Exporting Adult Products from Europe to the United States

[Catherine Ferrier]

Hello all,

Thank you so much for reading. I have a little question about exporting adult products (sex toys) to the United States and FDA requirements.

I work for a company in southern Europe that commercialises sex toys that have been first imported from China (so manufactured in China and repackaged in southern Europe). We are interested in exporting these toys to customers in the United States, but we've heard from a representative from a certain worldwide transportation that we're interested in working with that these types of toys are typically regulated by the FDA as Class II medical devices.

I've started to do a little bit of research, but I'm quite curious about a few things. First of all, must we absolutely register our products with the FDA or face a penalty for exporting our products to the US? We don't consider our products as "medical devices" per se, as we are not asserting that they offer any benefits beyond simple pleasure. I mean, does every single manufacturer/sex toy company that ships to the US actually register with the FDA? I've just started looking into the process and it seems quite onerous to say the least. Of course, we do want to follow the applicable laws to the letter, which is why I'm asking.

Also, I see that genital vibrators for therapeutic use are considered Class II devices, but are in fact "510(k) exempt"? Does this mean that were we to register our vibrators with the FDA, we would not have to submit a 510(k) for these products?

My endless thanks for any information you may have, and a very good day to you all.

 

[shimonv]

but we've heard from a representative from a certain worldwide transportation that we're interested in working with that these types of toys are typically regulated by the FDA as Class II medical devices.

Hi Catherine,
I did a brief check for you. FDA regulates devices such Therapeutic vibrator (product code IRO/ regulation 890.5975) and Genital vibrator for therapeutic use (product code KXQ/ regulation 884.5960). These are medical devices; sex toys are not. With that being said there are a lot of similarities between them and this can create problems with the US customs.

You need to make sure that the product labeling and shipment paperwork clearly shows that these are non-medical devices (toys or novelties).

Shimon

 

[Ronen E]

Hello all,

Thank you so much for reading. I have a little question about exporting adult products (sex toys) to the United States and FDA requirements.

I work for a company in southern Europe that commercialises sex toys that have been first imported from China (so manufactured in China and repackaged in southern Europe). We are interested in exporting these toys to customers in the United States, but we've heard from a representative from a certain worldwide transportation that we're interested in working with that these types of toys are typically regulated by the FDA as Class II medical devices.

I've started to do a little bit of research, but I'm quite curious about a few things. First of all, must we absolutely register our products with the FDA or face a penalty for exporting our products to the US? We don't consider our products as "medical devices" per se, as we are not asserting that they offer any benefits beyond simple pleasure. I mean, does every single manufacturer/sex toy company that ships to the US actually register with the FDA? I've just started looking into the process and it seems quite onerous to say the least. Of course, we do want to follow the applicable laws to the letter, which is why I'm asking.

Also, I see that genital vibrators for therapeutic use are considered Class II devices, but are in fact "510(k) exempt"? Does this mean that were we to register our vibrators with the FDA, we would not have to submit a 510(k) for these products?

My endless thanks for any information you may have, and a very good day to you all.

Hello Catherine and welcome to the Cove

The USA legal definition of a Medical Device:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Does any of your products claim to do any of the above? If not, it's not a Medical Device and the medical devices regulation doesn't apply.

I second the advice to clearly state on the labelling (packaging print, accompanying paperwork, accompanying and non-accompanying promotional materials) that such uses are excluded.

Cheers,
Ronen.