Importing Class II Male Latex Condoms From China to US

D

dhan89

#1
Hi Everyone,
I have several questions that I think you might be able to answer me. I would appreciate your help a lot.

Premise: Our company "X" is trying to import condoms from an FDA approved manufacturer in China. We've received some sample and we like their quality. The manufacturers are going to design our packaging design there.

Questions
1. Is our company considered a repackager/relabeler? If not, what are we? Importer? Initial distributor? (What is a I.D anyways?)

2. Product liability. If someone tries to sue me fore damages, am I responsible or is the manufacturer responsible. An attorney consulted that I get a Hold Harmless agreement with the manufacturer. What other suggestions do you have to protect me from claims from victims in case they decide to sue.

3. What forms, certificates should I have before they start manufacturing our condoms?
 
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Ronen E

Problem Solver
Staff member
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#2
Premise: Our company "X" is trying to import condoms from an FDA approved manufacturer in China. We've received some sample and we like their quality. The manufacturers are going to design our packaging design there.

Questions
1. Is our company considered a repackager/relabeler? If not, what are we? Importer? Initial distributor? (What is a I.D anyways?)
If the Chinese manufacturer packs & labels the product in your package, with your label, (regardless of who designed it), and you don't physically change the packaging and/or labeling or add layers (once you import the product), then you're not considered a repackager / relabeler. The same will apply if they use their own packaging & labeling, and you won't change / add anything. In plain English you will be an "importer", however, I'm not aware of such formal status in FDA terminology. In the latter you will be an Initial Distributor, who is the first entity which assumes responsibility when the device enters the USA. You will be required to register as such.

2. Product liability. If someone tries to sue me fore damages, am I responsible or is the manufacturer responsible. An attorney consulted that I get a Hold Harmless agreement with the manufacturer. What other suggestions do you have to protect me from claims from victims in case they decide to sue.
The following is in no way meant to be legal advice, as I'm not a legal expert. From a regulatory standpoint, though, the responsible entity is the one "owning" the label. If the product is labeled with your label (i.e. presenting you as the company who makes it available in the USA, regardless of who designed the label and/or applied it to the product) then you will be responsible. If you want to reduce your responsibility, you can purchase the product with the Chinese manufacturer's label (provided that as such the product is listed and cleared for marketing in the USA), and further distribute it. You can have your name mentioned on the label as a distributor ("distributed by...") if you go down this path, without bearing regulatory manufacturer's responsibility. I can't really say how all this will affect your situation if a user will sue you for damages.

3. What forms, certificates should I have before they start manufacturing our condoms?
If you intend to have your own label then you will be subject to all the requirements applicable to "specification developers", and they should register as a "contract manufacturer" (and comply with applicable regulations). If it's their label, then as a minimum you have to get their documentation showing the product is cleared for marketing in the USA, and that they have registered their establishment and listed the product, and you should have your registration as an initial distributor. Refer to the FDA website for all applicable regulations in the different arrangements; it would be impractical to detail them all here (the above are just the highlights).

Cheers,
Ronen.
 
M

MIREGMGR

#3
You say "FDA Approved" regarding the maker. The FDA of course does not "approve" makers. I assume you mean that the maker is a currently Registered Establishment. Do they also have the product that they will be private-labeling for you, Listed under their own name?

If they do, and if your purchase agreement and/or POs with them state that they are the regulatorily responsible Manufacturer and they are private labeling for you, then I agree that you do not have regulatory responsibility.

If however they have not Listed the product for which they will make a private labeled version for you, then in spite of the maker being a Registered Establishment, the FDA could find that you as the Initial Importer are regulatorily responsible for the product within the US, at least as distributed in your private labeled version. If such a determination were made, the FDA would expect you to List the product.

If you want to minimize your legal liability, I'm sure your lawyer will advise that you want to be a Distributor of a private labeled version of a product that the maker Listed.

Note in regard to the mention of "private labeling" here that I believe Ronen E's advice above, while correct in regard to his responses to your questions 1 and 2, is not correct regarding his response to your question 3. FDA handles the "private label" concept very differently from all other global regulators. It's entirely possible, and quite common, for a US distributor to sell a product carrying only their name, for which they have no regulatory responsibility and are factually only a distributor, if the purchase relationship is clearly documented to be one of "private labeling".
 
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