Talcum Powder- Baby Powder lawyers discuss FDA and Talcum Powder Warnings
Could The FDA issued a warning regarding Talcum Powder and the link to ovarian cancer?
The Maharashtra state Food and Drug Administration has collected Johnson’s and Johnson’s baby powder samples for lab testing. This action was taken after taking a cue from the death of a 62-year-old woman in America, which is believed to be due to sustained use of Johnson & Johnson’s baby powder. She passed away due to ovarian cancer.
The Maharashtra Food and Drug Administration (FDA) has given J & J a notice following a U.S. court’s verdict that awarded $72 million to a 62-year-old woman’s family after she died of cancer due to prolonged use of the company’s talcum powder.
The The Maharashtra Food and Drug Administration- FDA has collected samples of Shower to Shower, Dermicool, Ponds and Nycil talcum powder brands besides J&J from across Maharashtra and sent them to the laboratory to check if they follow the rules laid down under the Drug and Cosmetic Act.
The FDA In The United States
What Is The FDA’s authority over cosmetic safety
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. Cosmetic companies have a legal responsibility for the safety and labeling of their products and ingredients, but the law does not require them to share their safety information with FDA.
FDA monitors for potential safety problems with cosmetic products on the market and takes action when needed to protect public health. Before we can take such action against a cosmetic, we need sound scientific data to show that it is harmful under its intended use.
Talc: What it is and how it is used in cosmetics
Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg3Si4O10(OH)2.
Talc has many uses in cosmetics and other personal care products; in food, such as rice and chewing gum; and in the manufacture of tablets. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product.
Asbestos: What it is, why it’s a concern, and how to prevent its occurrence in cosmetics
Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen. For this reason, FDA considers it unacceptable for cosmetic talc to be contaminated with asbestos.
However the FDA has not issued any warnings regarding talc or talcum powder and despite the research showing that there may be a link between talcum powder and ovarian cancer, the Food and Drug Administration is taking no action.
There has been studies going back to the 1960s that suggest a possible link between the use of powders containing talc and the incidence of ovarian cancer. Questions about the potential contamination of talc with asbestos have been raised since the 1970s.
To prevent contamination of talc with asbestos, it is essential to select talc mining sites carefully and take steps to purify the ore sufficiently.
How FDA followed up on the latest reports
Because safety questions about the possible presence of asbestos in talc are raised periodically, FDA decided to conduct an exploratory survey of currently marketed cosmetic-grade raw material talc, as well as some cosmetic products containing talc.
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. We contracted with AMA Analytical Services, Inc. (AMA) of Lanham, MD to conduct this laboratory survey, based on demonstrated experience with asbestos analysis in complex matrices, appropriate facilities, equipment, personnel, analytical strategy, and budget criteria. The study ran from September 28, 2009 to September 27, 2010.
How the survey was conducted
The first step was to identify cosmetic talc suppliers and talc-containing cosmetic products. We found seven talc suppliers identified in the 2008 edition of the International Cosmetic Ingredient Dictionary and Handbook and two more by searching online. The contract laboratory contacted each supplier to request samples of its talc. Of the nine suppliers identified, four complied with the request.
We found talc-containing cosmetic products to analyze by visiting various retail outlets in the Washington, D.C. metropolitan area. The samples identified for testing included low, medium, and high priced products, along with some from “niche” markets, in order to cover as broad a product range as possible. A total of thirty-four cosmetic products containing talc were selected, including eye shadow, blush, foundation, face powder, and body powder. All cosmetic products were purchased from retail stores in the Washington, D.C. metropolitan area.
The contract laboratory analyzed the samples using polarized light microscopy (PLM) and transmission electron microscopy (TEM) methods published by the New York State Department of Health, Environmental Laboratory Approval Program. Each sample was analyzed three times using both methods.
The results of FDA’s survey and what they mean
The survey found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc. The results were limited, however, by the fact that only four talc suppliers submitted samples and by the number of products tested. For these reasons, 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. “As always, when potential public health concerns are raised, we will continue to monitor for new information and take appropriate actions to protect the public health.”