Regulatory Open Forum

Is it allowable to have proposition 65 warnings in the IFU supplied with a medical device rather than on the external packaging? 

regards
Mike

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Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

We contracted with an outside testing laboratory that handles Prop 65 testing and regulatory requirements for numerous areas.  They advised us that the warning must be on the package label or the product label.  Inserts are not considered labeling under Prop 65 like they are in the medical device arena.

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D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 28-Aug-2019 03:55
From: Mike Kilkelly
Subject: Proposition 65 warnings

Is it allowable to have proposition 65 warnings in the IFU supplied with a medical device rather than on the external packaging?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Warnings must be visible to the consumer at point of sale so they can make decisions based on the labeling.

------------------------------
Sarah Ware
Minneapolis MN
United States
------------------------------

Original Message:
Sent: 28-Aug-2019 03:55
From: Mike Kilkelly
Subject: Proposition 65 warnings

Is it allowable to have proposition 65 warnings in the IFU supplied with a medical device rather than on the external packaging?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Thanks you. As the product is sold online, I believe a warning is required on the website ("point of sale") but in addition does the warning also have to be on the product/package label or would a warning in the Instructions for use together with the website warning meet the requirements.

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Original Message:
Sent: 28-Aug-2019 09:17
From: Sarah Ware
Subject: Proposition 65 warnings

Warnings must be visible to the consumer at point of sale so they can make decisions based on the labeling.

------------------------------
Sarah Ware
Minneapolis MN
United States

Original Message:
Sent: 28-Aug-2019 03:55
From: Mike Kilkelly
Subject: Proposition 65 warnings

Is it allowable to have proposition 65 warnings in the IFU supplied with a medical device rather than on the external packaging?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Hi Mike.

In this case, if the product is only available online for purchase, then the use of the online order portal or product description would generally seem to be sufficient to meet the requirements since the purchaser is only going to receive the product after an online order.  However, where you place that warning is important.  I would suggest 2 places (yes, it is redundant but hear me out).  I would first put the statement at the very top of the product information page.  Don't place it somewhere that a person could "miss" seeing it because they didn't scroll down or click on a particular tab in the screen.  The second place I would place the warning is on the order confirmation page where you obtain consent to charge the person for the product.  Again, I would ensure that these products always appear at the top of the shopping cart regardless of the order in which they were added and also would offset the warning in color, typeface, or something else to ensure that the purchaser has a hard time "missing" the statement/warning.  This redundancy makes it very hard for a purchaser in California to argue that they were unknowingly exposed to the chemical(s) involved because your website was not forthright or it "hid" the exposure risks.  Remember, in California, when it comes to enforcement of Prop 65, individual consumers are authorized to act as "bounty hunters" and enforce the law in the name of the Attorney General of the State of California and if they are successful, they are allowed to keep a portion of the fines that you face and these penalties can be stiff.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 28-Aug-2019 10:30
From: Mike Kilkelly
Subject: Proposition 65 warnings

Thanks you. As the product is sold online, I believe a warning is required on the website ("point of sale") but in addition does the warning also have to be on the product/package label or would a warning in the Instructions for use together with the website warning meet the requirements.

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 28-Aug-2019 09:17
From: Sarah Ware
Subject: Proposition 65 warnings

Warnings must be visible to the consumer at point of sale so they can make decisions based on the labeling.

------------------------------
Sarah Ware
Minneapolis MN
United States

Original Message:
Sent: 28-Aug-2019 03:55
From: Mike Kilkelly
Subject: Proposition 65 warnings

Is it allowable to have proposition 65 warnings in the IFU supplied with a medical device rather than on the external packaging?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Hi Victor , Thank you for that. 
Your opinion then is that if the warning is posted online and the product is only available online then no need for warning on the product itself?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Original Message:
Sent: 28-Aug-2019 13:58
From: Victor Mencarelli
Subject: Proposition 65 warnings

Hi Mike.

In this case, if the product is only available online for purchase, then the use of the online order portal or product description would generally seem to be sufficient to meet the requirements since the purchaser is only going to receive the product after an online order.  However, where you place that warning is important.  I would suggest 2 places (yes, it is redundant but hear me out).  I would first put the statement at the very top of the product information page.  Don't place it somewhere that a person could "miss" seeing it because they didn't scroll down or click on a particular tab in the screen.  The second place I would place the warning is on the order confirmation page where you obtain consent to charge the person for the product.  Again, I would ensure that these products always appear at the top of the shopping cart regardless of the order in which they were added and also would offset the warning in color, typeface, or something else to ensure that the purchaser has a hard time "missing" the statement/warning.  This redundancy makes it very hard for a purchaser in California to argue that they were unknowingly exposed to the chemical(s) involved because your website was not forthright or it "hid" the exposure risks.  Remember, in California, when it comes to enforcement of Prop 65, individual consumers are authorized to act as "bounty hunters" and enforce the law in the name of the Attorney General of the State of California and if they are successful, they are allowed to keep a portion of the fines that you face and these penalties can be stiff.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 28-Aug-2019 10:30
From: Mike Kilkelly
Subject: Proposition 65 warnings

Thanks you. As the product is sold online, I believe a warning is required on the website ("point of sale") but in addition does the warning also have to be on the product/package label or would a warning in the Instructions for use together with the website warning meet the requirements.

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 28-Aug-2019 09:17
From: Sarah Ware
Subject: Proposition 65 warnings

Warnings must be visible to the consumer at point of sale so they can make decisions based on the labeling.

------------------------------
Sarah Ware
Minneapolis MN
United States

Original Message:
Sent: 28-Aug-2019 03:55
From: Mike Kilkelly
Subject: Proposition 65 warnings

Is it allowable to have proposition 65 warnings in the IFU supplied with a medical device rather than on the external packaging?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Hi Mike.

Correct.  I believe that the purpose of the law is to inform the purchaser at time/point of purchase about any potential exposure from purchase and use of the product.  Therefore, if the person is adequately warned on the website and the only place it can be purchased is through the website then I think you have complied with the law in my opinion.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 30-Aug-2019 05:08
From: Mike Kilkelly
Subject: Proposition 65 warnings

Hi Victor , Thank you for that.
Your opinion then is that if the warning is posted online and the product is only available online then no need for warning on the product itself?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 28-Aug-2019 13:58
From: Victor Mencarelli
Subject: Proposition 65 warnings

Hi Mike.

In this case, if the product is only available online for purchase, then the use of the online order portal or product description would generally seem to be sufficient to meet the requirements since the purchaser is only going to receive the product after an online order.  However, where you place that warning is important.  I would suggest 2 places (yes, it is redundant but hear me out).  I would first put the statement at the very top of the product information page.  Don't place it somewhere that a person could "miss" seeing it because they didn't scroll down or click on a particular tab in the screen.  The second place I would place the warning is on the order confirmation page where you obtain consent to charge the person for the product.  Again, I would ensure that these products always appear at the top of the shopping cart regardless of the order in which they were added and also would offset the warning in color, typeface, or something else to ensure that the purchaser has a hard time "missing" the statement/warning.  This redundancy makes it very hard for a purchaser in California to argue that they were unknowingly exposed to the chemical(s) involved because your website was not forthright or it "hid" the exposure risks.  Remember, in California, when it comes to enforcement of Prop 65, individual consumers are authorized to act as "bounty hunters" and enforce the law in the name of the Attorney General of the State of California and if they are successful, they are allowed to keep a portion of the fines that you face and these penalties can be stiff.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 28-Aug-2019 10:30
From: Mike Kilkelly
Subject: Proposition 65 warnings

Thanks you. As the product is sold online, I believe a warning is required on the website ("point of sale") but in addition does the warning also have to be on the product/package label or would a warning in the Instructions for use together with the website warning meet the requirements.

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 28-Aug-2019 09:17
From: Sarah Ware
Subject: Proposition 65 warnings

Warnings must be visible to the consumer at point of sale so they can make decisions based on the labeling.

------------------------------
Sarah Ware
Minneapolis MN
United States

Original Message:
Sent: 28-Aug-2019 03:55
From: Mike Kilkelly
Subject: Proposition 65 warnings

Is it allowable to have proposition 65 warnings in the IFU supplied with a medical device rather than on the external packaging?

regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------