California Prop 65 requirements as they relate to 820.120

jozy80

Registered
Hello!

Say you have an established product, but out of an abundance of caution (or because a new chemical was added to the Prop 65 list, or because your process changed and introduce new chemicals), you want to now put a Prop 65 warning label on it (when this was not deemed necessary in the past). Per the FDA's definition of "Label", this new label would fall into that definition, and therefore should be proven that it will remain legible, affixed, etc for the life of the product.

I'm curious how the experts here will recommend proceeding. I assume many companies buy pre-printed prop-65 labels which are significantly more cost effective than using the same material as our existing labels (using the same material would be easier to justify that they will stay affixed, legible, etc using equivalence). Seems you technically should not be putting those new off the shelf labels on the packaging until you validate that they will withstand the life of the product. I'm also assuming many companies would not delay a process improvement that they validated solely because they still needed to do additional packaging validation solely to prove that the new "prop 65 labels" will adhere for the life of the product.

That said, if you wanted to address the potential compliance concern of not having the prop 65 label on the product, I'd assume you may want to start labeling with it ASAP prior to validating it (perhaps justifying that the risk is low as the alternative is not having the customer have access to this information at all). Does anyone have any thoughts on how to go about reconciling this in a practical way? Maybe adding a temporary deviation to add a line to your "product label" that says to refer to your website for Prop 65 information, until you are able to qualify the new label? (on that note, while it seems the prop 65 standard is to put a label on the product, perhaps you can somehow argue that directing the customer to your website which has the info is providing sufficient awareness to the customer)

I realize Prop 65 is thought to be somwhat farcical at this point by many, but I am very curious to hear thoughts on this as I know I can apply them to other situations as well.
 

ScottK

Not out of the crisis
Leader
Super Moderator
the labeling has to be seen before or at the time of purchase... so put it on the packaging. Doesn't have to be on the device itself, right?
 

jozy80

Registered
Right, but the FDA still expects labels to be legible and adhered for the lifecycle of the product. This includes labels on packages (i.e. you have to prove your labels on the packages will still be legible with their identifiers, warnings, etc at the expiration of product)
 

yodon

Leader
Super Moderator
Or you could stop selling into California. (half joking)

Just me thinking out loud here, taking a risk-based perspective. (Does anyone in CA really care about that label?) Maybe do some durability tests (rub tests) for an immediate thing (it's not just adhering for the life, it's readability over the life when exposed to fluids and environment expected to be encountered!) and then have a (documented) plan to monitor to see if the label degrades over time. I would think the FDA would be more interested in ensuring labeling they care about is considered above a Prop 65 label. Often, having a well thought out, risk-based (documented) plan can go a long way. You might also look at the specs for the pre-printed labels to see if you can get lift there. Maybe they are "guaranteed" for so many years or laminated to protect the content.
 

jozy80

Registered
Or you could stop selling into California. (half joking)

Just me thinking out loud here, taking a risk-based perspective. (Does anyone in CA really care about that label?) Maybe do some durability tests (rub tests) for an immediate thing (it's not just adhering for the life, it's readability over the life when exposed to fluids and environment expected to be encountered!) and then have a (documented) plan to monitor to see if the label degrades over time. I would think the FDA would be more interested in ensuring labeling they care about is considered above a Prop 65 label. Often, having a well thought out, risk-based (documented) plan can go a long way. You might also look at the specs for the pre-printed labels to see if you can get lift there. Maybe they are "guaranteed" for so many years or laminated to protect the content.
Love it, thank you for the help! Basically, document as much up-front mitigation as you can (supplier cert/guarantee, any upfront testing, longer-term plan to fully comply with any necessary aging tests or longer term plan to transition to a more permanent solution, and justify risk is low to release as is--- and risk is probably higher to ignore the requirement and use NO labeling)
 

jozy80

Registered
Or you could stop selling into California. (half joking)

Just me thinking out loud here, taking a risk-based perspective. (Does anyone in CA really care about that label?) Maybe do some durability tests (rub tests) for an immediate thing (it's not just adhering for the life, it's readability over the life when exposed to fluids and environment expected to be encountered!) and then have a (documented) plan to monitor to see if the label degrades over time. I would think the FDA would be more interested in ensuring labeling they care about is considered above a Prop 65 label. Often, having a well thought out, risk-based (documented) plan can go a long way. You might also look at the specs for the pre-printed labels to see if you can get lift there. Maybe they are "guaranteed" for so many years or laminated to protect the content.
I don't suppose you might have any insight on whether each individual device package is needed to contain the warning-- i.e. if you sell direct to customer in branded "shipper boxes" where each shipper boxes contains 100 individually packaged products, must you label all of the 100, or can you get away with a single warning on the shipper box? Does the answer change whether or not the shipper box just has your company name on it vs also the device name? I assume the safest bet is to individually label the unit boxes, but if avoidable that makes things a bit easier
 

EmiliaBedelia

Quite Involved in Discussions
I don't suppose you might have any insight on whether each individual device package is needed to contain the warning-- i.e. if you sell direct to customer in branded "shipper boxes" where each shipper boxes contains 100 individually packaged products, must you label all of the 100, or can you get away with a single warning on the shipper box? Does the answer change whether or not the shipper box just has your company name on it vs also the device name? I assume the safest bet is to individually label the unit boxes, but if avoidable that makes things a bit easier
The California Code states that the warning needs to be provided to the individual who will be exposed to the chemical before they are exposed. So, if the devices are intended to be distributed and used individually it should be on the individual package. If you make something like, boxes of individually packaged pairs of gloves where the box is the saleable part number you could put it on the box. However, if the prop 65 chemical is in your EXTERNAL package (like in the packaging material or something like that) then I'd put it on the outer box.

Some other thoughts:
1) Prop 65 has a 1 year "grace period" if a chemical is added to the list (https://oehha.ca.gov/proposition-65/businesses-and-proposition-65). So if you are adding a warning because a chemical was added to the list, the regulation gives you time to do so.
2) Prop 65 labeling is not required by the FDA. Similarly to things like CE marking and translations, they don't care as much about labeling that doesn't contain information required by FDA regulation. IMO the issue of legibility, etc is mainly because product labeling becoming illegible, falling off, etc can lead to the product becoming misbranded/adulterated due to insufficient labeling. If the labeling isn't required by regulation, there's nothing illegal about it not being there. The bigger concern to me would be appropriately documenting the deviation in your own procedures just on principle.
3) If you don't have the presence of the prop 65 chemical in your risk assessment, how are you analyzing the "risk" associated with someone not being aware of it? Are you listing the risk of cancer/reprotoxic effects/etc in your risk analysis as a residual risk that you are required to label for? If you are adding new hazards to your risk assessment based on new prop 65 chemicals, are you then submitting a new 510k since you have a new risk profile?
This is where prop 65 becomes farcical to me, as it doesn't intelligently connect to a ISO 10993/14971 based risk assessment... but California didn't ask me.

Anyway, for the practical comment: my company just puts the prop 65 warning directly on our product label. I've found that the list doesn't change enough for our relevant chemicals to cause issues with frequency of updates, and it is also easier to control as some of our products have prop 65 chemicals and some don't.
 

jozy80

Registered
The California Code states that the warning needs to be provided to the individual who will be exposed to the chemical before they are exposed. So, if the devices are intended to be distributed and used individually it should be on the individual package. If you make something like, boxes of individually packaged pairs of gloves where the box is the saleable part number you could put it on the box. However, if the prop 65 chemical is in your EXTERNAL package (like in the packaging material or something like that) then I'd put it on the outer box.

Some other thoughts:
1) Prop 65 has a 1 year "grace period" if a chemical is added to the list (LINK). So if you are adding a warning because a chemical was added to the list, the regulation gives you time to do so.
2) Prop 65 labeling is not required by the FDA. Similarly to things like CE marking and translations, they don't care as much about labeling that doesn't contain information required by FDA regulation. IMO the issue of legibility, etc is mainly because product labeling becoming illegible, falling off, etc can lead to the product becoming misbranded/adulterated due to insufficient labeling. If the labeling isn't required by regulation, there's nothing illegal about it not being there. The bigger concern to me would be appropriately documenting the deviation in your own procedures just on principle.
3) If you don't have the presence of the prop 65 chemical in your risk assessment, how are you analyzing the "risk" associated with someone not being aware of it? Are you listing the risk of cancer/reprotoxic effects/etc in your risk analysis as a residual risk that you are required to label for? If you are adding new hazards to your risk assessment based on new prop 65 chemicals, are you then submitting a new 510k since you have a new risk profile?
This is where prop 65 becomes farcical to me, as it doesn't intelligently connect to a ISO 10993/14971 based risk assessment... but California didn't ask me.

Anyway, for the practical comment: my company just puts the prop 65 warning directly on our product label. I've found that the list doesn't change enough for our relevant chemicals to cause issues with frequency of updates, and it is also easier to control as some of our products have prop 65 chemicals and some don't.
Thanks for the thoughts, very helpful. I'll ask one more because it seems you are quite familiar with the regulations on this.

Technically, it seems one could argue many medical devices are not consumer products, and therefore would fall into "occupational exposures" (imagine any devices that are only sold to hospitals or doctors offices). Is there a case to be made that the manufacturer can send an annual notice to California customers, and then the customer would be on the hook for notifying any users in their facility? I assume there is a reason why this would not fly as it seems much more common to simply label the product.

I'm thinking that these annual notices may not be sufficient if 1) one of the customers is under 10 employees and therefore not subject to Prop 65 requirements, and 2) it seems very easy for the person who receives the notice to ignore/forget/leave the company etc and not properly communicate it to all users. In this instance, I could see the onus falling back on the manufacturer (though perhaps the California regulators may rule otherwise and say the manufacturer did their part?).

Other concerns for doing it this way- the manufacturer would need to come up with a way to guarantee these annual notices get sent out, AND if they get any new California customers, they need to ensure the notice gets sent out immediately too.

Another question-- what about providing the info electronically with an eIFU? Per California definition of labeling, it seems this would suffice?

Any additional thoughts appreciated!
 
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EmiliaBedelia

Quite Involved in Discussions
Just to be clear, my understanding is pretty much based on reading the code and other people's opinions on the internet :) but I'll give you my opinion anyway...

The short answer: putting a label on the product is not that difficult, doesn't require your customer to do any work, fully covers you from a regulatory perspective, and it's easily ignored (in this case, that's a good thing). What is the benefit of doing something different?


1) If your device exposes patients or any other people to a material, it is not an "occupational" exposure because they aren't employees. The code specifies that if an exposure is not a consumer product exposure or occupational, it is environmental, which requires either a sign to be posted, or notification to be provided to anyone in the affected area (every 3 months, not annually).

In reality a lot of purchasers (at least for larger healthcare orgs) will have a list of requirements that they check for during procurement so if they are in California they may ask about Prop 65 labeling at that point. It may be a no-go if you don't have a label and you inform the customer that they have to put up a sign or ship out a notice or something.

From a sales perspective... You are also then competing against other products that don't require additional work and aren't obviously "hazardous". Imagine the headache for a hospital of sending out a mass mailing or printing out and getting people to sign a form that warns them they could get cancer from one device. That's actual time and expense that you are forcing them to spend to use your product, when they probably have other options that don't require any work. My sales team would have a fit if I told them that was required to sell in CA!

2) For a consumer product an eIFU would not suffice based on the requirements for the warning:
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The reason mfgs. are risk averse about Prop 65 is that this isn't an argument you have with a regulator during an audit.... it is an argument you have to pay a lawyer to make for you in court. The penalties are something like $2500/day for not complying. Given the potential $$$$$$ of getting caught for not complying, it's just easier to do it.
 
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