FDA Issues Advance Notice of Proposed Rulemaking to Revise Nutrition Labeling; Action Commences Most Sweeping Food Labeling Effort Since 1993

On November 2, 2007, FDA published an Advance Notice of Proposed Rulemaking (“ANPR”) to revise nutrition labeling requirements for foods and dietary supplements.  FDA’s ANPR commences perhaps the most sweeping food labeling modification effort since 1993, when FDA issued the nutrition labeling rules mandated by the Nutrition Labeling and Education Act of 1990 (“NLEA”).

Since 1990, new nutrition data and information has emerged that FDA believes warrants revisiting nutrition labeling requirements.  These data include the 2005 Dietary Guidelines for Americans, and the Institute of Medicine’s (“IOM’s”) series of reports on the Dietary Reference Intakes (“DRIs”) for vitamins and other micronutrients, minerals dietary antioxidants and related compounds, and energy and macronutrients published from 1997 to 2004.  In addition, the IOM released a 2003 report, “Guiding Principles for Nutrition Labeling and Fortification,” on recommended use of its DRIs in nutrition labeling.

In the ANPR, FDA requests input from stakeholders as to which nutrients should be listed in Nutrition Facts and Supplement Facts labels, what new reference values should be used to determine percent daily values (“DVs”) and which factors should be considered in calculating DVs, as well as several specific issues regarding calories, fats, cholesterol, carbohydrate, protein, dietary fibers, sugar alcohols, sodium, chloride, vitamins and minerals.  Of these topics, there are two particular areas that are likely to generate the most debate: (1) the method for determining percent DV values; and (2) the proposed dietary fiber definition.  The IOM report recommended using a population-weighted method of calculating the percent DV, rather than the current population-coverage method.  If FDA were to adopt this recommendation, the percent DVs for most nutrients would probably decrease.  The IOM also recommended three new categories of dietary fiber linked to the physicochemical properties of the fiber, which would have a major effect on how dietary fiber content is calculated for the purpose of nutrition labeling.   

The November 2007 announcement is only an ANPR, the very early initial step in the rulemaking process.  The deadline for submission of public comments in response to the ANPR is January 31, 2008, but this deadline is likely to be extended, possibly more than once, and the rulemaking process can be expected to require three years or longer.