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FDA Proposes New Rule for Sunscreen Products

Posted 21 February 2019 | By Ana Mulero 

FDA Proposes New Rule for Sunscreen Products

The US Food and Drug Administration (FDA) proposed a new rule on Thursday to update regulatory requirements for most sunscreen active ingredients currently on the US market.

The 264-page proposed rule was decades in the making, with collaborators ranging from agency staff and outside scientific experts to patient advocacy groups. The new regulatory framework it describes is aimed at providing better assurance of the safety, efficacy and preventive qualities of over-the-counter (OTC) sunscreens.

A key component of the proposed rule relates to additional broad spectrum requirements on testing, argued Theresa Michele, director of the Division of Nonprescription Drug Products at FDA’s Center for Drug Evaluation and Research, during a conference call on Thursday. This is because an increase in SPF value does not necessarily guarantee that broad spectrum coverage and UVA coverage would proportionally increase under the current landscape for nonprescription sunscreen products.

“But the testing we are proposing would ensure that happens so that when consumers think they are getting a more protective product against skin cancer and early skin aging, they actually are,” Michele added.

Other provisions relate to dosage forms and labeling requirements. For labeling, the proposal involves the addition of active ingredients on the front of the sunscreen package in line with other OTC drugs.

The proposal also sets the stage for FDA to satisfy a mandate under the Sunscreen Innovation Act of 2014. The legislation required the agency establish an alternative regulatory review process for nonprescription sunscreen active ingredients. The proposed rule would address this requirement.

FDA Commissioner Scott Gottlieb noted during the conference call on Thursday that “providing broad spectrum sunscreen with SPF values of at least 15 are critical tools that we have for preventing skin cancer and protecting the skin from damaged caused by the sun’s rays.” He added, however, that “some of the essential requirements for these preventative tools have not been updated in literally decades.”

Gottlieb explained that the agency’s knowledge and understanding regarding sunscreen active ingredients has evolved since their initial evaluation. This growth in sunscreen sophistication has involved a greater understanding of the sun’s effects and the absorption of sunscreen through the skin.

Trends informing the agency’s work on the proposal related to consumer habits in terms of how, to what extent and with what frequency Americans are using these products. Gottlieb argued these formulations have “evolved as companies have innovated.” The proposal identifies the inclusion of 16 currently marketed active ingredients—including zinc oxide and titanium dioxide—as positively and two additional ingredients—aminobenzoic acid and trolamine salicylate—as ineligible for inclusion in the finalized monograph for OTC sunscreens. The agency is also proposing that additional information is needed for 12 other active ingredients.

The agency intends to consider comments submitted to a docket opened in conjunction with the release of the proposed rule as it works to finalize the new OTC monograph for sunscreen drug products.

Proposed rule


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