Safeguarding the public or propping up litigation

California’s Safe Drinking Water and Toxic Enforcement Act of 1986, known as Prop 65, has brought unprecedented scrutiny on many consumer products sold in that state, including dietary supplements. In a nutshell, Prop 65 requires manufacturers to lower levels of chemicals “known to the State of California to cause cancer or birth defects” to safe levels or include a warning on the product of the presence and dangers of such chemicals in the product. For supplements, this has mostly meant heavy metals in herbal or multivitamin/mineral products.

The intent of the law, it seems, is to keep manufacturers honest and safeguard California consumers from hundreds of chemicals on the State’s list of dangerous substances.  However, as the LA Times points out, “the law has been a boon not only to environmental and public health advocates but to plaintiff lawyers, who have reaped significant settlements over chemicals that have never been proved to cause significant harm at the levels in which they are present.” Apparently, any citizen can bring a lawsuit against a product or manufacturer that appears to violate Prop 65. However, the Times noted the CA Attorney General’s office has brought most cases. Read more of the LA Times Prop 65 analysis here.

The American Herbal Products Association (AHPA) has been acutely tuned into this situation in California, and AHPA President Michael McGuffin has spoken about this issue at supplement industry events, warning companies that market products in California of the potential troubles.

Some AHPA member companies have successfully fought off prop 65 lawsuits, including a ruling in 2001 that the presence of ethyl alcohol in liquid herbal products do not render them alcoholic beverages. Most notably, the judge cautioned “such listings should be read broadly … but 'broad' reading does not equate to 'absurd' reading."

McGuffin serves on a workgroup formed by California’s Office of Environmental Health Hazard Assessment (OEHHA) to help develop the regulatory language for Prop 65 warnings used by manufacturers. He produced a guidebook called Background on California Proposition 65: Issues related to heavy metals and herbal products, available via the AHPA Web site.

One of the wake-up-call actions of Prop 65 was an early 2009 suit against 56 dietary supplement manufacturers for failure to warn of the presence of lead, following publicized test results from FDA showing lead in 324 multivitamin/mineral products.