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CFR (Code of Federal Regulations) with Colorants

S

snowball852

Starting to get Involved
#11
#11
Re: CFR (Code of Federal Regulations) with Colorants help wanted

BerryBerryGud-

Were you able to get your issues resolved with FDA? We have recently received the same questions. Were you able to get the required information from your supplier? Did you end up having to run the toxilogical testing?

We are about to also contact NAMSA for input/advice. However, I'm beginning to be concerned that we chose the wrong ink.

Any help/advice/direction you (or others) can provide would be helpful. Does any know FDA's rationale for asking these questions?

Thanks!
Amy
 
Elsmar Forum Sponsor
B

BerryBerryGud

#12
#12
Hi Amy,
I did indeed end up getting this issue resolved, and succeeded in getting my submission approved. We ended up needing to do a series of extractions, followed by a toxicology risk assessment. You mentioned that you will be calling NAMSA; if you get in touch with the toxicology folks there, they can guide you through this.
While I was working through this issue, I received the same question, verbatim, from a different examiner on a completely different submission for a different client. In that case I had used a colorant from a supplier (Clariant) who had a Master File for their colorant. I obtained a MAF access letter from the supplier, and I am hopeful that I will not need to go the extraction route on that one. No word yet.
I have a third project underway, and I am pre-emptively selecting a Clariant colorant because I think having the Master File is an advantage.
The word on the street is that this is a new focus area and submitters can expect to see this question.
Good luck!
:cfingers:
 
AnaMariaVR2

AnaMariaVR2

Trusted Information Resource
#13
#13
Color Additives: FDA's Regulatory Process and Historical Perspectives
http :// www. fda .gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm

The Chemistry of Color Additives
http :// learningcenter. nsta .org/ products/symposia_seminars/fall08/FDA/webseminarI.aspx

How Safe are Color Additives
http: // www. fda. gov/downloads/ForConsumers/ConsumerUpdates/ucm048960.pdf

Color Additives
http :// www .fda. gov/ForIndustry/ColorAdditives/default.htm

Color Additive Inventories
http :// www. fda .gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/default.htm

ALL THESE LINKS ARE NOW DEAD
 
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J

Julien_Baie

#14
#14
Hi BerryBerryGud,

We recently received something similar regarding colorants. We use a black dye in our polymer matrix for a body fluid contact device that we make. We did find that our black colorant is listed under 21 CFR 74.2052 D&C Black No. 2. However it was listed only for use for cosmetics such as eyeliners.

So my question is, how do we explain that the use of the black colorant in our medical device is equally safe as the listed use as cosmetics? How do we prove this? If we cannot prove this, then what? Still need a toxicity study?

Here is the origianl comment from the 510k deficiency letter:

"You state that the polymer matrix is black in color. Please clarify, what colorants , additives , or residuals are present in the matrix by chemical names, as these components will contact an open wound/skin. Please state whether the colorants are FDA certified. If the colorants are not FDA certified ,they may require a color additive petition before the device may be cleared."

:thanx:

Julien
 
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M

MIREGMGR

#15
#15
My guess is that it will be easier for you to re-formulate your material using a colorant approved for your use-specifics, and if need be totally re-develop and test your product, than it would be to get FDA to approve a colorant petition.

Colorants are an old, nasty minefield at FDA, with much bad history. There was a time, within memory of people still working at FDA, when a number of colorants in extremely broad cosmetic, food-and-beverage-container, pharma-container and medical device use were revealed to be toxic, mutagenic, carcinogenic and the like. I'm quite sure FDA would very much like to not re-open those old files.

It's unfortunate that whoever managed your current plastics formulation wasn't cognizant that it's regulated territory.
 
B

BerryBerryGud

#17
#17
Hi Julien,
Most of the time, the colorant that is used to produce the color black in a polymer is Carbon Black. Even though there are ostensibly medical grade versions of Carbon Black, I believe that it is considered to be a carcinogen - so you might be fighting an uphill battle. I think the fact that the colorant you used is approved for another application doesn't help you that much.
If I were in your shoes, I would probably perform some extractions to show that the colorant is bound within your polymer and doesn't come out. Then I would follow that up with a toxicology risk analysis. As I alluded in one of my earlier posts, I tried doing this risk analysis myself and it didn't fly. Then I found a board-certified toxicologist from a well known test lab who was experienced in such analyses and I had him write it for me.
I think my product had much less contact than yours; but I had several colorants including carbon black - and with the approach I am suggesting I did get approval.
I think the suggestion to just go to a "natural," i.e. colorant free, polymer is probably the most solid idea, but I understand that sometimes it can be very difficult to make such a change.
I wish you good luck.
BBG
 
M

MIREGMGR

#18
#18
I think the technical challenge with carbon black is that it's normally produced by pyrolysis of a hydrocarbon feedstock, and the pyrolysis process is highly non-theoretical and results in all sorts of complicated carbon-hydrogen-whatever molecules being formed...and such a broad array of complicated carbon-hydrogen-whatever molecules inevitably will include molecules with biological functionality that makes them toxins, carcinogens, mutagens, teratogens and so forth.

Note that there also are iron-based black pigments, in addition to pigment-free black dyestuffs. Carbon black is not the only way to make substances black. And, I believe there are carbon blacks that are produced via processes other than pyrolysis and are essentially chemically pure, though they are much more expensive.

Of course, these alternatives to pyrolyzed carbon black might not work the same way in regard to dispersion and other process parameters, since the chemically complicated molecular mix of pyrolyzed carbon black makes it much more reactive and therefore aids dispersion and sometimes even strength.
 
B

BerryBerryGud

#19
#19
It is precisely this complexity which has motivated me to stay away from Carbon Black in future products. For products that need to be colored, I am trying to use colorants that at least have a MAF file with the agency.
This year I had 2 510(k)'s approved where I had detailed colorant questions. On one I took the extraction / risk analysis route; and on the second I used the master file route. In the long run,the master file route is more expensive because the colorants with master files are expensive.
BBG
 
J

Julien_Baie

#20
#20
Hello BerryBerryGud,

Thank you for your informative reply!

Here are two more questions based on what you said the other day:

1) Because our product has to be black, there isn't much choice out there. By looking at 21 cFR 73 and 74 listings, most of them are for contact lenses, sutures, or other very specific uses, which doesn't help me to decide whether the FDA will accept my selection. When you were selecting carbon black, did you try to explain to FDA that because for example DC Black No.2 is good for eye area use, it could be reasonable that it would be good for your product?

2) I saw some other organic black coloring that are listed under 21 CFR 73, such as 73.1410 logwood extract, 73.125 Sodium copper chlorophyllin, can be made into black. I wonder if those can be a substitute to carbon black. but once again, I am no polymer chemist, so I am not sure. Did you come across those?

3) you mentioned extraction study? how long does an extraction study take? how many more items did you have to do?

4) For getting an MAF file, are companies willing to give you the file? or did they just give you an authorization that FDA can look at their MAF that is on file with FDA?

:cool:

Julien
 
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