FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance previously issued in September 2007 and revised in June 2008. The Antimicrobial Agents Guidance provides information on what data is necessary in food additive petitions (FAPs), food contact notifications (FCNs), generally recognized as safe (GRAS) notices, and threshold of regulation (TOR) exemption requests to demonstrate that an antimicrobial agent achieves its intended technical effect in or on food or food contact articles.
Regulatory Authority Over Antimicrobial Agents
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA has broad authority over pre-market submission programs for substances used in food applications. As part of this authority, FDA regulates the use of antimicrobials in food applications, including in food contact materials. Depending on the uses of an antimicrobial agent as a pesticide or in certain meat, poultry or egg products, other agencies such as the US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) may have statutory authority. As part of a Memorandum of Understanding between FDA and USDA, the two agencies collaborate on the review of antimicrobial agents intended for use in USDA-regulated meat, poultry, or egg products.
Submission of Microbiological Data to FDA
As part of its approval process, FDA may require applicants to submit microbiological data to show that an antimicrobial agent is safe for its intended food use and achieves its intended effect. Given the broad scope of available antimicrobial agents and their range of conditions of use, FDA will consider a variety of factors and microbiological data to address issues related to use and safety. For example, under Section 409(c)(3)(B) of the FD&C Act, a food additive regulation will not be established if the data shows that the use of the additive will promote consumer deception or cause adulteration or misbranding of food in violation of the act. In such cases, microbiological data may be used to supplement information on the safe use of the food additive.
In addition, applicants should consider certain factors when developing an experimental protocol to test safety and intended effect. For example, the protocol should include the pertinent microorganism that may be present in a food, which is considered the most resistant microorganism of public health concern, for purposes of demonstrating efficacy. The guidance includes specific recommendations regarding the types of data and information that should be included in a submission to FDA to demonstrate that the use of an antimicrobial agent achieves the intended technical effect and that the proposed use level is the minimum level necessary to accomplish the intended effect.
- Food application submitters should consult with FDA in designing experimental protocols to show that the use of an antimicrobial agent is safe and has the intended technical effect. Consulting with FDA prior to experimentation is more likely to lead to a more efficient regulatory process.
- FDA recommends several resources on specific microbiological experimental methods. These test procedures may be useful in developing effective protocols to assess the technical effect of an antimicrobial.
This guidance shows that FDA is taking renewed interest in antimicrobial agents. Petitioners for FAPs, FCNs, GRN, and TOR are encouraged to present data that supports their antimicrobial agent’s safe use and intended effect.