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.
Dietary supplements must be marketed as and intended for ingestion, FDA tells Mayor Laboratories in a Dec. 9 warning letter. Claims that the Phoenix firm’s Vitamist sprays and YES.2 Performance Enhancers are absorbed through the mouth’s mucus membranes, even though the spraying action triggers swallowing and the reflex causes the products to be ingested, make them unapproved new drugs, FDA says