Senate HELP Hearing Focuses On WEN, High-Profile Cosmetic Safety Issues

Senate Health, Education, Labor and Pensions Committee members used the hearing as an opportunity to gain insight into current safety-assurance practices in the cosmetics industry, with national news issues such as WEN and Brazilian Blowout providing the backdrop.

WEN, Brazilian Blowout and nail salon safety were top of mind at the Senate Health, Education, Labor and Pensions Committee’s Sept. 22 hearing exploring “current practices in cosmetic development and safety.”

The committee convened the hearing at the request of Sen. Dianne Feinstein, D-Calif., and Sen. Susan Collins, R-Maine, sponsors of the Personal Care Product Safety Act, which would overhaul FDA's oversight of the cosmetics industry.

The senators took the occasion to push for advancement of their proposal, though perhaps due to the hearing’s timing late in Congress’s session, their colleagues were in short supply.

Public attendance was heavy; the only empty seats in the room were at the committee table.

Committee Chair Lamar Alexander, R-Tenn., explained in his opening remarks that his intent for the hearing was to better understand "how the safety of [cosmetic] products is reviewed before they go on the market, and how individual ingredients are reviewed to ensure they are safe."

Ranking Member Sen. Patty Murray, D-Wash., further noted that the hearing's main focus was not going to be on the bill's details, but rather on "the principle that guided its development – that Americans need more assurance that the products they use every day are safe.”

“The current system is failing consumers,” Collins asserted, pointing to the plethora of consumer complaints that Guthy-Renker has received about WEN, which it was not required to report to FDA.

Discussion quickly hit on issues that have been prominent national news, including controversy surrounding WEN Cleansing Conditioners and mass reports of hair loss and other adverse events linked to the line, which was developed by celebrity stylist Chaz Dean and is manufactured and distributed by Guthy-Renker LLC (Also see "FDA Seeks Info From Injured WEN Users, Docs As Investigation Continues" - HBW Insight, 19 Jul, 2016.).

While FDA was not a witness at the hearing, Alexander said he sent a letter to the agency asking why it took so long for the public to be alerted to potential health issues associated with WEN products.

Murray also took issue with the agency's perceived lack of action in the face of widely reported adverse reactions. In her opening remarks, she called the results of FDA's investigation into the issue "shocking," holding it up as an example of the agency's limited authority when it comes to removing hazardous products from the market.

"As of this morning, even after the FDA safety alert and press coverage of hair-loss issues, the agency does not have the authority to remove the products from the market," Murray said.

FDA’s consumer alert on WEN came shortly after the Rose Sheet published details from a letter from the agency to Rep. Frank Pallone, D-N.J., obtained through a Freedom of Information Act request. The letter revealed that FDA was investigating the WEN situation and had performed multiple site inspections, turning up more than 21,000 complaints registered with Guthy-Renker and Chaz Dean Inc. (Also see "FDA Tests WEN Conditioner’s MI/MCI Content In Pursuit Of Hair-Loss Answers" - HBW Insight, 6 Jul, 2016.).

Despite this information, FDA says it has not been able to pinpoint a cause for the adverse events attributed to WEN use or determine that the products are non-compliant, which then could be grounds for requesting a voluntary recall.

The PCPSA would empower FDA to order recalls and would provide the agency with far more information about marketed cosmetic products through registration and adverse-event reporting requirements, so it wouldn’t have to go digging in the dark when issues arose.

Collins also raised the WEN issue in her testimony before the committee, noting the case of 9-year-old Eliana Lawrence, who lost all of her hair after using WEN Cleansing Conditioner. Lawrence was on hand at a recent press conference held by Reps. Frank Pallone, D-N.J., and Leonard Lance, R-N.J., where her mother made a plea for more stringent cosmetics oversight.

The New Jersey senators were releasing their own draft discussion bill for cosmetics regulatory reform (Also see "Pallone Proposes House Companion To PCPSA; Will 2017 Be The Year For Reform?" - HBW Insight, 14 Sep, 2016.).

Collins pointed out that under current law, Guthy-Renker is not required to report to FDA the plethora of consumer complaints it has received on WEN products, which she called "deeply troubling."

"That current system is failing consumers," she asserted.

Scott Faber, executive vice president for government affairs and the Environmental Working Group, also noted in his testimony that he spent time over the summer with Lawrence "weeks after she started using WEN, lost all her hair and even her eyelashes."

During the hearing’s question-and-answer portion, Faber underscored FDA’s limited authority to take action against unsafe products. If a product is found to be adulterated – which he characterized as a "high bar" to reach – the agency must go through the Department of Justice in order to take action, which is not the case for other FDA-regulated products, the exec said.

Senators Raise Salon Safety Concerns

Collins also noted concern about nail-salon workers and hair stylists "who may be exposed to potentially harmful ingredients in products they use every day."

A series of New York Times articles in 2015 drew mainstream attention to salon employment practices and safety issues, including exposure to potentially hazardous cosmetic chemicals (Also see "N.Y. City Salon Crusade Includes Investigation Into Nail-Care Chemicals" - HBW Insight, 21 May, 2015.).

Feinstein similarly expressed unease about the working conditions for those employed in nail and hair salons.

"It was formaldehyde that brought me to this issue and watching Brazilian Blowouts being administered in cramped quarters in beauty salons," she said. "Manicurists who apply [gel nail polishes] are at increased risk. They work long hours and they breathe fumes all day. In some salons, there can be very poor ventilation."

Sen. Al Franken, D-Minn., said he was "somewhat unnerved" by the Times investigation exposing health problems experienced by workers, including high rates of cancer, miscarriages and children born with developmental delays.

Discussion led to questions aimed at Wilma Bergfeld, chair of the CIR Expert Panel and senior dermatologist and emeritus director of dermatopathology at the Cleveland Clinic, about CIR’s processes and the scope of its safety assessment work.

The Personal Care Products Council’s Chief Scientist Beth Jonas and Jack Black LLC founder and CEO Curran Dandurand, representing small businesses, also spoke to current safety standards and practices in the sector.

Despite the at times sobering subject matter, the hearing closed on a comedic note, which surprisingly did not come from former Saturday Night Live writer and cast member Franken.

Sen. Bill Cassidy, R-La., quipped, "I have to admit, I had to look up what Brazilian Blowout was on my phone. I'm a gastroenterologist and I had different images in my head."

[Look for more coverage from the Senate HELP hearing coming soon from the Rose Sheet.]