Insight Center: Publications

Court to Decide Whether FDA Regulation of Lead in Baby Food Pre-empts California Proposition 65

Food and Beverage Alert

Authors: William J. Walsh and AnnMarie Sanford


One of the rare California Proposition 65 trials began on April 8, 2013 – the Environmental Law Foundation (ELF) suit in Alameda County, CA Superior Court (ELF Lead In Food Case). ELF, a traditional environmental group that has been involved with Proposition 65 since its inception, alleges that most of the nation’s baby food and juice manufacturers and many retailers are in violation of Proposition 65 (the California toxics labeling law) for selling baby food and juices containing lead without warning labels.

Based on the trial briefs, the lawsuit seeks to dramatically expand the scope of Proposition 65. First, the defendants argue that the average concentration of lead in each of these products does not exceed the Proposition 65 safe-harbor exposure level for lead of one-half of a millionth of a gram of lead per day (0.5 µg per day) using long-standing Proposition 65 compliance methodologies. ELF argues that a violation must be calculated based on the highest single measurement of lead, not the average concentration from all measurements, because the Proposition 65 list of lead is based on noncancer effects. Traditionally, average concentrations have been used in Proposition 65 compliance calculations. Use of the maximum concentration would make compliance with Proposition 65 more difficult to prove. This case will decide this issue.

Second, the defendants argue that Proposition 65 conflicts with the Food and Drug Administration (FDA)’s regulation of lead in food and fruit juices – based on the FDA’s explicit finding of no hazard from the measured levels of lead in the fruit juices and foods subject to the Proposition 65 litigation, the infeasibility of the food industry to comply with both Proposition 65 and the federal regulatory scheme, and the likelihood that the Proposition 65 warning conflicts with the FDA’s policy of encouraging the consumption of fruits and vegetables (which the FDA adopted with knowledge that there are naturally occurring background levels of lead in these food items).

Finally, the defendants argue that the lead in food is naturally occurring and, therefore, explicitly exempted from Proposition 65, particularly because these lead levels are the lowest currently feasible using the best agricultural practices.

The defendants claim that application of Proposition 65 to food will be costly, result in more risk to the public rather than less risk (because there is no significant risk from these levels of lead in food and the public will lose the beneficial effects of eating fruits and vegetables), and clearly was not what was intended when Proposition 65 was voted on by the public.

Thus, the trial court has some difficult and important factual and legal decisions to reach. Given the significance of these issues, any trial court decision is likely to be appealed to the California Supreme Court. The defendants have a strong case, but the outcome cannot be predicted with absolute certainty. There have been other FDA-Proposition 65 pre-emption cases, but none have been dispositive. The appellate courts in California have tended to support a broad reading of Proposition 65 and more generally courts tend to move cautiously in matters involving food safety.

If ELF prevails, a significant amount of food sold in California may require labeling. This may affect food sold in other states because of the difficulty in ensuring the ultimate state in which the sale occurs. Additionally, the question of whether the maximum concentration should be used in a risk assessment may have application in analogous situations pursuant to other environmental statutes.

If the plaintiffs prevail, then each defendant will need not only to pay its share of the defense costs, but a ratable proportion of the plaintiff’s litigation costs, the civil penalties assessed by the court, and comply with any injunctive relief obtained by ELF. For example, the court may ban the sale of fruit juices or food containing lead above some concentration of lead or mandate a treatment technology, in which case the manufacturers may need to treat their products to remove lead or otherwise modify their production processes to lower the lead level. Such a requirement will increase the price of these fruit juices and other baby food. Even if the defendants prevail, the defendants may be required to pay the plaintiff’s litigation costs, which are likely to be significant.

William J. Walsh and AnnMarie Sanford

Learn more about our Food and Beverage Industry practice.

The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.

Data protection laws have changed, so we have revised our Privacy Policy.