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FDA Issues Two Sunscreen Guidance Documents (November 2016)

The Food and Drug Administration (FDA) has recently issued two guidance documents for sunscreen drug regulation and safety under the Sunscreen Innovation Act (SIA).

Sunscreen Innovation Act

The SIA was enacted on November 26, 2014 and was administered to amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to establish an expedited process for the review and approval of over-the-counter (OTC) sunscreens. Sunscreens are regulated as drugs in the United States because they claim to help prevent sunburn, mitigate the effects of overexposure to the sun, and reduce risks of skin cancer and early aging of the skin. The SIA mandates timeframes for product review after a request submission is made, and does not change existing standards for safety and effectiveness.

Guidance Document for Withdrawal of a 586A Request or Pending Request

The recommendations in this document address requests submitted under section 586A of the FD&C Act, which requires FDA to determine whether a nonprescription sunscreen active ingredient or combination of nonprescription active ingredients meets regulatory standards. FDA validates whether the ingredients are generally recognized as safe and effective (GRASE) for use under specified conditions, and whether they should be included in the OTC sunscreen monograph. Marketing products under OTC drug monographs ensures that a drug has been evaluated as GRASE and that labels are not misleading.

Guidance Document 586C

Under the SIA, FDA may assemble the Nonprescription Drugs Advisory Committee (NDAC) to provide recommendations on requests submitted to FDA for determination of whether an active ingredient is GRASE and should be added to the monograph system. Section 586C(c) specifies circumstances under which FDA is not required to convene NDAC.

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