Firms only mention US FDA approval when selling in the UK
By Tim Locke
WebMD Health News
Reviewed by Dr Rob Hicks
2nd February 2010 — “LaserCombs” are a relatively new class of product designed to fight hair loss – combining a brush with a special light source. They’re sold online in the UK with the marketing information saying they are “FDA approved” – meaning the US health regulator has cleared them for use.
There’s no mention of them being UK approved, which is because they are not classed as health products here.
They are sold online in the UK for around £350, with promises of “increased hair growth, cessation of hair loss, faster growing hair, more manageability and more vibrant colour”.
The Medicines and Healthcare products Regulatory Agency (MHRA) says the devices do not fall under its remit.
Jennifer Kyne from the MHRA told us by email, “Whether or not a specific product would be a medical device under Directive 93/42/EEC would depend on the claims being made for each individual product by its manufacturer. ’Hair loss’ or ‘balding’ is not regarded as being a medical condition and therefore products which claim to treat such problems will not be medical devices and would not require CE marking as such.”
“It should also be noted that the regulations in the USA are not the same as those in the EU and just because something has been FDA approved does not mean that it is a medical device under EU regulations.”
The Trading Standards Institute told us that because the devices are actually FDA approved, the marketing information is not misleading, as long as it is made clear this is a US clearance, and not a UK one.
Devices are safety approved
Randy Veliky, operations officer for Lexington International HairMax in the US which makes the LaserCombs told us, “We worked with regulatory consultants to pursue medical device clearance in the UK and other EU countries. We received the same response from the MHRA and others, that hair loss is just a sign of ageing,” so there was no need for medical device approval for cosmetic use.
However he points out, “The devices do have CE licences for laser and electrical safety.”
And he says they are “selling well” in the UK.
Many experts sceptical
Experts point out that it’s unclear how the comb actually works. This has led to scepticism about its effectiveness.
Rebecca Freeman, spokesperson for the British Association of Dermatologists told us by email, “Any type of hair loss can lead to self-esteem and confidence problems and many people, in a quest to regain hair growth or slow down hair loss, are being sold ineffective treatments. It is important for hair loss sufferers to visit a dermatologist to discuss all their treatment options and to look at the research available about each product before deciding whether or not to buy into expensive treatments.”
View Article Sources
NHS Choices – Hair loss
Jennifer Kyne , Medicines and Healthcare products Regulatory Agency (MHRA) press officer
Trading Standards Institute press office
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This entry was posted
on Thursday, February 4th, 2010 at 11:32 am and is filed under HAIR LOSS HEALTH NEWS.
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