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Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
MASSACHUSETTS - First Circuit Holds Putative Class Action Claims Alleging Deceptive Practices In Labeling of Lactase Product As Dietary Supplement Instead Of Drug When Product Claimed To Treat Lactose Intolerance...more
On August 14, 2023, a panel of judges for the United State Court of Appeals for the Ninth Circuit issued a published opinion affirming dismissal of two complaints alleging that food product labels advertising the amount of...more
On December 1, 2021, the U.S Food and Drug Administration (FDA) issued warning letters to several companies for marketing vaping products with unproven health claims. In a consumer update, FDA warned consumers that certain...more
The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more
With the passing of the 2018 Farm Bill, the market for cannabis pet products has rapidly grown. As a result, broad-reaching marketing campaigns highlighting the available products and the claimed benefits have become much...more
CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more
The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....more
A California federal judge tossed a proposed class action against allegedly “worthless” biotin dietary supplements on preemption grounds earlier this week, citing the Ninth Circuit’s recent decision in Dachauer v. NBTY, Inc.,...more
Deceptive Trade Practices - Meat Exporter Had No Duty Under FCA to Pay for Beef Inspection - In United States ex rel. Barrick v. Parker-Migliorini Int'l, LLC, 878 F. 3d 1224 (10th Cir. 2017), the court affirmed...more
Introduction. On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”)...more
Kanye's Promise of Exclusivity a Siren Song, Suit Says - Kanye West's latest drama involves the courtroom—specifically, a putative class action complaint alleging false advertising, unfair competition, and unjust...more
On December 2, 2015, Judge Vince Chhabria of the Northern District of California dismissed with prejudice claims that grocery retailer Trader Joe’s violated California’s Unfair Competition Law (UCL) by using the term...more
The Ninth Circuit Court of Appeals recently addressed preemption in the context of food and cosmetic labeling. Food Manufacturers Can Label Honey as “Honey” - In June, the Ninth Circuit issued an opinion in Brod v....more
In Eckler v. Neutrogena (certified for publication 7/1/15, Case No. B2536910), the California Court of Appeal, Second Appellate District, upheld the trial court’s determination that plaintiffs’ claims of mislabeling sunscreen...more
For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more