In a recent comment on the FDA's Guidance for Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application (IND) (79 Fed. Reg. 7204. Docket FDA-2010-D-0503), FutureCeuticals expressed its strong support for gold-standard, peer-reviewed clinical research on food and dietary ingredients and urged the FDA to properly supervise any clinical research on food or dietary ingredients under the purview of its oversight on food, not drugs.
"We ask that the FDA remove all current discussion of dietary supplements and conventional foods from the final guidance, and make it clear that an IND should only be required for a product that is intended to be marketed as a drug," said John M. Hunter, FutureCeuticals' executive vice president. "Furthermore, in the interest of ensuring safe development of dietary supplements and conventional food products, the FDA should focus its efforts on better enforcement of the current laws and regulations applicable to such products. Relevant safety standards, pre-market notification requirements, and manufacturing requirements are already in place to ensure the safety of dietary ingredients used in clinical research, but need to be properly interpreted and enforced by FDA."
FutureCeuticals pointed to its own strong history of conducting clinical trials on its stable of patented dietary supplement and functional food ingredients, and emphasized its responsible use of its published research to market these products.
In 2010, the FDA issued a draft version of the guidance (see 75 Reg. 63891) with the stated purpose of assisting clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an IND. The draft recognized that an IND is required only for research that involves a "drug," defined in the Federal Food, Drug, and Cosmetic Act to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body," and that "a dietary supplement is not considered a drug....if the intended use for which it is marketed is only to affect the structure or any function of the body."
However, the Draft Guidance also included the contradictory position that "whether an IND is needed for a clinical investigation evaluating a dietary supplement is determined by the intent of the clinical investigation" rather than the "intended use" of the product itself. This language was maintained in the final guidance which was issued by FDA in September 2013.
In sum, by this Guidance, the FDA created the scenario whereby the classification of any material as a drug solely depends on the clinical study outcomes and endpoints, rather than on how, where relevant, the material is actually marketed.
Under such circumstances, for example, university researchers engaged in studying the potential benefits of blueberries, or freeze-dried blueberry powder, on Alzheimer's disease might find themselves faced with the prospect of needing to file an IND on blueberries, as well as potentially conducting phase 1 through 3 clinical trials simply because of the intended clinical endpoints.
"We believe that significant changes are needed to the Final IND Guidance," wrote Hunter in the letter. "As written, the Final IND Guidance exceeds FDA's statutory authority by requiring INDs for studies of products that are subject to regulation only as dietary supplements and conventional foods. It is unnecessary from a public health perspective, and creates a significant disincentive for companies to commission the research needed to support responsible marketing of safe dietary supplement and conventional food products."
"We feel that this guidance forces companies to wrestle with unnecessarily complex, ambiguous, and at times contradictory concepts during research of food, dietary supplements, and normal human health," said Hunter. "There are arbitrary distinctions in the way the IND requirement applies, there is a clear conflict in this guidance with the 'race to market' provision of FDCA and, most of all, this guidance stifles research of the foods we eat and the supplements we take by placing burdensome and costly restrictions on their study."