Should FDA Have Power to Recall Beauty Products?

By Julie Edgar
WebMD Health News

Reviewed by Brunilda Nazario, MD

Sept. 26, 2016 -- Krista Calderon first bought Wen hair products more than a year ago, believing that using something billed as "natural" would be better for her hair.

At first, she noticed that her eyebrows lost their shape and figured that the person who waxed them had messed up. Then she noticed that her leg hair was patchy. Five months into using two of Wen's cleansing conditioners, she called the company to ask why she seemed to be losing hair. She was told she wasn't using the products properly.

By December -- 8 months after she started using them -- she saw that the part in her hair was widening. Around the same time, Calderon read an article on her Facebook page about complaints against Wen and "put two and two together," she says.

The experience left her with crippling anxiety.

"I didn't want to go out from January 2016 until recently. I really became a recluse," says Calderon, 26, who lives in Southern California. She estimates that from April to December 2015, she spent $300 on the Wen products, which are often advertised in late-night infomercials and in online ads. The cleansing conditioners sell for about $25 and up. She's since thrown them out, slowly regaining her emotional footing along with her hair.

Calderon is among tens of thousands of Wen by Chaz Dean Cleansing Conditioner users who had a similar experience. The company, based in Santa Monica, CA, has received more than 21,000 complaints about the products. But spokesman Joe Hixson denies they are the cause of the hair loss, breakage, and scalp irritation described by users. The company has proposed paying $26.2 million to settle a class-action lawsuit against it. Hixon says the settlement is not an admission of guilt.

It would pay out about $25 apiece to most of the plaintiffs, he says. It would also require the company to include a caution on the label.

Wen continues selling the conditioner and its other products, highlighting what some say is a lack of federal oversight of the $62 billion cosmetics industry.

The FDA doesn't have the authority to recall the products on its own or to test a product for safety until someone complains. That's what it did in 2014, after receiving 127 complaints about Wen cleansing conditioners -- the highest it had ever received about a hair cleaning product. The FDA sent a warning letter to the company and investigated its manufacturing sites. It issued an alert in July about the cleansing conditioners while it continues looking into what, if anything, led to hair loss and breakage.

Should the FDA's investigation find that something in the Wen products caused the reaction, the most the agency can do is ask the company to voluntarily pull them from shelves.

Given a heightened awareness of the health risks that ordinary beauty products and cosmetics may pose, Congress has stepped in with proposals to boost the FDA's authority.

Lawmakers have introduced two bills pushing for more regulation of cosmetics: the Safe Cosmetics Modernization Act, introduced by Rep. Pete Sessions, R-TX, and the bipartisan Personal Care Products Safety Act, co-sponsored by Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME). The Senate Health, Education, Labor and Pensions Committee held a hearing on the Feinstein-Collins bill on Sept. 22; it won't be put to a vote until 2017.

Both bills would require companies to register with the FDA, submit product ingredient lists, notify the FDA of any reports of serious side effects, and authorize the FDA to prohibit the sale of products that have been found to cause serious health risks. The Feinstein-Collins bill would also require larger cosmetics manufacturers to pay a fee based on annual revenues.

Feinstein says that the Wen case highlights why the bill is needed.

"With increasing evidence that certain ingredients are linked to a range of health concerns, ranging from reproductive disorders to cancer, it's critical that we update the 80-year-old law designed to ensure personal care products are safe," Feinstein wrote in an email.

The Personal Care Products Council, a lobbyist for the industry that represents companies like Procter & Gamble and Johnson & Johnson, has announced its support of the proposal, along with the Environmental Working Group and a handful of medical associations.

"We believe that well-crafted, science-based reforms will enhance our industry's ability to innovate and further strengthen consumer confidence and trust in the products they use every day," John Hurson, executive vice president for government affairs for the council, wrote in a media statement.

The Feinstein-Collins bill also mandates that the FDA test at least five ingredients in the products for safety. Every year, they would have to test different ingredients. In the first year after it passes, they include formaldehyde; propyl paraben; diazolidinyl urea; lead acetate; and quaternium-15. They are preservatives and antimicrobials found in products ranging from shaving cream to moisturizers.

Ingredients like parabens are endocrine-disrupting and can affect reproduction and organ development, says Heather Patisaul, PhD, a biology professor at North Carolina State University. She is a spokeswoman for the 18,000-member Endocrine Society, which supports the Feinstein-Collins bill.

There is also evidence that some of the chemicals, like formaldehyde, may raise the chance of getting cancer.

Patisaul acknowledges that age, sensitivity, and length of exposure to an ingredient affect how a person might react. Millions of people use creams, balms, and hair products every day, and don't have health problems.

"When we're thinking of how chemicals are affecting people, we need to consider how they affect sensitive individuals," she says. "We're not trying to demonize all chemicals, but to find a small subset that is the most problematic."

Law professor and former FDA attorney Patricia Zettler says that in the decades since the Food, Drug and Cosmetic Act was enacted, we know far more about the things we put on and in our bodies.

"It makes sense to consider whether the regulatory system we have is what we want," she says. Cost, though, is an issue, as is a lack of consensus on the safety of the chemicals that help our moisturizers stay fresher and smell better longer.

"Part of the issue with cosmetics may be that we just don't have scientific certainty about ingredients, so one thing to consider is, do we want labels or better information and research about the impact of ingredients and cosmetics? What do we want out of policy?" Zettler says.

Calderon, the former Wen hair products user, supports more transparency among cosmetics manufacturers. Simply using a hair product turned her life upside-down, she says. She stopped volunteering at a local health center and dropped out of a college class that required her to speak in public.

"Everybody thought I was losing my mind," she says. "In a sense, I was. I feel like gradually losing your hair is a little worse than losing it in clumps."


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SOURCES: Krista Calderon.FDA. U.S. Occupational Safety and Health Administration: "OSHA Fact Sheet: Formaldehyde." U.S. Sen. Dianne Feinstein. Heather Patisaul, PhD, professor, biological sciences, Center for Human Health and the Environment. WM Keck Center for Behavioral Biology, North Carolina State University, Raleigh. Personal Care Products Council. Joe Hixson, spokesman for Guthy-Renker. Patricia Zettler, former FDA attorney and current law school professor, North Carolina State University.

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