Labeling & Standards
September 6, 2005
FDA Takes Precedent-Setting Action Against California's "Prop 65" Labeling
In an action that could have implications for all food companies in the California market, Food and Drug Administration (FDA) Commissioner Lester Crawford stated in an August 12 letter that the state's requirement of mercury warning labels on tuna products — resulting from California's Proposition 65 (Prop 65) regulations — are contrary to federal food labeling laws. FDA's ruling could have far-reaching implications for other foods, including dairy, that are subject to FDA authority and could be targets for similar lawsuits.
In his letter to the California attorney general, Crawford notes that "California should not interfere with FDA's carefully considered approach of advising consumers of both the benefits and possible risks of eating seafood." In fact, Crawford states that tuna companies are not able to comply with both federal labeling rules and Prop 65, and "as a result, the latter is preempted under federal law."
"Rather than requiring warnings for every single ingredient or product with possible deleterious effects, FDA has deliberately implemented a more nuanced approach...taking action in instances of adulterated and misbranded foods and, only under exceptional circumstances, requiring manufacturers to provide warnings on their labels," Crawford writes. "As part of this deliberate regulatory approach, FDA has required warnings only in those instances where there is clear evidence of a hazard, in order to avoid overexposing consumers to warnings, which could result in them ignoring all such statements, and hence creating a far greater public health problem."
Created in 1986, Prop 65 is an environmental law that requires companies to label consumer products with a warning if they contain compounds that the state has deemed harmful. However, Prop 65 contains two unique provisions that set it apart from similar laws. The first provision — the "bounty hunter" provision — encourages private enforcement by entitling the plaintiff to recover attorney fees and 25% of the statutory penalties if they successfully bring in a Prop 65 action. The second provision is that the plaintiff only needs a minimal amount of evidence to bring a Prop 65 action, and then the entire burden shifts to the defendant to provide substantial proof of innocence. Due to the high cost of litigation and threatened fees, many businesses decide to pay out-of-court settlements rather than fight. This settlement trend has escalated the volume of threatened actions in recent years.
To read FDA's full letter, click here. For more information, contact Clay Detlefsen at cdetlefsen@idfa.org, (202) 220-3554.
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