Podcast - Made in the USA Claims
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Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
Welcome to Nutter's Beverage Breakdown, a periodic legal update on noteworthy developments related to the alcohol beverage industry, including industry news, federal and state updates, and more. ...more
The Mississippi Commission on Environmental Quality (“MCEQ”) and Tiffin Motorhomes, Inc. (“Tiffin”) entered into an Agreed Order (“AO”) addressing alleged violations of the Mississippi Hazardous Waste Regulations. See Order...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs,...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
Tractor maker Kubota North America Corporation will pay a $2 million civil penalty for falsely labeling its replacement parts as “Made in USA,” the largest civil penalty ever in a Federal Trade Commission (FTC) Made in USA...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
The latest Federal Trade Commission (FTC) Made in the USA (MUSA) case may be a bit of a head-scratcher that requires us to delve more deeply into FTC authorities and monetary recovery theories....more
The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more
The fact that the Federal Trade Commission (“FTC”) has been active over the last two-plus years is far from breaking news. While it has gained tremendous attention for its relatively new interest in certain big issues—e.g.,...more
The Federal Trade Commission (FTC) has increasingly prosecuted more deceptive U.S. origin claims under Section 5 of the FTC Act since the start of the COVID-19 pandemic than in the previous decade. This uptick in...more
Last week the Federal Trade Commission (FTC) announced it had issued a complaint and proposed consent order against Instant Brands LLC for allegedly marketing products as “Made in the USA,” when they were actually made in...more
Alvaro Bedoya Sworn in as FTC Commissioner Following Senate Confirmation. On May 16, Alvaro Bedoya was sworn in as FTC Commissioner. The U.S. Senate confirmed Bedoya to the FTC’s open Commissioner on May 11. ...more
Many importers are familiar with marking and labeling requirements for products imported into, and sold in the U.S. These include mandatory requirements such as U.S. Customs country of origin marking and labeling...more
The Federal Trade Commission (“FTC”) recently settled an enforcement action against an advertiser for $753,000 for deceptive “Assembled in USA” product claims, the first such settlement following the FTC’s recent adoption of...more
The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more
Historically, neither food companies nor the plaintiffs’ bar have lost sleep over “recyclable” or “recycled content” claims. Over the past year, however, there has been increasing attention to and scrutiny of recyclable...more
From severe shortages in medical masks and ventilation equipment worldwide to the curious “toilet paper desert” in America, COVID-19 is creating temporary and long-term disruptions in the availability of both highly...more
Thursday, March 5th, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on FDA action to develop an enforcement discretion policy and evaluate potential regulatory pathways for consumer...more
• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more
Do you manufacture, import, or market personal hygiene and wellness devices sold in drugstores? If so, you may be focused on U.S. Food and Drug Administration (FDA) compliance, but may not have considered the requirements of...more
In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially...more
This holiday season, brands are ready for bustling sales, special offers and joyful consumers. However, with regulators on the lookout for deceptive practices and plaintiffs’ attorneys ready to file class actions, the...more
The United States Department of Justice (“DOJ”) announced in an October 18th news release that Phillip Michael Huddleston pleaded guilty to violating the Resource Conservation Recovery Act (“RCRA”). DOJ states alleges that...more