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How Increased FDA Involvement Could Impact the Cosmetics Industry

The U.S. Food and Drug Administration (FDA) has largely avoided strict regulation over the cosmetics industry for more than a century. Now, over rising health concerns over the safety and manufacturing practices of some cosmetics, the FDA is increasing its involvement in the industry.

Cosmetics are popular in the United States. More than 40 percent of Americans between the ages of 30- and 59-years wear makeup on a daily basis, according to Statistica. About a quarter of all Americans wear makeup several times each week. Statistica says that the U.S. is the “most valuable beauty and personal care market in the world,” generating approximately $84 billion in 2016.

Unfortunately, cosmetics can cause adverse reactions in some consumers. A recent study found that complaints to the FDA regarding adverse reactions to cosmetic products doubled from 2015 to 2016. The FDA initiated an investigation of WEN by Chaz Dean Cleansing Conditioners after receiving 127 complaints directly from consumers; the FDA later discovered that 21,000 consumers had already sent complaints of scalp irritation and hair loss to the manufacturer.

FDA Involvement the Cosmetics Industry

Laws do not require cosmetic products and ingredients, aside from color additives, to gain FDA approval prior to hitting the market – the FDA’s authority is post-market only. Current law also does not require cosmetic companies to share consumer complaints or other safety information with the FDA.

The FDA investigates breakouts and issues recalls and alerts.

Certain laws and regulations also apply to cosmetics sold through interstate commerce. The FDA enforces laws enacted by Congress, and it issues regulations as authorized by Congress. Two laws pertaining to cosmetics sold in the United States Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These acts give the FDA the authority to regulate cosmetics.

The FD&C Act prohibits the misbranding or adulteration of cosmetics. The Fair Packaging and Labeling Act allows the FDA and the Federal Trade Commission (FTC) to issue regulations regarding packaging to ensure that labels disclose the net contents and provide other essential information about the cosmetic product.

The FDA also issues guidance documents that reflect the administration’s current perspective on a topic. Unlike the laws and regulations the FDA enforces, the guidance documents do not create or confer rights to any entity, nor do they bind the FDA or the public. Cosmetic manufacturers can use an alternate approach as desired, as long as the approach complies with applicable regulations.

The FDA can take a number of actions. The administration can perform inspections, import entry review and field examinations, issues import alerts and warning letters, seize cosmetics, and issue injunctions to ensure the safety of cosmetics distributed in the United States.

The FDA is Increasing its Involvement

The FDA has recently vowed to step up its oversight of the cosmetics industry, and is urging Congress to do the same, after reporting their findings of asbestos in children’s makeup. The FDA says it will work more closely with cosmetics manufacturers, request information about the procedures they use to ensure product safety, and to look more closely at the ingredients of cosmetics products. The FDA is also calling for cosmetic firms to register their products with the FDA voluntarily and list ingredients on their labels.

The steps by the FDA to increase involvement could have significant economic effects for the cosmetic industry. As a leader in Consumer Product Testing, Eurofins keeps our customers up to date on the latest regulations to ensure compliance. We can test and evaluate an unparalleled range of cosmetics, toiletries and raw materials for their efficacy, safety, and regulatory compliance. To learn more about our services, contact us today. Downloadable PDF.

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