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

Updated: Feb 4, 2022

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.

NDINs have experienced a wide range of variability in data requirements for the life of the program, starting in 1994 – from minimalistic datasets early in the process for notifying a new dietary ingredient to be added to dietary supplements, to something akin to a food additive petition, with the latter as the current prevailing threshold for filing. While much of the public believes there are no safety requirements for a supplement, the public is – in theory – wrong, as the requirements for filing a notification of a new dietary ingredient (a de facto premarket approval) are very stringent and too burdensome for many manufacturers, compelling some manufacturers to go to market without filing an NDIN. Therefore, the public belief of no restrictions to marketing is – in practice – somewhat correct, as some manufacturers have chosen not to file. There is a high probability the new proposed guidelines for the NDIN process will be issued this year, but with a reduced threshold for documentation of safety and possibly an allowance for synthetic biosimilars (i.e., synthetic substances identical to biologically derived products), a concept which has been embraced on the drug side of FDA. The synthetically-produced biological dopplegangers should have the same stereoisometry, chirality, etc., differing only in isotopic ratio. Labeling will likely require identification of synthetic vs. naturally-derived substances, but FDA enforcement will be difficult without expensive testing.

A definition of natural foods will prove to be as contentious as it has ever been, mainly over the issue of how much manipulation of a raw botanical or animal substance can be undertaken before the substance nor longer qualifies for a “natural” designation. The old stand-by definition of accepting any change that could occur in a homemaker’s kitchen or turning an acid into an ester or forming a salt may go by the wayside. Hopefully, cooler heads will prevail and allow simple interventions, for example, if it can be shown that a change only stabilizes the extract or performs some other preservation function, this minimal effect should be acceptable, as opposed to creation of a third substance without the properties of the natural reactants. Thornier questions will persist, such as the natural credentials of the production of vanilla (vanillin) from wood lignin or via genetically modified organisms (one researcher was even able to produce vanilla from cow dung[1]) – at first, you might think this is a chemical or fermentation process, not a natural process, until you learn that vanilla is produced in vanilla beans through a fermentation process of the vanilla bean itself.

Last on the list, and potentially of a more “Gordian Knot” quality for FDA, will be emerging questions concerning the distinction between food ingredients that have historically been considered “safe”, but now deemed to be “unhealthy”. The safe, but unhealthy, category is best exemplified by industrially-produced partially hydrogenated oils (PHOs). PHO, as margarine, was once considered a healthy substitute for butter, but PHO has undergone a role reversal and is now regarded as unhealthy, although the basis for this conclusion may be on flabby, unstable ground.[2] Now that FDA has opened the door to condemnation of these “unhealthy” ingredients, what now happens with ingredients such as sodium and sugar? The decision that some ingredients are unhealthy is a risk management decision as opposed to food safety – there may soon be a lawsuit questioning FDA’s role in risk management.

Other items of interest could include medical foods, claim substantiation and the future of animal feed ingredients, but the above list will provide plenty of thought, condemnation and gnashing of teeth in the next year. Buckle up, 2016 will be an exciting ride.

[2] BMJ 2015;351:h4962 doi: 10.1136/bmj.h4962 ( ; Published 23 September 2015)

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