To a hammer, everything is a nail. For those of us in the field of probiotic foods, a disturbing example of this rule is the approach of the FDA Center for Biologics Evaluation and Research (CBER) to probiotic research. CBER’s role is to evaluate biologic drugs – so when they see “probiotic” it seems they automatically think “drug.”
Drugs – according to US law – are substances that cure, treat, prevent, diagnose or mitigate disease, or (with the exception of foods) affect the structure or function of the human body. Impacting the structure/function of the human body, or reducing the risk of disease, is within the purview of both drugs and foods. But somehow, CBER – rather than CFSAN – seems to be the default center for evaluating probiotic research. And when CBER is asked to determine if a research study requires an investigational new drug (IND) application, the answer seems to be “yes.”
Why is this a problem? If you want to investigate a drug, it isn’t. In fact, you’d be crazy NOT to file an IND if your intent is to develop a drug. But if your intent is to conduct research that will substantiate claims on a food (or dietary supplement), then an IND is an expensive, time-consuming, unnecessary task, that may lock your product into the drug category. Furthermore, it sets into motion requirements for safety studies which may not be required for a food. CBER’s reach may go beyond publicly-funded studies, as the center seems to be combing through clinicaltrials.gov and proactively notifying study sponsors if they believe their study should be conducted under an IND. Institutional review boards are loathe to question the FDA, so even if an IRB considered a privately funded study to be safe, it may not allow the study to proceed without an IND.
Consequently, companies are turning to ex-US locations for conducting probiotic food research.
A must-read on this topic is a commentary (October 2012) titled “Clinical Studies Involving Probiotics: When FDA’s Investigational New Drug Rubric Applies — and When It May Not,” written by food law attorney, Fred Degnan (2012). The case is presented that not all human research involving probiotics falls under the “investigational new drug” (IND) rubric. A probiotic can fall along a continuum of regulatory classifications (food, drug, dietary supplement, medical food); drug should not be assumed (Degnan 2008).
The upshot of this regulatory positioning is that probiotic drug development in the US is alive and well. It’s the probiotic foods – and the researchers who want to study them – who will suffer.