WASHINGTON — The Consumer Healthcare Products Association today welcomed the introduction of the ACCESS Through OTC Innovation Act, legislation sponsored by Rep. Greg Landsman, D-Ohio, that aims to clarify how the Food and Drug Administration applies the Generally Recognized As Safe and Effective standard under the over-the-counter monograph system.
CHPA stated that the bill would promote innovation in the OTC market by bringing back clarity and consistency to the review process for new and updated self-care products.
“OTC medicines are the first line of care for most American families,” said Scott Melville, president and CEO of CHPA. “While Congress created the OTC Monograph Drug User Fee Program to support timely innovation, uncertainty around how FDA applies the GRASE standard has slowed progress and limited consumer choice. This legislation would realign the system with congressional intent and help families access more modern self-care options.”
The ACCESS Through OTC Innovation Act would reaffirm the GRASE standard and establish an early process to clarify what data is required for an OTC Monograph Order Request. CHPA said that approach would make it easier for manufacturers to update existing products, expand uses for well-established ingredients, and bring forward new OTC innovations while maintaining safety and effectiveness standards.
Congress updated the OTC monograph system in 2020 through OMUFA and recently renewed the program for another five years. While FDA has issued its first over-the-counter monograph order under the new framework, including for sunscreens, CHPA said that broader innovation has been limited due to inconsistent application of the GRASE standard.
By clarifying expectations and reestablishing a clear path, the association said the bill would strengthen self-care, expand consumer choice, and improve access to affordable OTC health solutions.
“We applaud Congressman Landsman for his leadership and commitment to empowering consumers and reinforcing the role of self-care in America’s health system,” Melville said.
