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FDA CFSAN outlines 25 priority guidance topics for the next year


The Center for Food Safety and Applied Nutrition (CFSAN) within the US Food and Drug Administration (FDA) has published a list of 25 priority guidance documents it will worth on over the next 12 months.

These are all Level 1 FDA advisory documents, which it publishes to: ‘set forth the agency’s initial interpretations of new significant regulatory requirements.’ The CFSAN will publish both draft and final versions of these as part of its 2021-2022 work plan.

In a press release on 29 June, the agency says that ‘it anticipates that it will publish many of these documents by June 2022.’ The guidance documents will not be legally binding, but the FDA hopes will still be useful for stakeholders in planning their own activities moving forwards, and getting timely feedback. Issuing the list is a new policy from the FDA, and it intends to do this on an annual basis with lists published each January. For the current list, an update will be issued in January 2022.

For the inaugural list over a third of topics – nine out of 25 – are directly related to interpreting elements of the Food Safety Modernization Act (FSMA). Eight more will target food safety issues. The remainder are split between other areas – allergens, nutrition, labelling, and dietary supplements – that are also overseen by the CFSAN.

For FSMA, the first document listed is on:

  • ‘Current good manufacturing practice and preventative controls, foreign supplier verification programs, intentional adulteration, and/or produce safety regulation: enforcement policy regarding certain provisions; guidance for industry
For FSMA, the first document listed is on:
  • Potential hazards for food and processes
  • Food allergen controls
  • The validation of process controls
  • The classification of whether food can be sold as ‘ready-to-eat’
  • Acidified foods.

For the other guidance on FSMA, several will elucidate the Foreign Supplier Verification Program; specifically rules for importers, and reasons for refusing a foreign food establishment assessment.

In food safety, there will be three publications, including guidance levels on heavy metals found in food.

This has been an area of concern raised with the FDA through H1 2021, and has included a call from the US House of Representatives Subcommittee on Economic and Consumer Policy to specifically address metals in baby food.

The CFSAN now plans to issue draft action levels for lead in baby foods and apple juice over the next 12 months.

The operation of the FDA’s Generally Recognised as Safe (GRAS) system has also been an area of regulation that legislators and public health safety groups have pushed to have reformed. The CFSAN plans to issue a new set of draft guidance on best practices for convening a GRAS panel as part of its 2021-2022 work plan.

Mirroring the work programme for CFSAN, the FDA’s Center for Veterinary Medicine (CVM) has also published a list of the guidance it plans to publish before December 2021.

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*Article originally published in Smithers' Food Contact World.