Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: The LawSci Forum is pleased to announce a new series on current issues in FDA law. This post is #1 in the series, with more in the coming weeks.]

We have all been tempted by late-night television infomercials and their promises. If the product works, our lives become more convenient; if it doesn’t, we’re only out a few dollars and the product will gather dust. For thousands across America, one product that promised a hair-care revolution left them scratching, itching, and balding.

The Food & Drug Administration (FDA) is investigating over 20,000 incidents of adverse events resulting from WEN by Chaz Dean. Los Angeles-based stylist Chaz Dean is the face of the WEN brand, endorsed by Brooke Shields, Alyssa Milano, and other celebrities. Sold on QVC, infomercials, and elsewhere, WEN is unlike most shampoos. It is marketed as a “revolutionary way to cleanse and hydrate the hair” without water.

There’s another way that WEN is unlike most shampoos: using WEN all too often results in large clumps of hair falling off one’s head. The FDA has received complaints of baldness in addition to hair loss, itching, and rashes after consumers tried WEN products. In July 2016, the FDA issued a Safety Alert to warn the public about potential results of using this hair care product. In that warning, the FDA noted that this was the largest number of reports ever received for a hair cleansing product.

Unsurprisingly, litigation has ensued. One California case has resulted in a preliminary class action settlement of over $26 million. Filed in the Central District of California, the suit alleges that the plaintiffs, and their similarly-situated class members, suffered hair loss and scalp irritation, among other injuries. One class representative allegedly lost one-third of her hair after she used WEN’s Sweet Almond Milk kit. In addition, plaintiffs claimed that the WEN was falsely advertised as safe and failed to warn users of potential harm.

Under the terms of the preliminary settlement, notice will be given to 6 million class members, defined as any American purchaser of WEN hair care products between November 2007 and August 1, 2016. A warning will be added to the product’s packaging telling users to seek immediate medical attention for adverse reactions. While many claimants in the class can submit claims for a $25 payment, those with more extensive damages can submit claims for additional recovery. For example, those that have lost more than 50% of their hair with minimal “hair regrowth” could recover as much as $20,000.

But, wait there’s more! The nature of the allegations against WEN have led many consumers, lawmakers, and even the New York Times to ask whether the FDA should have the authority to recall dangerous cosmetics from the market. Currently, the FDA is not authorized to order recalls of cosmetic products. Instead, such recalls are voluntary efforts by manufacturers or distributors.

A cursory inspection of the FDA’s name reveals that “cosmetics” is nowhere to be found in the title of the Food & Drug Administration. While the FDA notes that cosmetic companies and marketers “have the legal responsibility to ensure the safety of their products,” the WEN case provides an opportunity to reflect on the FDA’s regulatory authority over cosmetic products.  For example, the FDA may order warning statements on cosmetics that present health hazards and work with manufacturers on voluntary recalls. Time will tell whether WEN prompts further action to regulate cosmetic products.

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: The LawSci Forum is pleased to announce a new series on current issues in FDA law. This post is #1 in the series, with more in the coming weeks.]

We have all been tempted by late-night television infomercials and their promises. If the product works, our lives become more convenient; if it doesn’t, we’re only out a few dollars and the product will gather dust. For thousands across America, one product that promised a hair-care revolution left them scratching, itching, and balding.

The Food & Drug Administration (FDA) is investigating over 20,000 incidents of adverse events resulting from WEN by Chaz Dean. Los Angeles-based stylist Chaz Dean is the face of the WEN brand, endorsed by Brooke Shields, Alyssa Milano, and other celebrities. Sold on QVC, infomercials, and elsewhere, WEN is unlike most shampoos. It is marketed as a “revolutionary way to cleanse and hydrate the hair” without water.

There’s another way that WEN is unlike most shampoos: using WEN all too often results in large clumps of hair falling off one’s head. The FDA has received complaints of baldness in addition to hair loss, itching, and rashes after consumers tried WEN products. In July 2016, the FDA issued a Safety Alert to warn the public about potential results of using this hair care product. In that warning, the FDA noted that this was the largest number of reports ever received for a hair cleansing product.

Unsurprisingly, litigation has ensued. One California case has resulted in a preliminary class action settlement of over $26 million. Filed in the Central District of California, the suit alleges that the plaintiffs, and their similarly-situated class members, suffered hair loss and scalp irritation, among other injuries. One class representative allegedly lost one-third of her hair after she used WEN’s Sweet Almond Milk kit. In addition, plaintiffs claimed that the WEN was falsely advertised as safe and failed to warn users of potential harm.

Under the terms of the preliminary settlement, notice will be given to 6 million class members, defined as any American purchaser of WEN hair care products between November 2007 and August 1, 2016. A warning will be added to the product’s packaging telling users to seek immediate medical attention for adverse reactions. While many claimants in the class can submit claims for a $25 payment, those with more extensive damages can submit claims for additional recovery. For example, those that have lost more than 50% of their hair with minimal “hair regrowth” could recover as much as $20,000.

But, wait there’s more! The nature of the allegations against WEN have led many consumers, lawmakers, and even the New York Times to ask whether the FDA should have the authority to recall dangerous cosmetics from the market. Currently, the FDA is not authorized to order recalls of cosmetic products. Instead, such recalls are voluntary efforts by manufacturers or distributors.

A cursory inspection of the FDA’s name reveals that “cosmetics” is nowhere to be found in the title of the Food & Drug Administration. While the FDA notes that cosmetic companies and marketers “have the legal responsibility to ensure the safety of their products,” the WEN case provides an opportunity to reflect on the FDA’s regulatory authority over cosmetic products.  For example, the FDA may order warning statements on cosmetics that present health hazards and work with manufacturers on voluntary recalls. Time will tell whether WEN prompts further action to regulate cosmetic products.