Consumer goods sold in California, with certain exceptions, are subject to Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. The regulations that have been implemented in the years since place specific labeling requirements on products if they contain chemicals listed by the state as carcinogens or reproductive toxicants above specified limits. Failure to provide such warnings can result in action by the California attorney general or by any person in the public interest."
Prior to any action initiated by persons in the public interest," they must first issue a Notice of Violation that serves as a 60-day notice of intended action. These notices are delivered to companies with affected products as well as to the California attorney general. Since 2008, a number of supplement companies have received notices related to lead.
Lead is listed under Prop 65 both as a carcinogen and as a reproductive toxin, with a no-significant-risk level (relevant to carcinogens) of 15 mcg/d above any amount of lead that is naturally occurring," as that term is used under this law, and a maximum allowable daily level (MADL) for reproductive toxins, of 0.5 mcg above the naturally occurring level. Most actions against supplement companies have focused just on the MADL, and any product that presents more than 0.5 mcg of lead at the highest labeled daily consumption level is expected to provide a clear and reasonable" warning that it contains a chemical known to the state of California to cause birth defects."
The earliest supplement-related Prop 65 complaints, filed in 1996 and 1997, were focused on nationally sold calcium products, including both supplements and over-the-counter (OTC) antacids. These actions led to a settlement with the attorney general that established a naturally occurring tolerance of 1 mcg of lead after April 1, 1999. Since that time, products that contain 1 g of calcium have been able to bear as much as 1.5 mcg per daily serving (the MADL plus the naturally occurring amount) without requiring any consumer warning.
Though this decision was limited to the handful of settling companies, it has nonetheless served as something of an industry standard for products that contain calcium for more than a decade. But the attorney general informed the settling parties in May 2009 of its intention to modify this agreement in light of new evidence on the normal range of lead in multivitamin-mineral products.A recent settlement has now indicated the naturally occurring tolerance will be reduced to 0.8 mcg/d in a gram of calcium.
Not all Notices of Violation lead to settlements or even to formal complaints by these plaintiffs acting in the public interest." In some cases, the attorney general acts to bring complaints against companies that received notice from a private plaintiff, as it did against 56 supplement brands that were identified as noncompliant to the labeling regulation due to lead in their products in December 2008.
In 2011, 108 Prop 65 notices on lead were filed, and 172 were submitted during 2010, more than were submitted for dietary supplement products from 1996 to May 2010 combined.
California Prop 65 Notices of Violation continue to be issued, with 47 notices related to alleged lead levels in dietary supplements that would require additional labeling submitted in 2012 through mid-July. Of the 19 settlement notices submitted so far in 2012, all but two were filed by the same plaintiff, San Diego-based Environmental Research Center (ERC).
Settlement costs to industry in 2012 have already totaled nearly $1 million, with the average cost of each settlement amounting to about $48,000. It is important to note these settlement costs do not include any legal expenses incurred by the companies receiving these notices.
The products involved in these recent settlements range from green food and fiber powders, which continue to appear frequently in these Prop 65 notices, to herbal tablets and various joint, energy and womens formulas, among various other dietary supplements.
If you are interested in knowing the lead content of your products, a number of analytical labs can provide testing data to show if your products contain less than 0.5 mcg of lead per serving, the upper limit allowed without labeling under California Prop 65.
There are several resources to help the industry further understand and reduce its exposure to potential Prop 65 issues. A general overview, "Background on California Proposition 65: Issues Related to Heavy Metals and Herbal Products," co-authored by American Herbal Products Associations (AHPA) Prop 65 counsel, Trent Norris of Arnold & Porter, and AHPA president Michael McGuffin, is available for a limited time at no charge to industry members. To receive a complementary copy, email email@example.com. For further information and a more complete review of Prop 65, the educational symposium "Proposition 65: Preventative Measures & Defending Against a 60-Day Notice" is available at the online bookstore on the associations website (ahpa.org).
Merle Zimmermann, Ph.D., information analyst for the American Herbal Products Association (AHPA), graduated from the University of Maryland with a doctorate in computational chemistry in 2011. Zimmermann joined the AHPA team while a graduate student in 2009. A native of the Washington area, he specializes in collecting and interpreting large datasets of information for the association.