consume. If products are adulterated or dangerous, they should not be marketed.

“Foods and supplements are a national concern, demanding a uniform national standard and response,” he concluded. “Individual states have no business undermining the confidence of citizens in the wholesomeness and safety of products that FDA and USDA have determined are safe.”