CHPA Warns FDA’s Proposed GRAS Framework Changes Could Have Unintended Consequences for Dietary Supplements and OTC Medicines

(WASHINGTON, D.C.) - The Consumer Healthcare Products Association (CHPA) supports efforts to increase transparency and strengthen consumer confidence in the food supply but warns of potential consequences to dietary supplements and over-the-counter (OTC) medicines. In reviewing the U.S. Food and Drug Administration's (FDA) proposed rule regarding substances generally recognized as safe (GRAS), CHPA continues to emphasize that any reforms to the GRAS framework must be practical and science-based to avoid unintended consequences that could exceed FDA's existing resources without improving food safety.

"Improving transparency does not require upending a system that has long relied on scientific expertise and risk-based oversight," said Scott Melville, President and CEO of CHPA. "FDA should pursue practical reforms that strengthen public confidence while making the best use of agency resources to protect public health."

Under existing federal law, substances that are generally recognized as safe are treated differently from food additives based on scientific evaluation by qualified experts. CHPA has long maintained that any significant changes to the GRAS framework must remain consistent with the authority Congress provided to FDA and preserve the rigorous safety standards at the core of the current system.

CHPA will closely evaluate several aspects of the proposal, including:

• Unrealistic timelines to meet compliance given the broad scope of the proposed rule's impact, creating consequences for consumer access to dietary supplements and other FDA-regulated products;
• Lack of explicit federal preemption that could fuel a patchwork of conflicting or duplicative state requirements;
• Whether FDA has sufficient resources and review capacity to administer any expanded GRAS notification requirements without creating delays and inefficiencies that could impact product availability; and
• Whether the proposal appropriately balances transparency and oversight while remaining consistent with the statutory role of GRAS and existing FDA authorities.

CHPA looks forward to reviewing the proposal in detail and engaging with FDA and Congress to ensure any final approach creates a single national standard that is grounded in science, workable in practice, and protects consumer access to safe products.

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and OTC medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.