- On June 17, 2024, FDA published a proposed exemption for certain cottage cheese products from the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). FDA initially announced its intention to consider an exemption for cottage cheese regulated under the Grade “A” Pasteurized Milk Ordinance (PMO) in the preamble to the final Food Traceability Rule in November 2022.
- As we have previously blogged, the Food Traceability Rule is one of nine major finalized rules intended to implement the Food Safety Modernization Act and thereby reduce the prevalence of foodborne illness. The Rule is intended to allow for faster identification and removal of potentially contaminated food from the market. The Food Traceability List (FTL) designates the foods subject to the rule, and manufacturers must maintain additional records about critical tracking events in their supply chain related to foods on the list.
- 21 CFR 1.1360-1400 describe the circumstances and process by which FDA may exempt a food from the Food Traceability Rule requirements. In general, FDA will modify requirements applicable to a food or type of entity, or exempt a food or type of entity, when the Agency determines that application of the Rule’s requirements that would otherwise apply to the food or type of entity is not necessary to protect the public health. FDA may consider a modification or exemption on its own initiative or in response to a citizen petition. FDA uses a risk-ranking model inform the FTL by evaluating known or reasonably foreseeable hazards related to commodities.
- Cottage cheese is included on the FTL in the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened” based on the risk for Listeria monocytogenes and other pathogen contamination after pasteurization steps. However, because the PMO has specific processing requirements for Grade “A” cottage cheese that address these risk factors, and because Grade “A” cottage cheese undergoes enhanced regulatory oversight during manufacturing, FDA has tentatively concluded that application of the Food Traceability Rule requirements to Grade “A” cottage cheese is not necessary to protect public health.
- FDA is accepting comments on the proposed exemption until September 16, 2024. Keller and Heckman will continue to monitor and provide updates on the proposal and the Food Traceability Rule generally.
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Kraft Recalls “Unpleasant” American Cheese Singles
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- Kraft Heinz is recalling about 83,000 cases of its individually wrapped Kraft Singles American cheese, as they might be considered a choking hazard. The company stated that a “temporary issue” with one of its wrapping machines means that a “thin strip of the individual film may remain on the slice after the wrapper has been removed.” If not removed, it could be “unpleasant and potentially cause gagging or choking hazard.”
- The recall comes after several customer complaints of finding the piece of plastic on the cheese. No injuries or health issues have been reported and the faulty machine has since been fixed.
- The issue affects two types of packing, including 16-ounce “Kraft Singles American Pasteurized Prepared Cheese Product” with a “Best When Used By” date between January 10, 2024, and January 27, 2024. Individual packages in this recall contain an “S” and “72” in the manufacturing code on the packaging. Also affected are the 3-pound multipacks of “Kraft Singles American Pasteurized Prepared Cheese Product” with a UPC code of 0-2100060491-3 and a “Best When Used By” of January 9, 2024 and January 16, 2024.
- The recall comes after Kraft announced earlier this year that it was changing the packaging on its individually wrapped cheese to make them easier to open.
Feta Cheese Class Action Alleging Misleading Geographic Origin Dismissed
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Feta Maker Puts Greek Font Labeling Suit Out To Pasture (Law360 Subscription Required)
- A federal judge in New York dismissed a class action lawsuit alleging that a feta cheese package would deceive a reasonable consumer into believing the product had been made in Greece. We commented on this lawsuit when it was filed in August 2022, noting that the plaintiff’s success could depend on whether the package explicitly used the country name.
- The lawsuit, filed against Lactalis America Group Inc. on August 14, 2022, claimed that the labeling of the company’s President brand feta cheese falsely led consumers to believe that the product is made in Greece based on:
- Representation that the company is “Europe’s leading cheese expert;”
- The depiction of a gold olive branch; and
- The word “feta” stylized in an “ancient-Greek font.”
- In addition, the back label of the package states the cheese was “created by a family of artisan cheesemakers with over 80 years of French heritage” and “distributed in ‘Buffalo, NY.’”
- According to the judge, these facts are insufficient to state a claim that consumers would have been misled into believing the product is made in Greece. He stated in his opinion that “while a discerning shopper may associate feta cheese with Greek tradition, it is unreasonable to conclude that reasonable consumers would expect that a mass-produce cheese product was made in Greece based on little more than a font style, and in the absence of any statement that the product was made in Greece.” He also noted that without a statement that the product is made in Greece, “no reasonable consumer” would view the statement that the product is distributed in “Buffalo, NY” and referencing “French heritage” and automatically conclude that the product is made in Greece.
- The judge further dismissed the plaintiff’s remaining claims of unjust enrichment, negligent misrepresentation, fraud, and violations of express warranty, implied warranty, and the Magnuson-Moss Warranty Act for failure to state a claim, as well as a multistate misrepresentation claim due to lack of standing.
Class Action Alleges Feta Cheese Made in USA Misleadingly Suggests European Origin
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Feta Maker’s ‘Greek’ Claim Crumbles On Inspection, Suit Says (Law360 Subscription Required)
- A plaintiff’s success in one of the proliferating class action lawsuits over geographic origin hinges on whether the front label of the product at issue would lead a reasonable consumer to believe the product is made in a place other than where it is. Explicit use of a country name in such case may doom the defendant. In a lawsuit settled by Godiva Chocolatier, Inc. (“Godiva”), discussed here, for example, “Belgium 1926” was found to have created a plausible inference that the chocolates are of European origin. In contrast, however, for a yoghurt made in New York with a front label containing the “Icelandic Provisions” brand name and the phrase “Traditional Icelandic Skyr” against a snow-covered backdrop, a court found references to “Icelandic” to be akin to “in the style of Iceland,” which signals that the product is not made in the place that is named.
- On August 14, 2022, plaintiffs filed a putative class action complaint against Lactalis America Group Inc. in the United States District Court Western District of New York that alleges the labeling of Président brand feta cheese gives the false impression that the product is made in Greece, or at the very least in another European country. Facts that allegedly create the inference of Greek or European origin are:
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- “Feta” rendered in ancient-Greek font;
- A gold olive branch framing the brand name, Président; and
- The slogan, “Europe’s Leading Cheese Expert” over the top of the brand name.
The complaint also notes that the statements “created by a family of artisan cheesemakers with over 80 years of French heritage” and “Dist. By Lactalis American Group, Inc.” appear in small print on the bottom of the package, and contend that the United States origin of the product can be discovered by visiting third-party websites noting the product is “Freshly Crafted in the USA” and “Made in the European tradition.”
- Since the complaint only presents one side of the dispute, it is difficult to predict how this case will turn out. Keller and Heckman will continue to monitor and report on this litigation.
New Lawsuit Over Ortho-Phthalates in Mac & Cheese
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Annie’s Mac And Cheese Uses Harmful Chemical, Suit Says (Subscription to Law360 required)
- A putative class action complaint was filed in the U.S. District Court for the Eastern District of New York on April 1, 2021 against General Mills’ Annie’s macaroni and cheese products. The named plaintiff alleges that more than twenty products are mislabeled and falsely advertised as “Made with Goodness!” because the presence of ortho-phthalates is not disclosed on the packages.
- The complaint notes recent findings of phthalates in the cheese powder of other brands of macaroni and cheese products and alleges that General Mills “has tested its macaroni and cheese products and they do contain phthalates.” Further, the plaintiff points to the FAQ section of Annie’s website, including the statement, “We are troubled by the recent report of phthalates found in dairy ingredients of macaroni and cheese,” as evidence that the defendant “acknowledges the problem.” While the Annie’s website notes “the European Food Safety Authority (EFSA) has published risk assessment data which notes a Total Daily Intake of 0.05 mg/kg of body weight” as a threshold for levels of phthalates in food, and indicates that “any trace of phthalates are below the EFSA standard,” the plaintiff alleges that Annie’s products “were not safe or healthy for consumption.”
- Other courts have dismissed similar false advertising claims on the basis that the failure to disclose trace, non-harmful amounts of a chemical does not constitute misleading advertising where the substance is pervasive in the environment and present in many foods.
Sargento Foods Faces Two Labeling Suits Regarding “No Antibiotics” Claims on Cheeses
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- Two lawsuits filed against Sargento Foods in December 2020 (Phan v. Sargento Foods Inc., No. 5:20-cv-09251 (N.D. Ca.)) and January 2021 (Beyond Pesticides v. Sargento Foods, No. 2021-CA-000178 B (Sup. Ct. D.C.)) assert that “no antibiotics” claims on Sargento’s cheese products mislead consumers into thinking that the cows that produced the milk used in the cheeses are never treated with antibiotics. Sargento’s labels include a disclaimer that “no antibiotics” means that “our cheese is made from milk that does not contain antibiotics.”
- The claims in the litigation alleging false advertising rely on a 2018 publication from Consumer Reports that says a majority of consumers believe a “no antibiotics” statement on a food label means that animals producing the food never received antibiotics, and as such, a reasonable consumer would be misled by Sargento’s “no antibiotics” claim, despite the disclaimer. The suits also allege that one Sargento cheese product did present detectable levels of sulfamethazine, an antibiotic that is prohibited from use in lactating dairy cattle. Sargento has not yet responded to either lawsuit.
- Both FDA and USDA are working to address consumer concerns about antibiotic stewardship in food animal production. While antibiotics are sometimes used to treat bacterial infections in dairy cows, the Pasteurized Milk Ordinance developed by the FDA and adopted by most states require dairy farms to discard milk from cows treated with antibiotics for a specified withdrawal period and milk processers to test all milk, including organic milk, for the presence of beta-lactam antibiotics (such as penicillin and amoxicillin, among others) upon arrival at the milk processing facility before being added to a bulk supply. A fact sheet from the National Milk Producers Federation provides more details on antibiotic testing and this page from FDA provide more details on antibiotic testing. The USDA Food Safety and Inspection Service has also provided guidance for food labels that make animal raising claims, including claims about antibiotics.
Flavor Litigation Update: Smoked Cheese
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- A proposed class of consumers filed a complaint (Law360 subscription required) against the grocery chain Aldi Inc. on January 26, 2021 in the Eastern District of New York alleging that Aldi’s “Smoked White Cheddar – Deli Sliced Cheese” product is mislabeled because it allegedly achieves its smoked flavor from natural flavorings rather than by smoking the cheese. The complaint asserts that while “natural smoke flavor” is listed as an ingredient, the front panel of the product violates FDA flavor labeling regulations by failing to use a product identity statement that shows the flavor is added and not obtained through smoking.
- The Aldi suit closely follows claims in two previous cases filed in 2020 against Dietz & Watson Inc. in New York federal courts regarding smoked provolone and smoked gouda cheese products. Each case relies on the same FDA regulations, outlined in detail in our previous post, and highlights an FDA warning letter sent to Middlefield Original Cheese Co-op in 2017 that alleged that two Middlefield products were improperly labeled as “smoked cheese” when the flavor was obtained with added flavors rather than smoking the cheese.
- In the Dietz & Watson smoked provolone case, plaintiffs filed to voluntarily dismiss the suit with prejudice earlier this month; settlement details have not been made public. To date, Dietz & Watson continues to advertise the smoked provolone, gouda, and other smoked cheeses on their website; the package labeling and product identity statement do not appear to have changed from those depicted in the original complaints.
- The plaintiff’s counsel in the above three cases is Sheehan & Associates, a firm that has become known in recent years for its pursuit of class action litigation claiming harm to consumers from allegedly misleading food labeling. The Sheehan firm has represented a number of class action plaintiffs in the recent spate of flavor labeling challenges.
Proposed Class Sues Cheese Producer Over Smokey Flavor Labeling (Subscription to Law360 Required)
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- A proposed class of cheese buyers is suing Dietz & Watson Inc. in New York federal court, claiming that its smoked provolone cheese is falsely advertised because the cheese is made with “smoke flavor” instead of actually smoking the cheese in burning wood chips. Plaintiffs allege that the Dietz & Watson labels are not in compliance with FDA’s flavor labeling regulations, which state the following:
- If the food is commonly expected to contain a characterizing food ingredient and the ingredient is present in a sufficient amount to independently characterize the flavor of the product (regardless of whether the food contains any added natural flavors), the name of the ingredient should simply accompany the product name.
- However, if the product contains any artificial flavors simulating, resembling or reinforcing the characterizing flavor, the name of the food on the PDP must also be accompanied by the words “artificial” or “artificially flavored.”
- If, on the other hand, the food contains only added natural flavor derived from the characterizing ingredient, the product identity statement must include the name of the characterizing flavor and the word “flavored,” and may include a description of the flavor as “natural.”
- If none of the natural flavor used in the food is derived from the product whose flavor is simulated (i.e., if all of the natural flavor is from another source), the food in which the flavor is used must either be labeled with the name of the product from which the flavor is derived or be described as “artificially flavored.” 21 CFR 101.22.
- The Dietz & Watson label states that the product is “piquant & full flavor,” but does not appear to disclose that flavoring is used in the product to provide the smokey flavor. The class pointed to a 2017 FDA Warning Letter that stated foods using added flavors instead of the smoking process must declare that fact on the front label, while descriptions of the smoking process should not be in the ingredient list.
- The proposed class intends to represent buyers from New York and the other 49 states who bought the cheese. The suit brings claims under New York’s consumer protection statutes, as well as for negligent misrepresentation, breach of express and implied warranty, fraud and unjust enrichment. The complaint seeks unspecified money damages and an injunction barring Dietz & Watson from continuing to label its smoked provolone as it currently does.
Grated Parmesan Cheese Companies Can’t Escape Food Fraud Litigation on Excess Cellulose
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- Grated parmesan companies Kraft Heinz Co. and SuperValu Inc. have not been able to end multidistrict litigation that began in 2016, alleging food fraud for excess cellulose as an anticaking agent. While the defendants argue that the cellulose acted as an anticaking agent, plaintiffs allege that the cellulose was being used as a filler in the cheese marketed as “100% cheese.”
- A federal district court judge in Illinois has denied (Law360 subscription required) Plaintiff’s attempt to amend their complaints to reintroduce previously dismissed defendants, Publix and Target/ICCO. The judge also dismissed state law claims requiring plaintiffs to demonstrate that they relied on misrepresentations to make their purchases because of the plaintiff’s deficient pleadings. However, other state consumer protection claims that do not have the same reliance requirement have been allowed to proceed because the pleadings were sufficient for such claims.
- While FDA’s grated cheese regulation allows for companies to add cellulose as an anticaking agent in cheese to prevent clumping, using more than the minimum amount required to achieve the anticaking effect presents the possibility of a food fraud allegation. For more information on food fraud and other litigation risks, check out our Practical Food Law Seminar happening in Brussels on October 2-3, 2019.
U.S. Senators Urge Trump Administration to Protect Use of Cheese Names in NAFTA (Law360 subscription required)
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- On May 14, 2018, two dozen U.S. senators urged the Trump administration to protect the use of common cheese names in the North American Free Trade Agreement (NAFTA). Spearheaded by Sens. Tammy Baldwin, D-Wis., and Pat Toomey, R-Pa., the senators implored the administration to make sure that any new NAFTA deal is not hindered by rules of the EU-Mexico agreement that give EU producers exclusive rights to market certain cheeses under geographic names.
- As background to this issue, in April 2018, the European Union (EU) and Mexico announced they reached an agreement to update their 18-year-old bilateral trade agreement. The new deal would remove duties for all agricultural goods, offer protections for some EU cheese names, and create Mexican tariff-rate quotas for EU milk powder and cheese. The agreement would give new market access to the EU by introducing tariff-rate quotas for EU cheese exports to Mexico. During a five-year period, Mexico would gradually raise a quota of 20,000 tons for mature cheeses and 5,000 tons for fresh cheeses.
- The U.S. and EU have long battled over geographical indications (GIs) for products and was one of the core issues that prevented talks for the Obama-era Transatlantic Trade and Investment Partnership from progressing. The GIs pursued by the EU are commonly sold in the U.S., such as parmesan, which the EU believes must refer only to a cheese from the Parma region of Italy. However, such a rule would be in conflict with Mexico’s NAFTA commitments. According to the senators, “[i]f Mexico grants European cheese producers exclusive rights to use common cheese names, as reports indicate it has agreed to do, American producers will lose market share they have spent years developing.”
- We reported a similar issue on this blog in 2017, and as previously mentioned, granting the EU GI protections could cost the U.S. dairy industry billions of dollars. For example, U.S. producers shipped $1.3 billion worth of cheese to Mexico in 2017. Keller and Heckman will continue to monitor and report on the status of GIs within NAFTA.