Requests that the FDA require a new warning concerning the risk of esophageal cancer for all over-the-counter (“OTC”) drug products that are labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion and sour stomach

Dear Sir/Madam: Please find attached comments from the Consumer Healthcare Products Association on Citizen Petition FDA-2017-P-2733 requesting the addition of a warning to labeling for all OTC drug products labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion, and sour stomach noting that these products do not eliminate the risk of esophageal cancer. Our response notes the lack of evidence cited by the petitioners in support of their request; reviews current labeling which clearly describes the need to stop using these products and consult a healthcare professional if symptoms worsen or persist for more than 14 days; cites recent publications and professional Guideline documents from experts in the fields of gastroenterology and cancer incidence which outline the usefulness of these drugs in the treatment and prevention of heartburn; and provides a brief outline of the economic benefit of these products. In sum, we believe there is no credible evidence to suggest that OTC products indicated for the treatment of heartburn mask the symptoms of early esophageal cancer or delay its presentation. Please feel free to contact me if there are any questions. Regards, Jay Sirois Sr. Director, Regulatory & Scientific Affairs