Newsletter - September 9, 2021
Is It a Drug, Food, or a Medical Food? FDA Clarifies Regulatory Semantics
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...Read More
FDA Describes the Process to Develop New Antimicrobial Agents for Food
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...Read More
Is It a Drug, Food, or a Medical Food? FDA Clarifies Regulatory Semantics
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...Read More
FDA Describes the Process to Develop New Antimicrobial Agents for Food
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...Read More
