WASHINGTON, DC.— The Washington Legal Foundation (WLF) has called on the Food and Drug Administration to rescind a recently released guidance document that asserts agency approval rights over virtually all human research studies performed in the United States.  In formal comments filed yesterday with FDA, WLF argued that FDA lacks statutory authority to require that researchers obtain FDA approval of an IND (investigation new drug) application before undertaking a study.  WLF stated that FDA’s IND authority extends only to clinical research involving “investigational drugs” and generally does not extend to food, dietary supplements, and cosmetics.

FDA issued a final Guidance document last September, asserting for the first time that the Food, Drug, and Cosmetic Act (FDCA) requires researchers to obtain an IND from FDA for many human research studies into the health effects of food, dietary supplements, and cosmetics.  The Guidance was issued in final form without first providing interested stakeholders an opportunity to comment on the agency’s expanded jurisdictional claim.  The Guidance raised such consternation within the regulated community that FDA in January agreed to accept comments for a 90-day period.  WLF was one of scores of groups that this week filed comments urging that the Guidance be withdrawn.

WLF’s comments noted that the FDCA explicitly exempts food from its definition of a “drug.”  WLF argued that unless the clinical study is conducted for the purpose of supporting a later application for FDA permission to market the food as a drug, it is not subject to FDA’s IND authority.  WLF stated that preparing and submitting an IND can be quite expensive and thus that subjecting clinical studies of food to IND requirements could render them prohibitively expensive.  WLF argued that expanded IND requirements could be particularly devastating for research into “medical foods”—foods that are formulated to meet the needs of individuals with a disease, such as diabetes, that requires them to carefully control their diets.  WLF also faulted FDA for adopting the Guidance in violation of the Administrative Procedure Act’s notice-and-comment requirements.

Following the filing, WLF issued the following statement by Chief Counsel Richard Samp:

“FDA’s efforts to expand its oversight of human research studies could have a paralyzing effect on clinical research, while stifling innovation and product development.  Moreover, Congress has not granted FDA authority to exercise jurisdiction over food research.  It is particularly disturbing that FDA acted here without bothering to comply with procedural rules applicable to all federal agencies.”

WLF is a public interest law firm and policy center with supporters in all 50 States.  WLF frequently appears in judicial and administrative proceedings to ensure that administrative agencies adhere to the rule of law.