FDA announces updated draft guidelines for food manufacturing

FDA food guidelines overview: 

• Who: The U.S. Food and Drug Administration has released updated draft guidelines for food manufacturers. 
• Why: The guidance consists of FDA recommendations for food manufacturers to follow in regard to hazard analysis and risk-based preventive controls for human food. 
• Where: Nationwide. 

The U.S. Food and Drug Administration (FDA) has drafted new guidance for food manufacturers that encompasses hazard analysis and risk-based preventive controls for human food (PCHF). 

The guidance is intended to help food manufacturers comply with PCHF requirements regarding written food safety plans, hazard analysis, preventive controls, monitoring, associated records, corrective actions, and verification. 

“It is important for you to be aware of the potential hazards that may be associated with your food process and products,” the FDA wrote, in its draft guidelines. 

The FDA told food manufacturers that they only must apply preventive controls under certain conditions, such as if they identify “known or reasonably foreseeable biological, chemical, or physical hazards that require a preventive control.” 

“We do not expect that known or reasonably foreseeable hazards for a food require a preventive control in all facilities. We also do not expect that all possible preventive measures and verification procedures apply to all foods produced in your facility,” the FDA wrote. 

FDA notes its guidance does not establish ‘legally enforceable responsibilities’

Included in the FDA guidance are chapters called The Food Safety Plan, Conducting A Hazard Analysis, Preventive Controls, Food Allergen Program, and Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food, among others. 

The agency noted that its guidance does not establish “legally enforceable responsibilities,” but, instead, describes its current thinking on a number of topics and should be viewed only as a recommendation “unless specific regulatory or statutory requirements are cited.” 

“When you understand the potential hazards, it is easier to design and implement an FSP designed to control all identified food safety hazards that may cause illness or injury if they are present in the products you produce,” the FDA wrote. 

In January, the FDA released a separate draft guidance meant to try and reduce the amount of toxic heavy metals — including lead —  that are found in baby food. 

The draft guidance came in the wake of a 2021 federal report that determined a number of baby food manufacturers were allowing their products to contain high levels of toxic heavy metals. 

What are your thoughts on the FDA updating its draft guidelines for food manufacturers? Let us know in the comments! 

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