A consumer has alleged that Mondelez Global LLC misleads consumers by marketing its Oreo Fudge Cremes as "fudge covered" because the topping covering the cookies lacks milkfat. Leonard v. Mondelez Global LLC, No. 21-10102 (S.D.N.Y., filed November 28, 2021). The complaint lists several recipes for fudge to support its argument that fudge requires the presence of milkfat, while Mondelez produces its "fudge" with palm oils and nonfat milk. "Fudge covered cookies made with fudge ingredients such as dairy components, containing milkfat, are not a rare or pricy delicacy that would make a reasonable consumer 'double check' their presence by scouring the packaging," the plaintiff argues. "The front label creates an erroneous impression that essential fudge ingredients are present." The complaint compares the "fudge" ingredients to the "truthful and non-misleading 'Mint' representations, through words and pictures of peppermint leaf," which are accurate because the product contains peppermint oil, the plaintiff explains.…

A plaintiff has filed a putative class action alleging Abbott Laboratories Inc.'s Similac Pro-Advance infant formula is advertised as the company's "closest formula to breastmilk," allegedly misleading consumers into believing that the formula can convey the same benefits as breast milk. Conner v. Abbott Labs. Inc., No. 21-1463 (S.D. Ill., Benton Div., filed November 20, 2021). "Infant formula is critical for children whose mothers are unable to breastfeed or produce enough milk," the complaint asserts. "Marketing of infant formula sometimes goes beyond meeting those limited needs, to tout itself as an equivalent to breast milk. The representations that the Product contains lutein, vitamin E, DHA, and HMO—Human Milk Oligosaccharide, and the claim, 'Our Closest Formula to Breast Milk,' imply the inclusion of these constituents can approach the benefits from breast milk." The plaintiff seeks class certification, injunctive relief, damages and fees for allegations of fraud, unjust enrichment, negligent misrepresentation and…

By Of Counsel John Johnson III The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety Modernization Act (FSMA)’s Preventive Control Rule. This is the requirement that a food facility must have and implement a written food safety plan to control known or reasonably foreseeable food safety hazards. Additionally, the warning reflects that FDA continues to prioritize seeking compliance with preventive controls and sanitation practices to avoid undeclared Major Food Allergens (which we discussed in A Taste of FDA’s 2021 Food Priorities: Undeclared Major Food Allergens. The list has been expanded to include sesame, which we discussed in Look Beyond the Label: How the FASTER Act Impacts Food Manufacturing). FDA has been relatively silent about the Preventive Control Rule in 2021, issuing only four Warning Letters directly on that topic. For context, FDA issued at…

By Associate Anne Case-Halferty Evolving consumer demands, litigation trends and the disruptive effects of the COVID-19 pandemic were featured topics of the Ninth Annual FoodBev Exchange, which took place virtually November 9-10. Compliance and regulatory professionals from across the country shared best practices and discussed recent and emerging developments in the food and beverage industry, including: the growth of grocery e-commerce and food delivery services; data security and privacy concerns; and shifting regulatory enforcement priorities. Of Counsel John F. Johnson III led an in-depth panel discussion with prominent industry professionals about emerging FDA, USDA and FTC labeling priorities and advertising trends. Key topics included: pending legislation targeting food safety and quality standards; the possibility of further regulatory clarity by FDA on the use of “healthy” and “natural” labeling terms; and FTC’s newly finalized rule cracking down on marketers making false “Made in the USA” labeling claims. Panelists included Megan Galey,…

A plaintiff has alleged that Mondelez Global LLC misleads consumers about the butter content of its Lorna Doone shortbread cookies. Troutt v. Mondelez Global LLC, No. 21-1279 (S.D. Ill., Benton Div., filed October 19, 2021). The plaintiff argues that "the Product’s ingredients are inconsistent with what consumers expect from a food identified as 'shortbread cookies'" and asserts that "Dictionary.com defines shortbread as a 'a butter cookie commonly made in thick, pie-shaped wheels or rolled and cut in fancy shapes.'" Instead of butter, the plaintiff alleges, Mondelez uses "shortening provided exclusively from vegetable oils," resulting in a cookie that "lacks the nutritional, organoleptic, and sensory attributes of shortbread." Further, the consumer argues, the representation of Lorna Doone cookies as providing a '"Melt in Your Mouth' taste is false and misleading" because "vegetable oils do not melt at mouth temperature, and leave a waxy mouthfeel," while "[b]utter melts at mouth temperature and does…

The U.S. Food and Drug Administration (FDA) has released guidance on limiting sodium in processed and packaged foods. "Limiting certain nutrients, such as sodium, in our diets plays a crucial role in preventing diseases like hypertension and cardiovascular disease that disproportionately impact racial and ethnic minority groups; these diseases often result in hundreds of thousands of lives lost and billions in annual health care costs," the agency stated in a press release. The statement notes that "people consume 50% more sodium than recommended," and "about 70% of the sodium we eat comes from packaged, processed and restaurant foods." "[W]e recognize that most of the food consumption in the U.S. comes from a relatively small number of products and menu items in the marketplace that are produced by a limited number of food manufacturers," the guidance states. "It is possible that reformulation by these food manufacturers could lead to increased demand…

Several publications have detailed the story of Get Baked, a U.K. bakery, to examine how food regulations differ in the United Kingdom and the United States. Get Baked was forced to stop selling its 12-layer chocolate cake and raspberry glazed donut cookies after a U.K. Trading Standards inspector found the desserts to be topped with sprinkles that contain a substance labeled in the United Kingdom as erythrosine, or E127, an additive only approved for use in cocktail cherries and candied cherries, according to the BBC. In the United States, the substance is labeled as FD&C Red No. 3, according to NPR, and is allowed in foods but was restricted for some uses in 1990 after studies purported to show that "very high doses of the color additive can cause cancer in laboratory animals." The BBC also noted that studies have reportedly linked the additive to hyperactivity in children and an…

The U.S. Food and Drug Administration (FDA) has released two guidance documents on food contact substance notifications, pertaining to toxicology recommendations and administrative processes. The food contact substance notification process is "the primary means by which FDA regulates food additives that are food contact substances (FCSs)." The guidance documents define a food contact substance as "any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the use is not intended to have any technical effect in the food," per the federal Food, Drug, and Cosmetic Act.

The U.K. Environment Agency has announced a project "to establish standardised metrics to measure environmental performance of the food and drink sector." The agency "is aiming to make it simpler for businesses and for the public to understand the environmental performance of companies in key areas such as greenhouse gas reduction and resource efficiency," according to the announcement. The agency indicated that it intends to incentivize companies to establish "greener manufacturing processes and business operations helping to tackle climate change" and positioned the project as an aid to businesses intending to "effectively communicate their environmental performance to the public."

Shook Of Counsel John Johnson joins AIB International's Judi Lazaro for another installment of their webinar series answering commonly asked questions about FDA regulations. Join Johnson and Lazaro on October 25, 2021, at 1:00 p.m. CT to learn more about how to respond to an FDA inspector's finding of objectionable conditions. 483 may be the most dreaded number in food safety. This number is the designation for a form where an FDA inspector records objectionable conditions in your facility that may be violations of the Food, Drug, and Cosmetic Act. If an inspector hands you a Form 483, the next question is, “Now what do I do?” For the third webinar in this series, join John Johnson from the law firm Shook, Hardy & Bacon and AIB International’s Judi Lazaro, who have amassed decades of food safety and FDA compliance experience. They will ask each other those questions you’ve always…

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