The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional adulteration of food under the Food Safety Modernization Act. The guidance focuses on food defense corrective actions, food defense verification, reanalysis and recordkeeping. The rule applies to domestic and foreign companies required to register with FDA as food facilities.
Category Archives Issue
Miyoko's Kitchen Inc. has filed a lawsuit asserting that California infringed its First Amendment right to free speech by requiring the removal of "truthful messages and images from its website and its product labels—including the phrase '100% cruelty and animal free,' the use of the word 'butter' in the phrase 'vegan plant butter,' and even an image of a 'woman hugging a cow.'" Miyoko's Kitchen v. Ross, No. 20-0893 (N.D. Cal., filed February 6, 2020). The company reportedly received a letter from California in December 2019 that "orders Miyoko's to remove claims that its vegan products are '100% cruelty and animal free,' 'cruelty free,' and 'lactose free'—all entirely truthful statements." "For decades, plant-based producers have used terms like 'vegan cheese,' 'soy milk,' and 'cashew yogurt,'" the complaint asserts. "Consumers are not confused by these labels. In fact, plant-based dairy terms are so widely used that the [U.S. Food and Drug…
A California appeals court has determined that the "no sugar added" phrasing on Califia Farms' Cuties tangerine juice does not imply to consumers that competitors add sugar to their products. Shaeffer v. Califia Farms LLC, No. B291085 (Cal. App. Ct., entered February 6, 2020). The lower court dismissed the complaint, ruling that the "no sugar added" representation was truthful. The appeals court considered "statements a business affirmatively and truthfully makes about its product and which do not on their face mention or otherwise reference its competing products at all." The court found that a "statement may be 'fraudulent' (and hence actionable) if it is 'deceptive and misleading in its implications,'" but declined to hold as actionable truthful statements about a company's own product when the argument is that a reasonable consumer would "(1) likely to infer from such a statement that the very same statement is untrue as to comparable,…
A consumer has filed a putative class action alleging Tipp Distributors Inc. mislabels its Steaz iced tea as "lightly sweetened" despite containing "objectively high amounts of sugar, as added sugar." Taylor v. Tipp Distrib. Inc., No. 20-0712 (E.D.N.Y., filed February 9, 2020). Consumers paid a premium for Steaz believing it to contain less sugar than its competitors, the complaint asserts, but it contains 20 grams of added sugar, 40% of the recommended daily intake. "By consuming the Products and the 40% DV of added sugar, the average person who wishes to follow the DGA must consume no more than 30 grams of sugar across 1,920 calories (2,000 calories – 80 calories)," the plaintiff argues. "It will be difficult to impossible for the average, reasonable consumer to not consume more than 30 grams of sugar in everything else they eat or drink because many foods and beverages have added sugars, albeit…
Hornell Brewing Co. Inc. and its subsidiary Arizona Beverage Co. allegedly misrepresent their fruit snacks product as all natural despite containing citric acid, gelatin, ascorbic acid, dextrose, glucose syrup and modified food starch, a consumer alleges. Silva v. Hornell Brewing Co. Inc., No. 20-0756 (E.D.N.Y., filed February 11, 2020). The plaintiff argues that these ingredients are synthetic and cites a 2013 U.S. Department of Agriculture draft guidance decision delineating what materials are natural or synthetic. "Congress has defined 'synthetic' to mean 'a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plants, animals, or mineral sources," the complaint argues. Further, "[s]urveys and other market research, including expert testimony Plaintiff intends to introduce, will demonstrate that the term 'natural' is misleading to a reasonable consumer because the reasonable consumer believes that the term “natural,” when used to…
The Kansas City Star has detailed the story of Randy Constant, a Chillicothe, Missouri, man who fraudulently sold millions of dollars' worth of "organic" grains—as much as 7% of all the corn and 8% of all the soybeans sold nationally as organic in 2016. Federal investigators began looking into Constant when a competitor tipped off the government that it was impossible for him to have such high outputs legitimately. An FBI investigation revealed that he sold $140 million worth of "organic" grain from 2010-2017 that, if labeled correctly, would have likely been worth half of that total. The Star asserts that the U.S. Department of Agriculture had received a complaint in 2007 about Constant's soybeans, which tests showed were genetically modified in violation of organic regulations, but the agency failed to take any action. Attorneys for Constant argued that his fraud was a victimless crime, but the court disagreed, sentencing…
France's agriculture minister has reportedly announced that the country will prohibit the mass culling of male chicks shortly after they hatch and ban the castration of piglets without anesthesia in an effort to support animal welfare. The minister indicated his intention to have the regulations take effect by the end of 2021. Germany previously banned the practice, but a court invalidated the law until a method for determining the sex of an embryo in the egg can be developed.
The Portman Group, the U.K. alcohol industry's self-regulatory authority, has upheld a complaint against Trinchero Family Estates for its Ménage à Trois Midnight wine. Zenith Global brought a complaint arguing that the wine's name and marketing copy may breach the code by creating links between the product and sexual activity or sexual success. The panel agreed, finding that the text on the label—including "savour the pleasures of the dark"—did not dispel the sexual connotations of the Ménage à Trois name, which purportedly refers to the wine's blend of three varietals. “In this case, the Panel urged the producer to avoid linking the sexual meaning of the name to the product and remove the text description on the bottle which did this," the panel's chair commented in a press release. "The Panel’s decision is a reminder to all producers that care must be taken when marketing a product to ensure that…
A Public Health Nutrition study has purportedly found that "toddler milks," or "sugar-sweetened milk-based drinks for toddlers," are a growing market but are advertised as providing unsubstantiated benefits. Choi et al., "US toddler milk sales and associations with marketing practices," Public Health Nutrition, February 4, 2020. The researchers reportedly found that 45% of preschoolers (24 to 47.9 months) and 31% of young toddlers (12 to 23.9 months) consume sugar-sweetened beverages each day. "[T]oddler milk packages contain numerous nutrition-related and child development claims, such as ‘DHA and iron to help support brain development’ and ‘probiotics to help support digestive health’, which have not been supported by scientific research," the researchers assert. "These claims may mislead caregivers to believe that toddler milk provides benefits for their child’s nutrition and development." The researchers called for countries "to enact Code provisions" that would limit or prohibit the promotion of breast milk substitutes, including toddler…
A Florida federal court has dismissed a lawsuit alleging that Bacardi U.S.A.'s Bombay Sapphire contains a botanical classified as an adulterant in the state. Marrache v. Bacardi U.S.A., No. 19-23856 (S.D. Fla., entered January 28, 2020). "Numerous class actions have greatly benefited society, such as Brown v. Board of Education, In re Exxon Valdez, and In re Agent Orange Product Liability Litigation," the court's decision began. "This is not one of those class actions." The plaintiff "does not allege that the bottle of gin he bought containing grains of paradise caused him any health issues or other harm," the court noted. "He instead alleges that the product was 'worthless' because it was adulterated with grains of paradise." The court found that the 1868 Florida law prohibiting grains of paradise in alcohol was preempted by federal regulations finding that the botanical is generally regarded as safe. The plaintiff argued that the…
