The Food Labeling Modernization Act Introduced in Congress (Again)

On August 3, 2021, the U.S. House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and House Appropriations Committee Chairwoman Rosa DeLauro (D-CT) introduced the Food Labeling Modernization Act of 2021 (FLMA) (H.R.4917). A companion bill (S.2586) was introduced in the Senate by Senators Richard Blumenthal (D-CT), Sheldon Whitehouse (D-RI), and Ed Markey (D-MA). Rep. Pallone believes that “American consumers have a right to know what’s in the food they and their families eat, but that isn’t always easy with today’s opaque food labels and marketing claims.”[1] To aid consumers, the FLMA “will update [the] nation’s packaging requirements to provide clear nutritional information to consumers to help them make healthier and more informed purchasing decisions.”[2]

These bills would require FDA to set uniform requirements for front-of-package (FOP) labeling, require the FDA to define terms such as “natural” and “healthy,” require nutrition information to be displayed for online grocery items, and require manufacturers to submit labeling information to FDA, among other proposed measures. While versions of the FLMA have been introduced in the past, specifically in 2015 and 2018[3], this marks the first time such bills have been introduced with Rep. Pallone as Chairman of the House committee that has FDA jurisdiction and Democrats in the majority in both chambers. The fate of the FLMA remains unclear, but in light of the foregoing, and because the bills contain many provisions that would require manufacturers and retailers to change their food labels or food regulatory practices, developments regarding the FLMA bear monitoring. Below are select highlights of the bills:

Front-Of-Pack (FOP) Labeling

Under the FLMA, “summary nutrition information” would be required on the front of food labels. The bill directs FDA to promulgate regulations that: 

• create a standardized symbol that displays calorie information in relation to serving size as well as information on saturated and trans fats, sodium, added sugars, and any other nutrients “strongly associated with public health concerns”;
• create a system of warning symbols for foods high in saturated or trans fats, sodium, added sugars, and any other nutrients that should be limited or discouraged, along with a stop-light, points, star, or other signaling system to rank foods according to their overall health value; and
• require that the information appear on all products that bear a nutrition label, on the principal display panel (PDP), in a prominent design that contrasts with the packaging, and be easily legible.

The summary nutrition information requirements would need to be consistent with the Nutrition Facts Panel and recommendations of the Dietary Guidelines of Americans.

For foods that bear:

• “whole wheat,” “whole grain,” or “multigrain” related terms or representations, the PDP would need to display the amounts of whole and refined grains near the term or representation; 
• “fruit-flavored” or “fruit” related terms or representations, the PDP would need to display the quantity per serving and form of fruit near the term or representation; 
• “veggie” or “vegetable” related terms or representations, the PDP would need to display the quantity per serving and form of vegetable near the term or representation; or
• the term “yogurt,” the PDP would need to display the quantity per serving of yogurt near the term, or the first ingredient declared must be cultured milk, cultured cream, cultured partially skimmed milk, or cultured skim milk.  

Any foods that contain artificial dye or added artificial or natural flavoring must state that fact prominently on the PDP. Similarly, foods that contain artificial or natural noncaloric sweetener must so declare prominently on the PDP.

Conventional Foods

The FLMA would direct FDA to define “natural” and “healthy” based on a criteria set forth therein, and would also establish statutory definitions of “artificial” and “synthetic.”

Additionally, the bills would direct FDA to revise or promulgate regulations on the disclosure of sodium, added sugars, fat, and “low added sugar” claims for foods. For added sugars, FDA would need to promulgate a regulation that would set an added sugars level that would disqualify the food from making any health claims.

The bills would allow FDA to request documentation from a manufacturer on the substantiation for its health claims, after which the manufacturer would have 90 days to comply.

The FLMA also proposes changes to the nutrient content claim regulatory scheme, including to prohibit a trans fats nutrient content claim unless the food contains less than one gram of saturated fat per serving, or if it contains more than one gram of saturated fat, displays the level of saturated fat in proximity to the trans fats claim.

Food Allergens

The bills allow FDA to declare by regulation new major food allergens based on prevalence and severity of allergic reactions to the allergen. Foods would also need to declare “gluten-containing ingredients,” i.e., wheat, barely, and rye, in the manner foods declare major food allergens. For foods that are not packaged at retail, major food allergens and gluten containing ingredients would need to be displayed on a sign adjacent to the food. Hazard analysis and preventive controls will also need to include gluten-containing ingredients.

Submission to FDA of Food Label Information

Standards of Identity

These bills will direct FDA to review those standards of identity that require minimum levels of nutrients strongly associated with public health concerns or that require minimum levels of those ingredients that contain high levels of such nutrients, and to submit a summary report to Congress. FDA would also need to amend standards of identity to allow for the use of salt substitutes (e.g. potassium chloride) and require yogurt, lowfat yogurt, and non-fat yogurt to contain a minimum level of live and active cultures per gram.

Sugar Alcohols and Isolated Fibers

If a food contains allulose, polydextrose, sugar alcohols, or isolated fibers, that fact would need to be stated on the PDP. In addition, FDA would be directed to promulgate regulations establishing levels of allulose, polydextrose, sugar alcohols, or isolated fibers per serving that cause deleterious health effects and to require a warning on the labels of foods that contain levels above those established.

Sale of Food Online

The bills would require retailers who sell foods online to make available to consumers at the point of selection, prior to purchase, all the information that is required on the food label.   

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In sum, if passed, the FLMA would require significant changes to most food labels. While the sponsors believe these changes are necessary to ensure consumers have the information needed to make healthier and more informed purchasing decisions, we believe that, at present, such changes are not among FDA’s priorities. The FLMA would impose significant new obligations on the agency, as well as food manufacturers. FDA currently seems more inclined to focus its resources on food safety issues, particularly given that the agency updated its nutrition labeling requirements relatively recently.

That said, as noted above, the sponsors are the chairs of relevant committees and are in the majority in both chambers. We also note that FOP labeling is required by many countries outside the U.S., with a number of countries implementing requirements in recent years. Covington will continue to monitor closely any developments on these bills and other issues of importance to the food industry, and will keep our clients and contacts apprised.

If you have any questions concerning the updates discussed in this client alert, please contact the members of our Food, Drug, and Device practice.

[1] Press Release, U.S. House Committee on Energy and Commerce, Pallone, Delauro, Blumenthal, Whitehouse, and Markey Introduce Food Labeling Modernization Act (Aug. 4, 2021).

[2] Id.

[3] See Food Labeling Modernization Act of 2015 (H.R.4061); Food Labeling Modernization Act of 2015 (S.2301); Food Labeling Modernization Act of 2018 (H.R.5425); Food Labeling Modernization Act of 2018 (S.2647).