Are Vaginal Lubes Considered a Cosmetic Product?
A client recently asked me this question. She had approached a number of labs to get advice about a ‘vaginal lube’ she had formulated to help with ‘dryness’. She wanted to see about getting a Cosmetic Product Safety Report (CPSR), which is one of the things you need in order to sell cosmetics legally in the European Union. Her particular formulation was a simple one that contained all the ingredients you might expect in a water based gel serum.
One lab told her that it was a cosmetic, as long as it wasn’t marketed as a medicine i.e. does it make medical claims? Another lab categorically said it was classed as a medicine and they couldn’t help her.
I agreed with the first lab but the response of the second lab had us both stumped.
Initially I reasoned that there are other products, such as those intended to keep the mouth clean, which are considered a cosmetic product, despite being used inside the oral cavity. The likelihood is that things like toothpastes and mouthwashes can easily be swallowed; despite this risk, they are still classed as a cosmetic.
I wondered how this was different from a simple ‘vaginal lube’, so I revisited the legislation for clarification.
Essentially, to go somewhere close to answering the question, and to understand the second labs reasoning, we have to look at some basic female anatomy.
Most people will say that the vagina is the area that encompasses the whole of the woman’s genitalia. When my kids asked me what the male and female organs were called, I simply said ‘penis and vagina.’ In fact most people in the West use the term in common parlance even into adulthood. However, the term is not completely accurate; the vagina, in anatomical terms, is the birth canal that is inside of the woman’s body. There is also the vaginal opening which connects the birth canal (vagina) and the external genitalia.
Well, what does that have to do with cosmetics? I hear you ask.
A lot, as it goes. And it all comes down to how you talk about parts of the body as well as what is defined as a cosmetic, what is defined as a medicine and what falls at the interface.
The EU defines a cosmetic as;
…any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.
Under this definition we can argue that -even if used internally - it is a cosmetic because this ‘vaginal lube’ is not meant to treat any condition, it is for keeping the area in good condition. You could also argue that it is to ‘moisturise the external genital organs’, much in the same way a face cream keeps the face moist or moisturised.
Now let’s look at the EU Directive’s definition of a medicine:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
This is where it could get murky. You could argue that a vaginal lube for dryness helps ‘‘restore a psychological function.’ BUT, vaginal dryness is caused by a drop in estrogen levels (which is something that happens at a physiological level) and vaginal lubes do not act to ‘modify’ this, they don’t increase estrogen; they do not encourage or increase vaginal secretions; they replace them temporarily. In the same way, that adding glycerine to a facial moisturiser doesn’t increase the skin’s ability, at a physiological level, to make moisture.
Final Word
When it comes to products for the private parts, it’s all about how you frame it. My opinion is that you can indeed have a cosmetic product that is for the genitalia (even for the vagina) just make sure that when you approach your safety assessor you might want to clarify that it is to keep it in good condition, looking and feeling great. You might even want to call it a ‘moisturiser.’
But whatever you do, don’t mention the vagina!'
More info:
http://www.ctpa.org.uk/content.aspx?pageid=304
This has information on the definition as well as a borderline product http://www.europarl.europa.eu/RegData/etudes/IDAN/2015/554174/EPRS_IDA%282015%29554174_EN.pdf
UK guidance that mentions the MHRA (they decide if something is a medical product) https://www.gov.uk/guidance/decide-if-your-product-is-a-medicine-or-a-medical-device
See end of page 4 regarding cosmetic products - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/380280/guide_8_what_is_a_medicinal_product.pdf
How the US defines what a drug is and what a medicine is:
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/cosmetics-us-law