Michael McGuffin, president of the American Herbal Products Association (AHPA), testified in the San Francisco Superior Court on August 9 at a civil trial that challenges the long-established understanding that naturally occurring chemicals in dietary supplement products do not present exposures to these chemicals for purposes of California's Proposition 65.
The trial involved Proposition 65 complaints brought by a private plaintiff, Stephen Gillett, against Garden of Life Inc., Metagenics Inc., and Nature's Bounty Inc. (NBTY). The complaints allege that certain of the defendants' supplement products contain lead. The question stipulated for resolution at the trial was "whether, and if not, the extent to which," these companies' products, which are tablets, capsules, and powders marketed as dietary supplements, are "food" under California's Proposition 65's rule on exposures to "naturally occurring chemicals in a food." McGuffin appeared as a witness for the defendants.
"I was surprised to hear that this question could even be raised by anyone familiar with the legal status of dietary supplements as foods," said McGuffin. "It is widely recognized by the supplement industry and by regulators 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."
Under California's 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."
"There have been more than a dozen consent judgments involving dietary supplement marketers that included an allowance for a small amount of naturally occurring lead," added McGuffin. "In the earliest of these, the state was the plaintiff; in two others, Gillett himself was the plaintiff, and he acknowledged for purposes of these judgments that the supplement products in question were foods. He now seems bent on removing this precedent, and if successful, this action could reduce the options available to supplement companies to comply with this law."
Judge John E. Munter is presiding over this trial and expects to return a decision by October.
For more information on the impact of California Proposition 65 on marketers of dietary supplements, the AHPA educational symposium, Living with Proposition 65: Preventative Measures & Defending Against a 60-Day Notice, is available at the online bookstore on the association's website.