Congresswoman Rosa DeLauro Presses FDA on Zantac Findings Following Valisure’s NDMA Discovery

On March 7th, Congresswoman Rosa DeLauro sent a formal letter to FDA Commissioner Dr. Robert Califf, raising critical questions about the agency’s plans to investigate GlaxoSmithKline’s actions related to Zantac (ranitidine). The inquiry follows renewed scrutiny over the cancer risks associated with ranitidine—a controversy first brought to light by Valisure’s 2019 detection of NDMA, a probable human carcinogen, in Zantac and its generics.

As reported by Bloomberg, DeLauro’s letter comes in response to mounting evidence that the degradation of ranitidine into NDMA is a scientifically validated risk. Although recent lawsuits have debated the methodology of early findings, multiple sources—including FDA analyses, manufacturer-led tests, GSK’s own internal data from 2020, and even archived reports from as early as 1982—have confirmed that ranitidine is intrinsically unstable.

Zantac was pulled from the market in April 2020 following Valisure’s FDA Citizen Petition, which was the first to alert regulators to the issue. DeLauro now calls on the FDA to explain how it intends to evaluate these newly surfaced reports and hold manufacturers accountable for what may have been years of consumer exposure to a dangerous compound.

“This renewed call for accountability underscores the long-term public health importance of independent quality testing,” said Valisure Co-Founder & President, David Light.

Read Bloomberg’s full coverage →

Congresswoman Rosa DeLauro Presses FDA on Zantac Findings Following Valisure’s NDMA Discovery

March 7, 2023

On March 7th, Congresswoman Rosa DeLauro sent a formal letter to FDA Commissioner Dr. Robert Califf, raising critical questions about the agency’s plans to investigate GlaxoSmithKline’s actions related to Zantac (ranitidine). The inquiry follows renewed scrutiny over the cancer risks associated with ranitidine—a controversy first brought to light by Valisure’s 2019 detection of NDMA, a probable human carcinogen, in Zantac and its generics.

As reported by Bloomberg, DeLauro’s letter comes in response to mounting evidence that the degradation of ranitidine into NDMA is a scientifically validated risk. Although recent lawsuits have debated the methodology of early findings, multiple sources—including FDA analyses, manufacturer-led tests, GSK’s own internal data from 2020, and even archived reports from as early as 1982—have confirmed that ranitidine is intrinsically unstable.

Zantac was pulled from the market in April 2020 following Valisure’s FDA Citizen Petition, which was the first to alert regulators to the issue. DeLauro now calls on the FDA to explain how it intends to evaluate these newly surfaced reports and hold manufacturers accountable for what may have been years of consumer exposure to a dangerous compound.

“This renewed call for accountability underscores the long-term public health importance of independent quality testing,” said Valisure Co-Founder & President, David Light.

Read Bloomberg’s full coverage →

Congresswoman Rosa DeLauro Presses FDA on Zantac Findings Following Valisure’s NDMA Discovery

On March 7th, Congresswoman Rosa DeLauro sent a formal letter to FDA Commissioner Dr. Robert Califf, raising critical questions about the agency’s plans to investigate GlaxoSmithKline’s actions related to Zantac (ranitidine). The inquiry follows renewed scrutiny over the cancer risks associated with ranitidine—a controversy first brought to light by Valisure’s 2019 detection of NDMA, a probable human carcinogen, in Zantac and its generics.

As reported by Bloomberg, DeLauro’s letter comes in response to mounting evidence that the degradation of ranitidine into NDMA is a scientifically validated risk. Although recent lawsuits have debated the methodology of early findings, multiple sources—including FDA analyses, manufacturer-led tests, GSK’s own internal data from 2020, and even archived reports from as early as 1982—have confirmed that ranitidine is intrinsically unstable.

Zantac was pulled from the market in April 2020 following Valisure’s FDA Citizen Petition, which was the first to alert regulators to the issue. DeLauro now calls on the FDA to explain how it intends to evaluate these newly surfaced reports and hold manufacturers accountable for what may have been years of consumer exposure to a dangerous compound.

“This renewed call for accountability underscores the long-term public health importance of independent quality testing,” said Valisure Co-Founder & President, David Light.

Read Bloomberg’s full coverage →

On March 7th, Congresswoman Rosa DeLauro sent a formal letter to FDA Commissioner Dr. Robert Califf, raising critical questions about the agency’s plans to investigate GlaxoSmithKline’s actions related to Zantac (ranitidine). The inquiry follows renewed scrutiny over the cancer risks associated with ranitidine—a controversy first brought to light by Valisure’s 2019 detection of NDMA, a probable human carcinogen, in Zantac and its generics.

As reported by Bloomberg, DeLauro’s letter comes in response to mounting evidence that the degradation of ranitidine into NDMA is a scientifically validated risk. Although recent lawsuits have debated the methodology of early findings, multiple sources—including FDA analyses, manufacturer-led tests, GSK’s own internal data from 2020, and even archived reports from as early as 1982—have confirmed that ranitidine is intrinsically unstable.

Zantac was pulled from the market in April 2020 following Valisure’s FDA Citizen Petition, which was the first to alert regulators to the issue. DeLauro now calls on the FDA to explain how it intends to evaluate these newly surfaced reports and hold manufacturers accountable for what may have been years of consumer exposure to a dangerous compound.

“This renewed call for accountability underscores the long-term public health importance of independent quality testing,” said Valisure Co-Founder & President, David Light.

Read Bloomberg’s full coverage →