FDA Product Investigation: WEN

The FDA has released a statement about their investigation into WEN By Chaz Dean Cleansing Conditioners.  The FTC has received 127 reports from consumers in regards to the products.  It is the “largest number of report ever associated with any cosmetic hair cleansing product including cleansing conditioners.”  They are also investigating more than “21,000 complaints” they “learned of during inspections” of facilities.  They have not yet determined a cause for the adverse reactions. They are asking the company, consumers, and physicians for data to help them figure out the cause.

In the Information for Consumers statement the reports since 2011 mention:

• The Cleansing Conditioners
• Some mention using other WEN Products in addition to the cleansing conditioners
• 66% (5,689) of all hair loss complaints named the Sweet Almond Mint variety
• 2,537 complaints mentioned the Lavender variety
• 1,542 mentioned the Pomegranate variety

If you, or someone you know, has used their products and suffered an adverse effect please report it to the FDA.

Statement of FDA Investigation

 http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm511626.htm

The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products. 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. The agency also urges consumers to report to FDA any reactions they may have experienced when using these products.

As of July 7, 2016, the FDA had received 127 adverse event reports directly from consumers about WEN by Chaz Dean Cleansing Conditioner products, the largest number of reports ever associated with any cosmetic hair cleansing product, including cleansing conditioners. We also are investigating more than 21,000 complaints reported directly to Chaz Dean, Inc. and Guthy Renker, LLC that we learned of during inspections of manufacturing and distribution facilities.

The FDA has not yet determined a possible cause for the adverse events that have been reported, and today has called on the company to “provide any data that might help us to better understand the reports of hair loss associated with the use of WEN by Chaz Dean Cleansing Conditioner products.” The FDA also has reached out to physicians and other health care providers asking them to notify their patients of hair loss and other complaints associated with the use of these products and to report adverse events to the agency.

The FDA will provide additional updates as new information becomes available.

Additional Information

• Dear Physician Letter

• FDA Information for Consumers About WEN by Chaz Dean Cleansing Conditioners

• FDA Authority Over Cosmetics

• How to Report A Cosmetics-Related Problem

FDA Information for Consumers About WEN by Chaz Dean Cleansing Conditioners

 http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm511631.htm

The FDA is informing consumers about reports of reactions associated with WEN by Chaz Dean Cleansing Conditioners. The following information describes what the FDA knows about these products, what we’ve done, what we can do, and what consumers can do if they have a reaction.

What kinds of reactions have people reported to the FDA?

People have primarily reported hair loss, hair breakage, balding, itching, and rash.

How many reports has the FDA received?

Up to July 7, 2016, the FDA has received 127 reports from consumers. When the FDA inspected the manufacturing and distribution facilities for these products, we learned that consumers had reported reactions in more than 21,000 complaints submitted to Chaz Dean, Inc. and Guthy Renker LLC, the companies that market and manufacture the products. The law does not require cosmetic companies to share their safety information, including consumer complaints, with the FDA, nor does the law require mandatory reporting of adverse events to the FDA.

Have these reports named specific varieties?

The reports all mention use of WEN by Chaz Dean Cleansing Conditioners, although some also mention using them along with other WEN products.

The product line includes several varieties of cleansing conditioners. Guthy Renker stated that since 2011, at least 66 percent of all reports specifically about hair loss have named the Sweet Almond Mint variety. The following varieties were named most often in reported reactions:

• Sweet Almond Mint- 5,689 complaints
• Lavender- 2,537 complaints
• Pomegranate – 1,542 complaints

Does the FDA know what caused the reactions?

No. We don’t have enough information to determine the cause of these reactions. As stated above, the law does not require cosmetic companies to share their safety data or consumer complaints with the FDA. The complaints that have come directly to the FDA have not provided enough information to determine why some consumers experienced reactions when they used these products.

What is the FDA doing about these reports?

On January 17, 2014, the FDA sent separate letters to owners and officials at Chaz Dean and Guthy Renker LLC. In the letter, the FDA asked for the following information:

• Data on reports of hair loss and breakage
• Manufacturing locations
• What the firm had done to find out what caused hair loss and other reported problems
• Quality control procedures for evaluating product ingredients
• Any formulation changes that may relate to the reports.

The companies responded in writing on February 18, 2014. The responses they provided did not address the association between WEN by Chaz Dean Cleansing Conditioners and hair loss.

Since receiving the companies’ responses, we have conducted inspections of the manufacturing and distribution sites of WEN by Chaz Dean Cleansing Conditioners, and have had further discussions with the companies about safety data for their products, as well as what steps they have taken to address the complaints they have received. The FDA is in communication with the companies as part of an ongoing investigation.

What should consumers do if they have a reaction?

While the FDA continues this investigation, we are asking physicians and other health care providers to advise their patients about these reports and to contact the FDA if they have patients who have experienced such problems.  Additionally we encourage consumers to be cautious if using WEN by Chaz Dean Cleansing Conditioner products, especially if they notice problems such as hair loss, balding, itching, rash or other reactions.  If you have a reaction, stop using the product and contact your health care provider. Then, please tell the FDA about the incident.

You can report a reaction online or by phone:

• Contact the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088.
• Contact your nearest FDA district office consumer complaint coordinator.

When you report your problem to the FDA, please provide as much detail as possible about the specific product you used and your reaction. The more we learn about WEN products and the reported problems, the better we can determine the cause and if the FDA can take action under the laws we enforce.

What kind of action can the FDA take?

The FDA can take action against cosmetics on the market that don’t comply with the law, including cosmetics that are adulterated or misbranded. In some cases we can work with the Department of Justice to seize a product, in order to keep it off the market. While we can’t order a recall of a cosmetic, we can request one and work with companies to make sure their recalls are effective.

However, even with what we know so far about this product, including the adverse events, we are unable to determine that the product does not comply with the law. To learn more, see FDA Authority Over Cosmetics.

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