Congresswoman Rosa DeLauro Urged FDA Action on Ranitidine Months Before Nationwide Market Withdrawal
On December 18, 2019, Congresswoman Rosa DeLauro (CT-03) sent a formal letter to FDA Commissioner Dr. Stephen Hahn and HHS Secretary Alex Azar, calling for the immediate recall of ranitidine-containing drugs due to the presence of N-Nitrosodimethylamine (NDMA)—a probable human carcinogen identified by Valisure’s independent testing earlier that year.
DeLauro’s letter echoed the concerns raised in Valisure’s 2019 Citizen Petition, which detailed the inherent instability of the ranitidine molecule and its ability to degrade into dangerous levels of NDMA, particularly when exposed to elevated temperatures or over time.
On April 1, 2020, the FDA announced its request for all manufacturers to withdraw both prescription and over-the-counter (OTC) ranitidine products from the U.S. market, confirming the contamination risk and citing storage and time-based instability as key drivers of consumer exposure to unsafe levels of NDMA.
This marked a turning point in drug safety regulation, catalyzed by a combination of independent scientific evidence and Congressional pressure. As a result of the withdrawal, ranitidine products are no longer available for new or existing prescriptions or OTC use in the United States.
Valisure continues to support the urgent need for proactive, evidence-based decision-making to protect public health—and commends Congresswoman DeLauro for her early leadership in driving accountability and FDA action on this issue.
Read Congresswoman DeLauro’s full letter to the FDA and HHS here.
