Labeling for Manufacturer / Distributor information.

Java23

Involved In Discussions
Hi - Quite a few years ago, I had questions about manufacturer name and distributor name on labeling.
This issue has come up again and I will try to be specific here and hope that someone can guide me.

The company has its base outside of the USA - They are the legal manufacturer
ex: xyzzy company located in Japan

We are the same xyzzy company only we are listed as repacked/relabeler with FDA so they can ship to our US warehouse from out of the country. Tthe labeling shows our name as Distributer with our name and address and contact # on all labeling.

The legal manufacturer likes to show their name (same company) with the manufacturer symbol on all labeling along with the distributor information.

Question has come up as to - why do we need to include the Manufacturer Name on the label since the distributor name and contact information is already there?

So, for USA sales, is both the Manufacturer Name and the Distributor name required to be on the labeling? Or, is it compliant for USA to only have distributor information?

This has come up because some retailers have requested us to remove the name of the legal manufacturer from our labeling.

Any input would be greatly appreciated. Thank you in advance :)
 

EmiliaBedelia

Quite Involved in Discussions
I would agree with whoever raised the question, it's not necessary. The labeling requirements are given in 21 CFR part 801, relevant snip below. Note the "OR" - either of these options is acceptable as long as it accurately represents what you are actually doing.


Labeling for Manufacturer / Distributor information.
 

Java23

Involved In Discussions
Thank you - yes, I have read the regulations but the confusion arises at (c)
  1. Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for _", "Distributed by _", or any other wording that expresses the facts
    The manufacturer is our Headquarters which is overseas - we are the US agent / repacked/relabeler (distributor). Both the Headquarters (legal Manufacturer) and us (US Agent) Same company names. Our marketing group requested to remove the legal manufacturer name and simple keep only our name (distributor - same company as Manufacturer)
    Example: Legal Manufacturer - ABC company Ltd. (Japan) (contact info, address only on labeling
    Distributor - ABC company (US) and all contact info, address, telephone on labeling
    Problem arises whereby marketing group wants to remove legal manufacturer from labeling. I have instructed them to leave the legal manufacturer information on labeling either by stating manufactured by or using the manufacturer symbol.
    I am reading the regulation incorrectly? It states, when a device is not manufactured by the person whose name is on the labeling the name should be qualified with using either manufactured for / or distributed by. It seems the regulation would permit the removal of the Manufacturer name since we do include the Distributed by information.
    When I read, (e), it seems that since we distribute, from a warehouse that is not our principal place of business, we use the address of our US office as distributor.
    Sorry for the confusion but I am having a hard time and having discussions with others that have plenty of differing opinions and I want to make sure I understand what I am reading in the regulations.
    Thank you in advance for any further help you can provide.
 

Java23

Involved In Discussions
Hi - Quite a few years ago, I had questions about manufacturer name and distributor name on labeling.
This issue has come up again and I will try to be specific here and hope that someone can guide me.

The company has its base outside of the USA - They are the legal manufacturer
ex: xyzzy company located in Japan

We are the same xyzzy company only we are listed as repacked/relabeler with FDA so they can ship to our US warehouse from out of the country. Tthe labeling shows our name as Distributer with our name and address and contact # on all labeling.

The legal manufacturer likes to show their name (same company) with the manufacturer symbol on all labeling along with the distributor information.

Question has come up as to - why do we need to include the Manufacturer Name on the label since the distributor name and contact information is already there?

So, for USA sales, is both the Manufacturer Name and the Distributor name required to be on the labeling? Or, is it compliant for USA to only have distributor information?

This has come up because some retailers have requested us to remove the name of the legal manufacturer from our labeling.

Any input would be greatly appreciated. Thank you in advance :)
OOPS - I missed your first statement before you posted the regulation - haste makes waste...
 
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