In a 1988 hearing, Congress took the cosmetics industry to task for a rash of health and safety problems. Cosmetologists were reporting serious respiratory and nervous system damage. At least one woman had been permanently disfigured by flammable hair spray. And according to government data, nearly 1,000 toxic chemicals were lurking in countless other personal care products. Cosmetics companies were not doing enough to ensure that these products were safe, and the Food and Drug Administration did not have enough power to adequately police them.
When Edward Kavanaugh, president of the industry’s leading trade group, disputed those claims, Ron Wyden, then an Oregon congressman, stood firm. The industry’s safety apparatus was “a piecemeal patchwork system in dire need of repair,” Mr. Wyden said. Legislative reform was clearly needed.
That was 30 years ago. To date, no such reforms have been passed.
The American cosmetics industry is a $70 billion-a-year behemoth. The Food and Drug Administration’s Office of Cosmetics and Colors has an annual budget of just $8 million and 27 staff members. The laws governing the office’s authority run just two pages long and have not been updated since 1938, when they were first enacted. Such meager tools leave federal officials nearly powerless to regulate the makeup, lotions, toothpastes, deodorants and other elixirs that often are applied to the most intimate parts of the human body.
Industry leaders are right to note that, on the whole, cosmetic products have a good safety record. But in recent years, a fresh round of health and safety risks have left people wary.
Independent researchers have found asbestos in glittery products marketed to young girls; they’ve linked chemicals in nail polish to serious health problems in nail technicians; and they’ve traced reproductive health issues and mercury poisoning to hair and skin products used by many women of color. At the same time, some 200 people reached a settlement in a class-action lawsuit against Wen Hair Care, whose products they say burned their scalps and gave them alopecia; and nearly 12,000 people have sued Johnson & Johnson claiming that asbestos in the company’s baby powder gave them ovarian cancer. (Wen has said it believes that its products are safe; Johnson & Johnson has said its baby powder is safe and has never contained asbestos.)
Owing to a lack of resources or authority, the F.D.A.’s response to these issues has been incomplete.
House and Senate members have introduced several bills in recent years that would give cosmetics regulations a much needed face-lift and could allay a rising tide of consumer anxiety. But so far none of these bills has seen a vote.
While lawmakers dither, the F.D.A.’s oversight of the cosmetics industry remains astoundingly limited. The agency cannot require companies to submit safety data before they market a product, to adhere to basic manufacturing standards once they do or even to register with the agency, things drug and medical device makers are mandated to do. Companies don’t have to report problems — or “adverse events” — that consumers relay to them. And if regulators do hear of incidents, they cannot demand to be allowed to inspect a company’s records; they can only check a facility for visible flaws, like mold.
The F.D.A. also can’t ensure the safety of imported cosmetics, which have doubled in volume in the past decade. The agency inspects less than 1 percent of the three million or so cosmetics shipments that come in every year. Among those that it does test, roughly 15 percent are found to be contaminated or to contain dangerous ingredients.
The only panel tasked with determining the safety of individual cosmetic ingredients, the Cosmetic Ingredient Review, is funded and staffed by the Personal Care Products Council, a trade group that spends roughly $2 million a year on the panel — or about as much as it spends lobbying Congress. Industry leaders say that investment is proof of their commitment to safety. But, as the Environmental Working Group and other advocacy organizations have pointed out, it also creates a substantial conflict of interest.
That’s particularly alarming given that some of the panel’s conclusions have been at odds with those of impartial government entities like the National Toxicology Program. Of more than 5,000 chemicals that the panel has evaluated since its inception in 1976, only 11 have been found unsafe for use. The panel made those determinations not by testing chemicals or cosmetics directly, but by reviewing available data, which for many ingredients is paltry at best.
“We have learned a lot about these chemicals in recent decades,” says an F.D.A. regulator who is not authorized to speak to the press. “But we still don’t have a clear understanding of if or how well they might be absorbed through the skin or mucous membrane. That means women and children slather this stuff on every day without knowing what the real impact might be.” The Cosmetic Ingredient Review does not evaluate the risks of aggregate or cumulative exposure to an ingredient, from multiple products over many years, or the ways in which different ingredients might interact with one another. Its recommendations are not binding, and its member companies don’t have to say whether they follow them.
Industry trade groups have spent years quashing efforts to close these gaps in regulatory oversight. As court records show and several news outlets have reported, the Personal Care Products Council (then called the Cosmetic, Toiletry, and Fragrance Association) waged a decades-long war with regulators and consumer safety advocates over asbestos-laced talcum powder. As far back as the 1960s, the organization insisted that such powder was safe, even as its own members’ scientists warned that it might not be.
The group resisted calls to add warning labels to talc-based products and pressured government agencies to refrain from listing the ingredient as a carcinogen. It also attacked safety advocates, calling them “chemical terrorists,” while giving pricey vacations to lawmakers who had the power to act on those advocates’ concerns.
More recently, the industry has been split. Larger companies, including Johnson & Johnson, the leading talcum powder manufacturer, now say that they welcome stronger oversight, for the regulatory certainty and consumer confidence that it would bring. But smaller companies still argue that more regulations would crush them.
The cosmetics industry and the F.D.A. have also been divided. In 2014, when negotiations between the two sides collapsed, each side blamed the other. Amid their bickering, the status quo has remained — few regulations, growing consumer anxiety and no one with any power to fix the situation.
Consumer fear of chemicals is so great these days that scientists have a name for it — chemophobia. It leads people to avoid everything from genetically modified foods to essential medicines, often in search of “natural” alternatives. Such fears are frequently overblown or misplaced, but they underscore a real problem: Most of the products on store shelves are probably safe, but many may not be; how is anyone supposed to know the difference?
When it comes to cosmetics, it is nearly impossible to determine which products to worry about. But as incidents stack up and consumer confidence wanes, individual states are stepping in with their own rules.
Such patchwork fixes can only lead to more confusion. Passage of a strong federal bill is the only way to reverse those trends. A good one would enable the F.D.A. to commission independent reviews of cosmetic ingredients and recall tainted products, and would require cosmetics companies to register with the agency and report adverse events. Such measures are not too much to ask of an industry whose products are used by virtually everyone every day.
Taxpayers also will have to shoulder some new costs — for such efforts to succeed, Congress will need to grant the F.D.A.’s Office of Cosmetics and Colors a sizable budget increase.
Cosmetics companies want unfettered access to a multibillion-dollar market. Consumers want to know that the products they’re putting on their bodies are safe. Both sides can win — but only if Congress acts.
Tony Cenicola
The New York Times
**
Do You Know What’s in Your Cosmetics?
Thousands of chemicals, in billions of dollars worth of products, are being governed by regulations that haven’t been updated in decades.
by The Editorial Board, The New York Times
https://www.nytimes.com/2019/02/09/opinion/cosmetics-safety-makeup.html
In a 1988 hearing, Congress took the cosmetics industry to task for a rash of health and safety problems. Cosmetologists were reporting serious respiratory and nervous system damage. At least one woman had been permanently disfigured by flammable hair spray. And according to government data, nearly 1,000 toxic chemicals were lurking in countless other personal care products. Cosmetics companies were not doing enough to ensure that these products were safe, and the Food and Drug Administration did not have enough power to adequately police them.
When Edward Kavanaugh, president of the industry’s leading trade group, disputed those claims, Ron Wyden, then an Oregon congressman, stood firm. The industry’s safety apparatus was “a piecemeal patchwork system in dire need of repair,” Mr. Wyden said. Legislative reform was clearly needed.
That was 30 years ago. To date, no such reforms have been passed.
The American cosmetics industry is a $70 billion-a-year behemoth. The Food and Drug Administration’s Office of Cosmetics and Colors has an annual budget of just $8 million and 27 staff members. The laws governing the office’s authority run just two pages long and have not been updated since 1938, when they were first enacted. Such meager tools leave federal officials nearly powerless to regulate the makeup, lotions, toothpastes, deodorants and other elixirs that often are applied to the most intimate parts of the human body.
Industry leaders are right to note that, on the whole, cosmetic products have a good safety record. But in recent years, a fresh round of health and safety risks have left people wary.
Independent researchers have found asbestos in glittery products marketed to young girls; they’ve linked chemicals in nail polish to serious health problems in nail technicians; and they’ve traced reproductive health issues and mercury poisoning to hair and skin products used by many women of color. At the same time, some 200 people reached a settlement in a class-action lawsuit against Wen Hair Care, whose products they say burned their scalps and gave them alopecia; and nearly 12,000 people have sued Johnson & Johnson claiming that asbestos in the company’s baby powder gave them ovarian cancer. (Wen has said it believes that its products are safe; Johnson & Johnson has said its baby powder is safe and has never contained asbestos.)
Owing to a lack of resources or authority, the F.D.A.’s response to these issues has been incomplete.
House and Senate members have introduced several bills in recent years that would give cosmetics regulations a much needed face-lift and could allay a rising tide of consumer anxiety. But so far none of these bills has seen a vote.
While lawmakers dither, the F.D.A.’s oversight of the cosmetics industry remains astoundingly limited. The agency cannot require companies to submit safety data before they market a product, to adhere to basic manufacturing standards once they do or even to register with the agency, things drug and medical device makers are mandated to do. Companies don’t have to report problems — or “adverse events” — that consumers relay to them. And if regulators do hear of incidents, they cannot demand to be allowed to inspect a company’s records; they can only check a facility for visible flaws, like mold.
The F.D.A. also can’t ensure the safety of imported cosmetics, which have doubled in volume in the past decade. The agency inspects less than 1 percent of the three million or so cosmetics shipments that come in every year. Among those that it does test, roughly 15 percent are found to be contaminated or to contain dangerous ingredients.
The only panel tasked with determining the safety of individual cosmetic ingredients, the Cosmetic Ingredient Review, is funded and staffed by the Personal Care Products Council, a trade group that spends roughly $2 million a year on the panel — or about as much as it spends lobbying Congress. Industry leaders say that investment is proof of their commitment to safety. But, as the Environmental Working Group and other advocacy organizations have pointed out, it also creates a substantial conflict of interest.
That’s particularly alarming given that some of the panel’s conclusions have been at odds with those of impartial government entities like the National Toxicology Program. Of more than 5,000 chemicals that the panel has evaluated since its inception in 1976, only 11 have been found unsafe for use. The panel made those determinations not by testing chemicals or cosmetics directly, but by reviewing available data, which for many ingredients is paltry at best.
“We have learned a lot about these chemicals in recent decades,” says an F.D.A. regulator who is not authorized to speak to the press. “But we still don’t have a clear understanding of if or how well they might be absorbed through the skin or mucous membrane. That means women and children slather this stuff on every day without knowing what the real impact might be.” The Cosmetic Ingredient Review does not evaluate the risks of aggregate or cumulative exposure to an ingredient, from multiple products over many years, or the ways in which different ingredients might interact with one another. Its recommendations are not binding, and its member companies don’t have to say whether they follow them.
Industry trade groups have spent years quashing efforts to close these gaps in regulatory oversight. As court records show and several news outlets have reported, the Personal Care Products Council (then called the Cosmetic, Toiletry, and Fragrance Association) waged a decades-long war with regulators and consumer safety advocates over asbestos-laced talcum powder. As far back as the 1960s, the organization insisted that such powder was safe, even as its own members’ scientists warned that it might not be.
The group resisted calls to add warning labels to talc-based products and pressured government agencies to refrain from listing the ingredient as a carcinogen. It also attacked safety advocates, calling them “chemical terrorists,” while giving pricey vacations to lawmakers who had the power to act on those advocates’ concerns.
More recently, the industry has been split. Larger companies, including Johnson & Johnson, the leading talcum powder manufacturer, now say that they welcome stronger oversight, for the regulatory certainty and consumer confidence that it would bring. But smaller companies still argue that more regulations would crush them.
The cosmetics industry and the F.D.A. have also been divided. In 2014, when negotiations between the two sides collapsed, each side blamed the other. Amid their bickering, the status quo has remained — few regulations, growing consumer anxiety and no one with any power to fix the situation.
Consumer fear of chemicals is so great these days that scientists have a name for it — chemophobia. It leads people to avoid everything from genetically modified foods to essential medicines, often in search of “natural” alternatives. Such fears are frequently overblown or misplaced, but they underscore a real problem: Most of the products on store shelves are probably safe, but many may not be; how is anyone supposed to know the difference?
When it comes to cosmetics, it is nearly impossible to determine which products to worry about. But as incidents stack up and consumer confidence wanes, individual states are stepping in with their own rules.
Such patchwork fixes can only lead to more confusion. Passage of a strong federal bill is the only way to reverse those trends. A good one would enable the F.D.A. to commission independent reviews of cosmetic ingredients and recall tainted products, and would require cosmetics companies to register with the agency and report adverse events. Such measures are not too much to ask of an industry whose products are used by virtually everyone every day.
Taxpayers also will have to shoulder some new costs — for such efforts to succeed, Congress will need to grant the F.D.A.’s Office of Cosmetics and Colors a sizable budget increase.
Cosmetics companies want unfettered access to a multibillion-dollar market. Consumers want to know that the products they’re putting on their bodies are safe. Both sides can win — but only if Congress acts.