Regulatory Open Forum

Hi all, I'm trying to figure out the regulatory category of oils or creams that are applied topically to the outside of the vagina (clitoris, labia and outer areas) in order to increase arousal and pleasure during sex. For example, there's a product called Zestra that is an oil made of botanicals that seems to be marketing itself in the US as a cosmetic or something like that - not clearly a device (has no 510k) or drug. I've seen a similar product where you spray it on the outside parts of the vagina before sex to increase pleasure for the female. At initial review, I wouldn't think they could be cosmetics, because their use isn't about beautifying or cleansing. They're similar in form to lubricants (Class II devices) but they're not really about reducing friction or something physical, so not sure about that category. But I am wondering is if they'd be regulated as "General Wellness Products." 

I've reviewed the new Guidance and saw the rule that if a product is invasive, as defined by "penetrates or pierces the skin or mucous membranes of the body," then it is not low risk and is not covered by the guidance. The guidance considers sexual function/performance to be a potential category as long as you don't mention a disease. I'd think these oils fit the Guidance in terms of that, but these products talk about working by increasing vasodilation and smooth muscle relaxation to increase sensitivity, so I do think they must be penetrating the mucous membranes and thus would be invasive, and so can't be a "General wellness" product? I wonder then if you could argue increasing vasodilation is a physical action, and so it could be a lubricant (though I think biochemical processes have to happen to product Nitric Oxide and thus have vasodilation). Also the Guidance talks about considering if the CDRH regulates products of the same type in a different way, so that makes me think since vaginal lubricants are Class II devices, that'd make these types of products Class II devices too.

So in summary, crowdsourcing here to see if anyone knows what regulations would apply to market a product like Zestra?

Thanks!!
Hannah

Hi all, I'm trying to figure out the regulatory category of oils or creams that are applied topically to the outside of the vagina (clitoris, labia and outer areas) in order to increase arousal and pleasure during sex. For example, there's a product called Zestra that is an oil made of botanicals that seems to be marketing itself in the US as a cosmetic or something like that - not clearly a device (has no 510k) or drug. I've seen a similar product where you spray it on the outside parts of the vagina before sex to increase pleasure for the female. At initial review, I wouldn't think they could be cosmetics, because their use isn't about beautifying or cleansing. They're similar in form to lubricants (Class II devices) but they're not really about reducing friction or something physical, so not sure about that category. But I am wondering is if they'd be regulated as "General Wellness Products." 

I've reviewed the new Guidance and saw the rule that if a product is invasive, as defined by "penetrates or pierces the skin or mucous membranes of the body," then it is not low risk and is not covered by the guidance. The guidance considers sexual function/performance to be a potential category as long as you don't mention a disease. I'd think these oils fit the Guidance in terms of that, but these products talk about working by increasing vasodilation and smooth muscle relaxation to increase sensitivity, so I do think they must be penetrating the mucous membranes and thus would be invasive, and so can't be a "General wellness" product? I wonder then if you could argue increasing vasodilation is a physical action, and so it could be a lubricant (though I think biochemical processes have to happen to product Nitric Oxide and thus have vasodilation). Also the Guidance talks about considering if the CDRH regulates products of the same type in a different way, so that makes me think since vaginal lubricants are Class II devices, that'd make these types of products Class II devices too.

So in summary, crowdsourcing here to see if anyone knows what regulations would apply to market a product like Zestra?

Thanks!!
Hannah

Hi all, I'm trying to figure out the regulatory category of oils or creams that are applied topically to the outside of the vagina (clitoris, labia and outer areas) in order to increase arousal and pleasure during sex. For example, there's a product called Zestra that is an oil made of botanicals that seems to be marketing itself in the US as a cosmetic or something like that - not clearly a device (has no 510k) or drug. I've seen a similar product where you spray it on the outside parts of the vagina before sex to increase pleasure for the female. At initial review, I wouldn't think they could be cosmetics, because their use isn't about beautifying or cleansing. They're similar in form to lubricants (Class II devices) but they're not really about reducing friction or something physical, so not sure about that category. But I am wondering is if they'd be regulated as "General Wellness Products." 

I've reviewed the new Guidance and saw the rule that if a product is invasive, as defined by "penetrates or pierces the skin or mucous membranes of the body," then it is not low risk and is not covered by the guidance. The guidance considers sexual function/performance to be a potential category as long as you don't mention a disease. I'd think these oils fit the Guidance in terms of that, but these products talk about working by increasing vasodilation and smooth muscle relaxation to increase sensitivity, so I do think they must be penetrating the mucous membranes and thus would be invasive, and so can't be a "General wellness" product? I wonder then if you could argue increasing vasodilation is a physical action, and so it could be a lubricant (though I think biochemical processes have to happen to product Nitric Oxide and thus have vasodilation). Also the Guidance talks about considering if the CDRH regulates products of the same type in a different way, so that makes me think since vaginal lubricants are Class II devices, that'd make these types of products Class II devices too.

So in summary, crowdsourcing here to see if anyone knows what regulations would apply to market a product like Zestra?

Thanks!!
Hannah