In Brief: warning letters, UrgentRx OTCs fly, Innovus acquires Semprae

GMPs apply despite product discontinuation; format renders spray products drugs; Rogaine label clarified; UrgentRx OTCs take flight; Innovus acquires Semprae; Omega Protein closes plant; FDA evaluates consumer communication; and EU vitamin, mineral, botanical sales outpace forecast.

Discontinuing production of dietary supplements does not get Krier Foods, Inc. off the hook for complying with good manufacturing practices, FDA warns the firm in a Dec. 13 letter. The Random Lake, Wis., firm responded to inspection citations of GMP violations by declaring that after Feb. 1, 2013, it would no longer make supplements. But because the products remain on store shelves the firm still must comply with GMPs, including provisions that firms must retain written records for one year past shelf life or two years beyond the date the last batch was distributed. It also must meet serious adverse event reporting requirements for any supplements it made, FDA says.

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