Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

what is the difference between a drug and a cosmetic

What is the difference between a drug and a Cosmetic?

The simple answer is it depends on the claims you make for it.  So if you sell a shampoo to treat dandruff, it is a cosmetic.  If you say it cures psoriasis then that makes it a medicine.  The more complicated answer is that if you present a product in such a way as it seems to be making medical claims then there is a good chance that the regulators will take notice and take action.  This rule is pretty much a universal one.  There are differences from market to market on just what will trigger off an enforcement, but the principle is always the same.

A good example of how it works has just unfolded in the US.  Flawless Beauty, a brand from the Philippines, has been ordered to withdraw a whole set of products from the US market by the FDA.

The products, which they seem to sell under a range of brand names, are all variations on products intended to lighten the skin.  They have a number of actives including glutathione and vitamin C.   These aren’t dangerous at the levels normally used in cosmetic products. But they could give problems if the level was unusually high or if the instructions for use suggested using the products very frequently.  So the FDA were not concerned with the intrinsic safety of the products.  The problem was that they were being presented in a way that encouraged them to be misused.  There is a reason why skin lightening products need to be licensed as drugs.  Users need to be aware of the risks and to follow medical advice when using them.

I like the way the FDA have gone about this.  They have basically warned the public and put the onus on the manufacturer to withdraw the product.  One of the requirements of holding a drug license in Europe – and I imagine this is the case in the US as well* – is that the licensee has to have a plan in place for a product recall in the event that it needs to do so.  It’s one of the many reasons that drugs are a lot more expensive than you’d imagine they need to be.  The next time there is some newsworthy problem with a medicine watch out for what the spokesman says on the news bulletin.  They will very likely be very well informed about the batch history of where the product has been on sale.  That’s what planning does for you.

I hope I am not doing them a disservice but I doubt that our friends at Flawless Beauty had such a plan ready to roll when the FDA required them to recall their product.  They aren’t a drug company and it probably never crossed their mind that they might find themselves doing a recall on this scale.  It might not on the face of it sound like a very serious sanction.  But it will be costing them a fortune to comply.

Just to repeat the fundamental point here.  There is nothing, so far as we know, wrong with the actual products.  They are all quite safe when handled normally and for all I know they haven’t done any actual harm to anyone.  (Or at least that isn’t why the FDA have pulled them up so I assume they haven’t.)  So the problem is the way the description of the product has been worded on the pack.  Flawless Beauty can simply over-label the products in a compliant way and offer them for sale again.  Indeed they may well do exactly that.

Skin lightening products are big business around the world, but there is always going to be a need to draw the line between products that just keep your skin looking a bit fairer than it would when left to its own devices, and products that seriously affect your skin’s ability to protect itself from UV damage.  You can do yourself a lot of damage if you overdo it.  Damage to your skin can be very long lasting and you might find yourself obliged to wear dark glasses, hats with very wide brims and face scarfs.  Of course if you are Michael Jackson you can look cool while you are doing it.  But for most of us it would just be miserable.  Avoiding that kind of thing is down to simply making sure we follow the instructions.  So you have to be able to trust that the instructions are appropriate.  Well done to the FDA for protecting consumers from dangerously written pack copy.

https://www.fda.gov/Safety/Recalls/ucm593149.htm

* If anyone knows I’d love to know if my assumption is correct.

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