This is an interesting question. We have heard some suggestions that stainless steel requires Proposition 65 warnings due to the presence of chromium and nickel, but only certain compounds of chromium and nickel are on the Prop 65 list, and unless the product "exposes" a person to these compounds no warning is needed.
There is language in FD&C act suggesting that Prop 65 warnings fall outside the act and they are not preempted, but the court held in one case, Dowhal v. SmithKline Beecham, 32 Cal. 4th 910 (2010), that the specific FDA requirements at issue there for nicotine patches preempted Prop 65. In some other types of cases, including one involving nutritional supplements we are handling, we concluded there was no preemption.
On the merits, however, there are some Prop 65 settlements upholding the use of surgical stainless without warnings in earrings and body piercing items, so the key issue is that you will need to make a determination as to what the level of "exposure" of listed chemicals that results from implantation or use of the device you want to sell in California. In other words, the analysis is device-specific and you can't reach a firm conclusion without knowing the specifics of how a device uses stainless steel.
Yes, I know, a perhaps equivocal, but nonetheless accurate, answer.
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Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
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Original Message:
Sent: 12-11-2012 17:11
From: Laveeda Leflore
Subject: California Proposition 65
Does medical devices sold in the state of California that contains stainless steel required to have a warning label?
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Laveeda Leflore
Odyssey Medical, Inc
Bartlett TN
United States
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