Does Federal Law "Preempt" (Block) State Lawsuits for Mislabeling?

By Jesse Langel, Esq., LL.M.

| January 03, 2023

The below list explores the show-down between state law and federal law in the areas of food, beverages, animal products, medication, medical devices, dietary supplements, cigarettes, and more.

First, what is a brief definition of "federal preemption"?

Also referred to as the "Preemption Doctrine," the rule is that federal law supersedes any conflicting state law or common law duty—a concept rooted in the Supremacy Clause of the United States Constitution.

The Supremacy Clause Jesse Langel

First, federal law can expressly preempt state law through federal statute or regulation. The actual text of the statute or regulation contains direct language that preempts state law.

Secondly, federal law can impliedly preempt state law through a comprehensive regulatory structure that makes the full occupation of a particular field obvious. Known as "field preemption," federal law is so comprehensive that all state law in an entire field of law is overridden. Another type of implied preemption is known as "conflict preemption," where federal law preempts state laws that either (a) make it impossible for federal law to operate; or (b) frustrate the objectives of federal law. E.g., Crosby v. National Foreign Trade Council (2000) 530 U.S. 363, 371.

Congress’s purpose is the “ultimate touchstone” of preemption analysis.

To best understand the body of preemption law, it's best to study the evolution of the case law with an emphasis on U.S. Supreme Court jurisprudence.

A Chronological List of Court Rulings on Preemption

1963: A California statute adopting a percentage-of-oil test to gauge the maturity of avocados “did not have to yield to federal marketing orders adopting a calendar test of the maturity of avocados grown in Florida.” The California statute prohibited the transportation or sale of avocados that contained less than 8 percent oil by weight. The federal Agricultural Adjustment Act used only a calendar test to determine avocado maturity. State supervision of readying food for the market was of “peculiar local concern,” and within the scope of California police powers, held the U.S. Supreme Court. California’s stricter governance was not “ousted” (preempted) “automatically from the fact that Congress has regulated production and packaging of commodities for the interstate market.” Nor did California’s statute unreasonably burden interstate commerce or deny Florida growers equal protection under the Fourteenth Amendment. Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963).

1966: New York State had the legal authority to convict a meat distributor for misbranding beef frankfurters by adding into them excessive "extenders." Packages containing claims, "all beef" and "all meat" were misbranded as defined under New York Agriculture and Markets Law §§ 199-a, 200, and 201. It did not matter whether Defendant "knew" that the frankfurters were "adulterated" under state law. People v. Omage, 18 NY2d 770, 770-72 (Ct. App. 1966).

1972: Relating to sausage meat, a state law that required 12% protein, while federal law only required 11.2% protein, exceeded its authority and was preempted under federal law (FIMA). Michigan may only enforce federal misbranding provisions, especially those relating to "ingredient requirements," that is different than its own requirements. Armour & Co. v. Ball, 468 F2d 76 (6th Cir. 1972).

1973: Concurrent jurisdiction (states may hear cases in conjunction with federal court) exists under the Federal Meat Inspection Act (FMIA), so long as the state law at issue is identical to the federal law (FMIA). The court held that the FMIA did not preempt the state from enforcing it its own misbranding law. States have a long history of enforcing matters of food safety and food misbranding. Here, the USDA's pre-approval of labeling relating to imitation frankfurters did not preclude misbranding charges that were in total alignment with the directives of the FMIA. In Swift & Co., Inc. v. Walkley, 369 F. Supp. 1198, 1200 (S.D.N.Y. 1973).

1974: The presence of salmonella in chicken did not render it "adulterated" as defined in 21 U.S.C. 601(m) of the Federal Meat Inspection Act. The presence of salmonella alone, therefore, is not false or misleading, held the majority. A vigorous dissent disagreed with the premise that "labeling non-adulterated meat that is "inspected and passed" can never be false and misleading." The question held the dissent, is "whether a label is false or deceptive as determined by the ordinary meaning of the words used." Am. Pub. Health Ass'n v. Butz, 511 F2d 331, 333 (D.C. Cir. 1974).

Supreme Court federal preemption apply?

1985: In the realm of blood plasma collection, the U.S. Supreme Court found that FDA regulations did not preempt a Florida statute requiring donors be tested first for hepatitis and alcohol consumption. The FDA regulations, authorized under the “National Blood Policy,” have not “grown so comprehensive...to justify the inference of complete preemption.” “The regulation of health and safety matters is primarily and historically a matter of local concern, and the National Blood Policy is not a sufficient indication of federal dominance.” Plus, here, the FDA declared that it did not intend for the regulations to be exclusive. The court found too “speculative” the argument that Florida’s stricter health measures posed a threat to the federal government’s objective of ensuring an “adequate supply of plasma.” Hillsborough County, Fla. v. Automated Med. Laboratories, Inc., 471 U.S. 707 (1985).

1986: Relating to marketing and selling nonkosher meat as kosher meat, statutory penalties against a meat supplier were upheld under New York Agriculture and Market Law. This case supports Congress' intent to preserve the states' roles in regulating misbranded poultry. Matter of Nat Kagan Meat & Poultry, Inc. v. Gerace, 118 AD.2d 1043, 1043-44 (3d Dept. 1986).

1990: A Lanham-Act plaintiff was unable to rely on its competitor’s alleged lack of substantiation to serve as evidence of actual consumer deception. Plaintiff argued that Defendant Vick’s failed to substantiate an “active” ingredient because of its literal falsity. But to plead a deception injury under the Lanham Act, Plaintiff needed evidence, like survey evidence, to prove actual deception. In contrast, the FDA can conclude deception based on its findings as a federal agency. But a Lanham Act plaintiff is a private party and “is not entitled to the luxury of deference to its judgment.” “The effect of the advertisement on the consumer is the critical determination.” A plaintiff must advance actual evidence of consumer misinterpretation. Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990).

1992: The U.S. Supreme Court rejected an implied-preemption theory in a cigarette-labeling case to nullify a state breach-of-warranty claim. The court held, “a common-law remedy for a contractual commitment voluntarily undertaken should not be regarded as a requirement ... imposed under State law.” Only warning or labeling requirements would have been preempted—not state-law damages. Cipollone v. Liggett Grp., Inc., 505 U.S. 504 (1992). Down below is Canards (2017), which cites Cipollone to support its holding in a foie gras sales-ban case: "[t]he PPIA, which is silent on the topic of animal husbandry and feeding practices may not be read to supplant state law on an entirely different topic." Assn. des Éleveurs de Canards et d'Oies du Quebec v. Becerra, 870 F3d 1140 (9th Cir. 2017).

1994: California state law that added a temperature requirement on raw-chicken labels that sought to use the word "fresh" transcended its authority under the Poultry Products Inspection Act (PPIA). The "fresh" requirement was "in addition to" or "different than" requirements under PPIA since the PPIA had no such requirement. The court acknowledged, however, the applicability of concurrent jurisdiction—the state's power to enforce the PPIA label requirements that were identical to the PPIA. National Broiler Council v. Voss, 44 F.3d 740 (9th Cir. 1994).

1994: States may impose poultry-inspection standards even more rigorous than federal standards. Rather than displace state inspection standards, Congress envisioned a "marble cake scheme" where federal and state regulations would operate together. In fact, the federal secretary "offers state inspection programs technical and laboratory assistance, training, and partial funding." See U.S.C. § 454(a). Miss. Poultry Ass'n v. Madigan, 31 F.3d 293, 296 (5th Cir. 1994) (en banc).

1996: Relating to a faulty pacemaker, the U.S. Supreme Court denied preemption under the Medical Device Amendments to the FDCA (Food, Drugs, and Cosmetics Act). The plaintiff's negligence claim survived. Such a negligence claim merely enforced the federal Act and did not impose any requirement that was different from, or in addition to, what was prescribed under federal law. In other words, the "presence of a damages remedy does not change what is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing requirements under federal law." Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996).

1998: The Federal Cigarette Labeling and Advertising Act clearly and expressly preempts state laws on matters of labeling and advertising in cases premised on label disclosures and failure-to-warn theories. But in Geiger, a New York appellate court declined to preempt class-action Plaintiffs—who extracted lung and throat cancer—from asserting fraud and implied-warranty claims independent of labeling and advertising (i.e. product liability and warranty of fitness). The court, citing Cippilone (above), held that only labeling requirements were preempted—not state-law-tort damages. Here, in Greiger, Plaintiffs alleged that Phillip Morris and 11 other cigarette companies manipulated nicotine levels in ways that contributed to independent harms from a defective product. Upon remand, however, the class plaintiffs had failed to show common questions of law and fact needed to certify the class. Geiger v. Am. Tobacco Co., 674 N.Y.S.2d 775 (N.Y. App. Div. 2d Dept. 1998).

The scope of the Cigarette Labeling Act is so instructive for clarity, I cite it here:

Federal Cigarette Labeling and Advertising Act of 1969

15 U.S.C.A. § 1331. Congressional declaration of policy and purpose

It is the policy of Congress, and the purpose of this chapter, to establish a comprehensive Federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health, whereby--

the public may be adequately informed about any adverse health effects of cigarette smoking by the inclusion of warning notices on each package of cigarettes and in each advertisement of cigarettes; and
commerce and the national economy may be (A) protected to the maximum extent consistent with this declared policy and (B) not impeded by diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health.

1999: Similar to Grieger above, the legal theories in Plaintiffs’ cigarette class action were not preempted to the extent they were not premised on labeling or disclosures. Theories of strict product liability, fraud, and negligence were not preempted. This Labelle case cited Greiger, along with New York Appavoo v. Philip Morris, Inc. (N.Y. Sup. Ct. 1998) and Castano v. American Tocacco Co. (E.D. LA 1994) for the proposition that breach of implied warranty of merchantability is based on the “general warranty that a product is fit for use, and is thus independent of advertising and promotion.” The focus of implied warranty of merchantability is on the nature and characteristics of the product itself—not on warnings or labels. LaBelle v. Brown & Williamson Tobacco Corp., 2:98-3235-23, 1999 WL 33591435, at *6 (D.S.C. Mar. 18, 1999).

2000: Puerto Rico’s separate inspection-date requirement to appear in a federal inspection certificate was preempted by the Poultry Products Inspection Act. The PPIA, through comprehensive regulations, already dictates what must appear in official certificates and U.S. markings. The regulations omit a date-of-inspection requirement, which infers an intent to do so in this clearly occupied area. Northwestern Selecta, Inc. v.Munoz, 106 F.Supp. 2d 223 (D. Puerto Rico 2000).

2000: As to nutritional misrepresentations alleged against “Power Bar,” the federal NLEA did not preempt New York GBL §§ 349 and 350. The alleged misconduct violated NLEA by misrepresenting the amount of fat, vitamins, minerals and sodium contained in the bars. This parallel state action to obtain a private remedy for an identical federal violation was consistent with NLEA’s intent for state involvement. Rather than conflicting with federal law, GBL § 349(d) actually exempts any act or practice subject to, and in compliance with, federal rules, regulations, or statutes. Morelli v. Weider Nutrition Group, Inc., 275 AD2d 607, 607-08 (1st Dep't 2000).

2005: Peanut farmers who brought state-law claims against Dow for injurious pesticides were not preempted under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This Act preempts state claims premised on requirements for labeling or packaging. Alive and well were state tort theories not related to packagings, such as defective design, defective manufacture, negligent testing, and breach-of-express warranty claims. Bates v Dow Agrosciences LLC, 544 U.S. 431 (2005).

2007: The Federal Meat Inspection Act (FIMA) did not preempt Texas' prohibition against serving horse meat to Texans. FIMA does not preempt the field of meat commerce entirely. For implicit preemption to occur, state law must be in direct conflict with federal law, or the federal law must occupy a field so pervasively as to naturally exclude the state law. Field preemption requires a clear congressional intent of the field exclusively. Empacadora de Carnes de Fresnillo, S.A. de C.V., v. Curry, 476 F3d 326, 331 (5th Cir. 2007).

2008: Poultry labeling, while the province of the USDA generally, may transcend labeling and constitute actionable advertising if coupled with advertising. For example, point-of-purchase materials that contain additional images and promotional slogans may be actionable under the Lanham Act. Poultry labeling is under the jurisdiction of the USDA. Poultry advertising is under the jurisdiction of the FTC but may also be exposed to a private action under state law. In the label-review process for poultry, "FSIS's determination involves a highly technical and scientific review of the proposed label language, it does not involve a review of whether the language is misleading to the consumer when combined with images and promotional slogans." Tyson's claim, "Raised Without Antibiotics that impact antibiotic resistance in humans" was not afforded preemption. Sanderson Farms v. Tyson Foods, 549 F. Supp. 2d 708, 720 (D. Md. 2008).

2008: State common-law allegations against a manufacturer for a defective balloon catheter were preempted, held by the U.S. Supreme Court. The Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act required pre-approval of the Stage III device. The FDA had already established requirements for the device, and the patient did not allege a violation of any of those federal requirements(s). In the pre-approval process, the FDA reasonably assured the product’s safety and effectiveness reasoned the court. The patient's negligence, strict liability, and breach of implied warranty claims were preempted. State-law tort suits would interfere with the FDA’s extensive pre-market approval process for Class III devices. “Federal agencies are better positioned to set standards of care than common law courts,” noted the court. Riegel v Medtronic, Inc., 552 U.S. 312 (2008).

2008: Through graphic images of mountains on Aquafina water bottles, Plaintiffs claimed that such messaging implied that the water was derived from a non-public source. The lawsuit was preempted because the FDCA already regulates water labeling. The federal regulations are “not silent regarding implied claims about municipal sources of water supply.” Moreover, Aquafina qualified as “purified water,” and was therefore exempt from disclosing its water source under 21 C.F.R. § 165.110(a)(3)(ii)(Bottled Water). The FDA deliberately decided to exempt purified water from being required to disclose its source. In its “expert opinion,” the FDA concluded, “that representation of source is immaterial in the context of purified water.” "[T]he purification, and not the source, is the reason consumers buy it," the FDA determined. Where the issue is the product’s “standard of identity” (composition, labeling), state requirements may not conflict with federal standards. In re PepsiCo, Inc., Bottled Water Mktg. and Sales Practices Litig., 588 F. Supp. 2d 527, 532 (S.D.N.Y. 2008).

2009: The FDA, pursuant to the Food, Drug, and Cosmetic Act (FDCA) did not preempt a musician's state-law product-liability lawsuit against Wyeth over an injurious I.V. push medication. The state action did not "pose an obstacle" to the FDCA but instead "offered an additional and important layer of consumer protection that complements FDA regulation." Wyeth v. Levine, 555 U.S. 555 (2009).

2009: Pasta sauce containing “high fructose corn syrup” but marketed as “all-natural” did not impliedly preempt a state-deception lawsuit for mislabeling. The Nutrition Labeling and Education Act (NLEA) added a “savings clause” to the FDCA’s preemptive statute that expressly disavows implied preemption. (“The [NLEA] shall not be construed to preempt any provision of State law, unless such provision is expressly preempted under [21 U.S.C. § 343–1(a) ].” Pub.L. No. 101–535, § 6(c)(1) (21 U.S.C. § 343–1 note). Like other federal Acts, the FDCA’s preemptive statute contemplates state involvement to help enforce parallel cases, which is clear evidence against Congressional intent to exclusively occupy such nutritional labeling. Moreover, the FDA’s “policy” of defining “natural” as “nothing artificial or synthetic added” constitutes an unenforceable advisory opinion—not an authoritative regulation that would connote field preemption. Lockwood v. Conagra Foods, Inc., 597 F. Supp. 2d 1028 (N.D. Cal. 2009).

2009: Held not preempted by the Nutrition Labeling Education Act (NLEA) is New York City Health Code § 81.50, which requires fast-food restaurants, which voluntarily publish calorie information, to also post that calorie information on their menus. Under NLEA, restaurants are not required to attach a Nutrition Facts panel to the food they serve. See, 21 U.S.C. § 343(q)(5)(A)(i). But if a restaurant seeks to make a nutrient content claim (a qualitative fact like “heart healthy”), it must comply with NLEA. Here, to combat rising obesity, NYC was within its rights to enact Health Code § 81.50, a quantitative calorie requirement, which is “nutrition information,”—not preempted under § 343(q)—whereas a nutrient-content “claim,” a qualitative requirement, would have been preempted under § 343(r). “New York City merely stepped into a sphere that Congress intentionally left open to state and local governments.” Although the Second Circuit classified food labels as commercial speech, this city publication requirement survived a constitutional challenge under the First Amendment since the law was “reasonably related to its goal of reducing obesity.” New York State Rest. Ass'n v. New York City Bd. of Health, 556 F.3d 114, 117 (2d Cir. 2009).

2010: An aspirin label that met the "floor" requirements of federal regulation did not immunize Bayer for misrepresentations of safety and effectiveness, which is a "traditional claim of consumer misrepresentation." A label merely compliant under the FDCA does not "indicate that it could not still be misleading and therefore actionable under state consumer protection laws." In re Bayer Corp. Combination Aspirin Prods. Mktg. & Sales Practices Litig., 701 F.Supp.2d 356, 375–76 (E.D.N.Y. 2010).

2010: Relating to “organic” milk and related advertising claims (“humane,” “fresh air,” “organic pastures”), the 8^th Circuit ruled out express preemption. Organic certification is federally regulated by Organic Foods Production Act of 1990 (OFPA). The Act’s limited preemptive clause is 7 U.S.C. § 6507, which permits states to implement a more restrictive organic program but only with USDA approval. Otherwise, any state activity that encroaches upon the federal certification process is preempted. Here, Plaintiffs’ claims against Aurora’s certification company (QAI) were preempted. But “claims not interfering with Aurora’s certification are not preempted.” “Congress did not intend for requirements such as this to preclude a State from prosecuting a certified organic producer for violating the State's animal cruelty statute by abusing its livestock.” In re Aurora Dairy Corp. Organic Milk Mktg. and Sales Practices Litig., 621 F.3d 781, 794 (8th Cir. 2010).

2010: With regard to nutrient-content claims advertised by Vitaminwater, the court did not preempt claims related to a) Vitaminwater’s lack of compliance with FDA's fortification policy; and b) Vitaminwater’s featuring of only some—but not all—ingredients in its product name, and on its label. These two behaviors “accurately describe violations of FDA regulations, and accordingly may serve as a non-preempted basis of state law liability.” But implied claims related to Vitaminwater's high-sugar content were preempted since federal regulations omit high sugar content as a "disqualifying nutrient level." Generally, the FDA prohibits the use of single-nutrient health claims in products that are high in bad stuff, known as disqualifying nutrient levels. Under 21 C.F.R. § 101.14(a)(4), products can’t use single-nutrient health claims in products containing “13.0 grams of fat, 4.0 g of saturated fat, 60 milligrams of cholesterol, or 480 mg of sodium..." Bizarrely, sugar was excluded from this nutritional calculus. But Vitaminwater as "fortified sugar water" failed to contain the threshold 10 percent level of nutrients “prior to any nutrient addition” to qualify the product to display health claims. See, 21 C.F.R. § 101.14(e)(6). Known as the "Jelly Bean Rule," the law will not allow junk food to contain health claims simply because it is fortified with a single nutrient.

Below are the 12 advertising claims at issue:

The description of the product as a “Nutrient–Enhanced Water Beverage”
The phrase “vitamins + water = all you need” on the product label
Flavor names such as “rescue” and “defense”
The name “Vitaminwater” itself
The statement “vitamins + water = what's in your hand” on in-store advertising materials
The statement “this combination of zinc and fortifying vitamins can ... keep you healthy as a horse” on the label of Vitaminwater's “defense” flavor
The statement “specially formulated to support optimal metabolic function with antioxidants that may reduce the risk of chronic diseases, and vitamins necessary for the generation and utilization of energy from food” on the label of Vitaminwater's “rescue” flavor
The statement “specially formulated to provide vitamin [A] (a nutrient known to be required for visual function), antioxidants and other nutrients [that] scientific evidence suggests may reduce the risk of age-related eye disease” on the label of Vitaminwater's “focus” flavor
The statement “specially formulated with bioactive components that contribute to an active lifestyle by promoting healthy, pain-free functioning of joints, the structural integrity of joints and bones, and optimal generation and utilization of energy from food” on the label of Vitaminwater's “balance” flavor
The statement “specially formulated with nutrients required for optimal functioning of the immune system, and the generation and utilization of energy from food to support immune and other metabolic activities” on the label of Vitaminwater's “defense” flavor
The statement “specially formulated with [B] vitamins and theanine. The [B] vitamins are there to replace those lost during times of stress (physical and mental). Theanine is an amino acid found naturally in tea leaves and has been shown to promote feelings of relaxation. This combination can help bring about a healthy state of physical and mental being” on the label of Vitaminwater's “B-relaxed” flavor
The statement “specially formulated with nutrients that enable the body to exert physical power by contributing to the structural integrity of the musculoskeletal system, and by supporting the optimal generation and utilization from food” on the label of Vitaminwater's “Power–C” flavor.

In their Second Amended Complaint, “Plaintiffs alleged that “Vitaminwater violated FDA regulations by:

making health claims or implied nutrient-content claims despite the high amount of sugar in the product;
making health or certain implied nutrient content claims despite the fact that Vitaminwater has been fortified with vitamins in violation of the FDA's fortification policy; and
prominently featuring the name of some, but not all, of its ingredients in its product name and label.” [Naming it Vitaminwater while excluding sugar could mislead consumers].

The court held that “the first argument has been rejected by the FDA, but the latter two accurately describe violations of FDA regulations, and accordingly may serve as a non-preempted basis of state law liability.”
The presumption against preemption is used heavily in matters of public health and safety, such as matters involving food and drug sales. “Moreover, where Congress provides an express preemption clause, the presumption against preemption requires courts to read the clause narrowly.” See Lohr, supra, 518 U.S. at 485 (citing Cipollone v. Liggett Group, Inc., supra, 505 U.S. 504, 518, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992)). To have escaped preemption here, Plaintiffs would have needed to argue that 1) the parallel state requirements are identical to FDCA requirements, or 2) the preemptive clause of 21 U.S.C. § 343(r)(1)[Nutrition levels and health-related claims] does not reach the activity at issue. Not preempted would be a state requirement “respecting any claim of the type described in Section 343(r)(1).” 21 U.S.C. § 343–1(a)(5)[National uniform nutrition labeling](Nutrient levels and relationships to disease or health-related condition). “Claims based on statements not falling into those categories are not preempted,” ruled the court. As to stating an injury under New York law, the court accepted Plaintiffs' claim that the premium paid for Coca-Cola's deceptively advertised Vitaminwater constituted an injury. Ackerman v. Coca-Cola Co., CV-09-0395 (JG), 2010 WL 2925955, at *5 (E.D.N.Y. July 21, 2010).

2011: The National Childhood Vaccine Injury Act expressly preempted a private, design-defect lawsuit in state court. The Act intended to encourage vaccine improvements while providing immunity for design-defect claims. The Vaccine Act states that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death ... if the injury or death resulted from side effects that were unavoidable.” Implied preemption may apply to activity outside the explicit scope of the federal preemptive clause. Generally, the presumption against preemption can be overcome. Bruesewitz v Wyeth Inc., 561 F3d 233 (3d Cir 2009), affd sub nom. Bruesewitz v. Wyeth LLC, 562 US 223, 131 S. Ct. 1068 (2011).

2012: The U.S. Supreme Court held that the FMIA preempted a California law governing slaughterhouses' dealings with non-ambulatory pigs. The California law was passed in response to video evidence of animal cruelty at a slaughterhouse. FMIA explicitly addresses slaughterhouse operations so the California statute "runs smack into FMIA regulations." Natl. Meat Ass'n v Harris, 565 U.S. 452 (2012).

2013: As discussed in this blog, the court denied a preemption argument involving a label with the claim, "humanely raised" as being deceptively close to a near claim, "USDA Process Certified." Both a breach of express-warranty-claim and a fraud claim survived a dismissal motion. Hemy ((Does 1-10) v. Perdue Farms, Inc., (Does 1-10) CIV.A. 11-888 MAS, 2013 WL 1338199, at *1 (DNJ Mar. 31, 2013).

2013: At issue was Kraft’s Oscar Meyer label for lunch meat that advertised “98% Fat-Free • 50 calories per serving.” Class Plaintiffs argued that the ad misled consumers into believing ninety-eight percent of those fifty calories were fat-free when in actuality the product contained twenty-two percent fat by calories. Preemption was granted because Defendants complied with federal regulations that require fat-free claims to be based on the number of fat grams compared to the weight of their products. Florida’s statute (FDUTPA's) safe harbor provision exempts liability for an activity that complies with federal regulations. A different requirement would impose labeling requirements “in addition to, or different than” those set forth under federal law. See 21 U.S.C. §§ 467e, 678. Plus, FMIA and PPIA ostensibly preapproved the labels. See 9 C.F.R. § 381.132(a), § 317.4(a). Kuenzig v. Hormel Foods Corp., 505 Fed. Appx. 937, 938 (11th Cir. 2013)(unpublished).

2013: Relating to genetically modified corn in soup, a preemption defense was granted against an attack on Cambell's "all-natural" claim in chicken soup but denied against an "all-natural" claim in vegetable soup. The chicken-soup labeling is under the jurisdiction of the USDA—which pre-approves chicken labeling after it determines its truth. The vegetable soup, however, is under the jurisdiction of the FDA, which does not pre-approve non-meat labeling. Furthermore, the FDA's refusal to define "all natural" indicated its intent not to occupy the field of "natural" claims on labeling. The FDA enacted no “requirements regarding ‘natural’ for the Court to endow with preemptive effect.” Unfortunately for the plaintiffs, the court found that the FDA administrative process was better suited to resolving the "all-natural" dispute under the doctrine of primary jurisdiction. The court dismissed the case on that basis. For information about FDA pre-approval, see this blog. Barnes v. Campbell Soup Company, 2013 WL 5530017 (N.D. Cal. 2013).

2013: A vegan food producer of meatless foie gras (a pate produced by the livers of forcefully fattened ducks) sued a producer of meat foie gras claiming that the use of the slogan "the humane choice" cut into Plaintiff's sales. The case was brought under the Lanham Act, a federal statute giving private businesses a cause of action for injurious false marketing of competitors. Article III standing was established for the vegan food producer but was not established for the co-plaintiff, Animal Legal Defense Fund, a non-profit animal-advocacy group. The Lanham Act remedies commercial injuries only. Animal Legal Defense Fund v. HVFG LLC, 939 F Supp. 2d 992 (N.D. Cal. 2013).

2014: Preemption was not applied in a private Lanham-Act case by Pom Wonderful against Coca-Cola for allegedly misrepresenting the amount of pomegranate and blueberry juices in Minute Maid juice. Preemption was not at issue—preclusion was—since the “state-federal balance” was not in question. Here, the issue was whether the FDA, pursuant to the federal FDCA, precluded another federal statute (Lanham Act) from providing a private remedy. No, it doesn’t because a) the two statutes are complementary and have co-existed for 70 years b) the FDCA’s preemption clause does not preempt anything federal c) the FDA does not pre-approve juice labels, and d) there’s no textual evidence to support such preclusion, especially considering that both statutes serve different purposes. POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014).

2014: The express preemption clause of the Nutrition Labeling and Education Act (NLEA) did not stop a New York State consumer lawsuit over the ad claim of “fat-free” milk that was Omega-enriched and thus not "fat-free." The omega enrichments raised the milk fat content to one gram per serving, which exceeded federal regulation for “fat-free.” NLEA’s express preemption clause withholds preemption of state law that does not conflict with the NLEA, which it did not in this case. The state laws at issue imposed no affirmative requirement that would have differed from federal law. Moreover, private remedies under state law arising from violations of federal law are generally recognized. Koenig v. Boulder Brands, Inc., 995 F Supp 2d 274 (S.D.N.Y. 2014).

2014: Held not preempted were mislabeling claims against Whole Foods for advertising as “All Natural” products that contained Sodium Acid Pyrophosphate (“SAPP”), a synthetic ingredient. The FDCA, as amended by the NLEA of 1990, “expressly contemplates” that states will enforce their own food-labeling requirements, which must be ‘identical’ to the FDCA. The FDA has not issued a regulation defining the word “natural” but has “articulated a ‘policy’” to dictate that “natural” excludes anything artificial or synthetic. Taken on judicial notice was an FDA warning letter sent to a different company that concluded that SAPP contained in an “all-natural” food product was false and misleading. Moreover, listing a [synthetic] ingredient in the ingredient list does not shield liability for deceptive messaging on the packaging. Garrison v. Whole Foods Mkt. Group, Inc., 13-CV-05222-VC, 2014 WL 2451290, at *1 (N.D Cal. June 2, 2014), citing, Williams v. Gerber Products Co., 552 F3d 934 (9th Cir. 2008)(“fruit juice and other all-natural ingredients” placed on juice snacks for toddlers “to help toddlers grow up strong and healthy” were not cured of deception by an ingredient list; “reasonable consumers should [not] be expected to look beyond misleading representations on the front of the box to discover the truth from the ingredient list in small print on the side of the box”).

2014: Not preempted were Plaintiff's claims against Aveeno for use of Aveeno® Active Naturals® displayed on its personal-care products, and across its marketing channels. Six products including, “Creamy Moisturizing Oil” and “Natural Colloidal Oatmeal,” contain synthetic ingredients. Johnson & Johnson argued for preemption since all ingredients were disclosed properly in the ingredients list. But the FDA has purposefully issued no regulation or guidance governing the usage of the word “natural” on cosmetic labels. Nor is there a “federal requirement limiting brand-name usage for cosmetics beyond the general prohibition of misbranding.” Generally, advertising does not implicate preemption. The court noted that the congressional record explaining the text of 21 U.S.C. § 379s. Misleading or deceptive advertising is "outside the scope of preemption.” H.R.Rep. No. 105–399 (1997). Like in the VitaminWater case (Ackerman, above), the trademark Aveeno® Active Naturals® was a potentially misleading trademark. Goldemberg v. Johnson & Johnson Consumer Companies, Inc., 8 F. Supp. 3d 467 (S.D.N.Y. 2014).

2014: Held preempted by the FDCA were state-law claims against Listerine mouthwash that claimed to “restore enamel.” Plaintiffs alleged that loss of tooth enamel is irreversibly permanent rendering the label false and misleading. Listerine is classified as an over-the-counter (OTC) drug under the FDCA and does not enjoy the “presumption against preemption” as would food. But two regulatory monographs (guidelines for marketing OTC drugs) permit OTC drugs containing sodium fluoride “(1) to represent that such drugs prevent tooth decay and (2) to provide further labeling to explain how decay is prevented.” Through prior warning letters, the FDA has admonished J&J for claims that fluoride “fights plaque” but it has “expressed no concern” about that label claiming to “restore enamel.” The court found that the FDA has exclusive regulatory authority over the enforcement of the misbranding provision under 21 U.S.C. § 343 [Misbranded food] and under the express-preemption clause of 21 U.S.C. § 379r [National uniformity for nonprescription drugs]. No state-law state labeling “requirement” may be “different from,” “addition[al] to,” or “otherwise not identical with,” federal labeling requirements. Under this standard, preemption is applied when a) a state law prohibits labeling that is permitted under federal law, and when b) a state law prohibits labeling that is not prohibited under federal law. “The standard, in other words, is not whether a state law actively undermines federal law. It is whether state law diverges from federal law at all.” Here, to survive dismissal, Plaintiffs would have been “required to plead that the FDA has affirmatively prohibited the label.” Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371 (S.D.N.Y. 2014).

2015: Vermont’s statute requiring manufacturers and retailers to disclose genetic engineering in food was not “conflict preempted” by the FDCA as amended by the NLEA. Vermont’s disclosure requirement did not mandate modifications inconsistent with federal law. However, the statute’s restriction on the use of the word “natural” with genetic engineering was deemed an unconstitutional limitation on commercial speech. Grocery Mfrs. Ass'n v. Sorrell, 102 F Supp. 3d 583 (D. Vt. 2015).

2015: In New York, the plaintiffs alleged that "natural" and "all-natural" body care products contained 72 artificial or synthetic ingredients, which were prohibited by the Organic Foods Production Act of 1990. The court held that the products' "organic" status did not preempt a parallel false-advertising case. Segedie v Hain Celestial Group, Inc., 14-CV-5029 NSR, 2015 WL 2168374, at *2 (S.D.N.Y. May 7, 2015).

2015: With regard to "organic" labeling, California's highest court ruled that the intentional commingling of organic and non-organic herbs was not preempted by the Organic Foods Production Act of 1990. The Act's preemption applied only to 1) defining organic production and 2) certifying products as organic. The Act's express language does not preclude state lawsuits for misuse of an organic label to deceive consumers. Similar to other cases cited above, compliance with the federal Act is "only a floor, not a ceiling." Quesada v. Herb Thyme Farms Inc., 62 Cal.4th 298 (Cal. 2015).

2016: Plaintiffs claimed that Monster Beverage Corp. mislabeled its energy drinks as to caffeine amounts, effects, and safety. The court preempted only those legal theories that would compel further caffeine disclosures. Caffeine labeling is already regulated under 21 U.S.C. § 343(q) (caffeine need only be in the ingredient list— not specified as to amount). The need for safety warnings though is specifically carved out of the preemptive clause of FDCA. 21 U.S.C. § 343–1. As to other allegedly deceptive label advertising (“ideal combo” [of ingredients], etc.), the court found that the removal of such content did not equate to a “requirement” that would implicate preemption. Nor would the imposition of a safety warning implicate preemption because it is expressly excluded from preemption, as stated above. See Pub. L. No. 101–535, § 6(c)(2). “On-label claims or omissions that do not trigger caffeine-disclosure requirements are not preempted by the FDCA.” Fisher v. Monster Bev. Corp., 656 Fed. Appx. 819 (9th Cir. 2016)(unpublished).

2017: With respect to "100% natural" and "no preservatives" claims on a chicken label, the court found that the USDA's pre-approval of the label must given preemptive effect over state-law claims that, if granted, would require a different marking than what was contained on the label. Plaintiffs' claims were ingredient challenges. Unlike the FDA, the USDA has defined the word "natural" and "regulates it by requiring pre-approval by FSIS before the term can be used on a product label in the marketplace." Plaintiffs did not allege that Hormel misrepresented facts to FSIS; nor allege that Hormel prepared final labels that did not comport with approved sketch labels, nor allege that Hormel sold products that did not conform to pre-approved labels. Phelps v. Hormel Foods Corp., 244 F Supp. 3d 1312 (S.D. Fla. 2017).

2017: A California statute banning the in-state sale of foie gras was not preempted—either expressly or impliedly. Foie gras is a liver pate made from forced-fed ducks. Banning cruel feeding practices does not “stand as an obstacle to the PPIA’s objectives of regulating official establishments that slaughter and process poultry.” Nor did the statute hinder the PPIA from “ensuring that poultry products are wholesome, non-adulterated, and properly marked, labeled, and packaged.” The Ninth Circuit reversed below, holding that “Congress made clear that the PPIA's ‘ingredient requirements’ address the physical components of poultry products, not the way the animals are raised.” Assn. des Éleveurs de Canards et d'Oies du Quebec v. Becerra, 870 F3d 1140 (9th Cir. 2017).

2017: The Southern District of New York declined to preempt, under the PPIA, California’s sales ban on forced-fed foie gras. The case was transferred from California to New York, the location of Defendant’s operations. “Transferee courts are obligated to apply the law that the transferor court would have applied.” Plaintiff argued that the sale of the offending foie gras violated California Health and Safety Code Section 25982 (“A product may not be sold in California if it is the result of force-feeding a bird for the purpose of enlarging the bird's liver beyond normal size”). Plaintiff further argued that violation of 25982 served as a predicate for violating California’s deceptive business practices statute (“UCL” or “§ 17200”). As a separate issue, Plaintiff was not permitted to claim a violation of New York’s Animal Cruelty Statute (N.Y. Agric. & Mkts. Law § 353) as a predicate for violating California’s § 17200—only federal law or California law can serve as a predicate for violating California’s UCL. The Southern District relied on the preceding Canards case (above), which ruled that the PPIA did not preempt California’s ban on forced-fed foie gras. The court found that the “‘ingredient requirements’ of the PPIA cannot be read to reach animal husbandry practices because the federal law does not regulate in any manner the handling, shipment, or sale of live poultry products... The USDA has even represented in legal filings that ‘[t]he PPIA is wholly silent on the treatment of farm animals, (including feeding procedures) or methods of slaughter for poultry.’” citing, Ass'n des Eleveurs de Canards et d'Oies du Quebec v. Becerra, No. 15-55192, 14–15 (9th Cir. Sept. 15, 2017). The PPIA does not “mandate that a particular type of poultry be produced or not produced.” Moreover, under their policing powers, states may regulate the types of poultry sold within their borders under the PPIA. Evolution Fast Food Gen. Partnership v. HVFG, LLC, 15 CIV. 6624 (DAB), 2017 WL 4516821, at *8 (S.D.N.Y. Sept. 27, 2017), reconsideration denied 15 CIV. 6624 (DAB), 2018 WL 1779377, at *3 (S.D.N.Y. Mar. 28, 2018) (the court refused to re-litigate the preemption issue based on Canards, and further noted that SDNY was not bound by Canards yet was persuaded by it).

2017: Relating to cows that allegedly consumed GMO feed, the court rejected Plaintiffs’ claim that the milk produced therefrom was not “natural” and therefore actionable. Plaintiffs did not contend that Dannon’s milk contained unnatural ingredients. Instead, Plaintiffs “speculated” that since the cows at issue consumed GMO feed, were given antibiotics and were raised to increase milk yield, reasonable consumers were deceived into purchasing unnatural milk. The court found Plaintiffs’ claims to be “speculative,” “conclusory,” and a general grievance against animal husbandry and GMO use worldwide. Currently, federal law does not require labels to disclose GMO in products from which animals consumed GMO feed. See 7 U.S.C.A. § 1639b (prohibiting “a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance”). Podpeskar v Dannon Co., Inc., 16-CV-8478 (KBF), 2017 WL 6001845, at *3 (S.D.N.Y. Dec. 3, 2017).

2018: In an infection-disease case (salmonellosis), an infant suffered a brain injury and died. The Craten family sued Foster Poultry Farms, Inc. alleging negligence, strict liability, failure to warn, and breach of implied warranty of merchantability. The family tied together evidence of a) a salmonellosis outbreak involving poultry processed by Foster Poultry Farms, Inc., and b) circumstantial causation evidence, including expert reports, linking the boy’s disease to the particular outbreak strain tied to the Foster Farms’ poultry. Aside from the family’s failure-to-warn theory, which implicated a preempted labeling issue, all other causes of action were not preempted. Foster Farms argued that all other causes of action (negligence, strict liability, and breach of implied warranty) related to the “adulterant” salmonella and that the USDA was already charged with regulated adulterated poultry. But recall the 1974 case summarized above, Am. Pub. Health Ass'n v Butz, in which the majority held that the presence of salmonella alone in chicken was not an “adulterant” under federal law and did not alone render a label false or misleading. The distinction in Craten was that the salmonella was connected to a disease outbreak, and for that reason, the court declined to preempt injuries stemming from that outbreak. The court found that a jury would not have to “invade the province of the FSIS to find for the Cratens.” The legal theories of strict liability and breach of implied warranty did not survive as a matter of law, however, since a) salmonella occurs naturally in poultry and b) raw chicken is known to be safe when properly cooked. But the negligence theory went to a jury, which awarded the boy $6.5 million in damages. But the family’s contributory negligence, for failing to properly cook the chicken, accounted for 70% of the injury’s cause, reducing the net verdict for the family to $1.95 million. Craten v. Foster Poultry Farms Inc., 305 F Supp. 3d 1051 (D. Ariz. 2018).

2018: Plaintiffs sued makers of “Ester-C©” for packaging and labeling the patented form of vitamin C produced as calcium ascorbate. Plaintiffs alleged that Defendants’ claims of “immune support” and “The Better Vitamin C©” created a reasonable expectation that Ester-C reduces the risk of illness. But the court found that Plaintiffs “adduced no extrinsic evidence” of a) how consumers actually interpret Ester-C’s ‘immune support’; or b) how Ester-C’s bioavailability of its ascorbic acid formula is ineffective. Plaintiffs' “conclusory allegations” and “anecdotal testimony” were insufficient to establish how the “general consuming public” interpreted Ester-C’s marketing claims. And since Plaintiffs' implied-disease claims were “beyond the ken of the average layperson,” they needed expert evidence for the “requisite technical and scientific knowledge” to prove their case. Plaintiffs' production of a webpage taken from Oregon State’s website constituted inadmissible hearsay. Plaintiffs lost their case by summary judgment. Hughes v. Ester C Co., 330 F. Supp. 3d 862, 866 (E.D.N.Y. 2018).

2018: An ingredient-composition (water %) challenge to Costco’s Kirkland’s canned chicken was deemed preempted but Kirkland’s physical packaging, can sizing, shelf pricing, and unit pricing—that which do not “implicate FSIS-approved labeling”—were not preempted. In the case, Plaintiffs primarily asserted that Kirkland failed to disclose its water percentage on the cans in violation of federal regulation. The court, however, noting Kirkland’s “Product Formula” disclosures required by FSIS Form 7234–1 needed for pre-approval, coupled with liquid percentages already spelled out in Table II of federal regulation (9 C.F.R. § 381.157(b), were comprehensively broad and detailed to deserve preemptive effect. But, held the court, “FSIS review and approval may not be an impenetrable barrier to state law deceptive practice claims,” generally. As an evidentiary matter, Kirkland’s purported FSIS Form 7234–1 was not taken on judicial notice since its authenticity was disputed. Plaintiffs’ non-preempted claims (physical packaging, can sizing, shelf pricing, and unit pricing) were deemed not materially misleading, however, and were dismissed as a matter of law. The 2^nd Circuit Court of Appeals affirmed on both grounds: 1) PPIA regulations were provided preemptive deference on the ingredient-composition challenge; and 2) Kirkland’s other materials would not deceive the reasonable consumer. La Vigne v. Costco Wholesale Corp., 284 F Supp. 3d 496, 506 (S.D.N.Y 2018), affd, 772 Fed Appx 4 (2d Cir. 2019).

2018: Held impliedly preempted were state deception claims that “struck at the very heart” of the Organic Foods Production Act (OFPA). At issue was “organic” Similac infant formula that allegedly contained 16 non-organic ingredients. Defendant Abbot, as “producer” or “handler” seeking organic certification was required to write an “organic plan” describing practices and procedures, and listing all inputs including those present in the final product. OFPA § 6513; 7 C.F.R. § 205.201(a)(2). Organic products may not be “produced and handled” with synthetic chemicals (See OFPA § 6504) subject to exemptions contained in a “National List.” See OFPA § 6510(a)(1); 7 C.F.R. § 205.605(b). The certifying agent then performs an on-site inspection and reviews all of the inputs and methods of production. See 7 C.F.R. §§ 205.402(a)(4). Violation of the organic scheme may result in civil penalties imposed by the USDA (See 7 U.S.C. § 6519(c)(1)) or criminal prosecution for false statements. See 7 U.S.C. § 6519(c)(2). Here, for Plaintiffs to allege that the infant formula was not OFPA-compliant directly challenged “the certification decision itself” and was therefore preempted by it. The express preemption provision of the OFPA did not “weaken” the court’s “conclusion that there is an implicit conflict between the OFPA and the state laws alleged here. Marentette v. Abbott Laboratories, Inc., 886 F.3d 112 (2d Cir. 2018).

2019: Held preempted were allegations that a vitamin E supplement improperly used structure-function claims (“promote immune health” and “promote heart health”) because the product failed to actually reduce all-cause mortality. The court ruled that such an argument is preempted since it would impose labeling and substantiation requirements that would differ from the Food, Drug, and Cosmetic Act. 21 U.S.C.A. §§ 343(r)(6)[Misbranded food] and 343-1(a)(5)[National uniform nutrition labeling]. Held not preempted however were claims that “promoting immune health” could be misleading if the supplement increased the risk of all-cause mortality. The FDCA deems a food label misleading if it fails to reveal facts that are material with respect to consequences of normal use. 21 C.F.R. § 1.21(a)(2)[Failure to reveal material facts]. A “reasonable consumer would not expect to suffer an increased risk of death from taking the product.” But class Plaintiffs here failed to produce proof that vitamin E supplements are actually harmful versus simply useless. Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019).

2020: Milk sourced from “happy cows” on “Caring Dairy” farms expressed on one page of Ben & Jerry’s website was insufficient to plausibly allege actionable consumer deception. These statements, along with images on packages, were “intended to project to consumers an ‘image of animal husbandry’ that is more environmentally friendly than typical mass dairy production,” alleged Class-Action Plaintiffs. Furthermore, only 25% of the milk farmers participated in the “Caring Dairy” program while all others relied on “intensive cow confinement practices and extensive antibiotic use, which constituted a material omission, alleged Plaintiffs. But the “Caring Dairy” is voluntary and farmers who qualify receive higher compensation. The court found that Plaintiffs failed to plausibly allege that reasonable consumers would a) have seen the website claim before the purchase, and b) conclude that all milk in Ben & Jerry’s ice cream was “sourced exclusively from happy cows.” Plaintiffs assumed the milk was “sourced exclusively” [from "happy cows"], an interpretation rather than an actual misrepresentation, held the court. Materiality (significance when purchasing), which is a “mixed question of law and fact,” was not met here as a matter of law, held the court. Nor was the court convinced that the plaintiffs pleaded damages under the legal theories of breach of express warranty and unjust enrichment. The case was dismissed without prejudice. Ehlers v. Ben & Jerry's Homemade Inc., 2:19-CV-00194, 2020 WL 2218858, at *6 (D. Vt. May 7, 2020).

2020: Plaintiffs sued “L'Oréal” over its liquid cosmetics—Lift Serum and Eye Cream—that allegedly failed to dispense all of the product out of their containers. But the FDCA already governs “misbranded” labels, which prohibits labels that do not contain “an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.” 21 U.S.C. § 362(b). Moreover, the FDA has promulgated additional labeling requirements, including “a declaration of the net quantity of contents” in “fluid measure” for liquid or in weight “if the cosmetic is solid, semisolid, or viscous.” 21 C.F.R. § 701.13(a). Cosmetic regulations additionally specify where the net quantity must be placed on the label, the typeface used, and the units of measurement to be used. 21 C.F.R. § 701.13(e)(h), (j)-(p). If that was not enough, Congress added an expansive preemption provision covering cosmetics. 21 U.S.C. § 379s. In essence, Plaintiffs demanded an additional disclosure that would be “in addition to” or “different than” what is required under the FDCA. Plaintiffs did not adequately allege a “product-defect theory” but instead focused on alleged misbranding violations. Critcher v. L'Oreal USA, Inc., 959 F.3d 31, 36–37 (2d Cir. 2020).

2020: A California false-advertising lawsuit was not automatically preempted by valid structure-function claims (supports flexibility & range of motion” and “supports cartilage health & joint comfort”). “It is well established that supplement makers can be sued for false claims, and no federal preemption exists under the FDCA either by statute or by implication, since the FDA does not occupy the field and its controls are unaffected by private false advertising suits against supplement makers.” Relating to a glucosamine supplement sold by CVS, preemption applied only if Plaintiff's legal claims would hold Defendant to a different substantiation standard than the FDCA. Plaintiffs must produce some evidence of the claims’ falsity versus relying only on Defendant’s lack of substantiation. The lower court erred in not permitting Plaintiffs to introduce scientific literature that allegedly debunked glucosamine’s efficacy. Kroessler v. CVS Health Corp., 977 F.3d 803 (9th Cir. 2020).

2021: A consumer plaintiff challenged the veracity of Foster Farms’ “humane” certification made by the American Humane Association. The court affirmed that Plaintiff’s labeling claims were expressly preempted under PPIA 21 U.S.C.467e. Since the Secretary of Agriculture had approved the label showing the certification as not misleading, Plaintiff could not state a claim under state law based on the assertion that the certification was a sham. The court gave deference to the USDA pre-approval process. 9 C.F.R. 412.1, subd. (a). In December 2019, the FSIS updated its Labeling Guideline for animal-raising claims. With label certifications, label pre-approval only required the certifier's name, logo, and website on the sketch label. Animal-raising claims are considered “special statements” that must be included in a “sketch label” for approval of that sketch. 9 C.F.R. 412.1, subds. (c) - (e).). This court did acknowledge concurrent jurisdiction permits States to impose additional remedies for violation of the PPIA. Carol Leining v. Foster Poultry Farms and American Humane Association, 61 Cal. App. 5th 203 (2021).

2021: Held preempted were Plaintiff’s claims that Trader Joe’s mislabeled the percentage of retained water in its packaged chicken products (breasts, thighs, and wings). Plaintiff alleged that independent testing using different data-collection protocols contradicted Trader Joe's claim that the chicken products contained “up to 5% retained water.” But the court held that a) Trader Joe’s was required to maintain and make available to FSIS its data-collection protocol for measuring retained water [9 C.F.R. § 441.10(c)]; b) the products contained an inspection certificate that applied to “generic” retained water claims, as well as to “special” claims related to animal raising, and that both sets of claims were considered and pre-approved [Prior Label Approval System: Generic Label Approval, 78 Fed. Reg. 66826-01, 66827 (Nov. 7, 2013); 9 C.F.R. § 381.96]; c) the court would take judicial notice of the labels’ approvals, and would honor FSIS’s interpretation of PPIA’s preemption clause via an amicus brief; and d) express preemption applied to Plaintiff’s testing protocol and label challenges under 21 U.S.C. § 467e. Webb v. Trader Joe's Co., 999 F.3d 1196, 1204–05 (9th Cir. 2021).

2021: Relating to Hormel’s use of “natural choice” in advertising its meat products, neither the PPIA nor the FMIA preempted advertising beyond the labeling itself. “States are free to regulate advertisements” so long as they “do not encroach on the labeling itself.(21 U.S.C.A. §§ 457(c), 607(d)”). In activities traditionally occupied by state law, such as advertising, courts should presume that Congress did not intend to “override the historic police powers of the states.” But this presumption against preemption “may be overridden by a clear and manifest purpose of Congress.” The purposes of the FMIA and the PPIA are to ensure that meat and poultry products are “properly marked, labeled, and packaged.” (21 U.S.C. §§ 602 and 451). “Congress's silence “supports a reasonable inference” that, in passing the Acts, it had no desire to preempt states’ regulation of advertising.” The court cited U.S. Supreme Court case, Wyeth v. Levine (above), to illustrate the “decades of co-existence” between federal-label regulation and state-advertising laws. The accepted tension between them implies a lack of preemption. Animal Leg. Def. Fund v. Hormel Foods Corp., 258 A.3d 174 (D.C. App. 2021).

2021: Putative Class plaintiff sued the maker of the over-the-counter drug, Zicam Cold Remedy, for falsely advertising that its products are “clinically proven to shorten colds.” Plaintiff attacked the “products’ active ingredients, which differ across products.” But Plaintiff failed to adduce sufficient evidence to disprove Zicam’s claims that its products are “clinically proven to shorten colds.” Plaintiff was prevented from using Zicam’s alleged lack of substantiation as a means of proving her case. Plaintiff first needed to offer proof that the product is “not clinically proven to shorten colds.” Plaintiff argued a lack of “consensus in the scientific community” as to Zicam’s “clinically proven” claims. In other words, she offered a negative to prove a positive. The Court was “not persuaded by Plaintiff's conclusory allegations that the words “clinically proven” imply to reasonable consumers that there is a scientific consensus about the efficacy of Defendant's products.” Oddly, preemption was not overtly analyzed in this opinion when we know that the “FDA approves new drugs as a prescription or nonprescription drug products.” See, Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 355 (1938). Yamasaki v. Zicam LLC, 21-CV-02596-HSG, 2021 WL 4951435, at *1 (N.D. Cal. Oct. 25, 2021).

2022: On dark-chocolate products, the alleged mismatch between “cacao” on the front label and “cocoa” in the ingredient list did not trigger preemption under the FDCA. Although the FDCA contains an express preemption clause prohibiting states from imposing “requirements” not identical to “standards of identity” promulgated by the FDA, “nowhere in the standard of identity for ‘cacao products’ did the FDA address ingredients necessary for a product to be labeled as ‘cacao.’” The “standard of identity” essentially defines food, or “determines what a food product must contain to be marketed under a certain name.” But in this case, the court did not find the label misleading since it “made no representation about whether the cacao was processed” or about its “nutritional value.” Nor did the plaintiffs allege falsity of the ad claims. The case was dismissed. In a broad analysis of preemption under the FDCA, however, the court found that a “state requirement need not directly conflict with a federal requirement to be preempted.” Through the FDCA preemption clause, Congress was concerned with “interference with the industry's ability to market products in all 50 States in an efficient and cost-effective manner.” Lee v. Mondelez Intl., Inc., 22-CV-1127 (LJL), 2022 WL 16555586 (S.D.N.Y. Oct. 28, 2022).

2022: Walmart sells over-the-counter (OTC) cough medicine containing the active ingredient Dextromethorphan Hydrobromide (“DXM”), and labels it as “non-drowsy.” Plaintiffs who used it claimed it did cause drowsiness, and studies cited in the complaint proved so. But Plaintiffs’ claims were preempted for the following reasons. OTC drugs qualify as “generally recognized as save and effective” (GRAS/E) by meeting criteria set forth in a “monograph” 21 C.F.R. § 341.1 [Scope]. The monograph sets forth certain “indications” “warnings” and “directions” to be included on the label, including a “statement of identity” with the name of the product and the kind of medicine it is. 21 C.F.R. § 341.74 [Labeling of antitussive drug products]. “Before a monograph is published, an ‘advisory review panel of qualified experts’ prepare[s] a report containing its conclusions and recommendations to the Commissioner with respect to the safety and effectiveness of the drug.” 21 C.F.R. § 330.10 [Procedures for classifying OTC drugs...] The FDCA declares that drugs are “not misbranded” if they meet the monograph. 21 C.F.R. § 341.1 [General conditions for general recognition as safe, effective, and not misbranded] and 21 U.S.C. § 352 [Misbranded drugs and devices]. The FDCA’s express preemption clause “reaches beyond positive enactments, such as statutes and regulations, to embrace common-law duties.” 21 U.S.C. § 379r [National uniformity for nonprescription drugs]. Here, Plaintiffs’ claims do “not fall outside the scope of federal requirements, which would allow the claims to proceed.” “Nonprescription drugs are subject to careful and comprehensive regulation by the FDA,” held the court, while referencing the Food and Drug Modernization Act of 1997 that established the preemption clause at issue. Preemption broadly encompasses "requirements imposed on product manufacture or composition, labeling, advertising, or any other form of public notification or communication." Even though "non-drowsy" was not specifically mentioned in the relevant regulations, "may cause drowsiness" was mentioned evidencing the intent that the "subject matter" was federally regulated. But still, “all States may vigorously enforce requirements for nonprescription drugs and cosmetics that are identical to the Federal requirements, including the Federal prohibition against the adulteration or misbranding of these products.” Note that product-liability claims are exempt from preemption from the FDCA relating to OTC medicine. Goldstein v. Walmart, Inc., 22-CV-00088 (LJL), 2022 WL 16540837 (S.D.N.Y. Oct. 28, 2022).

2022: Held preempted were deceptive-labeling claims against Bayer’s “Coppertone Water Babies” sunscreen. Plaintiffs alleged that “hypoallergenic” and “free of oxybenzone” are false because they contain benzophenone and other undisclosed chemicals. But “Plaintiffs' claims were expressly preempted by FDCA labeling requirements for sunscreen, to the extent they result from the Product label's omission of benzophenone.” 21 U.S.C. § 379r(a). Benzophenone is neither an “active ingredient” nor an “inactive ingredient” requiring disclosure under 21 C.F.R. § 201.66. Benzophenone is a byproduct and the FDCA does not “mandate disclosure of degradation byproducts (like benzophenone).” Nor did Plaintiffs adequately allege that benzophenone is an allergen that would tend to disprove Bayer’s ad claim that the sunscreen is ‘Hypoallergenic & Gentle.’ Truss v. Bayer Healthcare Pharm. Inc., 21 CV 9845 (VB), 2022 WL 16951538, at *3 (S.D.N.Y. Nov. 15, 2022).

2022: Plaintiffs disputed as false the efficacy of a proprietary "vegan collagen" contained in skin care products that advertised "ADVANCED ANTI-AGING" also displayed on the package. Plaintiffs theorized that the "molecules in topically-applied collagen — vegan or otherwise — cannot penetrate the skin's top layer." But "Plaintiff has not plausibly alleged that vegan collagen is necessarily ineffective, alone or in the context of the Products' formulas." The court cited L'Oréal, decided the month before (September 2022), which rejected the same theory: "the collagen's inability to penetrate the skin does not render the packaging and its claims materially misleading." But the L'Oréal court did not dismiss the complaint because the language differed in that its "promised effects closely parallel the effects of naturally occurring collagen." Here, by contrast, the products tout "advanced anti-aging" generally. "This vague guarantee does not create the same association between artificial and natural collagen." The complaint here did not allege facts that Defendant could not deliver anti-aging benefits. Contrarily, a study cited in Plaintiffs' complaint admitted that "topical collagen is an effective moisturizer that can improve the appearance of lines and wrinkles." The plaintiffs' complaint also admitted that hydrating the skin and reducing lines and wrinkles are anti-aging effects. Because Plaintiffs failed to prove the falsity of the Defendant'santi-aging claims, the court dismissed the claim of breach of warranty for the same reasoning. Nguyen v. Algenist LLC, 22 CIV. 13 (KPF), 2022 WL 17251733, at *1 (S.D.N.Y. Nov. 28, 2022).