"ALCOHOL-FREE" CLAIM FOR INGESTED OTCs CONTAINING UP TO .5% ALCOHOL
This article was originally published in The Tan Sheet
Executive Summary
"ALCOHOL-FREE" CLAIM FOR INGESTED OTCs CONTAINING UP TO .5% ALCOHOL should be permitted by FDA, the Nonprescription Drug Manufacturers Association urged the agency in a Jan. 19 letter. Responding to FDA's October 1993 proposal to limit "alcohol-free" claims on systemic OTCs to products with zero percent alcohol, NDMA argued that while "consumers have a right to know that 'alcohol-free' means literally 'alcohol-free,' the practicalities [of] pharmaceutical formulation may not make it possible in all cases."