Day: 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 … Read more

You cannot claim your product is food while doing clinical trials that seem to make drug-like claims. An FDA Warning Letter to a microbiome company highlights the regulatory semantics regarding product designations and related regulatory obligations. Based on the endpoints selected for its clinical trials, Kaleido Biosciences Inc (KBI) was told by FDA that its … Read more