Clarifying FEMA GRAS in Sugar Reduction article

There are several statements about the Flavor and Extract Manufacturers Association of the United States (FEMA) in the article “Sugar Reduction in an Age of Clean Labeling” by Alex Woo, PhD, published in the February 2018 issue of Food Technology that require clarification.

FEMA has enjoyed a productive and long-standing working relationship with Food Technology. All of the FEMA Expert Panel’s articles announcing the “generally recognized as safe” (GRAS) status of flavor ingredients have been published in Food Technology (e.g., Hall and Oser 1965; Cohen et al. 2015), and Food Technology has published numerous other articles about the FEMA GRAS program (e.g., Hallagan and Manley 2010; Harman and Hallagan 2013).

On page 48 of the Woo article, the author makes several errors in describing flavors and aspects of the FEMA GRAS program that we wish to clarify and correct. The author did not cite any references for the statements. In addition to the readily available articles previously published in Food Technology, much information is also available to the public on the FEMA website (www.femaflavor.org). On page 48, the author stated, “… dual use flavor is a compound that is a sweetener at a high level but a tasteless sweetness enhancer below a FEMA preapproved low limit …”

“Dual use flavor” is an incorrect term to use when discussing flavor ingredients. FEMA GRAS flavor ingredients include flavoring substances (substances that impart or modify flavor), and flavor adjuvants that facilitate the function of flavoring substances in compounded flavors such as emulsifiers, solvents and preservatives (Hallagan and Hall 2009). FEMA GRAS status only applies to the specified conditions of intended use as a flavor ingredient. When the use of the substance accomplishes a technical effect in food other than flavoring (e.g., sweetening) such use must have separate regulatory authority. Such authority includes food additive status as granted by the Food and Drug Administration (FDA), FDA voluntary GRAS notification, or private GRAS determination. So, a FEMA GRAS conclusion confers regulatory authority to use a substance only under its conditions of intended use as a flavor ingredient. When a substance has FEMA GRAS status but may be capable of performing a function in food other than flavoring, such non-flavor uses must have separate and appropriate regulatory authority.

The author refers to “a FEMA preapproved low limit.” There are no “FEMA preapproved low limit(s).” There are three elements to the conditions of intended use for GRAS conclusions—the specified use of the substance, the use levels of the substance, and specified food categories in which the substance may be used. The FEMA Expert Panel describes use levels for which substances are GRAS for use as flavor ingredients but these are not “preapproved limits”—they are the levels that, in addition to the specified technical effect and food categories, comprise the conditions of intended use (Hallagan and Hall 2009).

Also on page 48, the author stated, “All these sweet taste enhancers are labeled as natural flavor in those countries that follow FEMA.” This statement is incorrect and in direct conflict with the Food and Drug Administration’s food and flavor labeling regulations at 21 CFR 101.22. Proper labeling conclusions for both the compounded flavor and the food to which it is added can only be determined by a thorough analysis of regulatory authority to use the flavor ingredient and the relevant FDA labeling regulations.

—John B. Hallagan, Senior Advisor, FEMA, IFT Member