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  • 1.  Prop 65 Warning Labels

    This message was posted by a user wishing to remain anonymous
    Posted 06-Apr-2018 09:44
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    This message was posted by a user wishing to remain anonymous

    How are various consumer products companies dealing with the new warning label requirements?New requirementsThe language frightens people, and there is no financially feasible way to test for the over 900 chemicals on the list.


  • 2.  RE: Prop 65 Warning Labels

    Posted 07-Apr-2018 03:53
    The medical device industry basically ignores prop 65 as states, in general, do not have authority to regulate medical devices.   Here's an AdvaMed letter to California with the full legal arguments: 

    https://oehha.ca.gov/media/downloads/proposition-65/crnr/comments/advmedtechcomments012516.pdf

    I'd welcome California experts to share their opinions, but I'm not aware of any companies that add CA Prop 65 warnings to prescription-only medical devices sold there.



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    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
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  • 3.  RE: Prop 65 Warning Labels

    Posted 08-Apr-2018 08:24
    Hello Roger,

    Good stuff here. How did California respond to this, since it is 2 years old..... I have a client who recently asked me if they had to start labeling on the crowded device or its accessories labels (or labeling) for nickel because of California. I could only tell him I didn't know of any (yet).

    Thanks, 

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (+1) 715-307-1850





  • 4.  RE: Prop 65 Warning Labels

    Posted 07-Apr-2018 17:37
    ​Hi Anonymous,

    Agree that a lot of companies largely ignore Prop 65, primarily because they can afford to take the hit if they are fined.  For smaller companies, the decision isn't so easy as the fines can add up quickly.  I would make sure your senior leadership team is aware of the pros and cons of compliance and also explore it from a customer perspective - do your California customers require this as part of their purchasing departments?    

    If your company plans to comply with Prop 65, in lieu of spending an insane amount of $$ doing testing, I would suggest first getting a list of all the chemicals comprising your raw materials to see if any are on the Prop 65 list.  If yes, then you'll need to determine if the content exceeds the limits in Prop 65. 

    Obviously, this can be quite a challenge for more complex devices where suppliers of sub-components are sourcing from multiple raw material suppliers, etc.  However, with finished devices manufacturers now having to consider RoHS, REACH, and Prop 65, you'll be able to readily get this data from a fair number of suppliers. 

    Hope this helps!

    Tina

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Auckland
    New Zealand
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  • 5.  RE: Prop 65 Warning Labels

    Posted 08-Apr-2018 10:21
    Hi A!

    My first point is a clerical one - most of the people in California no longer even notice the signs.  Fact is that it is sensory overload especially when compliance with the requirement can be as simple as posting a sign on the front door of the establishment warning of the potential "exposures" to these chemicals.

    I truly realized just how far from the original "stated intent" of Prop 65 we had fallen about 18 months ago when OEHHA sent out a notice of intent to list Aloe and Golden Seal extracts.  This was based on a single study (well done as it was, still just 1) that showed at least for aloe that the rats it was fed to saw increased tumors I believe in their GI tract.  Well, first thing is that if you continuously feed anything to a rat sooner or later you will find that it causes a tumor response.  But, the worst part of this "law" is that the OEHHA staff have no opportunity to look at the data before listing it - according to OEHHA they can only specifically add the chemical if it meets the criteria (having been found to be carcinogenic, teratogenic or reprotoxigenic.  When I submitted comments to the docket, I stated explicitly quoting from the study that was used that the study found that the most likely cause of the problem were anthrocyanins in aloe.  I suggested listing the anthrocyanins (since any regulation should be as specific as possible to comply with the intent) and not listing aloe.  Well, my comment was met with a simple response - "We can't look at the study we can only list what was tested".  Now, to me that makes no sense.

    Then consider the fact that when you cook any meat product you create chemicals that are on the Prop 65 listing.  But no meat products currently contain warnings.  Why?  Because it would mean that every meat would need to carry the warnings and people in other parts of the country who haven't necessarily been exposed to the overt insanity of the Prop 65 rule would never eat again!  Hey - just for fun, I bet you if I tested most vegetables or fruits that they would contain lead, inorganic arsenic, and even potential cadmium and mercury.  See any Prop 65 warning on these?   Nope.  Same reason.  

    Finally when you look at your supply chain information (whatever you can obtain of it - some companies are better than others and some are better prepared than others) you also need to look at the levels that you expose people to.  If the folks at OEHHA have had the "time" to do it they will have created a daily exposure level below which you are able to avoid the warning (the "safe harbor" provision).  If not, you can also do an assessment yourself or with a consultant running the analysis using the same overly conservative method that OEHHA uses and then you can review your exposures against that data.  If you fall below you at least have some data to defend the case if you are ever sued.

    Remember - Prop 65 is a problem for most companies.  Here is the issue - Prop 65 creates a pathway for private citizens to go after nonconforming companies in a "private Attorney General" manner.  Yes, they need to get a certificate from the AG in California to proceed with the case before they can fully file it, but honestly I have never seen a case denied a certificate by any AG in California since this insanity started.

    Good luck with your issue.  If you are in consumer products just know that you don't have any serious shield from Prop 65 in California.  Technically no product that poses an "exposure risk" to people is exempt.  In the device industry I know that they have argued that they are exempt from the regulation but if they are sued I don't know that the legal claims that they have made will stand up to a state court review since almost no company or trade group has won that sort of argument yet that I am aware of.  And you really need to be careful on this because if you warn about everything on pack (to avoid liability for not having a required warning) you are then guilty of over-warning and diluting the effectiveness of their scheme....

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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