Earlier this year, FDA issued two proposed regulations to update the nearly 20-year-old Nutrition Facts label on food packages to reflect “new public health and scientific information” regarding dietary recommendations and serving sizes. The 151 pages of proposed regulations elicited close to 600 comments from manufacturers, trade and consumer associations, medical and public health experts, and others when the comment period closed Aug. 1, 2014. Many applauded the changes, saying they were long overdue; some said they didn’t go far enough; and others called them costly and potentially misleading to the public.
“The FDA is proposing a new Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases, such as obesity and heart disease,” said FDA Commissioner Margaret A. Hamburg, MD, when the regulations were published in March 2014. “The new label would help consumers make better, more informed choices about the foods they eat and help support a healthy diet.”
While FDA has not indicated when it expects to finalize the regulations, the rules will become effective 60 days after publication and industry will have two years to comply. Implementing the label changes will cost industry $2.3 billion in one-time labeling, reformulation, and recordkeeping expenses in addition to “small” annual recordkeeping costs, FDA estimates. The agency says these costs will be far outweighed by national economic benefits, which will total $21.1 billion to $31.4 over 20 years. Foods imported into the U.S. must comply with the new rules.
But the FDA has likely underestimated the compliance costs. “There may be additional costs including potential product reformulations to maintain current nutrient claims and to reduce the amount of ‘added sugar,’ which is a new required declaration,” says David Acheson, MD, CEO, The Acheson Group and a former FDA associate commissioner for foods. Companies will also have to update and develop new policies and procedures and train employees. “All of these elements would add extra costs. As with all such types of changes, it is important to determine the public health benefit as well as the cost to industry from both an economic as well as a pure health perspective,” Dr. Acheson tells Food Quality & Safety.
The first proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels,” would update packaging labels with new mandatory and voluntary nutrient and reference values. These requirements reflect the most “current science” as reported in “Dietary Guidelines for Americans, 2010” issued by the Department of Health and Human Services. Among the many changes, FDA is proposing to list separately the amount of “added sugars;” require listings for potassium and vitamin D while making optional listings for vitamins A and C; revise the Daily Values for sodium, dietary fiber, and other nutrients; and remove Calories from Fat, because the type of fat is considered more important than its source.
The second proposed rule is called, “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.” It would update the single-serving size (“Reference Amount Customarily Consumed” or RACC) and require dual “per serving” and “per package” calorie and nutritional columns for packaged goods that could be consumed in one or more sittings, such as a 24-ounce (oz.) bottle of soda, a 19-oz. can of soup, or a pint of ice cream. The dual column format would be required if the package contains between two and four times the single serving size.
Eating habits have changed significantly since the 1970s and 1980s, when many RACCs were established. For example, a pint of ice cream is currently considered to be four servings, but FDA says two servings is more realistic. “The fact is, for many foods, we’re eating larger portions than we used to,” says Jillonne Kevala, PhD, an FDA supervisory chemist. The agency is proposing to change RACCs for about 30 food items. These revisions will likely have marketing implications. For example, if the serving size for ice cream doubles, so too would the calories, fat, sugar, and sodium content on the Nutrition Facts label. This, in turn, will impact manufacturers’ ability to make health and nutrition claims.