Proposed Sunscreen Innovation Act to Speed up FDA’s Review of Time and Extent Applications for Sunscreen Ingredients

March 17, 2014

By Riëtte van Laack

On March 13, 2014, U.S. Senator Jack Reed (D-RI) and U.S. Representative Ed Whitfield (R-KY) introduced the “Sunscreen Innovation Act” (S. 2141 and H.R. 4250, respectively).  The proposed legislation would amend the FDC Act to include a process for the review of potential sunscreen active ingredients.  The Act formalizes FDA’s time and extent program for sunscreen active ingredients but imposes time limits on FDA’s review.

In 2002, FDA published final regulations permitting companies to submit a time and extent application (“TEA”) to begin the process to amend an over-the-counter (“OTC”) monograph to add a new active ingredient that has been marketed for a material time and a material extent in the United States or elsewhere.  See 67 Fed. Reg. 3060 (Jan. 23, 2002); 21 C.F.R. § 330.14.  Under this program, FDA will consider accepting a TEA for inclusion in the OTC drug monograph system of OTC drugs initially marketed in the United States after May 1972.  For OTC drugs with marketing experience outside the United States, FDA requires proof that the product: (1) was marketed outside the United States as an OTC drug for purchase by consumers; and (2) was “marketed OTC for a minimum of 5 continuous years in the same country and in sufficient quantity” (although more than a single country may be appropriate depending on the extent of marketing).  21 C.F.R. § 330.14(b).  If, after reviewing a TEA, FDA determines that an active ingredient is eligible for OTC monograph inclusion, FDA publishes an eligibility notice in the Federal Register requesting the submission of data demonstrating that  the drug is generally recognized as safe and effective (“GRAS/E”) for its intended use.  After reviewing the data, FDA may publish a proposed rule, and then a final rule incorporating the new active ingredient into an OTC monograph.  In order to market the product, the active ingredient also must be recognized in the United States Pharmacopeia-National Formulary.  See 21 C.F.R. § 330.14(i).

Although FDA indicated it would “strive to complete TEA evaluations in 90-180 days,” FDA has not approved the TEA for a single sunscreen active ingredient (or any other ingredient) since the regulation was adopted in 2002.  Only recently did FDA issue its first determinations that data were insufficient to establish GRAS/E status for the sunscreen ingredients amiloxate and diethylhexyl butamido triazone (here and here).  FDA had determined amiloxate and diethylhexyl butamido triazone eligible for the TEA program in 2003 and 2006, respectively. 

The proposed Act keeps the TEA program largely intact but sets a specific time frame for FDA’s review and specifies a role for the agency’s Nonprescription Drugs Advisory Committee (“NDAC”).  Existing FDA eligibility requirements will be maintained.  Eligibility determinations will be made by FDA Division of Nonprescription Regulation Development.  Currently pending ingredient submissions that FDA already has determined to be eligible for the TEA program, will be considered eligible for the new review and approval process (i.e., they need not be re-reviewed for eligibility).

Under the proposed Act, once FDA has determined that the ingredient is eligible, it must submit the ingredient application to NDAC for a safety and effectiveness recommendation.  During the review process, NDAC would receive data from the public and communicate with the application’s sponsor to seek clarifying or  additional information.  FDA must accept or reject the Committee's recommendation.

The Act requires that the new submissions be reviewed within 11 months and that the current backlog (six TEAs for sunscreen active ingredients are pending) must be reviewed within 8 months.  Moreover, as proposed, FDA would be required to submit reports to Congress regarding its progress. 

Unrelated to the TEA program, the proposed Act also requires that FDA issue determinations regarding testing and labeling of sunscreen sprays and labeling of sunscreen drug products with SPF above 50.