April 7, 2009
A March 12, 2009, legal victory by the law firm Goodwin Procter may prove critical to dietary supplement manufacturers looking to defend claims brought under California’s Proposition 65. As many who do business in California know, Proposition 65 is the state’s law that requires companies to issue warnings to consumers if a product contains certain carcinogens or reproductive toxins. The law casts a long shadow over supplement manufacturers, many of whom have been sued under the law for allegedly selling supplements containing lead without providing Proposition 65 warnings. But, according to Goodwin Procter, supplement manufacturers can take encouragement from the California Court of Appeal’s March 12 ruling, which clarifies the requirements for Proposition 65 warning labels.

Goodwin Procter began working on this issue in 2004 when the California Attorney General filed a lawsuit against three major canned tuna companies—BumbleBee, Starkist and Chicken of the Sea—for not providing Prop 65 warnings about the presence of methylmercury in the companies’ canned tuna. In the lawsuit, the Attorney General claimed that the small amounts of methylmercury in canned tuna could harm an unborn child.

The tuna canners were handed a win by the trial court. After a subsequent appeal by the Attorney General, the appeals court affirmed the trial court’s ruling and found that the three tuna companies were not required to post Prop 65 warnings in connection with the sale of canned tuna in California stores.

The tuna companies’ win hinged on a defense known as the “naturally occurring exception,” Goodwin Procter said. The appeals court concluded that there is substantial evidence that virtually all the methylmercury found in canned tuna occurs naturally, independent of human activity. In fact, the court found that methylmercury, the type of mercury found in fish, is not emitted by pollution. And when a naturally occurring contaminant appears in a product—such as tuna fish or dietary supplements—Proposition 65’s warning requirement does not apply.

“This case has significant ramifications for the tuna industry and beyond,” said Forrest A. Hainline III, a partner in Goodwin Procter’s litigation department who was lead trial counsel in the case in the Superior Court in San Francisco and also argued the appeal. “The FDA has decided that consumers need to be informed in the appropriate way and that the Prop 65 warnings are unnecessary. 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.”

Related links:
Herbalife Responds to Contaminated Supplement Claims