Prop 65 and Dietary Supplements: Finally, a Small Win for Industry?

On February 13, the California Superior Court ruled in favor of several dietary supplement companies in a Proposition 65 case. The Court determined that the companies’ supplements in question are classified as food and therefore are exempt from the lead exposure warnings mandated for many products and materials under California Health and Safety Code Section 25249.5, better known as Prop 65.

Prop 65 was enacted as a ballot initiative in November 1986. The proposition was intended by its authors to protect California citizens and the state’s drinking water sources from chemicals known to cause cancer, birth defects, or other reproductive harm, and to inform citizens about exposures to such compounds via label warnings, no matter how infinitesimal or trace the exposure.

But there is one exception to the rule. According to Prop 65, and recognized by California’s Superior Court in this decision, the duty to warn regarding lead is not required if the product is a food and if the chemical in question is naturally occurring in a food.

In his statement of decision this February, the judge cited a 1987 challenge in which the petitioners argued that “many foods contain trace amounts of carcinogenic chemicals and that a requirement that warnings appear on all foods that may contain such chemicals would result in over-warning that would confuse the public and not advance public health.” In response to that 1987 petition, the California Health and Welfare Agency (HWA; now known as the Health and Human Services Agency) adopted an interim regulation known as Section 12713, one which exempts from Prop 65 foods that comply with safety laws and which are defined as food under federal law, specifically 21 U.S.C. § 321.

February Case

This February’s decision involves lawsuits plaintiff Stephen D. Gillett brought against several companies between August 2008 and December 2009 (consolidated by the Superior Court into one matter). The companies were: Atrium Innovations, Garden of Life, HVL, Metagenics, Milk Specialties, Nature’s Products, NBTY, and Whole Foods Market.

Gillett contended that these companies sold dietary supplements to California consumers without first warning them of potential lead exposure as per Prop 65. The defendants held that any potential lead exposure in their products falls within the “naturally occuring”-occurring in nature-exemption; therefore, no such warning would be required for their products.

As the judge, John E. Munter, reasoned in detail in his statement of decision, the defendants’ dietary supplements in this case are indeed classified as food according to the Federal Food, Drug and Cosmetic Act and thus “the exemption here is relevant.”

Future Implications

Although the judge’s February decision did not make anything better regarding Prop 65’s burden on the dietary supplements industry, “it prevents things from getting worse,” notes Michael McGuffin, president of the American Herbal Products Association (Silver Spring, MD). “Food products are exempt from Propositions 65’s warning requirement to the extent that contained listed chemicals are naturally occurring. Historically, this has applied to some supplements, such that, for example, some of the lead that is usually found in calcium is acknowledged to be naturally occurring. Because of this, calcium and multimineral supplements have not needed to provide warnings if the lead is below the naturally occurring level. This and similar exemptions would have been lost if the judge had ruled otherwise.”

And, as Steve Mister, president and CEO of the Council for Responsible Nutrition (Washington, DC), points out, “Just to clarify, the court decision does not exempt dietary supplements from the requirements of Prop 65. Under that initiative, food is permitted to omit certain levels of chemicals that are otherwise subject to Prop 65 notification requirements if the levels of those chemicals are ‘naturally occurring in the food product.’ So, for instance, certain low levels of lead or mercury that would have a zero threshold in other kinds of consumer products may have some allowable levels in food. In this case, the plaintiff argued that dietary supplements were not ‘food’ under the law, so they could not take advantage of the ‘naturally occurring’ exemption and would be held to zero-tolerance levels. The judge disagreed.”

He continues, “This is indeed good news for the industry. We have always asserted that we are ‘food’ under Prop 65, and this decision reaffirms that against overzealous plaintiffs that would undermine our well-established regulatory status.”