Search results for: preservative

  • Gerber filed a memorandum (Law360 subscription required) in support of its motion to dismiss a proposed class action that claimed the company had falsely advertised its baby food snack products as containing “no preservatives” even though they contained vitamin C. According to the lawsuit filed in November of 2023, the products were marketed in a misleading manner by bearing a label claim that they do not contain preservatives and listing the ingredient as “Vitamin C (Ascorbic Acid).” The plaintiffs allege that vitamin C is a preservative regardless of whether it is added to preserve the food or for some other purpose.
  • Ascorbic acid is generally recognized as safe for use in human food as both a chemical preservative and a nutrient. According to Gerber, the complaint is preempted because it conflicts with FDA’s regulatory scheme, “which does not require an ingredient to be labeled as a preservative unless it serves a preservative function.” Gerber claimed that vitamin C is used to fortify the products nutritionally, which are preserved through freeze drying, eliminating the need for further preservatives.
  • Gerber stated that consumers could not have been deceived by the “no preservatives” label since there is no ingredient in the products functioning as a preservative. It argued that it is “fanciful, illogical, and insufficient” to support a deception claim based on the theory that “no preservatives” should be interpreted to mean that there are no ingredients that could possibly function as a preservative, even if that is not their intended use.
  • This is one more case in a string of recent lawsuits challenging “no preservative” claims on products that contain ingredients that could function as a preservative. Keller and Heckman has previously blogged on and will continue to monitor these lawsuits.
  • A class-action lawsuit was filed (Law360 subscription required) last week alleging that Defendants’ Motts, LLP and Keurig DR Pepper Inc. falsely and misleadingly labeled their product, “Mr. & Mrs. T Original Bloody Mary Mix,” as containing “no added preservatives” when it contains citric acid, which is alleged to function as a preservative.
  • FDA defines “preservative” in part as “any chemical that, when added to food, tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils extracted from spices . . .” 21 CFR 101.22(a)(5). Citric acid is affirmed as GRAS in 21 CFR 184.1033 for general use in food. The Food Chemicals Codex monograph for citric acid describes its functions as a “sequestrant; dispersing agent; acidifier; flavoring agent.”    
  • Plaintiff argues that the primary function of citric acid in the product is as a preservative, regardless of any other functions it may perform, especially because “Defendants have not declared a contrary purpose for adding citric acid and the Products separately contain flavorings (i.e., ‘natural flavor’) as an ingredient.” However, we note that products may contain multiple flavors, and there is no requirement that a flavor be declared as such (i.e., citric acid, when used as a flavor, could be declared as “citric acid.”). Furthermore, citric acid could be used as a “flavor enhancer,” a substance “added to supplement, enhance, or modify the original taste and/or aroma of a food, without imparting a characteristic taste or aroma of its own.” 21 CFR 170.3(o)(11).
  • At the pleadings stage, the Court will have to decide whether Plaintiff has sufficiently alleged that citric acid acts as a preservative. Compare Hu v. Herr Foods, Inc.,251 F. Supp. 3d 813 (E.D. Pa. 2017) (holding that plaintiff failed to adequately allege that citric acid acts as a preservative in the product at issue) with Mason v. Reed’s Inc., 515 F. Supp. 3d 135 (S.D.N.Y. 2021) (holding that Plaintiff had adequately alleged that citric acid acted as a preservative). Although such cases frequently settle, we will continue to monitor and report on any substantive decisions in this case.

Pepsi Falsely Touts ‘No Preservatives’ In Izze Drinks, Suit Says (Subscription to Law360 required)

  • On December 1, PepsiCo and the equity firm behind Tropicana, PAI Partners, Inc., were named defendants in a proposed class action suit in New York federal court for its Izze-brand sparkling juice products which contain the common ingredients ascorbic and citric acids.
  • In an 18-page complaint, plaintiff Taylor alleged that the companies “systematically misled” the public by purportedly claiming the popular Izze sparkling juice beverages contain no preservatives, which she claims is a marketing tactic aimed towards health-conscious shoppers looking for more options that don’t contain preservatives.
  • The Izze-brand drinks include the phrase “NO PRESERVATIVES” on the front label; however, the ingredient statements featured on the product labels list both citric acid and ascorbic acid. The Izze line of drinks includes a variety of flavors such as sparkling blackberry, blackberry lemonade, peach, apple, pomegranate, clementine and grapefruit.
  • According to the complaint, citric acid functions as a preservative by acting as an acidulant and indirect antioxidant. Citric acid infiltrates, then either weakens or kills microorganisms in a product through direct antimicrobial effect and can lower a product’s pH level, according to the suit. Citric acid is one of the most widely-used acidulants in the food and beverage industry.
  • The complaint similarly claims that ascorbic acid, like citric acid, functions as an antioxidant that helps prevent microbial growth and oxidation in food products, thereby preserving their color and freshness. The FDA regulates the use of ascorbic acid in the formulation of wine and juice “to prevent oxidation of color and flavor components of juice” pursuant to 27 C.F.R. § 24.246.  The complainant alleges that ascorbic acid, like citric acid, has preservative effects even when used in small amounts, which in turn supports the conclusion that the products contain preservatives.
  • Plaintiff Taylor asserts violations of state consumer protection statutes and violations of New York General Business Law sections 349 and 350, and seeks relief in the form of compensatory, statutory and punitive damages, along with attorney fees and costs.
  • The case is Tiffany Taylor v. PepsiCo Inc. and PAI Partners Inc., case number 7:22-cv-10219, in the U.S. District Court for the Southern District of New York, and is another in the line of class action challenges to the use of preservative claims for products containing multipurpose ingredients like ascorbic and citric acid.  Defendants typically respond that these ingredients are used to add tartness to the product and are not used for any preservative effect.
  • Keller and Heckman will continue to monitor this case and report on any notable developments.

Ill. Judge Trims Fraud Suit Targeting Barilla Pasta Sauce (subscription to Law360 required)

  • A proposed class action lawsuit filed against Barilla America Inc. in October 2018 alleges that consumers in Illinois, California, and Kansas were misled by the claim “no preservatives” on jars of pasta sauce containing citric acid as an ingredient.  The plaintiffs assert that Barilla’s pasta sauce is deceptively labeled as containing no preservatives because the U.S. Food and Drug Administration (FDA) recognizes citric acid as a preservative that delays rancidity, prevents spoilage, and slows certain other changes in food.
  • On December 10, 2021 a federal judge in the Northern District of Illinois ruled from the bench that consumer fraud, breach of warranty, and unjust enrichment claims can proceed against Barilla over the allegedly deceptive labeling.  The judge ruled against the plaintiffs on implied warranty and negligent misrepresentation claims, although leave to amend was granted.  The judge also denied injunctive relief, finding that plaintiffs’ future harm is conditional, being dependent on their choosing to purchase the pasta sauce again as opposed to purchasing a different brand or making their own pasta sauce.
  • As discussed here, a similar false advertising lawsuit brought by the same attorneys was dismissed last year against Kraft Heinz Food Co. concerning its Capri Sun juice products containing citric acid.  The more succinct “no preservatives” labeling on the pasta sauce, however, may be distinguished from “no artificial preservatives” labeling on Capri Sun where the plaintiffs’ case was doomed by problems drawing a connection between the common industry practice used to artificially manufacture citric acid and the actual practice used by Kraft.
  • On November 19, a proposed class of consumers sued Del Monte Foods Inc. in Illinois federal court over a “no preservatives” claim on its canned Farmhouse Cut Green Beans. The proposed class alleged that the salt added to the green beans causes the “no preservatives” claim to be false and misleading.
  • The complaint, filed by named plaintiff Jaymee Fleming, alleges that consumers are increasingly looking for foods produced without preservatives, and that Del Monte charges a premium for its green beans by claiming that they have no preservatives. Fleming further alleges that the green beans packaging advertises that they are “with natural sea salt,” noting that salt can be added for taste as well as preservative effect. Fleming argues that Del Monte uses the salt as a preservative because it prevents deterioration of the green beans, makes it harder for bacteria to survive in the can, prevents and slows discoloration, and helps the green beans maintain texture and flavor. Thus, Fleming argues that the claim “no preservatives” is misleading to consumers who do not want to consume any type of preservatives in their food.
  • Fleming alleges that by using the salt, Del Monte gains an advantage over other companies and is able to charge more for its products by claiming that they are made without preservatives. Fleming seeks to represent two classes of consumers who purchased green beans: one for buyers in Illinois and another for buyers in North Dakota, Rhode Island, Michigan, Virginia, Wyoming, and Delaware. Keller and Heckman will continue to monitor and report on any developments.

The Daily Intake is taking a break for the Thanksgiving holiday and will return on November 29. We wish you a wonderful Thanksgiving holiday!

Kraft Dodges Suit Over ‘No Preservatives’ Capri Sun Label (subscription to Law360 required)

  • A proposed class action, filed in the Northern District of Illinois on October 25, 2018, against Kraft Heinz Food Co. accused the company of falsely advertising its Capri Sun juice as containing “no preservatives” when in fact it contains citric acid. Tarzian et al v. Kraft Heinz Food Company, Case No. 1:18-cv-07148. The complaint alleged that the representation that Capri Sun beverages contain “No Artificial Coloring, Flavors, or Preservatives” is unfair and deceptive advertising as the beverages contain a well-known preservative, citric acid.
  • In an order filed on October 10, 2019, U.S. District Judge Charles P. Kocoras dismissed the lawsuit and found that while the plaintiffs allege practices commonly used to manufacture citric acid throughout the industry, plaintiffs failed to draw a connection between the common industry practice and the actual practice used by Kraft.
  • This dismissal follows a dismissal of a similar matter in California federal court in 2015. Osborne v. Kraft Heinz Group, Inc., Case No. 3:15-cv-02653. In that case, plaintiffs accused Kraft of mislabeling Capri Sun drinks as “all natural” when they allegedly contained synthetic ingredients, including citric acid and natural flavor. In a hearing on the defendant’s motion to dismiss, U.S. District Judge Vince Chhabria found that plaintiff did not know whether the citric acid used in Capri Sun’s drinks was natural or synthetic. The judge ultimately granted Kraft Heinz’s motion to dismiss with leave to amend the complaint. The plaintiff never filed an amended complaint.
  • The 9th Circuit Court of Appeals affirmed the dismissal (Law360 subscription required) of a class action alleging that Del Monte Foods, Inc., falsely advertised its “Fruit Naturals” fruit cups as “natural” despite containing synthetic preservatives. The original lawsuit was filed in early 2023 and dismissed in October of that year.  
  • The fruit cups, which are labeled as “Fruit Naturals,” contain ingredients like potassium sorbate and methylcellulose gum. According to the plaintiff, Del Monte did not disclose that these ingredients are synthetic, and consumers are not “expected or required to ‘scour’ a product’s listed ingredients” to determine whether products are, in fact, natural. However, the district court found that, because the ingredients are specifically listed on the back label, the label was not “unambiguously deceptive” because the “front label, as clarified by the back label, [would not] mislead a reasonable consumer into thinking that the products don’t contain synthetic ingredients.”
  • In affirming the district court ruling, a 9th Circuit panel found that a survey cited by the plaintiff to support the deceptive nature of the label was uninformative because it asked respondents about the adjective “natural,” rather than the noun “naturals.” Here, the word is used as a noun in the name of the product. Further, the label depicts the picture and name of the fruit in the cups followed by the phrase “in extra light syrup.” This conveys that the fruit itself is natural, but the syrup may not be.
  • According to the panel, the labels are ambiguous, meaning that “’reasonable consumers would necessarily require more information before they could reasonably conclude’ that the front label makes a specific factual representation.” A reasonable consumer would look to the back label, which, here, “accurately and clearly discloses several synthetic ingredients,” thus resolving the ambiguity.
  • On June 27, 2023, the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) narrowly voted against a proposal to lower the maximum permitted limits for the food additives sodium and potassium nitrites (E 249-250) and sodium and potassium nitrates (E 251-252) because the proposed limits did not go far enough. Instead, a motion has been proposed that would ban the use of nitrites and nitrates in the EU following a four-year phase out period.
  • Nitrates and nitrites are widely used as preservatives in cured meat products such as bacon, ham, cold cuts, charcuterie, and some cheeses. Those in favor of a reduction and not a ban argued that nitrate/nitrite-free products are more expensive and therefore less accessible to some consumers.  In contrast, those in favor of a total ban cited the health concerns raised by the European Food Safety Authority (EFSA)’s January 2023 risk assessment on N-nitrosamines in food. N-nitrosamines are reaction products of nitrates and nitrites in certain food processing conditions. Many N-nitrosamines are genotoxic and carcinogenic and are associated with increased incidence of colorectal cancer.  However, the report also highlighted many uncertainties, including the levels at which N-nitrosamines are found in food products. 
  • The use of nitrates and nitrites as food additives has been restricted in certain EU member states such as in Denmark.  In the United States, nitrates are subject to a number of clearances, subject to certain limitations.  See e.g.  9 CFR 424.21(c) and 21 CFR 172.160, 172.170, and 172.175.
  • Keller and Heckman will continue to monitor the regulation of food additives in the EU.

  • Yesterday, FDA launched its new Dietary Supplement Ingredient Directory which contains a list of ingredients used in dietary supplements along with links to FDA’s actions and communications regarding the ingredients.
  • The Ingredient Directory will contain information on the two types of ingredients found in dietary supplements: “dietary ingredients” and “other ingredients.” A “dietary ingredient” is defined (in 21 USC § 321(ff)) as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. “Other ingredients” include ingredients such as fillers, binders, excipients, preservatives, sweeteners, and flavoring, and are listed separately on the label.
  • The Ingredient Directory will be periodically updated. However, it is not intended to be a comprehensive list of all ingredients used in dietary supplements and may not include all actions that the FDA has taken on a particular ingredient. For example, some duplicative actions or actions that no longer reflect the FDA’s current position may not be listed.
  • FDA’s Dietary Supplement Advisory listserv has been retired, but anyone subscribed to that list will receive updates to the Ingredient Directory.
  • On January 18, USDA published a final rule expanding the criteria of generic label approval for inspected meat, poultry, and egg products. The Expansion of Generic Labeling Rule is largely consistent with the proposed rule published in September 2020, which proposed to discontinue review of generically approved labels and expand the circumstances under which FSIS will generically approve food labels under its jurisdiction. Notably, the final rule does not eliminate the requirement to comply with USDA’s labeling regulations, but instead shifts the burden of compliance for generic labels onto the manufacturer.
  • Under the current regulations, FSIS evaluates sketches of some labels for approval, and approves others generically without submission to FSIS for sketch approval. To obtain sketch label approval, domestic meat and poultry establishments, egg product plants, and certified foreign establishments that are eligible to export product to the United States, or their representatives, are required to submit sketch labels to FSIS for evaluation, except when the label is generically approved by the Agency under 9 CFR 412.2. FSIS allows certain meat, poultry, and egg product labels that bear all required labeling features and that comply with the Agency’s labeling regulations to be generically approved (9 CFR 412.2(a)(1)). Generically approved labels do not need to be submitted to FSIS for sketch approval before they can be used on products in commerce. Generic label approval requires that all mandatory label features are prominent and conform to FSIS regulations. Although such labels are not submitted to FSIS for approval, they are deemed to be approved and, therefore, may be applied to product in accordance with the Agency’s prior label approval system.
  • The final rule will expand generic approval to products only intended for export that deviate from domestic labeling requirements and permit generic approval of the labels of products that receive voluntary FSIS inspection. It will also expand generic approval to:
    • (1) “Organic” claims that appear in a product label’s ingredients statement;
    • (2) Labels of products that receive voluntary FSIS inspection (e.g., exotic species);
    • (3) “Geographic landmarks” displayed on a product label (e.g., a foreign country’s flag, monument, or map); and
    • (4) “Negative” claims made on product labels that identify the absence of certain ingredients or types of ingredients (e.g., statements such as “No MSG Added,” “Preservative Free,” “No Milk,” “No Pork,” or “Made Without Soy”). However, the final rule does not include negative animal raising claims (e.g., “no antibiotics administered”).
  • As of the effective date, FSIS will no longer evaluate labels submitted to FSIS that are eligible for generic approval. FSIS will, however, continue to provide industry with relevant resources, including updated generic labeling guidance, and timely answers to generic labeling questions. FSIS has updated the FSIS Guideline for Label Approval and intends to update and reissue FSIS Directive 7221.1.
  • The final rule will become effective on March 20, 2023. Interested parties may submit comments on the revised FSIS Guideline for Label Approval on or before February 17, 2023 here. Keller and Heckman will continue to monitor and report on the USDA generic label approval rules.