News & Analysis as of

Safe Harbors Labeling

Greenberg Glusker LLP

Finalized Acrylamide Warnings and Related Legal Showdown

Greenberg Glusker LLP on

This week, the Office of Environmental Health Hazard Assessment (OEHHA) announced that the proposed Prop. 65 additional safe harbor warning options for acrylamide have become final. The safe harbor options will be included in...more

King & Spalding

Federal Trade Commission Issues New “Made In USA” Regulations

King & Spalding on

Creates New Enforcement Tools And Applies The Rule To Labels “Appearing In All Contexts” (i.e., On Product Packaging Or Online) - On July 1, 2021, the Federal Trade Commission (“FTC”) approved a final rule to implement new...more

King & Spalding

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

King & Spalding on

A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

McDermott Will & Emery

FDA Finalizes Guidance on Payor Communications

McDermott Will & Emery on

On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more

Proskauer - Advertising Law

Made-in-the-U.S.A. Complaint Does Not Make the Cut

In a case decided in December that flew beneath our radar, a judge in the Southern District of California dismissed without prejudice a proposed class action alleging that Citizens for Humanity falsely labeled its jeans as...more

Baker Donelson

OIG Still Rejects Lab's Free Labeling Services for Dialysis Facilities in Advisory Opinion No. 16-12

Baker Donelson on

8 Years and New Reimbursement Methodology Later - On November 28, 2016, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued an unfavorable advisory opinion, No. 16-12, regarding a...more

Troutman Pepper

State Safe Harbor Doctrines: A Life Preserver from False Advertising Claims Facing Alcohol Manufacturers?

Troutman Pepper on

Food and beverage companies, beset by lawsuits about their product labels, struggle to find consistent application of consumer protection laws across the country. The experience of one distiller and its use of one word on its...more

Davis Wright Tremaine LLP

FCC Releases Open Internet Transparency/Disclosure Rule Safe Harbor in the Form of Broadband Service “Labels” for End User...

The FCC has released its safe harbor disclosure framework under the Open Internet transparency requirements for end user customer disclosures, which take the form of a broadband “label” –not unlike the form of labels used by...more

Proskauer - Advertising Law

Sun-Blocked: California Court Dismisses Sunscreen Labeling Case

It’s summertime, and for many of us that means buying and applying sunscreen. Lots of it. Indeed, when selecting sunscreen rated at, say, SPF 30, we rely on national standards promulgated by the FDA. It thus comes as no...more

Pillsbury Winthrop Shaw Pittman LLP

The Label on Your "Handmade" Whiskey Is Causing More Problems Than You Think

The recent market for artisanal and handcrafted goods has spawned a spate of consumer class actions against makers of popular liquors, including Tito’s Vodka, Maker’s Mark, and Jim Beam, for using terms like “handmade,”...more

Polsinelli

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

Polsinelli on

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Morrison & Foerster LLP

Proposed Prop 65 Rules Won't Please Calif. Businesses

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

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