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FDA unveils Retail Program Standards and Botanical Safety Consortium

Posted: 15 November 2019 | | No comments yet

The FDA has issued the Voluntary National Retail Food Regulatory Program Standards, which outlines an effective retail food regulatory programme, as well as the convening of the Botanical Safety Consortium, which aims to strengthen the regulation of dietary supplements.

FDA announces Retail Program Standards and Botanical Safety Consortium

The US Food and Drug Administration (FDA) has issued the 2019 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards), which define the key elements of an effective retail food regulatory programme for state, local, tribal and territorial food regulatory jurisdictions. The FDA has also announced the convening of the Botanical Safety Consortium, which aims to strengthen regulation of dietary supplements.

Voluntary National Retail Food Regulatory Program Standards

The Retail Program Standards provide recommendations for designing and managing retail food regulatory programmes and help regulatory jurisdictions (or other responsible organisations) facilitate more effective inspections, implement foodborne illness prevention strategies and identify programme areas in need of improvement.

The 2019 edition of the Retail Program Standards incorporates changes based on recommendations discussed at the Conference for Food Protection 2018 Biennial Meeting and other minor editorial changes.   

These changes include:

  • A new tool entitled “Quick Reference – Applicable 2017 Food Code Provisions (Risk Factors and Interventions)” added to Standard 6 to assist food regulatory jurisdictions in comparing their Code risk factors and interventions to the 2017 FDA Food Code
  • Updates to Standard 3 that assists food regulatory jurisdictions in developing and implementing a programme policy
  • Clarifications within Standard 8 that assists food regulatory jurisdictions in evaluating conformance within the Self-Assessment/Verification Audit Form (criteria 1-4)
  • Updated weblinks within Standard 2: Appendix B-1 Curriculum for Retail Food Safety Inspection Officers to assist food regulatory jurisdictions accessing courses online.

The FDA encourages jurisdictions responsible for regulation development or regulatory oversight of retail food establishments that sell, serve, or vend food directly to the public to enroll in the Retail Program Standards. Enrollment in the Retail Program Standards conveys a jurisdiction’s intent to actively use the Retail Program Standards as a tool to assess and improve its retail food regulatory programme. If a food regulatory jurisdiction enrolls in the Retail Program Standards, it can also apply for federal funding to further assist their efforts towards strengthening their own programme. Enrollment, however, is not necessary to use the worksheets and materials available through the Retail Program Standards.  

Convening of the Botanical Safety Consortium

The FDA has also announced that the Botanical Safety Consortium (BSC) has formally been convened. This is the result of a Memorandum of Understanding (MOU) that was recently signed between the FDA, the National Institute of Environmental Health Sciences, and the Health and Environmental Sciences Institute (HESI), and it establishes the framework for the BSC.

The BSC was originally announced in the FDA’s February 2019 statement on the agency’s new efforts to strengthen regulation of dietary supplements through modernisation and reform. The Consortium’s aim is to provide a forum for scientists from government, academia, consumer health groups, industry and non-profit organisations to work collaboratively to generate a sound scientific basis for integrating existing safety data and the latest toxicology tools to evaluate botanical safety in dietary supplements.

With the execution of the MOU, specific guidelines for membership and participation in the BSC will allegedly be established by early 2020.

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