FSMA
The year started with a reminder that every food facility (and dietary supplement manufacturing operation) is required to file a renewed registration with FDA before the end of January and again biennially thereafter, and has finished with leading trade associations seeking revisions and clarifications on select aspects of the Food Safety Modernization Act (FSMA).
Recent comments from the American Herbal Products Association (AHPA) suggested revisions in two rules first proposed on Jan. 16, 2013: The Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food (HARPC) and the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
According to AHPA, the new rules could have a dramatic effect on its members’ businesses, because many of the botanicals used by AHPA members are classified as produce subject to these production standards. The proposed hazard analysis and risk-based preventive controls regulations for human food would not apply to GMP-compliant dietary supplement manufacturers but would apply to suppliers of dietary ingredients and other component ingredients that are used by dietary supplement manufacturers.
The Council for Responsible Nutrition (CRN) suggested additional clarification of the risk-based controls portion of the Act. The suggested clarification pertains to the responsibilities of manufacturers of dietary ingredients that are voluntarily complying with dietary supplement GMPs.
“We wanted to avoid any gray area, if you will,” said Duffy MacKay, CRN’s vice president of scientific and regulatory affairs.