Kasey Reese
Kasey Reese

An Ugly Side to Cosmetics: Does the Government Have Your Back?

August 12, 2019

Written by Kasey Reese with the guidance of Michael Modl

Washington is irritated. The cause? Baby powder. In early July, the Department of Justice (DOJ) launched a criminal probe into Johnson & Johnson over potential links between use of talc products, such as baby powder, and cancer.[1] According to Dr. Anne McTiernan, testifying before the U.S. House Oversight Committee, forty years of “high-quality” studies have provided a statistically significant link between talcum powder and ovarian cancer in over 14,000 women.[2] The problem: talcum-based baby powder remains on store shelves and in in the homes of consumers.

The case of Johnson & Johnson is part of the broader concern of consumer safety in the United States, especially as it relates to cosmetics. In 2017, makeup products from the retailer Claire’s tested positive for asbestos fibers, which increase the risk for mesothelioma and other forms of cancer. A review of the federal regulation of cosmetic products shows that the industry is self-regulating. The fact that cosmetics are subject to very little oversight serves as a reminder that consumers must be the guardians of their own health.

What is a Cosmetic?

Federal law defines cosmetics as, “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”[4] This definition encompasses makeup powder, lipstick, nail polish, lotions, shampoos, deodorants, and some toothpastes, to name a few examples. In short, if one walks into a local health-good store and purchases an over-the-counter product to apply to the body, it is very likely classified as a cosmetic.

There is an exception to this definition. Traditional bar soaps composed of animal fats or oils are not cosmetics.[5] Most bar soaps found in stores today, however, are cosmetics because they consist of detergents and other chemical cleansers. Today, it is very rare to come across true “soap” as defined by federal law.

Finally, certain products exist in the gray area between cosmetics and drugs. For example, some over-the-counter lotions have medicinal purposes to treat symptoms like itchiness or rashes, and certain shampoo products treat dandruff. In these instances, the product is treated as both a cosmetic and a drug, and is subject to the regulations of both definitions.

Federal Regulation of Cosmetics – The Food Drug and Cosmetic Act

The Food, Drug, and Cosmetic Act (FDCA) of 1938 is the core legislation directing the regulation of cosmetic products in the United States. The FDCA gives the Food and Drug Administration (FDA) the primary responsibility to conduct oversight of cosmetic products. The statutory language relates to adulteration and the misbranding of products.

Adulteration

After post-market testing, the FDA can deem a product adulterated if the “container contains a poisonous or deleterious substance, which may cause injury when the product is used as directed through labeling or customary use” or if the product contains “filthy, putrid, or decomposed substance(s) or… has been prepared, packed, or held under unsanitary conditions.”[6] The FDA maintains a list of ingredients in the Code of Federal Regulations that are harmful to human health.[7] If a product contains any of the ingredients listed in the regulation, the product would be deemed as adulterated.  Most importantly, this regulation does not require companies to share their ingredient lists with the FDA.

Misbranding

A product is misbranded if the “labeling is false or misleading and if its container is made, filled, or formed to be misleading.”[8] Specific language and labeling requirements can be found in the Code of Federal Regulations.[9]  Generally, identifying the manufacturer, utilizing proper ingredient names, providing a quantitative measure of product contents, listing accurate warning or caution statements, and making non-medical claims are the major requirements of a properly labeled cosmetic product. Again, this regulation does not require companies to secure pre-market labeling approval from the FDA.

Regulatory Powers of the FDA

Generally, the FDA has reactive regulatory powers over cosmetic products. The agency has the ability to test products currently on the market and inspect manufacturing facilities.[10] This testing and inspection is typically informed by the adverse events database that the agency maintains. The adverse events database is a compilation of reports by consumers, healthcare providers, and companies concerning suspected products that may have caused varying degrees of medical events, including deaths. The reporting is voluntary and the data is often very limited.

If the FDA determines that a product may in fact be adulterated or misbranded, there are a limited number of actions the agency can pursue. The first is to issue a warning letter to the manufacturer of the product in question, asking them to cease production and remove the product from the shelves. If the product continues to be marketed, the definitive step is to engage the Department of Justice (DOJ) and the court systems. The legal process can be costly and time-consuming. Unless a court order is secured, the company can continue selling its product. Finally, the FDA can win in the court of public opinion by working with media outlets and issuing warning statements to inform the public about the dangers of a suspect product.

Regulatory experts have voiced concerns about the government’s cosmetic oversight powers, or lack thereof. First, there is no list of approved ingredients and quantities that are safe to use in cosmetics, with the exception of color additives. Color additives are products used in foods and drugs and are subject to their own regulation. According to Scott Faber, the Senior Vice President of a national environmental health organization, “each day American women use an average of 12 personal care products that contain 168 different chemicals. Men use an average of six personal care products that contain 85 different chemicals.”[11] Consumers are applying hundreds of chemicals to their bodies on a daily basis, and there is no entity, aside from the manufacturer, verifying the safety of those chemicals.

Even more, once people start getting sick from a tainted product, the FDA has no recall authority. No matter the evidence, testing, and statistical significance linking a specific product to a human ailment, the product remains available to consumers until the legal process is complete. The federal government cannot force an immediate recall of the product.

Again, the legislative authority of the FDA is derived from the FDCA of 1938. Cosmetics clearly stand apart from food and drugs. The FDA has the power to pre-approve food and drug ingredients, order mandatory food and drug recalls, and proactively protect consumers. Consumer protection relating to cosmetic regulation, on the other hand, is outdated and rightfully being discussed in Congress.

Conclusion

Overall, consumer safety ends with the consumer. Individuals should always conduct personal research before purchasing and using any cosmetic product, in order to best maintain their health. Although the majority of cosmetic products are harmless, society must be vigilant toward the few that are not. Unlike other industries, the federal government does not always have the back of consumers in relation to cosmetics. This may change with new legislation in the future. Until then, keep aware of current events, read product ingredients and reviews, and remember that there may be an ugliness lurking within your beauty product.

*** If you or a loved one may have been harmed by a cosmetic, drug, or medical device please contact Axley Attorneys at 1-800-257-5661 or mmodl@axley.com


[1] https://www.reuters.com/article/us-johnson-johnson-talc-probe/johnson-johnson-faces-criminal-probe-related-to-baby-powder-bloomberg-idUSKCN1U726J

[2] https://oversight.house.gov/sites/democrats.oversight.house.gov/files/McTiernan-Statement.pdf

[3] https://www.nytimes.com/2019/03/05/business/claires-cosmetics-asbestos-fda.html

[4] 21 U.S.C. § 321

[5] https://www.fda.gov/cosmetics/cosmetic-products/frequently-asked-questions-soap

[6] National Institute of Standards and Technology, U.S. Department of Commerce. (2017). “A Guide to United States Cosmetic Products Compliance Requirements.” Pg. 9

[7] 21 C.F.R. § 700

[8] National Institute of Standards, pg. 9-10

[9] 21 C.F.R. § 701

[10] https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated

[11] https://cdn3.ewg.org/sites/default/files/u352/FINAL%20Testimony-min.pdf

For more information about "An Ugly Side to Cosmetics: Does the Government Have Your Back?," contact Michael J. Modl at mmodl@axley.com or 608.283.6702.