Guidance On Acetaminophen Allergy Warning Trails Industry's Change
Final US guidance adds CHPA's suggestion for an example for a warning on labeling for products containing both acetaminophen and aspirin, needed to highlight where “Allergy Alert” and “Liver Warning” statements are on those products' labels.
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The Consumer Healthcare Products Association encourages FDA to conduct a rulemaking to require label changes for acetaminophen OTCs the agency is suggesting in a draft guidance. The trade group also asks for clarity in the order warnings are placed on product labels.
FDA adds acetaminophen warnings; CHPA suggests 4-aminophenol standard; OTC HSA bill in House; supplement registration bill reintroduced; FSMA user fees still on hold; more scrutiny of energy drinks; and Public Citizen pans OTC Oxytrol.
“This is truly uncharted territory because we’ve never had this situation,” says CHPA senior VP David Spangler. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”