FDA advisory committees forgo restricting cough-cold sales, CHPA responds

WASHINGTON A pair of Food and Drug Administration advisory committees on Tuesday evening recommended that the FDA not place greater sales restrictions on the sale of dextromethorphan by placing the ingredient on the controlled substances schedule. The panel of FDA advisers voted to not schedule DXM by a vote of 15-9.


"Today's FDA advisory committee decision not to recommend scheduling [over-the-counter] cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of over-the-counter medicines containing dextromethorphan,” the Consumer Healthcare Products Association stated in a release following the decision. “Because of cough's widespread prevalence and effects, it's vital for people to have OTC access to safe and effective self-treatment. Dextromethorphan is in nearly 90% of OTC cough suppressants sold today,” the statement read.



"We do, however, recognize the need for continued education to keep any abuse levels low,” the CHPA added. “We also have long called for federal legislation that would limit purchases of bulk quantities of dextromethorphan to manufacturers who are registered with FDA. We believe that a statutory ban on sales of dextromethorphan medicines to those under 18 [years of age] would limit abuse.”


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