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)
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Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more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
Health Canada has implemented sweeping amendments to labelling requirements under the Natural Health Products Regulations (NHPR) as a result of challenges identified in recent years surrounding the widespread use of Natural...more
When you think of the relationship between alcohol and food, the classics come to mind: tiramisu, coq au vin and beer cheese. While there is a long culinary tradition of using alcohol in food, the newest trend is to utilize...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
The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) addressed in a December 6th letter the Hazardous Materials Regulation (“HMR”) applicable to the marking requirements for a Department of...more
On August 7, 2019, EPA took long awaited action concerning the inclusion of Prop 65 warning statements for glyphosate on EPA registered pesticide labels, which will likely impact the broader ongoing debate over EPA approval...more
Recently, the Federal Trade Commission (“FTC”) and the U.S. Food & Drug Administration (“FDA”) issued joint warning letters to four sellers of e-liquids, the nicotine “juice” used in vaping regarding their use of social media...more
Recently, the FDA released industry guidance regarding biosimilar product labeling, which is entitled “Labeling for Biosimilar Products” (“Biosimilars Labeling Guidance”). The Biosimilars Labeling Guidance provides...more
On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product...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
After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more
The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more
What are the concerns for filling a growler? A growler is either a bottle or a large glass. The distinction is solely dependent on the manner in which the brewer fills the container. When is a growler a bottle? A growler is a...more
An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more
California’s Proposition 65 warning requirements (Health & Safety Code Sections 25249.6 et seq.) have long been a major concern for businesses that want their products offered for sale in the state’s large marketplace....more
On October 31, 2014, the Occupational Safety and Health Administration (OSHA) responded to an August 2014 petition from the American Coatings Association (ACA) and other trade associations to extend the June 1, 2015,...more