Podcast - The FTC Takes Action Against Old Southern Brass for False "Made in the USA" Claims
Podcast - FTC's Approach to Made in the USA Claims
Proposition 65 – Changes That Will Impact the Cannabis Sector
PODCAST: Williams Mullen's Trending Now: An IP Podcast - False and Misleading Advertising, Label Review
Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California)
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Pandemic Marketing 101: Do’s and Don’ts to Market Your Brands, Products, and Services Safely
Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
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
On June 12, 2024, the U.S. District Court for the Eastern District of California preliminarily enjoined the California Attorney General and all private enforcers of California Proposition 65 from filing new lawsuits to...more
Under California’s Proposition 65 (“Prop 65”), businesses are required to give “clear and reasonable warnings” to consumers regarding potential chemical exposure if their product contains a chemical “known to the state to...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
Judge Richard Seeborg of the Northern District of California recently ruled in favor of Miyoko’s Kitchen in a suit concerning Miyoko’s labeling of its plant-based spread as “vegan butter.” In doing so, Judge Seeborg...more
The trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more
Supremes Deny Energy Drink Company’s First Amendment Petition - 5-Hour Energy drink maker asks to pour unsubstantiated claims down the drain - Free Speech Spotting - Not too long ago, we covered a dustup between a state...more
First Amendment Rescues Butter Marketing from Regulation’s Hot, Hot Knife - Miyoko’s Kitchen can keep buttering up consumers, but must let the hormones go - Precious?...more
On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction...more
LEGISLATION, REGULATIONS & STANDARDS - France to Ban Mass Culling of Male Chicks - France’s agriculture minister has reportedly announced that the country will prohibit the mass culling of male chicks shortly after they...more
WHAT IS, AND IS NOT, ADVERTISING? At the outset it is important to understand what is, and is not, considered to be advertising or an advertisement under U.S. law. Generally speaking, as applied to any product, be it beer,...more
Enacted in 1991 to stem the tide of telemarketing calls, the Telephone Consumer Protection Act (TCPA) restricts “the making of telemarketing calls and the use of automatic telephone dialing systems and artificial or...more
I. Factual Background - During the 34-day government shutdown occurring between December 2018 and January 2019, producers and importers of beer, wine and distilled spirits needing label approval to bring new products to...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
China to Tariff U.S. Food Commodities - China has reportedly imposed tariffs on imports of U.S.-made agricultural products, including pork, soybeans, wheat, beef, orange juice, whiskey and corn, following the United...more
A recent Federal Court decision on the issue of whether to grant a preliminary injunction in the ongoing saga of the appropriateness of adding the pesticide Glyphosate to the CA Prop 65 list has become the grist for the “Fake...more
FDA Announces Final FSMA Produce Safety Rule - The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing...more
The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more
The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more
In September 2016, the Food and Drug Administration (FDA) took a number of actions concerning the use of the term “Healthy” in the labeling of food products. The FDA published notice in the Federal Register on the use of the...more
Defend Trade Secrets Act of 2016: An Overview - Why it matters: The Defend Trade Secrets Act of 2016 (DTSA) was signed into law on May 11, 2016 and gives trade secret owners a federal cause of action for injunctive...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
On August 18, 2015, the U.S. Court of Appeals for the D.C. Circuit reaffirmed its 2014 ruling that struck down the requirement that public companies must disclose to the Securities and Exchange Commission (SEC), and on their...more