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Misbranding

Cozen O'Connor

AGs Urge EPA to Adopt Rule Preempting State Labeling Requirements

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Eleven Republican AGs filed a petition for rulemaking to the EPA demanding that it amend its regulations under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) regarding additional labeling or packaging...more

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

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Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more

Kaufman & Canoles

K&C Sports & Entertainment Law Weekly Roundup - June 2024 #2

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Game equipment company Sport Squad Inc. deceptively marketed some of its pickleball paddles as approved by the sport’s national governing body even though the approval had been rescinded, a consumer class action alleges....more

Morrison & Foerster LLP

Implied Preemption for Dietary Supplements Is Here to Stay

On April 15, 2024, in a big win for the continued validity of implied preemption, the Supreme Court declined to hear an appeal of the First Circuit’s preemption-based dismissal of a proposed misbranding class action. The...more

Mitchell, Williams, Selig, Gates & Woodyard,...

FIFRA Enforcement: US Environmental Protection Agency and Paris, Missouri Pesticide Dealer Enter into Consent Agreement

The United States Environmental Protection Agency (“EPA”) and Logan Agride – Service, Inc (“Logan”) entered into an April 15th Consent Agreement and Final Order (“CAFO”) addressing alleged violations of the Federal...more

Arnall Golden Gregory LLP

Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device Reprocessor for Changes to Marketed Products

“Every little one, every little one,” a song lyric from Bruce Hornsby and the Range’s 1986 single, “Every Little Kiss,” comes to mind when we read a recent Food and Drug Administration Warning Letter issued to a reprocessor...more

Fishman Haygood LLP

U.S. Eleventh Circuit Rejects FIFRA Preemption in Roundup Case

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As of May 2022, Monsanto, the company that developed the allegedly cancer-causing weed killer Roundup, has settled more than 100,000 lawsuits, and paid nearly $11 billion in settlements. Despite this massive number, 30,000...more

Epstein Becker & Green

Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care

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The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done...more

Patterson Belknap Webb & Tyler LLP

“Fit” For Dismissal: SDNY Rejects Class Action Misapplying FDA’s “Healthy” Regulation

When is a food “healthy”?  And who gets to decide?  A recent decision from the Southern District of New York touched on these questions in the context of an implausible consumer class action—though the court ultimately didn’t...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding and adulteration. The RightEye Vision...more

King & Spalding

2022 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement

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In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices.  A summary of the noteworthy...more

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

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The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | December 2022

LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...more

Goodwin

Avoiding Misbranding: Words Matter When Describing the Regulatory Status of 510(k) Cleared Devices and Registered Device...

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​​​​​​​When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more

Patterson Belknap Webb & Tyler LLP

Tenth Circuit Reverses, Finds Bakery’s Lanham Act Claim Under-Proofed

A common maxim in the service industry is that the customer always knows best. But a recent decision from the Tenth Circuit suggests that the maxim has its limits when it comes to interpreting ambiguous marketing claims.  In...more

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

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On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Vicente LLP

FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

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On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products....more

Foley Hoag LLP

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

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The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

Patterson Belknap Webb & Tyler LLP

Into the Lime Light: Suit Challenges Amount of Lime in Hint of Lime Tostitos

Hold onto your chips.  This blog has covered an array of dubious mislabeling theories, but a recent complaint filed in Illinois federal court may take the guac: a proposed class-action complaint against Frito-Lay North...more

The Volkov Law Group

Avanos Medical Pays $22 Million to Settle Criminal Mislabeling Charges for Surgical Gowns

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Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....more

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Manuka Honey and Waterslides

This week, we take a look at a decision addressing what a “reasonable” consumer will know in purchasing a product (and distinguishing the Seventh Circuit in the process), and at another assessing the legality of Washington’s...more

Alston & Bird

Food & Beverage Digest – June 2021

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Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, plaintiffs can’t remember the taste...more

Pillsbury - Gravel2Gavel Construction & Real...

A Court-Side Seat: SCOTUS Further Clarifies Alien Tort Statute; Revisiting WOTUS

What follows is a brief account of some of the notable U.S. environmental and administrative law cases recently decided. THE U.S. SUPREME COURT - Article II, Section 2 of the Constitution vests the President, with the advice...more

Hogan Lovells

2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

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In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more

Alston & Bird

Food & Beverage Digest – November 2020

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Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and settlements affecting the food, beverage, agribusiness, and cosmetics industries. This month, vanilla is the finest of the...more

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