Potential conflicts of interest and appearance issues

The Food and Drug Administration, when issuing draft guidance on convening a GRAS (generally recognized as safe) panel, gave examples of conflicts of interests and appearance issues. 

Sources of conflicts of interest include:

● Ownership of any equity of an affected entity (excluding equity held through a publicly traded diversified (i.e., non-food sector specific) mutual fund);

● Compensation for services, such as management or consulting services to an affected entity (excluding honoraria for service on the GRAS panel);

● A role as director, officer, trustee, general partner or employee of an affected entity (including trade and professional associations);

● Funding for research purposes from an affected entity, regardless of whether there is post-grant oversight;

● A debt relationship of any kind with an affected entity, whether as lender, borrower, holder of debentures, or the like;

● Any of the above examples with respect to a spouse, minor child, general partner or prospective employer.

Examples of appearance issues include:

● Direct and predictable effect on the current financial interest of a household member, including adult children and parents, as well non-relatives in residence;

● Having or seeking a business, contractual or other financial relationship with an affected entity; 

● Having a household member or relative with a close personal relationship who is an affected entity; 

● Serving in the last year as an employee, officer, director, consultant, agent, attorney, trustee, contractor or general partner for an affected entity; 

● Having a spouse, parent or dependent child who currently serves or is seeking to serve as an employee, officer, director, consultant, contractor, agent, attorney, trustee or general partner of an affected entity; 

● Being an active participant in an organization that is an affected entity; 

● Consistently and strongly advocating specific views or positions on a scientific issue relevant to safety assessment; 

● Having one’s own work as a key element of the relevant evidence for safety of the substance under the conditions of its intended use.