What Does the FDA say about Baby Powder Ovarian Cancer?

Is Baby Powder Pharmaceutical or Cosmetic in Nature?

March 18, 2020 - Most people have heard about the Johnson & Johnson baby powder issues. Johnson & Johnson markets its traditional baby powder with talc, as well as Shower to Shower with talc; both of these powders can potentially cause ovarian cancer when used for feminine hygiene purposes. Additionally, questions have recently arisen over whether these talcum powders also contain asbestos fibers. Across the nation, there are currently more than 20,000 pending lawsuits against J & J from women who have developed ovarian cancer after using J & J’s baby powder with talc or Shower to Shower with talc for decades.

In the first few talcum powder ovarian cancer lawsuits, plaintiffs claimed—based on scientific data which backed up the claims—that talc fibers can travel through the reproductive system, finding their way to the ovaries, whether they result in inflammation, and eventually, ovarian cancer.  There have been a number of extremely large verdicts awarded to plaintiffs over the past several years by jurors who believed J & J was responsible for the ovarian cancer diagnoses. Although J & J has appealed all of the verdicts, with the majority being reversed on errors of law or venue (not on the scientific data), the presence of asbestos fibers in the talcum powders could open up new issues of safety.

What is the Stance of the FDA Regarding Talcum Powder? Many people are under the impression that the FDA regulates products like baby powder, however, in truth, the FDA has little regulatory power over cosmetics or hygiene products. The FDA definition of “cosmetics,” include any article intended to be “rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the body,” for the purpose of promoting attractiveness, or altering the appearance. Under this definition are moisturizers, perfumes, powders, makeup, shampoos, hair coloring, and deodorants.

The FD & C Act prohibits the marketing of adulterated or misbranded cosmetics as far as interstate commerce is concerned, however a cosmetic is only considered adulterated if it contains a poisonous substance. The FDA’s legal authority over cosmetics, however, is totally different from its legal authority over drugs, biologics and medical devices—none of these items require FDA premarket approval. In short, the burden for ensuring a cosmetic or hygiene product is safe falls to the manufacturer, which is extremely alarming. Some smaller manufacturers have started adding additional information to their labeling to help consumers feel a bit safer, but J & J has refused to do the same.

The FDA Breaks Its Silence on Baby Powder with Talc Because of Asbestos - The FDA has largely remained silent regarding the potential issues with talc, and whether talc fibers could be responsible for ovarian cancer. This silence was recently broken when 33,000 containers of J & J baby powder with talc were recalled, after the FDA found evidence of asbestos, a known carcinogen. The decision to pull the baby powder (sourced from China and distributed last year) is a black mark against J & J, making it difficult for J & J attorneys to continue to claim the baby powder with talc is safe.  Trace levels of chrysotile asbestos were found in samples from a container of baby powder bought from an online retailer.

The company was informed of the results, recalling bottles from lot numbers 22318RB out of “an abundance of caution,” according to a J & J spokesperson.  In real terms, when a container of J & J talcum powder tests at two percent chrysotile asbestos, this means there are approximately six million fibers of chrysotile in that one container. This hardly installs confidence for those who use the product, whether on their baby’s bottom or for feminine hygiene purposes.

Although J & J has acknowledged that asbestos was found in at least some powders, they maintain that perhaps the product was adulterated by someone else…or that maybe a mistake was made in the lab. What we know is that there are no safe levels of asbestos, and the fact that it has been found in J & J baby powder may open up an entirely new level of claims for damages against the company. 

Getting the Help You Need from an Experienced Talcum Powder Attorney - If you are one of the thousands of people injured after using J & J talcum powder, it is important that you speak to a knowledgeable talcum powder attorney. A well-qualified baby powder ovarian cancer attorney will evaluate the facts of your unique case, determining whether you have a valid claim against J & J. Such an attorney can also ensure all crucial deadlines are met, while answering any questions you may have regarding your claim.

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Author: Andrew Sullo
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