The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Lance Shuffert for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Shuffert was convicted of one felony count under Federal law for, with the intent to defraud and mislead, causing a drug to be misbranded while it was held for sale after shipment in interstate commerce. The factual basis supporting Mr. Shuffert’s conviction, as described below, is conduct relating to the importation into the United States of any drug or controlled substance. Mr. Shuffert was given notice of the proposed debarment and an opportunity to request a hearing to show why he should not be debarred. As of March 4, 2024 (30 days after receipt of the notice), Mr. Shuffert had not responded. Mr. Shuffert’s failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance, when finalized, will provide recommendations to the dietary supplement industry on Master Files for new dietary ingredients. The purpose of this draft guidance, when finalized, will be to help industry comply more easily with the new dietary ingredient notification requirement by providing recommendations on the submission and use of Master Files that contain identity, manufacturing, or safety data that can be used to support a new dietary ingredient notification. New dietary ingredient Master Files are submitted solely at the discretion of the Master File owner and are not required by statute or regulation.