FDA Proposes TEA Framework for OTC Non-Sunscreen Ingredients

By Riëtte van Laack –

As required by the Sunscreen Innovation Act (SIA), FDA published its proposal for the review of Time and Extent Applications (TEAs) for non-sunscreen ingredients (the SIA lays out the framework for sunscreen ingredients). It now is evident that a TEA will take time, considerable time.

FDA’s proposed regulation addresses several aspects. First, it proposes new regulation 21 C.F.R. 330.15 which lays out the timing of a TEA. Second, this new regulation describes measurable metrics that FDA will use to track the timelines set forth.

The TEA process consists of several steps, the eligibility determination, the filing determination, review of the safety and effectiveness data, preparation of a proposed rule, comment period, and preparation of a final rule. The timing laid out in the proposed rule essentially means that this process likely will take more than 6 years. That is, if the sponsor provides the data without any delay, the data are complete, FDA determines that the ingredient is GRASE, and the comment period for the proposed rule is limited to 90 days.

The TEA process beings with the submission of the TEA containing data that support the marketing history. If the data meet the eligibility data, FDA publishes the notice of eligibility. As proposed, FDA will make the eligibility determination within 180 days (6 months) of submission of the TEA. Next, the Agency must make a filing determination. FDA proposes that it will make this determination within 90 days (3 months) after the sponsor has confirmed that it considers the data complete. If the sponsor submits the safety data at the same time as the TEA, FDA will make the filing determination within 90 days after the eligibility determination.

FDA will issue a notice of proposed rulemaking regarding the safety and effectiveness of the ingredient within 1,095 days (36 months). If the Agency determines the ingredient is not GRASE, it will inform the sponsor earlier of this determination via a feedback letter (within 730 days (about 24 months)). A final rule would be issued within 912 days (30 months) after closing of the comment period. Thus, the process from start to finish may take 6 + 3 + 36 + 3 +30 = 78 months. This assumes that there are no extensions, the sponsor submits complete data with the submission of the TEA, and FDA determines that the ingredient is GRASE.

The proposed framework does not apply to the TEAs that were pending before the enactment of the SIA. Sponsors of those TEAs had the option of requesting their own framework. Three of the six pending TEAs requested a framework previously. For the three remaining pending TEAs, FDA proposes to use the date that FDA publishes the final rule, 21 C.F.R. § 330.15 as the date of filing (i.e., the sponsors of these TEAs may expect a response from FDA at the latest 36 months after the publication and if the ingredient is determined GRASE, a final rule codifying that determination will issue within 69 months).

FDA also proposes to amend the current regulation for TEAs, i.e., 21 C.F.R. § 330.14. Notably, FDA proposes to include provisions that spell out how FDA will determine whether it will file the TEA, i.e., whether the safety and effectiveness data are sufficiently complete to allow a substantive review. In addition, FDA proposes definitions of certain terms, and a provision regarding the withdrawal of a TEA and safety and effectiveness data.

Thus far, the TEA process has been used infrequently. Since 2002, FDA has received six TEAs. Nevertheless, FDA estimates that it will receive two additional non-sunscreen TEAs per year.