The American Herbal Products Association (AHPA) expressed support and satisfaction over a decision rendered by California Superior Court Judge John E. Munter on Feb. 13, when Munter ruled in favor of the defendants in a trial that involved Proposition 65 complaints that questioned whether products marketed as dietary supplements are "food" under California's Proposition 65's rule on exposures to "naturally occurring chemicals in a food."
The complaints, brought by plaintiff Stephen Gillett against Garden of Life Inc., and AHPA member companies Metagenics Inc., and Nature's Bounty Inc. (NBTY), alleged that certain of the defendants' supplement products contained lead and challenged the long-established understanding that naturally occurring chemicals in dietary supplement products do not present exposures to these chemicals for purposes of Proposition 65.
"AHPA is very satisfied with this ruling," said AHPA President Michael McGuffin. "In his decision, the judge ruled correctly to ensure that this option is retained for supplement companies that face Proposition 65 lawsuits."
McGuffin, a recognized expert on Proposition 65, had testified on Aug. 9 during the trial in support of the defendants.
Under Proposition 65, consumer goods sold in the state must generally provide a "clear and reasonable warning" if chemicals listed by the state as carcinogens or reproductive toxicants are present above specified limits. For food products, the limits that trigger a warning requirement are those that are present in excess of any naturally occurring amount, including presence "as a result of absorption or accumulation of the chemical, which is naturally present in the environment" so long as the chemical "did not result from any known human activity."
In his decision, Munter ruled that the intent of the California Health and Welfare Agency was to adopt the same definition of "food" for Proposition 65 under California's Sherman Food Drug and Cosmetic Law as was defined in federal law under the Food, Drug, and Cosmetic Act of 1938. Therefore, each of the products at issue is a dietary supplement and is classified as a "food."
McGuffin noted that prior to this decision, there had been more than a dozen consent judgments involving dietary supplement marketers that included an allowance for a small amount of naturally occurring lead. In the earliest of these, it had been acknowledged for purposes of these judgments that the supplement products in question were foods.
Furthermore, the supplement industry and regulators have "widely recognized that any product lawfully marketed as a dietary supplement is a food, and there are precedents in Proposition 65 settlements of allowances for naturally occurring chemicals in these products," added McGuffin.