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(Podcast) The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
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Hot Topics in International Trade A Year in Review (Quickly)
The regulatory landscape for consumer-packaged goods (CPG) brands is shifting, with artificial food dyes emerging as a central focus of both state and federal scrutiny. Recent actions by the federal and state governments,...more
On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more
On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more
In recent years, plaintiffs have increasingly set their sights on kratom, a controversial botanical supplement, as a target for litigation. With at least 15 putative class-action cases filed in the past year alone, this...more
Clean Beauty Legal Risks Clean beauty claims have become the current "flavor of the month" for consumer class action lawsuits, particularly in California, New York, Florida, and Texas, where plaintiff's bar activity is...more
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more
Attend ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to stay ahead of the latest environmental and sustainability developments impacting cosmetics and personal care products...more
In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more
Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more
In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Update on Sesame Allergen Labeling - The U.S. Food and Drug Administration (FDA) has released an FDA Voices “Catching Up with Califf” update that addresses the practice...more
FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more
If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more
A bipartisan coalition of AGs from 27 states, the District of Columbia, and three territories has called on the FDA to deny marketing authorization for non-tobacco nicotine products (NTNs) which are currently marketed without...more
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...more
The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more
The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...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
Dietary supplement manufacturers seeking to explain and market their products must carefully craft statements on supplement labels to ensure compliance with the Food and Drug Administration’s (“FDA’s”) regulations regarding...more
The U.S. Food and Drug Administration (FDA) sent a shot across the bow of the cannabidiol (CBD) industry on November 25. The FDA disclosed that it issued warning letters to 15 companies “for illegally selling products...more