5 replies to this topic

[ronrico145]

Good afternoon,

I must say that I am a new comer to this site, but it has given me a lot of very valuable information. So thanks!

Now my question that I desperately need help with.

My company needs to make a change in our ingredients from "lemon juice" to "citric acid". The reason is a safety change since lemon juice alone could not get our product pH 4.60 where as citric could. Citric acid is naturally found in lemon juice so the change is relatively speaking minimal. Now the problem is we have about 200,000 cups with labels already printed and for us to get through all of them would take close to 8-9 months. Is there anyway to move forward with this change without repercussions from the FDA? Is there a petition or some way to claim business hardship over this as it would kill us financially?

Thanks for your help!

[Ian R]

Hi
The problem is 'Lemon Juice' contains citric acid, but Citric acid is not lemon juice.
The usual production process for citric acid is via fermentation not 'extracting' it from lemons.
This also raises the issue of whether the the citric can be guaranteed free from GMO.
For some EU and UK retailers we have to check the status of the citric acid through the Valid-IT system if it is used in own label products.

I would not consider the change to be minimal but actual a significant change in terms of labelling.

I can't speak specifically about FDA regulations but EU labelling would require you to declare the presence of citric acid as opposed to lemon juice.
In the EU citric acid is defined as an additive with the number E330, but lemon juice is ... well .... lemon juice.
You have to declare it as either the E number or the name along with the function of the additive.

regards

[Tony-C]

Good afternoon,

I must say that I am a new comer to this site, but it has given me a lot of very valuable information. So thanks!

Now my question that I desperately need help with.

My company needs to make a change in our ingredients from "lemon juice" to "citric acid". The reason is a safety change since lemon juice alone could not get our product pH 4.60 where as citric could. Citric acid is naturally found in lemon juice so the change is relatively speaking minimal. Now the problem is we have about 200,000 cups with labels already printed and for us to get through all of them would take close to 8-9 months. Is there anyway to move forward with this change without repercussions from the FDA? Is there a petition or some way to claim business hardship over this as it would kill us financially?

Thanks for your help!

Almost certainly will require a label change, perhaps if you still add a bit of lemon juice that may help. You could apply for temporary approval:

Requests for temporary approvals must be submitted to FSIS Labeling and Program Delivery Division (LPDD) through regular submission procedures.

More guidance in this attachment:

 Temp Approval Labels.pdf   22.06KB   54 downloads

Good Luck,

Tony

[ronrico145]

I dont know what to say other than you all are the best! This is exactly what I was looking for and you both delivered!


Thank you, thank you, thank you!

[RMAV]

Almost certainly will require a label change, perhaps if you still add a bit of lemon juice that may help. You could apply for temporary approval:

Requests for temporary approvals must be submitted to FSIS Labeling and Program Delivery Division (LPDD) through regular submission procedures.

More guidance in this attachment:

 Temp Approval Labels.pdf   22.06KB   54 downloads

Good Luck,

Tony

It should be noted the scope of the links above is 9 CFR (United States Code) whereas the OP's situation may fall under 21 CFR.
http://www.fda.gov/F...ide/default.htm

I am not a label expert so I do not know how/if 9 cfr is different from 21 cfr in terms of labeling regs. Enjoy!

[Tony-C]

It should be noted the scope of the links above is 9 CFR (United States Code) whereas the OP's situation may fall under 21 CFR.
http://www.fda.gov/F...ide/default.htm

I am not a label expert so I do not know how/if 9 cfr is different from 21 cfr in terms of labeling regs. Enjoy!

Not sure anyone can claim to be an expert!

9 CFR - Code of Federal Regulations - Title 9: Animals and Animal Products - Not sure what the product is but believe the principle should be the same.

Did review the document you refer to previously:
Food Labeling Guide - Guidance for Industry: A Food Labeling Guide
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

The only thing found that may assist was this:
Section 6. Ingredient Lists - Guidance for Industry: A Food Labeling Guide
L55. Is it permissible to use stickers to make changes in labeling?
Answer: Correcting label mistakes in any manner is acceptable if the final label is correct and complies with all
regulations at the time of retail sale. The stickers should not cover other mandatory labeling, and should adhere tightly.

Regards,

Tony