Statement from CHPA Regarding FDA’s Final Order on PEG 3350

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Press Releases and Statements | Apr 9, 2018

“The Consumer Healthcare Products Association (CHPA) applauds the U.S. Food and Drug Administration (FDA) for issuing a recent order in support of the full and complete switch from prescription to nonprescription status for the laxative active ingredient polyethylene glycol (PEG) 3350. Consumers today are more empowered than ever to take their health into their own hands with an increasing array of choice and access to safe and effective over-the-counter (OTC) medicines. The order confirms the same ingredient, absent a meaningful difference (such as the use or strength), may not be prescription and OTC at the same time.  

“PEG 3350 was first officially approved as a nonprescription (OTC) medicine nearly 12 years ago. But since that time, some manufacturers of products containing the identical ingredient for the same use, refused to withdraw their Rx-labeled products from the market and to re-apply for OTC status, which is required under the Federal Food, Drug, and Cosmetic (FD&C) Act. This week’s FDA action resolves any remaining questions on this matter and reminds manufacturers to respect the formal procedures underpinning the Rx-to-OTC switch process and to work cooperatively to honor these regulations to prevent consumer confusion in the marketplace.

Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products.