A Message from the President: What’s on the Horizon for 2016

The last two years initiated a trend on the food side of the Food and Drug Administration (FDA) to be more responsive to populist demands, even when the demands were less based on science than on political pressure or populist outcry. To FDA’s credit, it was able to hang tough on their agreement on the safety of biotechnology products (including the approval of GMO salmon, the reduced arginine Simplot potato and, the non-browning apple) and aspartame, but consumers are beginning to reject the latter as a matter of choice, not intimidation from peers. FDA waivered a bit on the safety-in-use of caffeine in drinks and, may have started down a slippery slope with FDA’s new flexibility enforcing food standards with its decision not to pursue “Just Mayo”. This coming year promises to have significant impact on several specific issues: Generally Recognized as Safe (GRAS) determinations, New Dietary Ingredient Notifications (NDIN), a definition for natural and, action against foods once considered safe, but now deemed “unhealthy”. How sensitive FDA is to fallout from populist demands and internet bloggers will determine the degree of change FDA makes to each of these issues.

On the matter of GRAS determinations, the predominant issue is finalizing the GRAS notification process, which has been in the draft or “proposed” form since 1997. According to an agreement between FDA, the Center for Food Safety and the court, the finalized rule will be issued no later than August, 2016. There is a high probability that FDA will also take this opportunity to revise and include a more modern take on the 1982 (et seq.) Redbook (the FDA guidelines for the degree of testing used in determining the safety of food ingredients), providing greater support for computational toxicology and demanding more precise data on consumption (eliminating back-of-the-envelope calculations based on food groups in 21CFR§170.3(n) and consumption data from the 1970’s). There will also likely be a demand to include probable consumption from natural sources and as dietary supplements, to provide a more complete estimate of the total daily intake of an ingredient. Also likely to be required in a GRAS notification is a certification statement attesting to the fact that all relevant information (i.e., the good, bad and the ugly) has been included in the document – no more cherry picking the data! A more thorough vetting of Expert Panelists and potential conflicts of interest as promoted by the Pew Institute report is probably not in the cards for 2016. As a compromise measure with the Center for Veterinary Medicine (CVM), GRAS determinations will likely have an increased emphasis on documentation of the functionality (utility) of the ingredient. While the finalized GRAS notification process rule should theoretically address all the concerns with both of the FDA Centers (i.e., the Center for Food Safety and Nutrition and CVM), CVM may also issue additional requirements for a GRAS notification for feed ingredients following the finalized rule in August of 2016.