A colossal 21,000 complaints to the manufacturer of a US hair care product, as well as another 100-pluse to the FDA – America’s regulatory body for food and drug products – has not been enough to take the controversial item off the shelves, despite claims that it can lead to hair loss.
The product in question – WEN by Chaz Dean Cleansing Conditioner – is currently embroiled in a lawsuit involving hundreds of people across the US. But because it is a cosmetic product, rather than a prescription drug, it is extremely hard for the FDA to intervene.
Slipping through cracks
A new report from Northwestern University in the States explores how innumerable products of this nature are effectively slipping through the regulatory cracks. In fact, a team led by Dr Steve Xu, a dermatology researcher at the university’s Feinberg School of Medicine in Chicago, says that there have been just 5,144 adverse events reported to the FDA between 2004 and 2016, something which he feels is not representative of the real story.
“This is a $430 billion-a-year global industry with millions of products on the market, but we are only getting, on average, between 200 and 400 adverse events per year,” he says. “That represents significant under-reporting. If we want more public safety and to keep dangerous products off the market, the first step is to make sure we have reasonably good data. The key point of our results is we don’t have it.”
While apparently under-reported, there is no disguising the hike in complaints to the FDA in 2016, where a 100-per cent rise may be attributed in part to people who had found fault with WEN products.
These people likely represent some of the 21,000 who have complained directly to WEN and its distributor Guthy-Renker following alleged scalp problems and hair loss that they say its Cleansing Conditioner caused.
So widespread is the WEN issue that the FDA took the unusual steps of issuing a safety alert about the product last year which read: “While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider.”
However, this, at the moment, appears to be all they can do.
Says Xu: “The FDA has much less authority to recall cosmetics from the market in stark contrast to drugs or medical devices. It’s harder for the FDA to get harmful cosmetics off the shelves.”
Database is needed
Xu says the point of his study has been to broaden the awareness of the need for a database to which everyone with a complaint against the makers of a cosmetic product can contribute.
With specific regard to WEN, Xu said: “If this was a drug, the story would be much different in regards to regulatory action. Three or four people can be wrong, but it’s hard to ignore 21,000. It’s concerning when 21,000 people complained to the manufacturer, and the FDA received only 127 of those.”
The FDA and its UK counterpart the MHRA do a thorough job of regulating prescription medications and have considerable powers when it comes to ensuring that products are well-tested and proven before they hit the market. Indeed, the two main drugs that have been approved by both the MHRA and the FDA for pattern hair loss treatment have been through rigorous testing of both their safety and efficacy.
Over-the-counter treatments don’t always contain gentle, organic or plant-based ingredients, and many are literally crammed with chemicals. As has been repeated by medical professionals many times before: always read the label and follow the instructions. If you notice any adverse symptoms, discontinue use immediately.
The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.