As plaintiffs have racked up billions of dollars in judgments against pharmaceutical giant Johnson & Johnson, and federal prosecutors have issued subpoenas to the company, one question has lingered over allegations that it lied about the presence of asbestos in its baby powder: How could such an iconic American product stay on the shelves for decades as consumers rubbed their body with a notorious carcinogen?
The answer lies, at least in part, in an obscure “self-regulatory” body that has anointed itself the authority on cosmetic product safety despite being entirely funded by the industry’s leading trade association and overseen by its top executives.
That body is known as the Cosmetic Ingredients Review (CIR). It’s organized under the auspices of the nation’s leading cosmetics trade association—a group that is comprised of household-name companies such as Procter & Gamble, Unilever, and Johnson & Johnson itself, which lobbies on behalf of the industry, and has poached staff from the very agency overseeing it.
The CIR has no formal regulatory role. But in the absence of federal oversight, it is often the main entity to offer assessments on the safety of cosmetic industry products. Its verdicts can determine whether a product stays or remains on the shelf, or whether those products include warning labels informing consumers about potential health hazards. And new documents show that at least one official with the group used his government connections to scuttle efforts to impose new safety regulations on the industry.
That sort of revolving door between government and industry is common in Washington. But the degree to which the cosmetics industry has been allowed to regulate the safety of its own products, and allegations that those products have caused ovarian cancer, has shocked even jaded consumer-rights advocates.
“The Johnson & Johnson asbestos scandal is a classic case of a major company using its financial clout and networks to quash scientific studies that raise serious health concerns and to intimidate both private researchers and government officials into playing along,” said Craig Holman, a spokesman for the consumer watchdog group Public Citizen.
“The asbestos-talc health concerns are self-regulated by the cosmetic industry,” Holman added, but “at any point government officials could have stepped into the fray.”
A the heart of the controversy is the presence of asbestos in talc, a key ingredient in Johnson & Johnson’s iconic baby-powder products. The company is facing multiple state and federal lawsuits over its products’ alleged cancer links. Last month, the Justice Department subpoenaed Johnson & Johnson for internal records pertaining to the safety of its talc-based products. And just this week, a California court levied a $29 million judgment against the company.
Those were just the latest developments in a long-running legal and public-relations battle for Johnson & Johnson. In the course of that battle, internal records have emerged that show the company and its talc suppliers were aware as early as the 1970s that its products might contain traces of asbestos.
Johnson & Johnson has called reporting on those internal documents an “absurd conspiracy theory,” and it continues to deny that its products have contained carcinogens. “Decades of participation with the U.S. Food and Drug Administration (FDA) and other global regulators has continually proven the product to be asbestos-free,” the company says on its website.
Much of the scientific support for that position has come by way of the CIR.
CIR was devised in the 1970s as a scientific safety organization, after Congress unsuccessfully moved to impose stringent regulations on cosmetics companies, including mandatory pre-market testing. The organization operates under the auspices of the Personal Care Products Council (PCPC), which is the industry’s leading trade group and represents about 600 cosmetics companies, or roughly 90 percent of the industry.
CIR’s job, in essence, is to act as a consumer-safety watchdog, a role that federal regulators have largely eschewed. And it’s embraced that mission, boasting that it “remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum.”
It’s a scientific body staffed by experts in various medical research fields. But its work is entirely underwritten by the industry it studies. The body that directs CIR’s work, its steering committee, is comprised of a number of scientific professionals. But it also includes PCPC’s chief executive, its vice president for science, and another trade association executive tasked with CIR oversight.
In the absence of government regulation, CIR acts as the de facto authority on the safety of mass-market cosmetics products, routinely testing its own member companies’ products and billing their findings as official scientific determinants of their safety. Of the more than 5,000 chemical ingredients that it’s reviewed, the CIR has deemed just 11 of them “unsafe.”
Talc is among the ingredients the group deems “safe,” and hence does not warrant any sort of proactive consumer warning. A 2013 CIR study found that the material could not possibly cause ovarian cancer, as it could not “migrate” through a woman’s genital tract. Even if it did contain asbestos. In other words, it couldn’t be the specific cause. That study undergirds PCPC’s position that safety concerns regarding Johnson & Johnson products are largely unfounded.
The Food and Drug Administration, the agency tasked with overseeing the cosmetics industry, has acknowledged that the potential for such migration is “indisputable.” But the agency has largely punted on more affirmative questions of talc safety—frequently citing a lack of resources. That has left CIR as virtually the only public authority on the matter.
CIR has consistently said that it is not necessary to include warning labels advising consumers of its potential links to ovarian cancer. And it’s actively fought efforts to press the FDA to impose such requirements, consistently maintaining in official responses to potential regulatory actions that it has not found a scientific basis for claims that its member companies’ products pose significant cancer risks.
Such a designation would be disastrous for Johnson & Johnson in particular. Though its baby powder products comprise a relatively small portion of the company’s revenue, they are integral to its family-oriented brand. The California court judgment last week dealt a significant blow to the company’s stock prices.
The CIR’s parent organization declined to comment on that work, or its role in assessing the safety of Johnson & Johnson’s talc products, citing ongoing litigation.
The CIR bills itself as a scientific body, not an advocacy group, and in court depositions it has acknowledged that it would be problematic if CIR were perceived as an arm of the industry it’s charged with dispassionately studying.
But its ties to the industry are numerous. CIR is housed in the same downtown Washington D.C. office as the PCPC, and derives its funding from the group’s member companies.
Those companies generally focus on and finance scientific work in which they have a clear and immediate commercial interest. Lead PCPC scientist Linda Loretz has testified, for instance, that Johnson & Johnson and its chief talc supplier provide “roughly” 65 to 70 percent of the funding for PCPC’s Talc Interested Party Task Force, an internal, ad hoc body separate from the CIR that focuses on scientific, legal, and regulatory issues surrounding the ingredient.
That task force has devoted considerable resources to preventing federal regulators from imposing labeling requirements on talc-based products manufactured by Johnson & Johnson and other PCPC members. Momentum for such a measure picked up in the late 1980s and early 1990s, and resulted in a number of official requests, known as citizens petitions, encouraging the FDA to impose warning labels on talc-based products noting their potential carcinogenic ingredients.
One such petition was filed in late 1994 by the Cancer Prevention Coalition (CPC), a public-health group. In July 1995, the FDA responded. John Bailey, then the head of the agency’s cosmetics division, told the CPC that it was unable to move on that request “because of the limited availability of resources and other agency priorities.”
Internal documents released in the course of lawsuits against Johnson & Johnson indicate that cosmetics industry already viewed Bailey as a key ally in government. When the National Toxicology Program, a division of the National Institutes of Health, met in 2001 to discuss the issue of asbestos in talc, executives at Luzenac—a major talc producer subsequently acquired by Imerys—discussed ways to make sure Bailey was in the room.
“We are going to attempt to get [Bailey] to be present at the NTP Executive Committee during the talc discussion,” wrote Luzenac’s director of environment and safety, according to a copy of the email released during court proceedings last year. “We need someone at the Executive Committee meeting to ‘carry-our-water,’” and Bailey “can be considered a fair-minded ally.”
That email was sent in February 2001. Less than a year later, Bailey left his post at FDA and signed on as the director of chemistry at the PCPC. In 2006, he was appointed its chief scientist, a role that gave him a slot on the CIR steering committee.
“We hired him because of his—I mean, obviously the fact that he had FDA background was—was considered a good thing,” Loretz testified last year as part of a lawsuit against Johnson & Johnson, according to a transcript of her deposition. ”The general fact was he had a wonderful background with FDA and cosmetics, that made him a valuable employee to the Council.”
In his capacity as a member of the CIR steering committee and the PCPC’s lead scientist, Bailey worked on the exact same issues he had at FDA. But this time he was doing so on behalf of the regulated industries rather than than the agency tasked with regulating them.
When another citizens petition was filed in 2008 requesting the FDA impose a talc-labeling requirement, Bailey spearheaded the campaign to beat back that effort. He used his connections at FDA to secure a meeting between PCPC staff and top agency brass, including his successor at the cosmetics division and the FDA’s acting administrator, where the citizens petition was discussed. The FDA never acted on the petition.
The same lack of resources has hamstrung FDA efforts to proactively study the potential health hazards of talc. Around the time that the PCPC was battling the labeling citizens petition, the FDA undertook such a study. But it didn’t have the internal resources to do the examination itself. “Because FDA’s cosmetic laboratories do not have the equipment needed to perform the analyses, we searched for a qualified outside laboratory to do the work,” the agency explained.
That outside laboratory “found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc”—a finding heralded by the industry to this day to underscore the safety of its products.
But the FDA qualified those findings. “Only four talc suppliers submitted samples,” the agency noted. So “while FDA finds these results informative, they do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination.”
Just this month, the FDA announced findings of a new talc study. “Independent tests” of cosmetic powder products sold by the retailers Claire’s and Justice confirmed the presence of asbestos in three samples.
But even in light of that finding, there’s not much that the FDA can do to warn consumers of potential harm from talc. So the agency was reduced to pleading with industry to voluntarily disclose that information.
“Although the law doesn’t require cosmetic products to be registered with the FDA,” the agency wrote, “we’re also calling upon cosmetic firms to take responsible steps to voluntarily register their products and list ingredients, including talc, used in their products.”