FDA Describes the Process to Develop New Antimicrobial Agents for Food
(Thursday, September 9, 2021)
In an updated guidance document on developing new anti-microbial agents for use in food products, FDA listed the various common questions from developers of such agents with detailed answers to meet regulatory expectations. Emphasis is placed to defining the minimum level of an agent necessary to accomplish the intended action. Anti-microbial agents are considered food additives and need to follow the same application process as any other ingredients added to food products. However, unlike nutritional ingredients anti-microbial agents need to demonstrate identify, targeted microbes, describe conditions for use and any limitations there-on, detailed reports on experiments conducted to evaluate the anti-microbial action, and define recommended use practices. When developing experiments for evaluation, one must simulate intended conditions of use, use appropriate controls and reasonable justification for the target microbes, and consider unintended consequences of adding the anti-microbial agents or radiation exposure to the quality of the food it is subjected to. FDA states that “efficacy data should show a quantifiable reduction of target microbes in the samples treated with the antimicrobial agent when compared to corresponding negative controls (e.g., the treatment absent the active antimicrobial agent) and that the intended use level is the minimum level necessary to achieve such a reduction.” FDA recommends that the developers discuss any proposed experimental protocols with FDA prior to initiating them to ensure FDA acceptance of the resulting data. Nothing in the guidance should be a surprise for experienced microbial researchers. However, having an explicit FDA guidance with the detailed description should help secure management support for the extensive efforts involved in such development.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC