CRN: IND guidance could run against spirit of DSHEA

12-Jan-2011 - Last updated on 13-Jan-2011 at 15:14 GMT

Pharma research? Nutra research? Perhaps both...

As the Food and Drug Administration (FDA) prepares final guidance on Investigational New Drugs (INDs) a leading trade group has warned of the damaging effect on nutrient research that could follow if the application of INDs is not modified from the current draft guidance.

The Washington DC-based Council for Responsible Nutrition (CRN) submitted comments to the FDA highlighting why nutrient research could sometimes be applied in both the pharma and food spheres.

A demarcation between the two would defeat the intention of the 1994 Dietary Supplement and Health Education Act (DSHEA), it said, and called for certain types of research o be exempt from NDI requirements.

“While CRN agrees that a product’s intended use should dictate its regulatory category, we question the rationale for allowing a product’s regulatory category to drive scientific inquiry,” the CRN’s vice president of scientific and regulatory affairs, Duffy MacKay wrote in a nine-page submission.

MacKay wrote his group was concerned, “some aspects of the Draft Guidance may have the unintended consequence of acting in opposition to the spirit” of DSHEA, and create, “unnecessary obstacles to the continued scientific study of dietary supplements.”

He added that DSHEA had authorized the establishment of the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) to study the benefits of dietary supplements in maintaining health and preventing chronic disease and so ‘dietary supplements’ had been mandated to be studied in a pharma and nutra ways.

“The potential for a dietary supplement to have a dual definition, which is dependent on its intended use, has resulted in much confusion amongst the research community.”

Nutrients versus drugs

Industry is concerned some nutrients like omega-3s or probiotics may require NDIs if they are to be studied, and that there will be a bias to disease endpoints as there are no validated endpoints for wellness.

“For example, an investigator interested in evaluating a yogurt product from the grocery store that contains beneficial bacteria for its ability to prevent constipation in a healthy population would be required to file an IND. This seems incongruent with the intent of the IND…”

MacKay highlighted further clarity was needed because:

Much nutrient research was academia, not commercial driven and academia need to be alerted to the guidance and its implications for their work, especially when an IND is required.
Cost and proprietary science concerns would see companies pulling out of the scientific process if INDs are required for certain trials.
IND approaches across various sectors are not unified and an IND policy in the Center for Food Safety and Applied Nutrition (CFSAN).
The current system may see an inundation of INDs.
Many nutrients possess a variability that does not fit the IND model.
Obtaining an IND does not necessarily improve study safety or quality.

He pointed out a grey area in that DSHEA does not permit a, “product that does not contain an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which existence of such investigations has been made public.”

But the FDA has indicated a citizen’s petition, such as the one currently being appraised for a hormone produced by Canadian firm Ovos Natural Health, could be a way to have nutrients that have been subject to drug research classified as dietary supplements, via the New Dietary Ingredients route.

MacKay called for the FDA to specify financial penalties for conducting trials without INDs.

The full statement can be found here.