Shook Partner Connor Sears has authored "Food, Drug, Cosmetic Cos. Should Expect More Additive Suits" for Law360. In the article, Sears explores the recent spate of litigation alleging that additives approved for use by the U.S. Food and Drug Administration (FDA) are causing harm to consumers because the same additives are not approved for use in certain other countries. Challenged additives are used in a wide variety of foods, including fish, cereal, dairy, meat, candy and more. "Considering the wide scope of products that may face future lawsuits, manufacturers and distributors may be curious about how courts have treated similar lawsuits," Sears notes. He suggests that courts may approach additives lawsuits similarly to how lawsuits alleging harm from partially hydrogenated oils (PHOs) were decided between 2015, when FDA determined PHOs to be unsafe for food, and 2018, when a ban on their use took effect. Read the full article >>
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Chambers and Partners has listed Shook's Food, Beverage and Agribusiness Practice as Band 4 in its USA - Nationwide rankings. According to Chambers, "The Shook, Hardy & Bacon team is respected for its representation of companies in the food and agribusiness space, including manufacturers and distributors of feed additives and animal food. The group counsels clients in a range of issues, including product labeling, marketing, product safety and regulatory compliance." One person who provided feedback for Chambers' research reportedly stated, "The team is excellent, they are very responsive." Shook's other Chambers rankings included a Band 1 designation for Product Liability & Mass Torts and a Band 2 listing for Product Liability: Consumer Class Actions.
Shook Of Counsel John Johnson III will co-present "Food and Dietary Supplement Regulation Year-in-Review" on Wednesday, March 30, 2022, at the Food and Dietary Supplement Safety and Regulation Conference. The conference, which takes place March 30-31, will be presented virtually by the Food and Drug Law Institute. "This session will recap the most significant recent developments in food and dietary supplement regulation and enforcement, including updates on FDA and United States Department of Agriculture (USDA) inspections, FDA and Federal Trade Commission (FTC) warning letters and enforcement, and compliance challenges faced by manufacturers and retailers," according to the conference agenda. "Panelists will also discuss the extent to which federal regulation and enforcement may have impacted private litigation over the past year."
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…
Shook Of Counsel John Johnson III will join AIB International's Judi Lazaro for the second webinar in a series on answering frequently asked questions about the U.S. Food and Drug Administration. During the webinar, Johnson and Lazaro will ask each other questions, then they will end the session with an open Q&A. Join the session on Monday, July 26, 2021, from 2:00 to 2:30 p.m. CDT. Register now >>
Shook Of Counsel John Johnson III will answer "That Food Safety or FDA Question You’ve Always Wanted to Ask" in a webinar presented by AIB International on Friday, June 4, at 11:00 a.m. CDT. The webinar will be live and will feature answers to questions commonly asked about food safety as well as questions provided by the audience. Register now to join the webinar on June 4.
Former U.S. Food & Drug Administration (FDA) Associate Chief Counsel Kristin Kaplan joins Shook, Hardy & Bacon, further expanding the firm’s regulatory capabilities. Kaplan has a deep understanding of regulatory issues and the nuances of the government agency after advising FDA for eight years and serving an in-house role at a global leader in animal health. “Her combined FDA insight and in-house experience make Kristin invaluable as we deepen our regulatory capabilities,” said Shook Chair Madeleine McDonough. “It is critical for our clients facing litigation to align with our regulatory team to anticipate and address developing legal developments.” Kaplan counseled FDA on a variety of issues, including new animal drug applications stemming from biotechnology and recalls of foods, animal foods and drugs. She later became Deputy General Counsel for one of the world’s largest animal health leaders, where she provided strategic insight on various issues including regulatory, compliance, and health, safety…
Shook Partner Jim Muehlberger and Of Counsel John Johnson III have authored an article for Law360 detailing litigation targeting honey producers. "Honey producers have sometimes been accused of diluting their product with syrup," they explain. "They have also faced many other accusations, including that their honey contains contaminants, that it lacks some key quality characteristic, or that its country of origin has been wrongly declared." The article discusses the relevant U.S. Food and Drug Administration regulations, noting that the agency "has not generally developed legally enforced quality parameters for honey," as well as litigation targeting the product. "In the 2010s, a wave of litigation focused on filtered honey, which has the pollen removed from it to meet consumer preferences for characteristics like increased clarity and slower crystallization. In these suits, the plaintiffs alleged that the filtered honey was not honey because, according to some definitions, '[no] pollen … may be removed except where this is unavoidable in…
In spring 2020, the U.S. Food and Drug Administration (FDA) started regulating food importers under the Foreign Supplier Verification Program (FSVP). FSVP requires a food importer to create a due diligence program to review and approve its foreign suppliers and conduct activities to verify that the food is produced in a manner that provides at least the same level of safety as the U.S. requirements. FDA started to fully enforce FSVP by issuing Warning Letters, import alerts and even import refusals for non-compliance. Shook FDA and Food, Beverage and Agribusiness attorneys John F. Johnson III and Elizabeth Fessler will present the webinar “FDA’s Foreign Supplier Verification Program Enforcement: Learned Lessons from FDA’s First Actions,” exploring the lessons that can be learned from these first enforcement actions and providing practical recommendations for what food importers can do to minimize the risk of FDA enforcement. The one-hour webinar, which is sponsored by…
A New Mexico federal court has dismissed allegations that several food companies falsely labeled beef as a "Product of the USA" because the cattle were raised in other countries but brought to the United States for slaughter and processing. Shook attorneys represented Tyson Foods Inc. in the litigation. Lucero v. Tyson Foods Inc., No. 20-0106 (D.N.M., entered August 27, 2020). "Plaintiffs do not seek to impose equivalent requirements as those imposed by the [U.S. Department of Agriculture (USDA)] or to enforce the USDA's labeling requirements," the court stated. "Rather, they seek to impose different labeling requirements by asking this Court to declare USDA approved labels misleading. Plaintiffs' interpretation of 21 USC § 678 would render the express presumption clause a nullity." The court, holding that all of the plaintiffs' claims were preempted and that the plaintiffs failed to state a claim as a matter of law, dismissed the case with prejudice.
