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FDA Says Limited Authority Restricts Safety Oversight of Cosmetics

The personal-care products industry supports cosmetics regulatory reform at the FDA.

WASHINGTON — The U.S. Food and Drug Administration acknowledged in a letter to Sen. Dianne Feinstein (D., Calif.) that its outdated regulatory authority over cosmetics has largely hampered it from restricting potentially harmful ingredients going on the market and responding to consumer complaints of adverse reactions.

Feinstein released the letter Thursday that she received from the FDA in response to questions she submitted about the agency’s authority over personal-care products. The FDA’s response laid bare the shortcomings and effectiveness of its ability to regulate the industry, which has introduced thousands of new products into the market over the past several years.

“Under current law, FDA has much less legal authority to protect consumers from unsafe cosmetics than it does for other products the agency regulates,” said Dayle Cristinzio, the FDA’s acting associate commissioner for legislation. “Even though Congress has updated FDA’s enforcement authorities over other products, it has not done so for cosmetics. As a result, FDA’s oversight of cosmetics is limited.”

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The FDA’s regulatory authority over cosmetics is contained in a two-page section of the Federal Food, Drug and Cosmetic Act of 1938, and all stakeholders involved, including the personal-care products industry, argue it needs to be expanded and updated.

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Legislation aimed at overhauling the FDA’s authority over cosmetics is pending in Congress. Feinstein is a cosponsor of comprehensive FDA cosmetics regulatory reform legislation in the Senate.

The FDA is investigating one case in particular that underscores the agency’s limited authority and the need for regulatory reform. The agency initiated an investigation into Wen hair-care products in July after it received 127 complaints from consumers.

During the course of the investigation, the FDA found that Chaz Dean Inc. and Guthy-Renker LLC, the companies that market and manufacture the products, had received 21,000 complaints from consumers about a cleansing conditioner that has allegedly caused significant hair loss, visible bald spots and other adverse side effects.

The current statute does not require companies to share their safety information with the FDA, nor does the law require mandatory reporting of “adverse events.”

“The absence of a requirement to submit adverse event reports has significantly delayed our efforts to ascertain and respond to the complaints because we did not learn of them in a timely way,” Cristinzio said in the letter.

The FDA does not have the ability to recall products that pose a serious health risk. It can only ask manufacturers to voluntarily recall unsafe products.

Feinstein also asked the agency how a systematic review process of ingredients for safety and authority to limit or restrict harmful ingredients — something she has proposed in her own legislation — would change FDA’s authority.

Cristinzio said it would allow the FDA to restrict harmful ingredients “under a more consumer protective safety standard.” Under the current statute, cosmetics products and other ingredients, with the exception of color additives, do not need FDA approval to go on the market and manufacturers are not required to submit safety information to the agency, he said.

“FDA’s authority is limited to taking post-market actions against cosmetics that are shown to be adulterated [for example, if it contains a poisonous ingredient that makes the product harmful when used according to directions on the label or in the customary way] or misbranded [for example, if its labeling is false or misleading],” he noted.

The agency currently relies largely on the Cosmetic Ingredient Review expert panel, an independent, industry-funded panel of medical and scientific experts that meets quarterly to assess the safety of cosmetic ingredients. FDA can also inspect manufacturing facilities, but it does not have the authority to inspect records on cosmetics, as it does on all other product categories, he said.

Under Feinstein’s bill, Cristinzio said the FDA could restrict the use of an ingredient before it is put on the market if it determined there was insufficient information to “show a reasonable certainty” of no harm.

“The burden would be on the marketers of the ingredient to show that it was safe rather than on FDA to show that it was unsafe,” he added.

Cristinzio also conceded that the agency does not know the concentration of ingredients in personal-care products because there is no legal requirement for that and it does not have the authority to require companies to submit their safety studies.

The Obama administration “recognizes the need to strengthen FDA’s regulatory program for cosmetics,” he said, noting that the president has asked for expanded authority in the past few budget proposals he has submitted to Congress.

“The FDA’s letter makes crystal clear the need to pass the ‘Personal-Care Products Safety Act’ to better protect public health and ensure the safety of the products every American uses every day,” Feinstein said. “The FDA also debunks the notion that an industry-funded review of ingredients is sufficient to evaluate their safety and determine the appropriate amounts that should be used in personal-care products. Independent review of ingredients by FDA, which is the central provision of our bill, is critical.”