Press Release - Citizen Petition Asks FDA to Determine That California’s Proposition 65 Conflicts Irreconcilably With Federal Law as Applied to Foods

January 2008

Seeking to avoid giving an untruthful and misleading Proposition 65 "warning" for the nutritious foods and dietary supplements it sells to California consumers, Swanson Health Products Inc. today has filed a petition with the Food and Drug Administration (FDA) urging the federal agency to determine that Proposition 65 conflicts irreconcilably with the federal statutes and regulatory scheme governing foods. Swanson's attorneys, Carol Brophy and Stephanie Sheridan  of Sedgwick Detert Moran & Arnold LLP, indicated this citizen petition to the FDA is the first such petition to raise the conflicts preemption issue with respect to foods and dietary supplements.

Proposition 65, which covers a list of more than 800 chemicals and chemical families, requires manufacturers who expose an individual in California to any detectable amount of a chemical known to the state to cause cancer or reproductive toxicity to give a clear and reasonable warning. However, according to Swanson's attorneys, Proposition 65 does not differentiate between substances that are beneficial to life, chemically inert in the body or hazardous, resulting in confusion among consumers, mislabeling of products and a conflict between federal and state laws.

"Proposition 65, when applied to foods and dietary supplements, causes consumer confusion because it misbrands wholesome products and frustrates FDA's ability to carry out its statutory mandates," Sheridan said. "Virtually all foods and dietary supplements contain detectable levels of one or more of the 800 chemicals listed under Proposition 65, because these chemicals occur naturally in the environment and cannot be removed. Proposition 65 compels alarmist warnings at negligible levels, diluting the importance of FDA advisories regarding real hazards."

Under federal law, the Federal Food, Drug and Cosmetic Act (FFDCA) grants the FDA authority to establish food safety standards, good manufacturing practices, and to regulate food labeling. Brophy asserts a conflict in law exists because food and dietary supplement manufacturers cannot comply with both the FFDCA's restrictions against misleading statements and Proposition 65's obligations to place warnings on all products having a detectable level of a listed chemical.

"We have been put in a no-win position," said Kari Graber, Quality Control/Compliance manager for Swanson. We know our products are safe and either meet or exceed FDA standards. However, we are forced by Proposition 65 to label our products as hazardous, which confuses our California customers. We need one standard, and that standard should be set at the federal level."

Swanson has requested that the FDA issue a directive finding that Proposition 65 conflicts with the FFDCA and initiate a full evaluation to ensure all parties have an opportunity to be heard before the directive becomes final.

Proposition 65 private enforcement actions against food and dietary supplement manufacturers are escalating. Brophy said immediate action is needed by the FDA to put a stop to the "bounty hunter" tactics that create a maze of arbitrary and inconsistent standards.

"In the view of many, Proposition 65 permits legalized extortion of the business community by private enforcers, who retain 25 percent of any civil penalty as well as all attorneys' fees and costs," she said. "The costs of mounting a defense is prohibitive, a fact that these bounty hunters count on. In the 21 years that Proposition 65 has been law, thousands of businesses have been forced to settle with plaintiffs in cases involving tens of thousands of products, and many defendants have been sued over and over again, even for the same products." 

Swanson Health Products is located in Fargo, N.D., and has been a leading vitamin and health products company since 1969. With a mission of "Bringing Wellness to the World," Swanson brings the highest-quality nutritional supplements to customers by offering innovative products and exceptional customer service. Additional information about Swanson and its products can be found at www.swansonvitamins.com.