FDA FOOD Advisory Committee COI Disclosure Statement

Read by Jenny Slaughter of the

ETHICS AND INTEGRITY STAFF, OMP, FDA

 

The Food and Drug Administration (FDA) is convening today’s meeting of the Food Advisory Committee under the authority of the Federal Advisory Committee Act (FACA) of 1972.    With the exception of the industry representatives, all members of the Committee are special Government employees (SGEs) or regular Federal employees from other Agencies subject to federal conflict of interest laws and regulations.

 

FDA has determined that members of this Advisory Committee are in compliance with Federal ethics and conflict of interest laws including but not limited to  18 U.S.C. § 208 and 21 U.S.C. § 355(n)(4).  Under 18 U.S.C. section 208, applicable to all Government agencies, and 21 U.S.C. § 355(n)(4) applicable to FDA, Congress has authorized FDA to grant waivers to special Government employees who have financial conflicts when it is determined that the Agency’s need for a particular individual’s services outweighs his or her potential financial conflict of interest.

 

Members who are special Government employees at today’s meeting, including special Government employees appointed as temporary voting members, have been screened for potential financial conflicts of interest of their own as well as those imputed to them, including those of their employer, spouse or minor child related to the discussions on July 13-15, 2005 regarding the FDA Draft Report: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.  These interests may include investments; consulting; expert witness testimony; contracts/grants/CRADAs; teaching/speaking/writing; patents and royalties; and primary employment.

 

In accordance with 18 U.S.C. Section 208 (b)(3), full waivers have been granted to the following participants: to Drs. Suzanne Teuber and Soheila Maleki.  Please note that all interests are in firms that could potentially be affected by the committee's discussions.

 A copy of the written waiver statements may be obtained by submitting a written request to the Agency’s Freedom of Information Office, Room 12A-30 of the Parklawn Building. 

In addition, the following individuals are participating as FDA’s invited guest speakers on today, July 13, 2005:

Rene Crevel, Ph.D.

Susan Hefle, Ph.D.

Anne Munoz-Furlong

Steve Taylor, Ph.D.

and Robert Wood, M.D.

 

The following individuals are participating as FDA’s invited guest speakers on tomorrow, July 14, 2005:

Pekka Collin, M.D., M.P.H.

Alessio Fasano, M.D.

Donald Kasarda, Ph.D.

Cynthia Kupper, R.D., C.D.

and Joseph A. Murray, M.D.

Lastly, Drs. Jeffrey A. Barach, Ph.D. and Mark Nelson, Ph.D. are the industry representatives on the Committee at the meeting.  They are acting on behalf of all related industry.  Dr. Jeffrey A. Barach is employed by National Food Processors Association and Dr. Mark Nelson is employed by the Grocery Manufacturers of America.