Salt, chicken, and more were on the minds of federal regulators in April, as the U.S. Food and Drug Administration (“FDA”) issued proposed rules and labeling guidance on food products, and the USDA was petitioned to better define its labeling of “pasture-raised” versus “free range” chicken. In litigation, consumer fraud class actions concerning “natural” and/or “preservative-free” claims on fitness drink labels remained popular, and one suit culminated in a large, multi-million dollar class action settlement in the Southern District of New York.

1. Guidance on Labeling

Dietary Guidance Statements to Promote Healthy Nutrition

The FDA issued draft guidance for food manufacturers on how and when to use Dietary Guidance Statements on food labels. Dietary Guidance Statements are words or images that appear on labels to help consumers make healthier food choices. Examples include: “Eat leafy green vegetables as part of a nutritious dietary pattern” or “make half your grains whole grains.”

There are several key takeaways from the draft guidance, including that a food item whose packaging contains a Dietary Guidance Statement should contain “a meaningful amount” of the food (or food groups) to which the Dietary Guidance Statement refers. The “meaningful amount” criteria varies based on the type of “food group equivalent” (i.e., fruits, vegetables, grains, dairy and proteins).

Moreover, food items labeled with a Dietary Guidance Statement should not exceed certain levels of saturated fat, sodium, and added sugars. Levels for each of these nutrients vary based on the particular type of food. A lengthy Appendix to the draft guidance specifies levels of these nutrients in different food products.

Further, Dietary Guidance Statements should be substantiated by “consensus reports,” including scientific evidence and/or research, such as generally accepted dietary recommendations developed and/or recommended by experts.

Harris Beach’s Food and Beverage attorneys are well equipped to guide manufacturers in the nuances of how the proposed guidance applies to labeling of specific food products.

FDA’s Proposed Rule Regarding Salt and Salt Substitutes

The FDA proposed a rule entitled Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods that would permit manufacturers to use a salt substitute (rather than sodium) in foods by changing the standards of identity in 80 foods.

By way of background, since the 1930s, FDA has defined these foods using standards of identity to describe necessary ingredients and, in some cases, formulations or manufacturing processes, in order to ensure food products contain the ingredients that a reasonable consumer would believe them to contain (i.e., fruit jams must contain a certain amount of fruit). Standards of identity generally specify salt as a required or optional ingredient across many foods, but the amendment to the standards is aimed at reducing sodium intake by permitting manufacturers to “use . . . safe and suitable salt substitutes to replace some or all of the salt used in the manufacture of standardized foods.” Critically, the rule requires that any salt substitute added to a standardized food be either an approved food additive or generally recognized as safe for its intended use.

The proposed rule is significant in that it takes a “horizontal approach” by seeking to amend standards of identity across all standardized foods, rather than targeting particular types or subsets of standardized foods, to allow for greater flexibility in the food manufacturing industry as a whole. The amendments to standards of identity also provide for increased flexibility in labeling, as manufacturers would be permitted to use salt substitutes without being required to label food as “low-sodium” or “reduced sodium” products, which themselves are regulated terms.

Comments on the proposed rule are due within 120 days after the date of publication in the Federal Register, which has not yet occurred. Harris Beach’s attorneys will continue to follow the rule-making process and provide updates as they develop.

A Game of Chicken: “Pasture-Raised” versus “Free Range”

In a move that may lead to significant developments for labeling in the poultry industry, Perdue Foods filed a petition requesting the U.S. Department of Agriculture (“USDA”) differentiate between the terms “pasture-raised” and “free range.” Perdue requested the USDA promulgate labeling regulations that make clear “pasture-raised” claims are not synonymous with “free range” claims, because “free range” simply denotes that chickens spend time outside in a wide variety of environments, which may not necessarily include a pasture. Perdue claims the differentiation in terms is necessary to reduce consumer confusion.

The company is awaiting an FDA response to its petition and Harris Beach Food and Beverage attorneys continue to monitor developments and implications for the poultry industry.

2. Consumer Fraud Claims Alleging Mislabeling of Fitness Drinks as “Natural” or “Free From Preservatives” Continue to Remain Popular

Consumer fraud lawsuits alleging the words “natural” or “preservative free” on food and beverage labeling are misleading because the products contain alleged “additives” or “preservatives”—which we previously reported on here—continued into April. A large class action settlement, and the continued filing of lawsuits that seek to attack “natural” and “preservative free” claims on food and beverage labels, illustrate the importance of meticulous record-keeping, which may enable manufacturers to provide clear evidence of ingredients and the manufacturing process to support labeling and packaging claims.

“No Preservatives” Claim Ends with Large Settlement

In Hezi v. Celsius Holdings, Inc., the United States District Court for the Southern District of New York approved a $7.8 million settlement between a class of plaintiffs and Celsius, the manufacturer of fitness drinks, for alleged mis-labeling which was premised on the claims the company’s beverages contain “no preservatives” despite listing citric acid as an ingredient. Similar to other lawsuits we reported on, plaintiffs claimed that product contained chemically manufactured, rather than natural, citric acid, and thus the beverages’ labels were deceptive. Plaintiffs in the Hezi case further claimed the citric acid constituted a preservative because it was added not for flavor, but to extend the products’ shelf life.

Rowdy Beverage Facing Similar “No Preservatives” Lawsuit

A similar beverage labeling class action has been filed against Rowdy Beverage Inc. in the United States District Court for the Southern District of California. Plaintiffs allege the company’s Power Burn energy drinks contain misleading labels, which claim that they are preservative free when they contain both citric and ascorbic acid. Plaintiffs further claim these ingredients are in fact used as preservatives to prevent microbial growth and oxidation.

Harris Beach Food and Beverage Counseling and Litigation Experience

Harris Beach routinely helps clients who manufacture and distribute food and beverage products to develop product labels and packaging, create marketing and advertising materials, institute record-keeping practices to comply with all legal and regulatory developments, assess potential litigation risks, initiate recalls and issue safety alerts where appropriate, and defend litigation and/or regulatory agency actions. We work closely with experts to conduct product testing, ensure accuracy of labeling, and bolster defenses in potential and/or actual litigation involving contamination claims.

If you have any questions about the information in this Legal Alert or other related matters, please contact attorney Jaime L. Regan at (212) 912-3506 and, attorney Abbie Eliasberg Fuchs, leader of the Mass Torts and Industry-Wide Litigation Industry Team at (212) 313-5408 and, or the Harris Beach attorney with whom you most frequently work.

This alert does not purport to be a substitute for advice of counsel on specific matters.

Harris Beach has offices throughout New York state, including Albany, Buffalo, Ithaca, Long Island, New York City, Rochester, Saratoga Springs, Syracuse and White Plains, as well as Washington D.C., New Haven, Connecticut and Newark, New Jersey.