Mesh News Desk, July 20, 2016 ~ The U.S. Food and Drug Administration says it has received 127 adverse event reports about the WEN Hair products.
Promoted on television by celebrity stylist, Chaz Dean, the FDA says his office has received 21,000 complaints. Complaints include reports of balding, rashes and hair breakage. See the FDA notice here.
WEN offers a natural, botanical, herbal cleaning solution without the use of harsh sulfates found in most shampoos that make the suds. The WEN website says
Is WEN® safe?
A complaint does not mean it is an actual injury but could represent an individual looking to join a “class action” and perhaps receive some money. Considering that the ads featuring actress Alyssa Milano were very popular and distributed by online marketer Gunthy Renker, it’s likely many people have seen and even purchased the products. There have been 40 million bottles sold if you believe Mr. Dean
The Dallas law firm of Christiansen Davis LLC has filed a product liability lawsuit in Los Angeles.
Interesting with 100,000 pelvic mesh complaints, there was never a posting on the FDA’s website with how to complain to the FDA. So we are borrowing the Wen Hair complaint file and posting it here.
In the case of a reaction or problem with a cosmetic product, the first step is to stop using the product and contact your healthcare provider. FDA does not provide medical advice. Then, report the problem to FDA.
Tell FDA If You Experience:
- A reaction after using a cosmetic, such as a rash, redness, burn, hair loss, headache, infection, illness or any other unexpected reaction, whether or not it required medical treatment.
- A problem with a cosmetic product, such as a bad smell, color change, other sign of contamination, or foreign material in the product.
Types of Products that are Considered Cosmetics
Cosmetics products are not the same as drug products, and they are regulated differently by FDA. Here are some examples of cosmetic products:
- Tattoos and permanent makeup
- Face and body cleansers, moisturizers and other skin lotions and creams
- Deodorants and makeup
- Baby lotions and oils
- Hair care products, dyes, conditioners, straighteners/relaxers, perms
- Hair removal creams
- Nail polishes
- Shaving products
- Perfumes and colognes
- Face paints and temporary tattoos
How to Report a Problem with Cosmetics
If you are a consumer, health professional, or member of the cosmetics industry who wants to voluntarily report a complaint or adverse event (illness or serious allergic reaction) related to a cosmetic, you have three choices:
- Call a FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
The law does not require cosmetic companies to report problems to FDA. Therefore, your report is very important in order to help keep the cosmetics market safe. When you contact FDA, you are asked to include the following information in your report, if known:
- About the Person Affected
- Name and contact information (address, phone, and e-mail address)
- Age, gender, and ethnicity
- About the Product
- Name of the product and the manufacturer
- Product codes or identifying marks on the label or container [Note: do not discard the product packaging and labeling. They provide information that will help FDA investigate the problem]
- When and where the product was purchased
- About the Problem
- Description of the reaction or problem
- Description of medical treatment provided, if any
What FDA Will Do with Your Report
Once a report is received:
- FDA will keep your report confidential.
- FDA will add the report to our database so that we can see if other people are reporting the same problem.
- FDA will use the information to determine if the product or similar products have a history of problems and represent a public health concern that needs to be addressed.
FDA may not take action on every report received, but the Agency does check all reports to determine if action is necessary to protect the public health.