Labeling Requirements and COO (Country of Origin)

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curiousone

#1
I am looking for a direct answer to the question, "if a product is made of a fabric that originated in China does the Country of Origin then become "made in the USA" after manufacturing has changed the item from a fabric to say a orthopedic pillow case?"
I know that a tariff shift will take place as far as NAFTA goes, but I thought that because the product changed from a simple fabric (made in China) to a pillow case (sewn in the US) the Counrty of Origin becomes the US because it has made a considerable transformation in to the final product it has become.
I am new to the Regulatory Arena and am somewhat confused on this issue and would appreciate any clarity to this topic.:thanx:
 
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C

curiousone

#3
Re: Labeling and COO

Thanks Somashekar, that is what I have understood, but others here keep making me think that I am incorrect in my understanding. Thank you very much for your help!!
 
A

Adele

#4
Hi - there is a really good site which we used to understand this type of question - http://www.accessdata.fda.gov/scripts/ora/pcb/tutorial/les2_oasis.htm.

The example they use on this website is:

FDA considers the country of origin to be that of the actual manufacturer. U.S. Customs Service considers it to be the country where the product last underwent a "substantial transformation" (resulting in an increase in value). For example:

ABC Co. in Japan manufactures stereo systems, which contain a CD player manufactured by XYZ Corp. in Korea.
(1) USCS considers Japan to be the country of origin – based on ABC Co. manufacturing the stereo system.
(2) FDA only regulates the CD player and considers the country of origin to be Korea, where the CD player was manufactured.


So in your case the fabric is manufactured into the FDA regulated product (the orthopedic pillow case) in the USA so the country of origin is the USA.
 
M

MIREGMGR

#5
The information above by Adele pertains to importability. Different analytical approaches are applied than for labeling.

It is a mistake, for labeling of a product to be marketing within the US, to mix the FDA's and the Commerce Department's rules. They are not compatible and do not lead to equal conclusions.

Within the US, the specific label language "Made In xxxxxxx" must be based on Department of Commerce rules. That specific language is required by those rules.

The specific language "Manufactured By yyyyyyyy" on the other hand is not required to be present in many cases, but if used must be based on FDA rules. It may be accompanied by the Manufacturer's address and other contact information. The FDA "Manufacturer" for labeling purposes is not the company that actually made the product...it's the company that's legally responsible for the product on the US market. In many instances, most obviously in the case of offshore contract manufacturing, the import-declaration manufacturer and the labeling Manufacturer will not be the same company.

As examples, many of the products made by the company for which I work, sold under our name or by one of many companies for which we private label, are labeled "Made in China" and "Manufactured By yyyyyyyyyy, (address), USA". Both of these statements are legally correct on the same label.
 
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C

curiousone

#6
Thank you Adele and miregmgr, I see why there can be some confusion. Determining the Country of Origin depends on who is asking; FDA or Customs. So, just to make certain that I understand correctly, the fabric that we purchase from a vendor in China is used to manufacture a orthopedic pillow case here in the US and according to the FDA, the COO is the US, and according to Customs the Country of Origin is China. Am I correct? Or am I still confused?:agree1:
 
M

MIREGMGR

#7
...the fabric that we purchase from a vendor in China is used to manufacture a orthopedic pillow case here in the US and according to the FDA, the COO is the US, and according to Customs the Country of Origin is China.
I think you're partly talking about status at time of importation, and partly about status after fabrication. Let's focus on one at a time.

The initial question is, is the item in fact FDA regulated in its present form?

Chinese fabric in unfabricated form is not a medical device. Therefore the FDA is not involved at time of importation.

For Customs, the COO definitely is China. Presumably that's where the fabric actually was made, and it's where whoever sold it to you shipped it from.

Once the fabric is made into ortho pillowcases in the US, those pillowcases will be medical devices. Their labeling may state "Manufactured by (you, your address, USA)", depending on the labeling approach you use. It will state "Made in USA" if you may want to export them.
 
C

curiousone

#8
Miregmgr,
I understand what you are saying and agree with you. Now, let's take the same fabric from China and ship it to Mexico (a sister company) where they sew the cover(case) that is then shipped to the U.S. where it is filled with fiber to make it into an orthopedic pillow.
Being shipped into Mexico from China the COO would be China according to Customs, when shipped (exported) from Mexico to the US the COO would then be Mexico, correct? The label then would have to state Made in Mexico, finished in the US? Or Made in Mexico of components of China, finished in the US. What is the proper way to label?:thanx:
 
M

MIREGMGR

#9
let's take the same fabric from China and ship it to Mexico (a sister company) where they sew the cover(case) that is then shipped to the U.S. where it is filled with fiber to make it into an orthopedic pillow.
Being shipped into Mexico from China the COO would be China according to Customs
US Customs would have no stance on a shipment directly from China to Mexico...or are you talking about Mexico Customs here?

when shipped (exported) from Mexico to the US the COO would then be Mexico, correct?
As far as I know, yes.

The label then would have to state Made in Mexico, finished in the US? Or Made in Mexico of components of China, finished in the US. What is the proper way to label?
Is the unstuffed pillowcase a medical device at time of importation? If so, its label for US marketing as an unstuffed pillowcase would state Made in Mexico, I think.

The finished stuffed pillow would be labeled for US marketing as Made in USA, I think.
 
C

curiousone

#10
Miregmgr, the bottom line (I believe to be true) is I believe the label needs to read (at minimum): Made in Mexico, finished in the US. Unless, someone has information to the contrary, that is what I plan to go with. Thanks for all your help; feel free to continue communications if you have more to add.
 
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