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What happens if your supplier makes a minor change to formulation and you have artwork on stock?

label subingredients ingredients raw materials fda

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#1 karemfiori

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Posted 14 April 2020 - 02:18 PM

Hi everybody,

 

I have a question regarding subingredients.

I have cases in stock with their artwork already approved. The artwork has ingredients, subingredients, allergens, etc.

The issue is my raw material suppliers changed their cheeses formulation, they added a couple of ingredients and they are not declare on my artwork (and I can not throw this away), this changes does not modify my allergen profile.

My question is Does FDA has an exception or something written what is it supposed to do if your suppliers changed formulation and you have artwork on stock?



#2 GMO

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Posted 15 April 2020 - 09:21 AM

I'm not sure about US legislation but by gut feel is if you're adding ingredients it's a problem, if you're taking it away (i.e. overdeclaring) it's not even if it doesn't impact allergens.

 

One get out clause may be if they are "processing aids" and so not declarable.  Another may be if you have a catch all term like "flavourings".  If you can explain what the change is, it might be easier to advise?



#3 majoy

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Posted 15 April 2020 - 12:56 PM

So the supplier did not inform you of this change ahead? Depends on how big your company is and how much of this cheese are you purchasing. If you are big enough that you can go tell your supplier to revert to the old formulation until you finish off the remaining artwork, then this will be my recourse. I can also look for another cheese supplier with similar ingredient declaration and use that for now.

 

Is the added ingredient food additives? or just generally food stuff? a bit difficult decision if its food additives as some have restrictions and must be declared. Cheeses generally would only have milk, cheese cultures, enzymes and plus food additive or colours.

 

I have never heard monitoring or enforcement actions on label by regulatory, unless there is a complaint or the inspector assigned in your facility is doing a label verification check, then this is where they will only be aware that there is an addition or mislabeling has occurred.

 

Now, the next more important thing is prevent this from recurring.


"Whatever you do, do it well..." - Walt Disney


#4 karemfiori

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Posted 15 April 2020 - 01:04 PM

We are a small company, so ask them to change to their previous formulation not an option.

Basically they added preservatives, and they add and removed general ingredients, oil, starches among others.



#5 majoy

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Posted 15 April 2020 - 01:42 PM

I'm not sure where your product falls, but there is a USDA FSIS procedure for temporary label approval -  meat and poultry products.

 

3. Labels for temporary approval (9 CFR 412.1 © (4)).

A temporary label approval may be granted for labels with a regulatory deviation that does not pose any potential health, safety, or dietary problems to the consumer. Temporary approvals will be granted for up to 180 days, and plants can apply for one extension of up to an additional 180 days. Plant transfers are a special type of temporary approval which is granted approval for 60 days with one additional extension. Temporary label approval is granted on a case-by-case basis.

Example: A supplier changes ingredients and fails to inform the establishment, and the establishment needs to make a minor correction to the ingredients statement. The establishment can apply for a temporary approval to use the existing label, even though it does not have the correct ingredients statement.

Only LPDS can grant temporary approvals for labels with deficiencies. The submitter must address the four conditions for temporary approval listed in 9 CFR 412.1 (f) and explain how they meet each condition. As part of their label application, they must also explain exactly what is wrong with their label. Example: A change in the ingredients statement from what was approved in the past. The submitter would submit both ingredients statements and highlight the differences between them

 

https://www.fsis.usd...pdf?MOD=AJPERES


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#6 GMO

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Posted 15 April 2020 - 01:48 PM

The preservatives may not be declarable if they form no function in the finished product.



#7 moskito

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Posted 16 April 2020 - 12:49 PM

Hi,

 

I am a food law expert based in Europe (and for Europe) and to certain extent familiar with US legislation but not with the legal practice (e.g. court decision).

Documentation

1) Contract and specification? -> announcement in advance and clear comunification/agreement of time point for change (that it, what we have for our supplier)
2) Who is the FBO with the legal responsibility? Who is creating the list of ingredients etc. based on what information/detail level? I guess its you (not only packaging)?

 

First: The list of ingredients has to be correct.

 

For some "grey" area with minor changes and change over for a limited time minimum 3 questions arsises:
a) risk to consumers like allergy you mentioned already (but there might be some others) 
b) misleading the consumer/expectation of consumers (e.g. clean label -> not mentioning some new additives; the number of ingredients is very short and now long etc. )
c) Nutrition facts? changed/unchanged?

 

Rgds

moskito



#8 Hoosiersmoker

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Posted 16 April 2020 - 01:37 PM

My suggestion would be along the lines of majoy's: Either print, or have printed, the new ingredients portion of the label and overlay it for the remainder of the stock you still have. If the change was not made within the agreed upon period, and you can't overlay the new ingredients label, you should charge all cost back to the customer.







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