WASHINGTON – When the barber Los Angeles Chaz Dean threw his almonds and mint lavender scented hair care products – backed by celebrities such as Brooke Shields and Alyssa Milano – he sold millions. But his formula got an unexpected result. Itching, rashes, including hair loss in large groups, both adults and children
More than 21,000 complaints have been filed against your Wen hair care, and Mr. Dean, the, golden hair stylist to the stars blue eyes, found himself at the center of an intense debate over the power of government to ensure the safety of a cosmetic sector with about $ 50 billion in annual sales.
The national distributor based in Santa Monica, line haircare Dean is part of a care trade association of beauty that has been aggressively lobbying Congress to block the passage of the new strict legislation that would give the Food and Drug Administration the authority to test the ingredients used in cosmetics and issuance of mandatory withdrawals for products that are found to be unsafe.
The struggle has pitted independent smaller players against industry giants beauty products, adhere to the proposed rules, seeing them as a way to recovery of public trust, and have the size and muscle to meet them.
Each side has its champions in Congress: Senators Dianne Feinstein, Democrat of California, and Susan Collins, Republican of Maine, for larger companies, and Representative Pete Sessions, Republican of Texas, come to support of his home state company, Mary Kay, that manufacturers and distributors of independent cosmetics joined to fight the Feinstein-Collins legislation. Sessions has introduced legislation backed competing and largely written by Mary Kay and independent companies.
“Whether you are in business and is not involved in politics, then politics is your business run,” said a presentation prepared by Mary Kay last summer for sales representatives and obtained by The New York Times.
The fighting comes amid growing concern among consumers about the safety of products for beauty care and follows a series of other alerts, including the discovery of hair products and creams for skin that contain hazardous ingredients such as formaldehyde and mercury .
“People do not realize actually no regulation of cosmetics,” said Frank Pallone Jr. representative, Democrat of New Jersey. He, along with Ms. Feinstein and Ms. Collins has pushed to strengthen a 1938 law that was passed to regulate the pharmaceutical industry, but contained two pages that deal with cosmetics, leaving essentially unregulated.
Joe Hixson, Guthy-Renker spokesman, Wen distributor, said the company has “evidence and studies that show that we Wen is safe and does not cause hair loss.”
Mr. product for hair care do not really Dean foam. Instead, Mr. Dean promotes itself as “a revolutionary way to clean up” the hair without the use of detergents or traditional sulfates, chemicals, some consumers have objected to.
“Besides sounding like ‘Zen’, the system is a completely reverse way of looking at hair cleansing,” the product website enjoys. “Therefore, ‘Wen’ is” new “spelled backwards.” The company also sells what it calls “soft unique formulations for pediatric use.”
Miriam Lawrence Denver Wen said he used sweet almond mint conditioner cleaner hair of her daughter, Eliana, then 9, about three times the end of 2014. A few days later, the brush her daughter was full of hair. Three weeks later , Eliana was bald.
“It changed our lives in just a couple of shampoos. It’s ridiculous,” said Mrs. Lawrence, whose daughter has grown back most of his hair and eyebrows. “It was as very soft, no harsh chemicals.”
Mr. Pallone, in a letter to the F.D.A. Guthy-Renker and has pressed for answers about the Wen case. And in an interview he cited as an example of why the current law is failing and more stringent regulation is needed.
For legal reasons, the government’s hands are tied.
This is partly because unlike pharmaceutical companies, cosmetics companies are not required to notify the government of reports on adverse reactions. “” – Even if someone dies
The F.D.A. has instead had to rely on consumers stepping forward, and from July 7 , only 127 reports were submitted to the agency detailing the problems with the line Wen hair care. But the inspectors sent to the premises of the company date back to 2011 learned that complaints to the company and the total distributor of more than 21,000, the agency said last month.
“You know how the stars was said to be so good, it made your hair more manageable, shinier?” Said Bonnie Iqbal, 55, of Albany, who was last year of those who sued the company after her hair began to fall. “So I thought, you know, I’d try it.”
Patricia J. Zettler, a health law and policy expert at Georgia State University and former F.D.A. lawyer, he said that in the current legislation, the agency could take action against the company only if they could prove a product had been mislabeled or contaminated. If the product proves to be dangerous but legal, the government has no recourse.
“The bottom line is, if the company has not violated the law, there’s really nothing F.D.A. can do,” said Ms. Zettler.
Even in the absence of federal action, Guthy-Renker, in a “business decision” according to late June to a legal agreement $ 26,250,000 – has not yet been approved by a federal judge – that would pay up to $ 25 for each person who has bought a bottle since the products were introduced Wen and as much as $ 20,000 to people who allege hair loss or other injury. However, the product is still being sold, and the F.D.A., other than the issue of a notice saying they are looking for in the field, has taken no action.
The bill Feinstein-Collins aims to eliminate these dead spots. It would, for the first time, requires cosmetics manufacturers reported “serious adverse reactions” to their products to the F.D.A. as they arrive and create an annual report of all “adverse events”. Also it gives the agency the authority to order companies to recall products found to be dangerous.
The bill would collect about $ 20 million in fees from companies beauty care to help cover the cost of confirming the safety of five ingredients each year who are suspected of cause problems, such as lead acetate, a color additive in hair dyes, and quaternium-15, a certain preservative used in cosmetics and shampoo.
The legislation has won the backing of heavyweights including Estee Lauder, whose brands include Clinique, Origins, MAC, La Mer, and Bobbi Brown; Johnson & Johnson, Neutrogena and Aveeno manufacturer; and Procter & Gamble, whose brands include Pantene, Head & Shoulders, Herbal Essences and Olay. Industry officials said they decided to embrace the legislation after becoming increasingly concerned that a decline in consumer confidence could hurt its sales.
“The bill Feinstein-Collins is supported by a broad and diverse group of individuals and groups who all want the same thing group – cosmetics regulations that best serve public health and to give consumers confidence in the products and ingredients they choose for their families, “Darrel Jodrey, a group federal higher pressure in Johnson and Johnson, said in a statement
Major, consumer and health non-national profit environmental, such as the American Cancer Society, the environmental Working Group and Good Housekeeping Institute, have also supported the plan.
But even before Ms. Feinstein formally introduced its legislation in April 2015, manufacturers and distributors of independent cosmetics, which Guthy-Renker has been a member pay dues for more than a decade, was transferred to defeat him, internal documents obtained by the Times show.
During a strategy session March 2015, at the offices of the New York law a commercial counsel association, Locke Lord, industry executives briefed his team pressure, which he explained already had approached the office of Representative Fred Upton of Michigan, chairman of the Committee on Energy and Commerce, with jurisdiction over the FDA
Michael Lunceford, vice president of Mary Kay supervision lobbying and public relations divisions the company had done preliminary work through the Direct Selling Association, where he is on the board, to help efforts reappointment of Mr. Upton 2012. the organization bought billboards, radio and press “to win the candidates’ attention in order to cultivate an advocate of direct selling industry “, according to an industry newsletter.
Guthy-Renker hired its own help of well-connected Washington: William R. Nordwind, a lawyer and lobbyist who spent a dozen years as a member of staff and campaign aide to Mr. Upton. Mr. Hixson, Guthy-Renker spokesman said the company had not publicly taken a position on the bill Feinstein-Collins, although with the financial support of the association of independent cosmetic industry. Mr. Nordwind team, from the lobby firm Venable, has contacted the Congress on behalf of the company, said Mr. Hixson.
“They have a bad history there now,” Rober Härmälä, former adviser to the House, which calls for manufacturers and distributors of independent cosmetics, said of Guthy-Renker and line Wen products. “They do not want to be the face of the industry for having done this.”
Mary Kay claims credit for persuading Sessions, whose area of Dallas, the district is near its headquarters, to sponsor alternative legislation. Mr. Sessions’s proposal would still require care companies notify the beauty of the F.D.A. “serious adverse events cosmetics,” but would not give the agency the power to order the withdrawal or collect fees from industry to pay for new programs, such as safety assessment of cosmetic ingredients. Most important for direct marketers like Guthy-Renker, Mary Kay and other members of the group of independent, comprehensive and cosmetics would be retroactive pre-empt tougher state laws.
“We can not be out there saying ‘no, we do not like Feinstein’s law,'” he said in an interview Härmälä.
Mr. Sessions, after the introduction of legislation, became a favorite of the cosmetics industry, financial campaign records show, emerging as the largest recipient in Congress of employee donations Mary Kay, and taking donations of at least 10 other industry executives, including Pam Busiek, the president of the independent manufacturers and distributors of cosmetics. Executives Guthy-Renker were not among the donors.
More industry donations were sent to representatives of Eddie Bernice Johnson, D-Texas, and Bill Flores, R-Texas, the only two other House lawmakers to help sponsor the bill.
W. Crayton Webb, Mary Kay spokesman, said the company is committed to help pass a law that increased federal oversight of the industry, but opposed the bill Ms. Feinstein . because. “falls short of providing a clear and uniform national safety level”
Ms. Busiek added: “We want something that is not acute fatigue.” Mr. Dean declined to comment.
The F.D.A. He declined to comment on the proposals. So far, the agency said, it found no evidence of contamination or false labeling of products Wen, the only two product defects that can be used to put pressure on a company to agree to a voluntary recall. The agency has asked the results of safety tests and other manufacturing data, but can not force the company to give any information.
For consumers who deal with thinning hair, itchy scalp and other problems, the additional responsibility to take their case to the government can be a difficult task – and certainly a confusing one. The government should be helping them, they say.
“It would be very good for the FDA to step a little more,” said Melanie Guitzkow, a student of 20 years old, who said her hair began to fall when Wen is used In secondary school. “Some things, like, should not be in the market because they are harmful.”