Natural Foods Merchandiser

California's Prop 65 proposes new regulations

By Mitchell Clute

California's Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its ballot name, Proposition 65, has long bedeviled supplements manufacturers who complain that its comprehensive list of 800 chemicals known to be reproductive toxins or carcinogens is far too broad and leads to spurious lawsuits against manufacturers.

Now the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment has proposed additional regulatory language specifically for ingredients that are both beneficial to human health and known carcinogens at high dosages. The OEHHA proposal would require that any product containing an ingredient over an allowable amount would have to carry the standard warning: "This product contains chemicals known to the State of California to cause cancer and/or birth defects or other reproductive harm."

OEHHA's draft proposal suggests that the level for triggering a health warning should be any amount of a beneficial nutrient that exceeds the recommended daily intake or, in cases where no RDI is established, 20 percent of the limit for toxicity. Vitamin C supplements, as one example, would automatically trigger a warning (if a single study showed it caused cancer or reproductive harm) because they are often 1,000 percent or more of the established RDI; however, there is no evidence to date that such dosages cause harm.

"That approach is really arbitrary and artificial, especially considering that RDIs are not in the least a measure of toxicity," said Michael McGuffin, president of the American Herbal Products Association, which requested that OEHHA withdraw its proposal. "The problem they're trying to solve is nearly nonexistent, and the danger is that they'll establish a broad solution that will remove the mechanism that's already working." On May 16, several days after NFM interviewed McGuffin, he was appointed to an OEHHA workgroup to help develop regulatory language for Prop 65.

The existing approach is simply to list in the regulations on the Prop 65 Web site ( what quantity of an ingredient is cause for concern.

Currently, vitamin A is the only ingredient that is listed as both a beneficial nutrient and, in the form of retinol, a possible carcinogen or reproductive toxin, but California updates the list each year based on new research.

"In defining beneficial nutrients, they took the position that only substances which have a recommended daily intake should be considered," McGuffin said. "In response, we gave them numerous examples of substances without an RDI, for which [the Food and Drug Administration] has established a health claim. For example, take soy protein—should we say it isn't a beneficial nutrient, just because it doesn't have an RDI?" he said.

"The problem with this proposal was that it was a sledgehammer solution to a tiny tack of a problem."

Mitchell Clute is a Fort Collins, Colo.-based freelance writer.

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