2022 Significant Developments in the Tobacco Industry and What to Expect in 2023 (Part One) - Regulatory Oversight Podcast
Proposition 65 – Changes That Will Impact the Cannabis Sector
Comment Deadline Approaching: Proposed Amendments Restricting Use of Prop 65 Short-Form Warnings
Cannabis Counsel Cast: Proposed Prop 65 Regulation Would Require Cannabis Products to Warn About Impacts on Child Behavior and Learning
Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California)
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
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more
Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more
Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more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
MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more
The U.S. tobacco industry is subject to a variety of regulators at the federal and state level. In this first of a two-part series focused on significant regulatory developments in the tobacco industry, Stephen Piepgrass is...more
On December 5, 2022, the Minnesota Board of Pharmacy filed a lawsuit against three affiliated Minnesota hemp companies seeking condemnation and destruction of several million dollars worth of gummy edibles. Ironically named...more
As 2022 drew to a close, the Wall Street Journal reported that the FDA is finally considering releasing potential guidance regarding cannabidiol (“CBD”) in the coming year. While the exact timeline and scope of the FDA’s...more
Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the tissue and cartilage in his...more
The California Office of Administrative Law (OAL) recently approved a revised Proposition 65 warning label requirement for the use of acrylamide in food and beverages. California’s Office of Environmental Health Hazard...more
The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing...more
In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the...more
Cannabis operators (from marijuana to hemp-derived products such as CBD) often get the sense they are one of the central targets of the federal government’s reach. But they are not in the same league lately as the COVID-19...more
PFAS – per- and polyfluoroalkyl substances – are a family of human-made chemicals, often referred to as “forever chemicals,” and are found in a wide range of products used by the food supply industry. Because of their...more
On March 2, 2021, the U.S. Food & Drug Administration (“FDA”) issued a consumer update in the form of a “what you should know” regarding formaldehyde in hair smoothing or straightening products, such as keratin treatments....more
...Robots are everywhere – but perhaps just not how everyone imagined them. For decades, the promise of robots brought to mind devices like R2D2 and C3PO, or perhaps Rosie the Robot from The Jetsons – autonomous, intelligent...more
A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more
Following a series of Warning Letters issued throughout 2020 related to recalls due to allergen labelling errors, the U.S. Food and Drug Administration (FDA) recently issued a Constituent Update emphasizing the agency’s focus...more
On August 28, California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead state agency for the assessment of health risks posed by chemical substances, released a draft report concluding its review of the...more
On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend the Proposition 65 regulations. Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986,...more
On July 15, 2020, a California state court made an important ruling upholding the validity and application of regulations exempting coffee from Proposition 65 warnings. Better known as Proposition 65, the California’s...more
Ninth Circuit considers whether federal law takes precedence over California statute requiring warnings about chemicals. Hardeman v. Monsanto, pending before the Ninth Circuit Court of Appeal, raises issues as to whether a...more
The Federal Trade Commission (FTC), in its mission to protect consumers from deceptive and unfair commercial practices, has been particularly vigilant during the COVID-19 pandemic because of an expected increase in outright...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice....more