The Food Safety Modernization Act Needs Clarification

As the broadest overhaul to the safety of foods since 1937, FSMA contains many overlapping standards and The Council for Responsible Nutrition is requesting clarification.

Additional clarification was suggested by The Council for Responsible Nutrition (CRN) pertaining to the risk-based controls section of the Food Safety Modernization Act (FSMA). CRN submitted the suggested clarification to the Food and Drug Administration as part of a public docket that pertains to the responsibilities of manufacturers of dietary ingredients. Specifically, manufacturers complying with dietary supplement Good Manufacturing Practices voluntarily.

“We wanted to avoid any gray area, if you will,” CRN’s vice president of scientific and regulatory affairs, Duffy MacKay said. He described the various regulations that govern the sale, manufacture and import of finished products, foods and dietary supplement ingredients in the United States as overlapping and complex even before the advent of FSMA. Since the advent of the Food Drug and Cosmetic Act itself, in 1937, FSMA is the most intense change in the safety regime for foods.

Under the Part 111 requirements, which covers dietary supplement GMP regulations that have been fully implemented since 2010, as far as risk-based preventive controls are concerned, manufacturers should already be doing many of the things FSMA specifies. In some ways, manufacturers are adhering to more rigid standards than FSMA suggests, such as the prerequisite for an adverse event reporting systems.

However, manufacturers of the ingredients for these products do not have to comply with Part 111. Manufacturers of the ingredients are held to the standards entitled Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food, in Part 110. Dietary ingredient manufacturers have chosen, in many cases, to voluntarily comply with Part 111 to be safe but it does constitute one example of an overlap, according to CRN.

About LoveLifeSupplements.uk.net

Love Life Supplements (http://lovelifesupplements.uk.net) was created with a clear goal in mind -- to provide premium quality GMP supplements and vitamins at outstanding value for money. GMP stands for Good Manufacturing Practice and are the principles set out by the Regulating Medicines and Medical Devices (MHRA) which underpin pharmaceutical medicine.

 

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