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Help! Accidental misbranding..what do I do?

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afend

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Posted 15 November 2014 - 08:44 PM

Hello all,

 

I make ready to eat popcorn sold online direct to consumers. I just received a complaint that we used the wrong label on the wrong flavor and sent it out. I know if the product contains an allergen but the incorrect label does not declare it, we would need to. However, in this case it was reversed: the actual product was allergen free but the incorrect label declared allergen. 

 

Would FDA require us to send the correct label to all those who received the mislabeled product?

 

Thank you!



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Charles.C

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Posted 15 November 2014 - 08:55 PM

Hello all,

 

I make ready to eat popcorn sold online direct to consumers. I just received a complaint that we used the wrong label on the wrong flavor and sent it out. I know if the product contains an allergen but the incorrect label does not declare it, we would need to. However, in this case it was reversed: the actual product was allergen free but the incorrect label declared allergen. 

 

Would FDA require us to send the correct label to all those who received the mislabeled product?

 

Thank you!

 

It may well depend on where on Earth you (or perhaps the popcorn) are located ?

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


afend

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Posted 15 November 2014 - 09:09 PM

Oops, I'm in United States and shipping to consumers in the Unite States.



Charles.C

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Posted 16 November 2014 - 12:50 PM

Dear afendrick,

 

Don't recall ever seeing this allergen query before. :smile:

 

I guess yr basic query is - (a) Is there a (safety) case to answer ?(b) any other case to answer ?

 

The implications may depend on the specific mislabel, eg i seem to recall that in USA, it is FDA-acceptable to declare a product may contain A,B,C,D,E,F (eg via unintentional cross-contamination from multiply-used equipment). I'm less sure about a wrong statement like  "contains peanuts". No overt hazard but a potentially psychological one ?

 

This 2014 link doesn't answer yr question but illustrates the complexity of the general problem  -

 

http://www.foodsafet...portable-foods/

 

Hopefully some US posters have encountered this situation ? :smile:

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


teaks

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Posted 20 November 2014 - 03:31 PM

Afendrick,

 

I expect that you found out about the labeling error when a customer called?  

While no health/safety issue exists, this might classify as a "market withdrawal" rather than a recall. At the very least, it can help you test your ability to recall product by identifying all of the affected customers.  

I would contact your customers to provide the correct information to them.  Your customers will appreciate it.  

Then you may want to think about how to manage/control/verify product labels.

 

Good luck!



CMHeywood

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Posted 20 November 2014 - 06:58 PM

My opinion:  it is not an FDA Class I, II or III recall because it doesn't present a risk to the consumer.  However, I do agree that you should withdraw the mislabeled product to be safe.





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