Proposition 65 Update

Consumer goods sold in California, with certain exceptions, are subject to Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. Since this law passed, regulations have placed specific labeling requirements on products that contain chemicals considered carcinogens or reproductive toxicants above specified limits. Failure to provide warnings can result in action by the California attorney general or by any person in the public interest."

Prior to action initiated by persons in the public interest, these individuals must issue a Notice of Violation that serves as a 60-day notice of intended action. Notices are delivered to both the company with affected products and the California attorney general. The rate at which these notices have been delivered to dietary supplement companies has increased dramatically in recent years from that seen prior to 2010.

Most notices concerning dietary supplement products have been related to lead, which is listed under Prop 65 as both a carcinogen and reproductive toxin, with a no-significant-risk level (relevant to carcinogens) of 15 mcg/day and a maximum allowable daily level (MADL) for reproductive toxins of just 0.5 mcg.

Actions against supplement companies have focused primarily just on the MADL; products containing more than 0.5 mcg of lead at the highest labeled daily consumption level are required to bear a clear and reasonable" warning that they [contain] 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, calcium products have been able to bear as much as 1.5 mcg per daily serving (the MADL plus the naturally occurring amount) without a consumer warning.

In 2012, 85 Prop 65 notices regarding alleged lead levels in dietary supplements above the MADL but lacking appropriate labeling were filed. This rate is similar to that of 2011, which had 108 Proposition 65 notices filed, although neither reached the levels seen during 2010, when 172 were submittedmore 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 relating to alleged lead levels in dietary supplements that would require additional labeling submitted from January to mid-April 2013. Continuing the pattern seen in previous time frames, the same plaintiff, San Diego-based Environmental Research Center, filed all but two of these 10 settlement notices. .

Of the 35 settlements that took place in 2012, only two included provisions related to naturally occurring lead, as were discussed in the early calcium settlements. In most supplement notifications, all observed lead is presumed to be anthropological in nature.

Settlement costs to industry during 2012 alone amounted to nearly $1.8 million. Include settlements completed just in January 2013 and that figure increases to $2.7 million, with the average cost of each settlement in the last six months amounting to about $100,000.

This average settlement is double what was seen during the first half of 2012, when the average was closer to $50,000. These settlement costs do not include legal expenses incurred by the companies receiving these notices.

The product lines involved in these recent settlements continued to provide a cross-section of the dietary supplement marketplace. The most recent settlements often included powdered protein or fiber preparations, but also covered a number of purely herbal products and foods.

A variety of resources are available for industry members who would like to have more information about California Prop 65 and related matters. For instance, "Background on California Proposition 65: Issues Related to Heavy Metals and Herbal Products," coauthored by American Herbal Products Associations (AHPA) Prop 65 counsel Trent Norris of Arnold & Porter and AHPA President Michael McGuffin. INSIDER readers can receive a complimentary copy of "Background on California Proposition 65: Issues Related to Heavy Metals and Herbal Products" by contacting Merle Zimmermann., Ph.D., [email protected].

Additionally, a number of analytical labs can provide testing data to show if products contain less than 0.5 mcg of lead per serving, the upper limit allowed without labeling under California Proposition 65.

Merle Zimmermann, Ph.D., information analyst for the American Herbal Products Association (AHPA, ahpa.org), 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.