PCPC Sounds Off on US FDA's Sunscreen Proposals


The Personal Care Products Council (PCPC) and Consumer Healthcare Products Association (CHPA) have submitted comments to the U.S. Food and Drug Administration's (FDA) proposed updates to its sunscreen requirements in a recent Tentative Final Monograph (TFM).

In a joint statement, the two organizations agree with the FDA that sunscreen use plays a "critical role in protecting the public health and must be encouraged," but note that some of the FDA's comments may "be causing undue worry and confusing consumers about the exact purpose of the FDA's actions... [which] may result in unintended negative health effects by deterring consumers from using sunscreens."

The PCPC and CHPA took exception to several points in the TFM, including:

  • The proposed reclassification of 12 sunscreen active ingredients as Category III—including oxybenzone, avobenzone and octinoxate;
  • "Failure to leverage existing safety data";
  • "Lack of consideration of newer toxicological methods for certain endpoints";
  • "Underestimated test costs and economic impacts to industry" due to proposed changes to sunscreen manufacturing frameworks; and
  • Potential for consumers to not utilize sunscreens due to the perception that they are unsafe, and other unintended consequences.

An emailed statement on the TFM from the PCPC reads:

"Our organizations and our members urge FDA to take more direct action to make clear to consumers that the agency still considers sunscreens to be safe, still recommends that the public uses sunscreen regularly, and is not proposing to remove sunscreens containing the active ingredients that FDA has proposed to re-classify as Category III from the market. We do not think that the agency’s proposal to re-classify the twelve active ingredients as Category III is the most appropriate approach under the existing legal framework.

"... Over the next several months as FDA works through the rule-making process, communication to prevent consumer confusion will be critical to prevent a public health crisis. Now is the time for regulations and guidance for communication to evolve in parallel.

PCPC and CHPA are committed to supporting FDA in achieving its public health mission and providing consumers with the resources they need to make informed decisions."

Read the PCPC and CHPA's full statement here: www.personalcarecouncil.org.

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