FDA (Rockville, MD) should declare that California’s Proposition 65 conflicts with federal law and hinders its ability to regulate foods and supplements under the Federal Food, Drug, and Cosmetic Act of 1986 (FFDCA), according to a new Citizen’s Petition.
The petition, sent to FDA on January 18 on behalf of Swanson Health Products Inc. (Fargo, ND) by the law firm Sedgwick, Detert, Moran, and Arnold LLP (San Francisco), claims that Proposition 65 confuses consumers by mandating hazard warnings on products that contain very low or negligible amounts of suspected toxins.
Passed by California voters in 1986, Proposition 65 requires the state to publish an annual list of chemicals known to cause cancer, birth defects, or reproductive harm. Proposition 65 also requires businesses to provide a “clear and reasonable” warning if consumers are exposed to chemicals on the list.
According to California’s Office of Environmental Health Hazard Assessment (OEHHA), however, businesses may be exempt from the warning requirements if chemical exposures are low enough to avoid posing significant health risks (see sidebar on page 20). That determination is often made in court.
California’s attorney general, district or city attorneys, and even private individuals “acting in the public interest” can file lawsuits against businesses alleged to violate Proposition 65. Companies that fail to provide warnings could face penalties of up to $2500 per violation per day.
Proposition 65 Warnings: Safe Harbors and Other Thresholds
Proposition 65 prevents businesses from exposing consumers to listed chemicals without providing a clear and reasonable warning. Under certain circumstances, however, some companies may be exempt from those requirements.
Businesses with fewer than 10 employees may be exempt, as well as companies with products that cause exposures that are low enough to avoid creating a significant risk of cancer, birth defects, or other reproductive harm, according to California’s Office of Environmental Health Hazard Assessment (OEHHA). OEHHA relies on two different standards for substances that cause cancer and substances that cause birth defects.
OEHHA doesn’t consider chemicals that cause cancer to pose a significant risk if the level of exposure would not cause more than one case of excess cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime.
On the other hand, chemicals that cause birth defects or reproductive harm are required to have warnings if exposure levels exceed 1/1000 of the level shown to cause harm to humans or lab animals.
OEHHA also provides numerical guidance levels, also called safe harbor numbers, for about a third of the listed chemicals.
Source: Office of Environmental Health Hazard Assessment.
Although the law mandates that warnings be clear and reasonable, critics of Proposition 65 contend that the required statements needlessly mislead and alarm consumers.
“Proposition 65, when applied to food and dietary supplements, causes consumer confusion because it misbrands wholesome products and frustrates FDA’s ability to carry out its statutory mandates,” says the petition’s coauthor, Stephanie Sheridan, an attorney at Sedgwick. “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.”
Because Proposition 65 requires labeling that could be misleading, products that bear unnecessary warning labels may run afoul of FDA’s requirements against misbranding, say some experts.
That can put manufacturers in a no-win situation, according to Kari Graber, QC/QA manager at Swanson Health Products.
“We know our products are safe and either meet or exceed FDA standards,” Graber says. “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.”
Proposition 65’s enforcement provisions, which permit lawsuits by private individuals, sometimes called “bounty hunters” by defense counsel, are another point of contention for the law’s opponents. Swanson’s petition notes that settlement agreements between private entities and manufacturers often result in standards that vary from one case to the next. Critics also claim that the process puts an unfair burden of proof on the defendants.
“At trial, the plaintiff need only show that one of over 800 listed chemicals is present in any amount, and the defendant is left to prove at trial that the exposure at issue did not require a warning,” states the petition.
In Swanson’s case, the petition alleges that the private enforcer that initiated the action, the group As You Sow (AYS; San Francisco), did not contest that the manufacturer’s products complied with FFDCA requirements or that the products met standards set by AYS in settlements with other companies.
Sedgwick attorney Carol Brophy, the other coauthor of Swanson’s petition, notes that while the costs of mounting a defense can be prohibitive, private parties that file the cases can retain 25% of the penalties while recouping their own legal costs if they win.
“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,” Brophy says.
Despite the proliferation of Proposition 65 warnings on consumer products and in places of business, the law remains popular among many California consumers who are worried about the potential health risks of chemical exposure.
Adding Chemicals to the Proposition 65 List
Last May, 775 substances were on Proposition 65’s list of chemicals known to cause cancer, birth defects, or other reproductive harm. New substances can be added through one of four ways, according to California’s Office of Environmental Health Hazard Assessment (OEHHA).
1. Designation by one of two committees on OEHHA’s science advisory board: the Carcinogen Identification Committee (CIC) or the Developmental and Reproductive Toxicant (DART) Identification Committee.
2. Designation by an organization considered an “authoritative body” by the CIC or DART Identification Committee. Examples include FDA (Rockville, MD), the Environmental Protection Agency (Washington, DC), the National Institute for Occupational Safety and Health (Atlanta), the National Toxicology Program (Research Triangle Park, NC), and the International Agency for Research on Cancer (Lyon, France).
3. Requirement by federal or state agencies to provide warnings that the chemical causes cancer or birth defects. Examples include some prescription drugs.
4. Listed in the California Labor Code as causing cancer, birth defects, or other reproductive harm. According to OEHHA, this was the method used to establish the initial chemical list following the passage of Proposition 65 in 1986.
Source: Office of Environmental Health Hazard Assessment.
According to OEHHA, Proposition 65 warnings have led to the removal of carcinogens from correction fluids and paint strippers, as well as the reformulation of nail-care products that contained chemicals that cause reproductive harm. By requiring warnings on alcohol containers, Proposition 65 also helps promote greater public awareness about the risks of drinking alcoholic beverages during pregnancy, notes OEHHA.
Proponents of the law say that manufacturers have the opportunity to prove the safety of their products in court. Some supporters also claim that Proposition 65 provides greater local control of health issues when the federal government fails to act. Critics, however, maintain that the law creates a patchwork of regulations that are expensive and unnecessary.
OEHHA appears aware of the controversy. To gather feedback about Proposition 65 from the public and other interested parties, OEHHA held a public workshop last November. Moreover, in a January 31 press release, the office noted that several issues related to food and supplement regulation could be on its agenda in 2008.
Potential changes up for discussion this year include reorganizing the law’s “clear and reasonable” warning requirements, narrowing the exemption requirements for some exposures to nutrients and foods, and revising the methods for calculating maximum allowable dose levels, also known as “safe harbor” levels. OEHHA also plans to discuss warnings about foods that contain listed chemicals.
California Office of Environmental Health Hazard Assessment's Overview of Proposition 65:
Safe Harbor Levels:
List of Chemicals, as of September 28, 2007:
Sedgwick, Detert, Moran, and Arnold LLP:
As you Sow:
Swanson Health Products: