Perineal Use of Talc Powder is Considered Cosmetic?

The U.S. Food and Drug Administration classifies talc as a cosmetic. Cosmetics are regulated less stringently by the FDA.

North Little Rock, AR, June 14, 2016 -- Deane Berg, Jacqueline Fox, and Gloria Ristesund have become martyrs in the fight against Johnson & Johnson's talcum powder. Berg and Ristesund are survivors of ovarian cancer, and the cases they filed against the company have led juries in South Dakota and Missouri to conclude that Johnson & Johnson was negligent in refusing to provide warning of talc's hidden dangers. Fox, who passed away in 2015, showed the jury that Johnson & Johnson also engaged in advertising campaigns specifically designed to manipulate minorities. In the wake of those decisions, the million dollar question, taken up by thousands of women all over the world has been, “How could they do this to us?”

According to Eileen Kroll, an attorney for talc's ovarian cancer victims, the answer is simple and horrifying. Because the U.S. Food and Drug Administration (FDA) classifies talc as a cosmetic, she says that, “it's truly a corporate decision of what to do with this product.” The corporate decision has been exactly what one would expect. Just as cigarette companies in the mid-twentieth century fought studies implicating cigarettes as carcinogens, Johnson & Johnson has also fought the more than twenty unfavorable studies conducted since 1982 which indicate that frequent, extended perineal talc use can increase the risk of ovarian cancer by as much as 33%.

Selective science has been Johnson & Johnson's modus operandi for more than two decades. Its latest proponent is the Cosmetic Ingredient Review (CIR) Expert Panel, which concluded in 2015 that “talc is safe in the present practices of use and concentration described in this safety assessment.” The study, which Johnson & Johnson claims was conducted independently, provides the company with ground to stand upon as it prepares for the next round of litigation. Johnson & Johnson is able to maintain the illusion of reasonable doubt in the face of mounting evidence for one very important reason�"the archaic conditions stipulated by the Federal Food, Drug, and Cosmetic Act.

Passed by Congress in 1938, the Act gave cosmetic manufacturers wide latitude to regulate themselves as they saw fit. Cosmetics are not to be “unadulterated” or “misbranded,” but the FDA has very little authority to ensure consumer safety. It does not have the ability to test and approve products before they are introduced to the market, manufacturers are not required to list their ingredients, and companies are under no obligation to report “adverse events” to the federal government when cosmetic use goes awry. The FDA is careful to note on its website that there is a difference between products which are regulated by the FDA and products which are approved by the agency. Almost eighty years after the Act, the FDA's power to regulate is still limited to ensuring that products are “safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled.” That limitation renders the government especially impotent when the questionable product does not manifest its more insidious side effects until years and years of regular use results in unforeseeably deadly consequences.

In recent years there have been signs of progress, but there have also been reminders of how well-equipped companies like Johnson & Johnson are to combat the specter of heightened government regulation. Congresswoman Jan Schakowski introduced the Safe Cosmetics Act of 2010, but it died on the House floor. In the summer of 2013, the FDA and cosmetic manufacturers agreed to a tentative outline of regulative legislation, but the talks crumpled acrimoniously. The FDA accused the industry representatives of having a change of heart and said that its cavalier behavior would “put Americans at greater risk from cosmetics-related illness and injury than they are today.” Johnson & Johnson, through its lobbying vehicle the Talc Interested Party Task Force, delayed government intervention for more than twenty years by producing company-friendly studies and generating confusion about its prized product.

The talc verdicts represent much more than Johnson & Johnson's marketing and distribution habits. They represent an entire cosmetic industry hiding behind a seventy-eight year old law and a hobbled and handcuffed federal agency to the detriment of an unsuspecting public.

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