U.S. – The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) have released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.
FDA guidances are documents that elucidate the agency’s interpretation of, or policy on, a regulatory issue.
The FDA formulates guidances primarily for industry, but also for other stakeholders and its own staff.
It uses them to address such matters as the design, manufacturing, and testing of regulated products, scientific issues, content and evaluation of applications for product approvals, and inspection and enforcement policies.
They are not legally binding but they show stakeholders one way of reaching their regulatory goal.
Nonetheless, stakeholders are free to use other approaches that satisfy the relevant law and regulations.
The list focuses on Level 1 draft and final guidances which the agency anticipates to publish by June 2022.
Level 1 guidances present the agency’s initial interpretations of new significant regulatory requirements, describe substantial changes in FDA’s earlier interpretation or policy, and deal with complex scientific or highly controversial issues.
The FDA is taking this action to offer stakeholders increased transparency and additional insights into the foods program priorities.
Although the FDA’s intent is to publish all draft and final guidance topics on the list, modifications in plans may be needed to support emerging issues and Administration priorities.
The FDA’s list of guidance topics is just one of several resources that the foods program routinely shares with stakeholders and partners to help inform them of agency priorities.
Most proposed and final rules are tracked collectively and are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget.
The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government-wide.
In the future, the FDA intends to release the list of anticipated human food guidance topics at the beginning of each calendar year with updates scheduled for mid-year.
The list released is set to be updated by the end of January 2022.