Good Manufacturing Practices and Labeling for Drugs and Food
In another initiative, FDA is reviewing its current Good Manufacturing Practices (CGMP) regulations, both for foods and drugs. As a primary initiative and pursuant to the Food Safety Modernization Act, FDA will establish preventive controls for food facilities. These new regulations will address and modernize the CGMP for food establishments. This initiative may also include the CGMP regulations pertaining to pharmaceuticals. These revisions would accommodate advances in technology and control of components. Taken together, FDA anticipates that the revisions would provide greater assurances of safety and quality and address some of the challenges presented by the globalization of the food and pharmaceutical industries.
FDA is also pursuing reviews to revise and update labeling regulations for both food and drugs. As part of its Nutrition Initiative, the agency intends to review and revise the food label regulations to improve and increase the nutrition information available to consumers and help them make better, more informed choices about the foods they eat and provide to their families. In a related effort, FDA intends to begin a review of its regulations relating to patient packaging and inserts for pharmaceuticals to determine whether information can be communicated in a more direct and understandable manner.
CGMP regulations, or changes to them, do not generally reduce costs, though there is a presumption of unquantifiable public health benefits from good manufacturing practices. Examples of such benefits include supply chain security for drugs and establishment of preventive controls for food facilities, which improve product safety and reduce the harms associated with poorly manufactured or produced products.
