The Food Labeling Modernization Act Is Back Again…

On April 2, Rep. Frank Pallone, Jr. introduced the Food Labeling Modernization Act (FLMA) of 2018, an updated version of the FLMA of 2015. As we previously reported, the FLMA of 2015 was an updated version of the FLMA of 2013.

The FLMA of 2018 differs from the FLMA of 2015 in a few respects. Some provisions in the 2015 bill have been removed because they are no longer relevant, e.g., since FDA amended the nutrition labeling regulations in 2016, there no longer is a need for a bill requiring that FDA modernize the nutrition facts panel.  Some other provisions have been amended to be more specific.  Notably, the 2018 FLMA provision requiring front of package labeling is more prescriptive, in that it specifies that  “there shall be a single, simple, standard symbol system that displays calorie information related to the serving size . . . and information related to the content of saturated and trans fats, sodium, added sugars, and any other nutrients that the Secretary determines are strongly associated with public health concerns,” whereas the 2015 version provided that “[t]here should be a single simple, standard symbol system that displays calorie information related to a common serving size, and information related to nutrients strongly associated with public health concerns.”

The 2018 bill contains only two truly new provisions, namely a provision related to the compliance date of FDA’s 2016 nutrition labeling regulation and a provision related to labeling of phosphorus.

Specifically, the bill would prohibit any further extensions of the compliance date for FDA’s final regulations updating the Nutrition Facts label. Last year, FDA proposed to extend the compliance date for those regulations until January 1, 2020, for manufacturers with $10 million or more in annual food sales, and to January 1, 2021 for manufacturers with less than $10 million in annual food sales in the United States.

For foods containing phosphorus, the 2018 FLMA requires the disclosure of phosphorus immediately after or next to the ingredient statement, along with the quantity reported in milligrams per serving or, alternatively, declaration of the amount of phosphorus (in mg) in the  Nutrition Facts panel.  In response to its proposal to amend the nutrition labeling regulation, FDA had received numerous requests to make phosphorus declaration mandatory. However, FDA denied those requests because, while “a mandatory phosphorous declaration may aid patients with chronic kidney disease and dialysis patients,” FDA concluded that phosphorus is not a nutrient of public health concern for the general healthy U.S. population.

Much of what is included in the 2018 FLMA is already on FDA’s agenda as outlined FDA’s Nutrition Innovation Strategy, e.g., defining natural and redefining healthy. The bill limits FDA’s freedom in doing so by setting specific guardrails, such as a limit to the amount of added sugars for foods that would qualify for the healthy claim.  The 2018 FLMA appears to still focus on nutrients.  As FDA has recognized, modern nutrition science no longer focuses on nutrients, such as total fat, cholesterol, and added sugars, but focuses on certain foods and dietary patterns.