“OTC manufacturers share FDA’s commitment to providing consumers with products that are safe and effective. OTC medicines are held to high quality standards and when a safety concern arises, manufacturers work closely with FDA to review the issue and available data. In the case of ranitidine, months ago, CHPA members took appropriate voluntarily action to recall their products and begin their own investigations in accordance with the FDA while FDA continued its own independent scientific review.
“FDA’s statement points out, ‘we didn’t observe unacceptable levels of NDMA in many of the samples that we tested’, but results indicate that NDMA levels may increase over time or when exposed to high temperatures. We look forward to learning more about the agency’s work and testing results to fully understand the product storage conditions that could lead to potential formation of NDMA. FDA also states that, ‘a person taking a drug that contains nitrosamines at, or below, the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer’.
“While CHPA respects FDA’s decision to act out of an abundance of caution, it is also important to take into account consumers’ need to treat occasional heartburn, which, if left untreated, can lead to more serious health issues such as damage to the esophagus, tooth damage, and ulcers. Consumers should read FDA’s Q&A and speak with a healthcare provider if they have any questions.”
