April 7, 2014
Paul L. Ferrari
Center for Food Safety and Applied Nutrition (HFS-024)
U.S. Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
RE: Docket No. FDA-2010-D-0503-0017; Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND
Dear Mr. Ferrari,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Food and Drug Administration's (FDA) February 6, 2014 final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled "Investigational New Drug Applications (INDs)—Determining whether Human Research Studies can be Conducted without an IND" (the "Guidance"). With over 75,000 members comprised of registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States committed to improving the nation's health through food and nutrition across the lifecycle. Our members conduct and apply cutting-edge research related to food, nutrition, and dietetics through work in various settings such as universities, academic research centers, governmental departments, non-profit research agencies, and the food industry.
The Academy believes the Guidance, when applied to research on foods, is overly burdensome and urges FDA to (1) withdraw section VI(D)(2) of the Guidance related to conventional foods and (2) modify the Guidance to clarify that an IND framework is not necessary for conventional foods or dietary supplements that are proposed for investigation solely to evaluate their effect on the structure or any function of the body or for a possible health claim.
The Guidance as Applied to Foods is Unnecessary and Inappropriate
Requiring an IND for studies that will not result (nor are intended to result) in the development of new drugs or drug claims represents an extremely narrow view of nutrition research and presents multiple issues for the food and nutrition research community, including many possible unintended consequences. This new and onerous requirement was included in the final Guidance without notice or comment and FDA has not proffered any rationale for adding it or identified any problems with the current regime of oversight by IRBs that might necessitate it. In short, the Guidance as applied to foods is a solution in search of a problem.
The guidance narrows food and nutrition research endpoints to solely include taste, aroma, or nutritive value and does not allow U.S. researchers to determine the strength of relationships between food components and the important functional endpoints they provide for the general population, excepting with an IND. It is inappropriate that research on nutritive and physiologic effects in a general population (such as the reduction of risk of disease and structure/function endpoints) be required to be conducted under an IND.
Further, FDA misapprehends case law in suggesting that a product's characterization as either a food or a drug varies depending on the intended structure or function effect to be studied. There is no legal justification for individualized assessments of a product's intended use; if a product is consumed by consumers generally primarily for taste, aroma, or nutritive value, it is a food.2 As the court notes, coffee and prune juice do not lose their characterization as foods just because they "may be consumed on occasion for reasons other than taste, aroma, or nutritive value;" research into such other reasons thus should not require an IND.3
The Academy appreciates the opportunity to comment on this Guidance with significant potential impact on food and nutrition research and hopes to discuss these recommendations in greater detail in the near future. Please contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at [email protected] or Pepin Tuma at 202-775-8277 ext. 6001 or by email at [email protected] with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Nutrilab v. Schweiker, 713 F.2d 335 (7th Cir. 1983).
3 Id at 338.