Food Labeling Modernization Act of 2018 Likely Reveals Consumer Groups’ Priorities for FDA Nutrition Innovation Strategy – May Spur More Class Action Lawsuits

The Food Labeling Modernization Act of 2018 (H.R. 5425) was introduced on April 4, 2018, by Rep. Frank Pallone, Jr. (D-NJ), the ranking member of the House Energy and Commerce Committee.  A joint press statement announcing the bill was released by Rep. Pallone and co-sponsor Rep. Rosa DeLauro (D-CT), the ranking member of the House Appropriations Subcommittee for Labor, HHS, Education and Related Agencies. The announcement indicated that Sen. Richard Blumenthal (D-CT) plans to introduce a companion bill in the Senate.

The bill would make a number of major changes to current food labeling laws.  Although there is little to no chance of advancing in the current Congress, this bill provides an indication of consumer advocacy organizations’ priorities in the area of food labeling reform.  Such organizations will likely try to achieve some of the goals of the legislation by participating in administrative and regulatory proceedings to be conducted by the Food and Drug Administration (FDA) as part of that agency’s recently announced Nutrition Innovation Strategy.  Further, specific provisions of the bill could be used to inspire new legal theories for class action lawsuits challenging food labeling claims. The bill is thus noteworthy.

The Food Labeling Modernization Act of 2018 would make the following changes in food labeling law:

  1. Front-of-Pack Nutrition Labeling

The bill would require all human food products that are required to bear nutrition information (other than dietary supplements) to also include a single, standard front-of-pack (FOP) nutrition label.  Specifically, it would require the principal display panel of such products to provide “summary nutrition information that reflects the overall nutritional value of the food or specified ingredients.”  It would also prohibit any other “summary nutritional information” in addition to or inconsistent with the required standard FOP information.  Presumably, this provision is intended to prohibit other private FOP nutrition symbols or statements, e.g., the Grocery Manufacturers Association Facts-Up-Front program.   

FDA would be required to issue regulations requiring such FOP summary nutrition information, based on the following principles:

  • There should be a single simple, standard symbol system that includes calorie information per serving, information related to the content of saturated and trans fats, sodium, added sugars, and other nutrients that FDA determines are strongly associated with public health concerns.
  • Consumers should be able to quickly and easily comprehend the meaning of the symbol as an indicator of a product’s contribution to a healthy diet.
  • The information should appear in a consistent location on the principal display panel (PDP), have a prominent design and have sufficient size and contrast.
  • The information should be consistent with the product’s Nutrition Facts panel and with recommendations of the Dietary Guidelines for Americans.
  • The information should aim to facilitate consumer selection of healthy products, including among nutritionally at-risk sub-populations.
  • FDA should periodically evaluate the FOP information to assess its effectiveness.
  • Implementation should be accompanied by consumer education and promotion campaigns.

The bill would also require FDA to employ an approach that clearly distinguishes between products of greater or lesser nutritional value.  To this end, the bill suggests, but does not mandate, warning symbols, stop-lights, points, stars, or other commonly recognized signaling systems to rank foods according to their overall health value.

  1. Whole Grain” Label Statements

 The bill provides that, if a food (other than a dietary supplement), a) bears the terms “made with whole grain,” “multigrain,” “whole wheat,” “whole grain” or similar terms or representations about whole grain content on the PDP, b) declares whole grain content by weight, c) is a wheat bread, pasta, or similar product that is typically made from wheat, or d) contains any similar descriptions suggesting the product contains whole grains, then the product label must conspicuously disclose the amount of whole grains expressed as a percentage of total grains in immediate proximity to such terms.

  1. Labeling of Foods Containing Flavorings, Sweeteners, and Colorings

The bill would require that any food (other than a dietary supplement) that contains any added natural or artificial coloring, any added natural or artificial non-caloric sweetener, or any added natural or artificial flavoring to prominently state such fact on the PDP. 

This would be a departure from current FDA regulations:

  • FDA regulations require declaration of flavorings on the PDP only under certain circumstances. If a food’s label makes any direct or indirect representation about the food’s primary recognizable flavor(s) by word, vignette, or other means, then such flavor(s) is considered the food’s characterizing flavor(s) and the name of the characterizing flavor(s) must accompany the statement of identity on the PDP.  If the food contains any artificial flavor that simulates, resembles, or reinforces the characterizing flavor, or if the food contains no natural flavor derived from the food whose flavor is identified in the name of the characterizing flavor (e.g., “key lime pie” flavored with other citrus fruits), then the words “artificial” or “artificially flavored” must accompany the name of the characterizing flavor.

21 C.F.R. § 101.22(i).  

  • FDA regulations currently require identification of colorings in the ingredients declaration only. In addition, FDA considers all added colorings to be artificial colorings; it does not recognize “natural colorings.”
  • FDA regulations currently require identification of non-caloric sweeteners in the ingredients declaration only. In addition, the amount of sugars in grams is required to be declared in the Nutrition Facts panel, and the amount of sugar alcohols in grams is also required in the Nutrition Facts panel if a food contains sugar alcohols and makes a nutrient content claim about sugars or sugar alcohols.

21 C.F.R. § 101.9(c)(6)(ii) and (iii).

  1. “Health-Related” Structure/Function Claims

The bill refers to “health-related” structure/function claims and gives FDA discretion to request that such a claim be substantiated not later than 90 days after the agency requests the manufacturer to do so. It also provides that, if FDA requests substantiation for a structure/function claim made for a food (other than a dietary supplement), the manufacturer must provide FDA all documentation in its possession relating to the claim.  The bill, however, does not establish a specific substantiation standard for FDA to apply when reviewing structure/function claims.

  1. New Restrictions on Nutrient Content Claims About Trans Fat

The bill would prohibit claims on food labels about the level of trans fats unless the food contains less than one gram of saturated fat per serving or, if the food contains more than one gram of saturated fat per serving, the label must disclose the level of saturated fat in immediate proximity to the claim.  The disclosure must appear with appropriate prominence no less than one-half the size of the claim with respect to the level of trans fats.

Food products are currently required to disclose the amount of total fat and saturated fat if they bear a cholesterol claim and contain an amount of total fat or saturated fat that increases risk of diet-related health conditions. The bill would extend this requirement to trans fat.

  1. Natural” Claims

The bill provides that not later than two years after enactment, FDA must promulgate a regulation defining the term “natural.”  The FDA definition must exclude, at a minimum, the use of any artificial food or ingredient and be based on data on consumers’ understanding of the term as used in connection with food.  The bill requires FDA to conduct consumer surveys and studies and to issue a call for relevant research from the public, including but not limited to research with respect to consumer understanding of the term “natural” in relation to the term “organic.”

  • The bill would prohibit use of the term “natural” on food labels (other than dietary supplements) if the food contains any artificial ingredient, including any of the following:
  • Any artificial flavoring or artificial coloring;
  • Any ingredient that is synthesized whether or not it has the same chemical structure as a naturally occurring ingredient;
  • Any ingredient that has undergone chemical changes (such as corn syrup, high fructose corn syrup, high maltose corn syrup, maltodextrin, chemically modified starch, and cocoa processed with alkali), except for:
    • Food that has undergone traditional processes used to make food edible, to preserve food, or make it safe for human consumption (e.g., smoking, roasting, freezing, drying, fermenting); and
    • Food that has undergone traditional physical processes that do not fundamentally alter the raw product or which only separate a whole food into component parts (e.g., grinding grains, separating eggs into albumen and yolk, or pressing fruits to produce juice); and
    • Any other food or ingredient specified by the FDA by regulation to be “artificial.”

The term “synthetic” under the bill would mean “a substance that is formulated by a chemical process or by a process that chemically changes a substance extracted from a naturally occurring plant, animal, or mineral source, except that such term does not apply to a substance created by naturally occurring biological processes.”

  1. Healthy” Claims

The bill would require FDA to amend its existing regulation defining the implied nutrient content claim “healthy” for foods (other than dietary supplements).  Specifically, it would require that FDA amend the definition of “healthy” (21 C.F.R. § 101.65(d)) to take into account the presence of added sugars and whole grains.  A food that contains grains would not qualify for a “healthy” claim unless at least half of the grains, by weight, are whole grains.  FDA would also be directed by the bill to prohibit “healthy” claims for foods that contain more than 10 percent of the Daily Value of added sugars per serving. 

  1. Compliance Date for the Changes to the Nutrition Facts Panel

The bill would prohibit any further extensions of the compliance date for FDA’s final regulations updating the Nutrition Facts label issued in the Federal Register on May 27, 2016.  FDA, under the Trump Administration, has 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 U.S. 

  1. Changes to the Ingredients Declaration

The bill would establish the following new formatting requirements for the ingredients declaration on labels of foods (other than dietary supplements), with appropriate exemptions for small packages:

  • Use of upper and lower case characters;
  • Serif and non-condensed font types;
  • High contrast between text and background; and
  • Bullet points between adjacent ingredients.

The bill also contains new requirements for characterizing ingredients in the name of a food or on the PDP.  The bill requires that the named characterizing ingredient be either the “predominant” ingredient in the food, or the PDP disclose, in letters not less than one-half the height of the letters used in the name of the food, the percentage of the characterizing ingredient.

For foods containing phosphorus, the bill would require the disclosure of phosphorus in the ingredient list along with the quantity reported in milligrams per serving.  The bill provides an exemption to this requirement if the quantity of phosphorus is declared in the Nutrition Facts panel.

  1. Caffeine Content Labeling

The bill would require that, if a food (other than a dietary supplement) contains at least 10 milligrams of caffeine per serving from all sources, the label must include a statement of the number of milligrams of caffeine per serving and the serving size.  The statement of caffeine content would be required to appear with appropriate prominence on the information panel of the food.

  1. Allergen Labeling for Sesame

The bill would add sesame to the list of major food allergens in Section 201 (qq)(1) of the Food, Drug, and Cosmetic Act.

  1. Information about Major Food Allergens

The bill provides new format requirements for the disclosure of major food allergens.  The bill would require that the names of major food allergens be printed immediately after or adjacent to the list of ingredients in a type size no smaller than the type size used in the list of ingredients.  In the case of a nonpackaged food, the name of the major food allergen would have to be placed on a sign adjacent to the food in a type size no smaller than the name of the food item.

  1. General Provisions for Label Submission to the Agency

 The bill mandates that FDA require all manufacturers and importers to submit to the agency labels of food in interstate commerce including the Nutrition Facts panel, ingredient list, an image of the PDP, all nutrient content claims, and all “health related” claims appearing on the package.

  1. Civil Penalty Authority

The bill provides FDA with civil penalty authority for knowing violations for failure to comply with the label submission requirement (in an amount not to exceed $10,000 for each day on which such violation continues with respect to such food).

Expect to see at least some of these issues raised in future proceedings implementing the FDA’s Nutrition Innovation Strategy.  FDA’s strategy indicates that the agency will be examining the definition of “healthy,” reviewing current requirements for ingredient labeling, and possibly addressing some of the other matters raised in the legislation.  Stay tuned.

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