Tag Archives: GRAS Conflicts of Interest

Food additive approvals … are conflicts of interest endangering consumers?

The FoodFacts.com website offers an extensive collection of information on controversial ingredients – which include many food additives. BHA, BHT, TBHQ, Azodicarbonamide, Sodium Benzoate and numerous food dyes are just examples of the many additives that are currently considered GRAS – or Generally Recognized as Safe by the FDA.

After educating yourself on any of these additives, it’s surprising to find that they are included in the GRAS list. We sometimes wonder why an additive that’s also included in antifreeze made it into our food supply … or how coloring that has been shown to exacerbate ADHD tendencies in children is still an allowable ingredient. Today we read about a study that may provide some insight into these and other important questions regarding the safety of a variety of different additives.

The study was conducted by the Pew Charitable Trusts in Washington, D.C. Researchers used conflict of interest criteria developed by a committee of the Institute of Medicine to analyze 451 GRAS notifications that were voluntarily submitted to the FDA between 1997 and 2012.

For the 451 GRAS notifications, 22.4 percent of the safety assessments were made by an employee of an additive manufacturer, 13.3 percent by an employee of a consulting firm selected by the manufacturer and 64.3 percent by an expert panel selected by either a consulting firm or the manufacturer, according to the results.

“Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. 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 where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns,” the study concludes.

The Food Additives Amendment of 1958 allows manufacturers to determine when an additive is GRAS. After a GRAS determination is made, manufacturers are not required to notify the U.S. Food and Drug Administration (FDA), although in some instances the agency is notified, the authors write in the study background. The study goes on to add that the individuals that companies select to make these determinations may have financial conflicts of interest.

Marion Nestle, Ph.D., M.P.H., of New York University, commented on the study saying it provides an important addition to the growing body of evidence for undue food industry influence on food safety policy. Nestle also commented that the lack of independent review in GRAS determinations raises serious questions about the public health implications of unregulated additives in the food supply, especially the additives that the FDA does not even know about.

FoodFacts.com wanted to get this important information out in front of our community. We should all be aware of the possibility that the Generally Recognized As Safe designation can be more about food manufacturers than food safety. In response to these findings, we encourage our community to reach out within their own networks and educate other consumers regarding the use of controversial ingredients in food  products.   Our knowledge can be a powerful thing. And as always, let’s avoid processed foods, so that we can avoid the questionable additives that are lurking in our food supply.

http://media.jamanetwork.com/news-item/research-examines-conflicts-of-interest-in-approvals-of-additives-to-food/