Is It a Drug, Food, or a Medical Food? FDA Clarifies Regulatory Semantics
(Thursday, September 9, 2021)
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 product meets the definition of a drug and not food or medical food as claimed by the company. Hence, two of the clinical trials conducted by the company were deemed illegal and the sponsor was told to immediately address the deficiencies apparently by either filing the required IND applications or stopping the trials. The FDA Warning Letter issued to KBI is a classic read on FDA’s interpretation of the applicable laws to product designations and clinical trials, and should be a must read by anyone planning clinical trials with multi-use regulated products. According to its website, KBI is a “clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health”. A review of the company’s pipeline shows that it is developing several microbiome-based therapeutic and preventative products with multiple completed and ongoing clinical trials. The clinical trials in question were intended to evaluate KBI’s product KB-109 in Covid patients. At the time of FDA’s audit, the company’s two clinical trials in Covid patients had already recruited about 400 patients at 23 clinical sites. FDA did not agree with the company’s argument that its trials were food trials or KB-109 is a medical food. FDA honed on the fact that both trials included specific endpoints related to the benefits of KB-109 in Covid patients with regards to reduction of symptoms, duration of the disease, and immunological response to the infection. Besides, KBI itself had told FDA in a pre-IND meeting last July that it intended to explore KB-109 as a “treatment of mild to moderate COVID-19”, clearly a drug claim. FDA provided a detailed response to KBI’s arguments that KB-109 is a food and/or a medical food. It also clarified that while a product can be both a food and drug based on the claims for each use, FDA’s objection was only to the illegal clinical trials. It is not known why KBI, which has other IND programs, and it seems was interested in filing an IND of these trials last year, decided to proceed with these trials without an IND. It is also a testimony to FDA’s lack of enforcement resources that FDA questioned the legality of the trials after they were already quite advanced in their operations. While FDA did not mention any penalties for the FDA-designated illegal clinical trials, it is a messy situation for KBI. The sponsor will need to address FDA’s objections by informing all patients who participated in the trial about FDA’s notice, amend protocol to remove the endpoints objected to by FDA, re-consent, and take other operational measures. Closing the clinical trials at this advanced stage may not be an option due to concerns with patients enrolled and on treatment and filing an IND in retrospect could probably raise additional issues with FDA. It would be interesting to see what remedial actions are acceptable to FDA.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC