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DeLauro Statement on FDA Calling for Market Withdrawal of All Ranitidine Products

April 1, 2020
Press Release

NEW HAVEN, CT (April 1, 2020) Congresswoman Rosa DeLauro (CT-03) today issued the following statement after the United States Food and Drug Administration (FDA) requested a withdrawal of all products with ranitidine—the active ingredient in Zantac—from the market. DeLauro called on FDA to recall these drugs in December of last year due to high levels of N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen. She reiterated that call for action in January at an event to reintroduce the Recall Unsafe Drugs Act with Valisure—an analytical pharmacy based in New Haven, Connecticut, that has studied this drug—as well as medical experts.

“The FDA’s action to take ranitidine products off the market is the right move, although it took far too many months to get here. The dangers of ranitidine have been clear to many people in the medical community for some time, and the health of countless people was put at risk due to this delay. That is unconscionable. Dozens of countries around the world were months and years ahead of the United States in taking ranitidine products off the shelves. Moreover, the FDA still lacks the mandatory recall authority to ensure dangerous products are taken off the shelves expeditiously. This is not hypothetical: voluntary recalls of homeopathic products have been refused in the past. Now more than ever, we cannot rely on the good faith of companies when people’s lives are on the line. That is why I will continue fighting to make the Recall Unsafe Drugs Act the law of the land.”

Currently, the FDA has mandatory recall authority over other products that the agency regulates, such as medical devices, food, and biological products. Unfortunately, when something goes wrong with drugs, the FDA has to rely on drug manufacturers to recall their products. More often than not, drug manufacturers heed the warnings of the FDA when products are causing harm. However, there are times when manufacturers refuse to recall their products, even in the face of overwhelming evidence suggesting that they are causing illness or even death to consumers. DeLauro’s Recall Unsafe Drugs Act would close this loophole and enable the FDA to step in and issue a mandatory recall.