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Makeup Made Safe: How the FDA Protects Consumers from Dangerous Cosmetic Products

Makeup Made Safe: How the FDA Protects Consumers from Dangerous Cosmetic Products

Our team of Milwaukee product liability attorneys of Casey Law Offices, S.C. recently wrote about a cover-up scandal carried out by Johnson & Johnson (J&J) executives related to the company’s talc baby powder products. It turns out company leadership knew for decades that there were occasional traces of asbestos in the talc but denied knowledge of it. (You can view that story by clicking here and visiting our blog entry.) Since we published that article, we have received inquiries about talc’s use in other products, particularly cosmetics and whether or not makeup is safe. What is the answer?

No FDA Oversight for Most Makeup

Cosmetic products and ingredients — with the exception of color additives — do not have to undergo Food and Drug Administration (FDA) review or approval before they go on the market. Cosmetic companies have a legal responsibility to accurately label the ingredients in their products, but they are not required by law to share their safety information with the FDA.

The FDA does monitor for safety issues with cosmetic problems on the market and has been known to take action when needed to protect the health of the public. It is worth noting that the FDA has never flagged any cosmetic products because of asbestos-laced talc. To its credit, though, the FDA conducted its own research on possible presence of asbestos in cosmetic-grade raw material talc, as well as some cosmetic products containing talc.

Yearlong Study for Asbestos in Raw Cosmetic Talc

The FDA contracted with AMA Analytical Services, Inc. of Lanham, MD to conduct its 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 2009-2010.

According to the FDA’s findings:

“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 FDA survey found no asbestos fibers or structures in any of the samples. However, the FDA admitted the results were limited by the fact that only four talc suppliers submitted samples and by the number of products tested. Due to these reasons, the FDA agreed that the study did not prove that most or all talc or talc-containing cosmetic products currently marketed in the U.S. are likely to be free of asbestos contamination.

A statement from the FDA read, “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.”

We applaud the FDA’s willingness to conduct its own research. We are also encouraged by some of the other steps the FDA takes to protect consumers across the country.

Hair Coloring Just Got Safer

Under the law, coal-tar hair dyes do not need FDA approval, unlike color additives in general. But hair dyes from plant or mineral sources do. Lead acetate is sometimes used as a color additive in progressive hair dye products, which are applied over a period of time to achieve a gradual coloring effect.

In 1980, lead acetate was permanently listed as a color additive for the safe use in cosmetics for hair coloring. However, in 2017, a color additive petition was submitted, requesting that the FDA repeal the regulation that provides for the use of lead acetate in hair dyes. After reviewing the newer available data, FDA concluded that the datasets no longer support the safe use of lead acetate as a color additive in progressive hair dyes. On October 30th, 2018, the FDA published the final rule to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp.

Import Alerts & Recalls

The FDA also issues Import Alerts advising import inspectors to be on the lookout for shipments of dangerous makeup that contains harmful amounts of lead in them. In some cultures, eye cosmetics contain kohl, kajal, al-kahal, surma, tiro, tozali, or kwalli, all of which contain unacceptable levels of lead. It is entirely feasible for cosmetic products made outside of the United States to be brought to trading ports with lead and other contaminants in them.

The FDA also will recall products that are unsafe due to a host of reasons. When a product is recalled by the FDA, manufacturers will need to take immediate action to stop the product from reaching more shelves, as well as notifying consumers of the recall and what can be done in response. In many cases, manufacturers offer a return of the product’s cost.

A few recent cosmetic product recalls are:

  • Hain Celestial Group, Inc.’s Avalon Organics Refreshing Lemon Bath & Shower Gel and Avalon Organics Nourishing Lavender Bath & Shower bottles were recalled due to elevated levels of microbiological counts.
  • Bath and Body Works’ Pure Simplicity Body Acai Berry 8 fluid oz. and Pure Simplicity Body Fragrance Free 8 fluid oz. products were recalled due to potential contamination with Enterobacter aerogenes and/or Enterobacter gergoviae.

(Additional recent recalls can be found at https://www.fda.gov/Cosmetics/ComplianceEnforcement/RecallsAlerts/default.htm.)

Milwaukee Product Liability Attorneys On Your Side

We at Casey Law Offices are always looking for ways to help the people of our communities stay safe and sound. We will continue to keep an eye open for product safety recalls and share important information for you to review in our blog. Be sure to visit frequently for updates.

If you or a loved one have been injured by a defective or dangerous product, please do not hesitate to reach out to our law firm. Our Milwaukee personal injury attorneys have more than 25 years of trial-tested, legal experience tackling high-stakes cases for clients in a variety of cases. With us in your corner, you can rest easy knowing your case is in good hands.

Call (414) 272-3776 today or send our law firm an email to put a FREE case review on your calendar.

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