Category Archives Spotlight

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,…

Shook Partner Cary Silverman joined the U.S. Chamber Institute for Legal Reform's (ILR's) Oriana Senatore for an episode of the organization's podcast Cause for Action to discuss his work preparing "The Food Court: Developments in Litigation Targeting Food and Beverage Marketing." Senatore asks Silverman,  "Can you give us a flavor for this litigation? What types of food lawsuits are courts seeing and what is driving this increase?" "Flavor is exactly the right word, because that's the type of lawsuits that we're seeing most recently," Silverman explains. "Lawsuits that are concentrating on the flavoring or the ingredients of products seem to be, as one might say, the 'flavor of the month' of this type of litigation. We've seen, in our 2017 paper,  there were certain types of lawsuits, like slack fill, that were sort of the rage a couple of years ago. While those have fallen to the wayside for various…

Shook Partner Cary Silverman, Partner Jim Muehlberger and Of Counsel Adriana Paris have authored a report on behalf of the U.S. Chamber Institute for Legal Reform on food and beverage marketing. The executive summary appears below, with permission from the Institute for Legal Reform. For additional reading on this subject, please see Muehlberger and Silverman's August 10, 2021, Law360 article, "TransUnion Ruling Should Help Curb DC Consumer Claims" (PDF download also available). Lawsuits targeting food and beverage labeling have reached record levels. The unrelenting surge of class actions results from imaginative, shakedown lawsuits generated by a relatively small group of attorneys. Four years ago, the U.S. Chamber Institute for Legal Reform (ILR) documented a dramatic rise in food and beverage marketing litigation. Since that time, the number of food class actions has continued to rise, and the COVID-19 pandemic did nothing to slow them down. This paper explores the latest…

By Anna El-Zein and John Johnson III Sesame is the ninth Major Food Allergen with the passage of the Food Allergy Safety, Treatment, Education, and Research Act (FASTER) Act on April 23, 2021. Starting on January 1, 2023, any food “introduced or delivered for introduction into interstate commerce” must appropriately declare the presence of “sesame” as a major food allergen. However, the FASTER Act is more than just updating food labels; it also implicates supplier controls, Food Safety or HACCP Plans, sanitation practices and other procedures. With the compliance deadline looming, companies must start thinking about how FASTER affects their procedures sooner rather than later. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a packaged food is misbranded if the label fails to declare the presence of a major allergen, either in the ingredient list or in a “contains” statement. With the addition of sesame to the “Big 8,”…

Shook Partner Cary Silverman has authored a report exploring the rise in class actions filed in New York, which, he explains, "is largely a result of lawsuits targeting businesses that sell food and beverages." Class Action Chaos: The Rise of Consumer Class Action Lawsuits in New York, created in partnership with the New York Civil Justice Institute, details how "the percentage of class action lawsuits targeting products that New Yorkers place in their shopping carts, grab at a grocery store, or buy at a restaurant has gone up." "Lawsuits claiming that businesses mislead consumers in how they labeled, marketed, or advertised food made up about one-third of deceptive practices class actions in 2015. Now, these 'food court' lawsuits account for about 60% of New York’s consumer class actions – exceeding deceptive practices claims against all other products and services combined. Over 100 food class actions were filed in New York…

By Shook Of Counsel Brandon Arber The Massachusetts Supreme Judicial Court has affirmed a lower court's grant of a mistrial in Fitzpatrick v. Wendy's Old Fashioned Hamburgers of New York, Inc. This was a bone-in-the-hamburger case, causing a broken tooth and multiple surgeries. The lower court had found that the plaintiff's counsel used “so-called 'reptile' litigation tactics" in the closing, including: "But you know what, when Wendy's and JBS sells all those burgers, they are more than happy to take our money. We pay for the burger. It goes to them. But when a burger hurts somebody, no responsibility. No accountability. Shame on them, honestly—shame on them.” "Are these important rules in our community? Are we going to enforce them? Are you going to enforce them? If the rules that we talked about here, the safety rules, if those are important you need to speak to that and your verdict…

By Associate Anna El-Zein & Of Counsel John Johnson III Recent actions by the U.S. Food and Drug Administration (FDA) suggest that, in 2021, the Agency will sharpen its focus on enforcement efforts to ensure packaged foods appropriately declare the presence of major food allergens. In a series of high-profile warning letters and press releases, FDA confirmed that it is moving beyond expecting non-compliant food to be recalled and is concentrating on how companies are preventing the issue. Manufacturers and private labelers need to audit their practices and expect an FDA inspection, especially if they have had an allergen-related recall. What the Law Requires The Federal Food, Drug, and Cosmetic Act (FDCA) deems a packaged food misbranded if the label fails to declare the presence of a major allergen, either in the ingredient list or in a “contains” statement. This requirement and the list of major food allergens is found…

In response to the COVID-19 pandemic, the demand for hand sanitizer has increased exponentially. Manufacturers of much-needed hand sanitizers face a maze of regulatory rules and restrictions in every country in which their products will be sold. For example, the U.S. Food and Drug Administration has monitored hand sanitizers entering the market, and the agency has regularly updated its list of recalled hand sanitizer products, including many that have been sold at national retailers. In an infographic overview, Shook consumer products attorneys guide the producers of hand sanitizers and retailers through what they need to know to successfully make, label and sell their products in the U.S., U.K., Canada and Mexico. Learn the relevant details and questions to ask about each country’s requirements; guidance on product ingredients, product testing, labeling, promotion and distribution of hand sanitizers; and direct actions to take to ensure products get safely to market in full…

The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due diligence program to review and approve foreign suppliers of imported food. In May 2020, FDA placed two companies on Import Alert 99-41, which is essentially an import ban where an importer cannot import the food until they implement an appropriate FSVP to FDA’s satisfaction. This is not the first time FDA placed a company on Import Alert 99-41. However, the previous import alert listing concerned a company that imported food associated with a recall and foodborne illnesses. In this instance, there is no indication that the food caused any food illnesses or was otherwise non-compliant; rather, it appears that the only issue was the importers failed to comply with the FSVP requirement. This inherently changes the tenor of an FSVP inspection because they now…

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