For consumers waiting to understand an over-the-counter ingredient’s status, a review schedule can answer when an agency should act without answering whether the ingredient is safe. FDA’s November 23, 2016 final rule established timelines and public performance metrics for specified non-sunscreen time-and-extent applications, or TEAs. It was effective December 23, 2016. [2016-28120][2016-07612]

The system separated procedural gates. An eligibility decision was due within 180 days of submitting a TEA. A filing determination was due within 90 days of submitting safety and effectiveness data. That second step assessed whether the submission was sufficiently complete for substantive review, not whether the scientific case had succeeded. Conflating those decisions would turn an administrative milestone into an unsupported health assurance. [2016-28120][2016-07612]

The April 4 proposal explains the public-interest mechanism: completeness screening and withdrawal provisions were intended to make review more predictable and avoid spending resources on submissions no longer being pursued. The final also provided annual public metrics tracking performance against deadlines. Together, the documents show how FDA intended to make its work more visible; they do not establish that the deadlines were actually met. [2016-28120][2016-07612]

Coverage remained narrow. Sunscreen ingredients were outside this timetable, as were specified non-sunscreen TEAs submitted before November 27, 2014 under the statutory exception. Later stages had their own clocks, rather than a single deadline for approval. For readers, the meaningful accountability question is whether the agency reached the required decision at each stage, not whether every application produced a new product. Both documents come from the same rulemaking. [2016-28120][2016-07612]

Source documents

  1. Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applicationshttps://www.govinfo.gov/content/pkg/FR-2016-11-23/html/2016-28120.htm
  2. Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applicationshttps://www.govinfo.gov/content/pkg/FR-2016-04-04/html/2016-07612.htm