Judge Rules Dietary Supplements are Food Under Prop 65

A San Francisco Superior Court judge recently ruled that dietary supplements are “food,” which may exempt the manufacturers from having to provide health hazard warnings for their products that contain chemicals known to cause cancer and reproductive harm under Proposition 65.

In 2008, citizen enforcer Stephen Gillett brought a case against supplement manufacturers Garden of Life Inc., Metagenics Inc., and Nature’s Bounty Inc. alleging that their products exposed consumers to lead and that they needed to provide a health hazard warning as required by Proposition 65.  The defendants in the case argued that their products were considered a food and, thus, exempt from the warning requirement so long as the lead was “naturally occurring.” Defendants relied on Section 22501 of Title 27 of the California Code of Regulations—a regulation adopted by the former lead agency for implementing Proposition 65, California’s Health and Welfare Agency—for their argument that the supplements were food.

The judge in the case, the Honorable John Munter, ruled in favor of the defendants, noting that “Proposition 65 and its current implementing regulations do not expressly define the term food.”  However, Judge Munter analyzed the regulatory history, including the final statement of reasons issued by the Health and Welfare Agency, of section 22501.  Judge Munter noted that the regulation defined “food” as “having the same meaning as under federal law, expressly referencing 21 U.S.C. § 321(f)."  Dietary supplements are considered foods according to federal guidelines.

While this decision represents a win for the supplement makers, the litigation still has a long way to go. Defendants now bear the burden of proving that the lead in their products is “naturally occurring,” as well as their defense that the amount of lead in the products does not exceed the Proposition 65 safe harbor levels for lead.

The Chanler Group represents citizen enforcers who, acting in the public interest, commence actions against businesses offering products for sale in California that contain chemicals known to cause cancer or reproductive harm without first providing the health hazard warning required by Proposition 65. Citizen enforcers bringing Proposition 65 actions in the public interest may obtain a Court Judgment imposing civil penalties, an injunction requiring reformulation of products, and/or provision of health hazard warnings. The Chanler Group has represented citizen enforcers of Proposition 65 for more than twenty years.