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Intervening material on Information panel

FDA labeling

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#1 kick

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Posted 21 November 2018 - 09:35 AM

Is "May contain" or "any statement saying possibility for cross contamination" considered to be an intervening material ?



#2 FSQA

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Posted 23 November 2018 - 09:32 PM

Is "May contain" or "any statement saying possibility for cross contamination" considered to be an intervening material ?

Kick,

 

(It should be based on the regulation of the country/region and following is based on FDA labeling/ US regulations);

 

I was not able to find a direct regulation to Advisory labeling as an intervening material, but IMO advisory statements are not required under FALPCA;

Link -(https://www.fda.gov/...m106890.htm#q13)

Does FALCPA require the use of a "may contain" statement in any circumstance?

No. Advisory statements are not required by FALCPA.

 

Now, in the FDA labeling guide (https://www.fda.gov/...n/UCM265446.pdf) Section 3, Q7/ Page 6);

7. What is the prohibition against intervening material?

Answer: Information that is not required by FDA is considered intervening material and is not permitted to be placed between the required labeling on the information panel (e.g., the UPC bar code is not FDA required labeling). 21 CFR 101.2(e)

 

Based on the above, IMO: these advisory statements will be considered as an intervening material. 


Edited by FSQA, 23 November 2018 - 09:32 PM.


#3 Charles.C

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Posted 23 November 2018 - 09:59 PM

Is "May contain" or "any statement saying possibility for cross contamination" considered to be an intervening material ?

 

Hi kick,

 

Pls supply a little context/ref to source of  "intervening material"


Kind Regards,

 

Charles.C


#4 kick

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Posted 24 November 2018 - 06:08 AM

Hi Charles,
Thank you for the reply.
http://wayback.archi...s/ucm106546.htm
Based on this article and articles you have mentioned, I just wanted to check companies using lines such as " manufactured on equipment that process egg product as well."
Are they complying to the requirement?

I found this article as well which is somehow clearing things about precautionary labeling..

https://farrp.unl.ed...lergic-consumer

This type of labelling (also termed advisory labelling or defensive labelling) is strictly voluntary and not required by federal regulation.

But still question remains..Precautionary labeling somehow misleads consumer..
And based on the above article, it is not required by federal regulations.
So why companies using it..Aren't GMP enough? Are they complying to the requirement?



#5 kick

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Posted 24 November 2018 - 06:14 AM

Really sorry, thank you so much FSQA for the reply..Even I have gone through the mentioned links and think the same that it should be an intervening material, but companies are using it. So, wanted to check where the regulations says it can be done..



#6 Charles.C

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Posted 26 November 2018 - 12:24 PM

Hi Charles,
Thank you for the reply.
http://wayback.archi...s/ucm106546.htm
Based on this article and articles you have mentioned, I just wanted to check companies using lines such as " manufactured on equipment that process egg product as well."
Are they complying to the requirement?

I found this article as well which is somehow clearing things about precautionary labeling..

https://farrp.unl.ed...lergic-consumer

This type of labelling (also termed advisory labelling or defensive labelling) is strictly voluntary and not required by federal regulation.

But still question remains..Precautionary labeling somehow misleads consumer..
And based on the above article, it is not required by federal regulations.
So why companies using it..Aren't GMP enough? Are they complying to the requirement?

 

Hi kick,

 

I'm not quite sure how the above relates to "intervening material" but with respect to allergens, as I think you deduced, the "may contain" encyclopedia of phrases is basically a fudge to permit legal protection against "potential events". It's as simple as that.

 

Additionally, FDA do not interpret such a labelling  statement as a justification for not implementing detailed cleaning procedures to minimize cross-contamination. It's the opposite.


Kind Regards,

 

Charles.C


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#7 FSQA

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Posted 26 November 2018 - 02:48 PM

think the same that it should be an intervening material, but companies are using it. So, wanted to check where the regulations says it can be done..

I am unable to find one that allows it, but would like to tag along with you to see if someone can back that here.

 

 

But still question remains..Precautionary labeling somehow misleads consumer..
And based on the above article, it is not required by federal regulations.
So why companies using it..Aren't GMP enough? Are they complying to the requirement?

Yes, it misleads the consumers and I concur with Charles  in the above post:

"the "may contain" encyclopedia of phrases is basically a fudge to permit legal protection.

Additionally, FDA do not interpret such a labelling  statement as a justification for not implementing detailed cleaning procedures to minimize cross-contamination. It's the opposite."

 

Here is a good blog read on this topic:

https://www.foodalle...lergen-labeling



#8 kick

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Posted 26 November 2018 - 06:00 PM

Thank you, FSQA, for sharing the blog. It was quite informative.
Thank you, Charles. the "may contain" encyclopedia of phrases is basically a fudge to permit legal protection against "potential events". Does that mean companies won't be liable in case of adverse event if they have mentioned particular allergen in precautionary statement?







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