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Labeling Public Health

BakerHostetler

New State Laws Limiting the Use of PFAS in Consumer Products Continue to Proliferate

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Over the past few years, the regulation of per- or polyfluoroalkyl substances (PFAS) in consumer products has exploded. While manufacturers, distributors, and retailers have focused on significant new consumer product PFAS...more

ArentFox Schiff

Will California’s Proposed Acrylamide Warning Amendment Under Proposition 65 Pass Legal Muster?

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California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed additional safe harbor warnings for products containing acrylamide in response to recent litigation questioning the constitutionality of such...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

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On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

Troutman Pepper

TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes

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As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more

Troutman Pepper

U.S. District Court Vacates FDA Deeming Rule With Respect To Premium Cigars

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On August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016...more

Nelson Mullins Riley & Scarborough LLP

First Substantial Reform of Cosmetics Law Since FDR Administration

President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), as part of the Consolidated Appropriations Act, 2023. This is the first major reform of cosmetics regulation since the Federal...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Bennett Jones LLP

Health Canada Implements New Labelling Standards for NHPs

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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

Cozen O'Connor

California Splits from the FDA: CBD Now Permitted in Food, Beverages and More

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On Wednesday, October 6, 2021, California Governor Gavin Newsom signed into law Assembly Bill 45 (AB-45) that “prohibit[s] restrictions on the sale of dietary supplements, food, beverages, cosmetics, or pet food that include...more

Goodwin

California Finally Breaks From FDA On CBD: Governor Newsom Signs AB-45

Goodwin on

On October 6, 2021, California Governor Gavin Newsom signed AB-45, creating an explicit framework for the manufacture and sale of hemp-derivative products in the state of California. While hemp was legalized at the federal...more

McDermott Will & Emery

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

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The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 2

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Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice. The...more

Troutman Pepper

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

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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

Akin Gump Strauss Hauer & Feld LLP

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

Hogan Lovells

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

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Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

Mintz - Health Care Viewpoints

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

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