A paper from researchers at The Pew Charitable Trusts and three US universities and published by the peer reviewed JAMA Internal Medicine claims that there are serious financial conflicts of interest in the way the US Food and Drug Administration allows food manufacturers to determine whether additives to food are “generally recognized as safe” (GRAS).  Food additives that are determined to be GRAS can be used in food without further regulatory approvals. The consequence of the conflict of interest finding is that some food additives are being brought to market without the kind of third party independent testing that Congress intended when it gave authority to the Food and Drug Administration to determine which ingredients are generally regarded as safe.

Note that the Canadian Food Inspection Agency does not rely on US GRAS determinations though Canadian consumers may be exposed to substances which have been determined to be GRAS in the US without additional food safety review in Canada.

To qualify for a GRAS determination in the US, manufacturers of additives must conclude that the use of the additive is safe. Safe is defined to mean “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” The safety of the GRAS additive must be generally recognized, which “requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.”

The Pew researchers found the following for the 451 GRAS notices voluntarily submitted to the FDA between 1997 and 2012:

• 22.4% were made by an employee of an additive manufacturer
• 13.3% were made by an employee of a consulting firm selected by a manufacturer, and
• 64.3% were made by an expert panel selected by the manufacturer or a firm that was a consultant to the manufacturer.

In no case was the GRAS determination made by an expert panel selected by an independent third party.

The study concludes: ” The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances when the manufacturer does not notify the FDA of the determination. When manufacturers or their consultants convene an expert panel to make GRAS determinations, they often pick one of a small number of individuals to serve on the panel.”

The complete research report, with more details of the GRAS determination process and of its perceived flaws, is available at http://archinte.jamanetwork.com/article.aspx?articleid=1725123#Results