News & Analysis as of

Food and Drug Administration (FDA) Marketing

Knobbe Martens

FDA and FTC Crack Down on Delta-8 THC Copycat Products

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In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more

Fox Rothschild LLP

Minnesota Attorney General Takes Action Against Businesses that Market Nicotine Products to Minors

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Billions of dollars are spent each year on tobacco marketing expenditures. With the increasing use of e-cigarette products, businesses may feel tempted to expand their marketing to other audiences, including minors. ...more

Troutman Pepper

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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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

DLA Piper

Microplastics Allegations “Don’t Hold Water”: Illinois District Court Tosses Claims Against Bluetriton Brands

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A recent opinion from the Northern District of Illinois may dampen the prospects of plaintiffs seeking to challenge the labeling of bottled water and other beverages based on the alleged presence of microplastics....more

Mintz - Health Care Viewpoints

FDA Rolls Out Innovative New Designation Programs in Response to Congressional Mandates

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more

Arnall Golden Gregory LLP

Here We Go Again; FDA’s Back in Town Again: OPDP Issues a Second Notice of Violation in Less Than a Month

Much like how Ray Charles lamented in 1967, the pharmaceutical industry is saying, “Here we go again, she’s back in town again,” as the Food and Drug Administration issued its second Notice of Violation in a month. Last week,...more

Arnall Golden Gregory LLP

Can’t Hardly Wait: OPDP Issues a Notice of Violation Where Risk Information Was Not Provided Adequately

In 1987, the influential garage rock band, The Replacements, led by Paul Westerberg, sang, “I can’t hardly wait.” Years later, the Food and Drug Administration issued a Notice of Violation — the second this year — to a...more

Cozen O'Connor

FTC and FDA Warning Letters Continue to Weed Out Misleading Marketing of THC-Containing Products

Cozen O'Connor on

The FTC and the FDA have sent cease-and-desist letters to five companies alleging that their marketing of edible products containing Delta-8 tetrahydrocannabinol (THC) violates Section 5 of the FTC Act because the packaging...more

Troutman Pepper

What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

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In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and...more

Shook, Hardy & Bacon L.L.P.

FDA Approves Qualified Health Claims for Yogurt

The U.S. Food and Drug Administration (FDA) will allow qualified health claims asserting the consumption of yogurt is associated with a reduced risk of type 2 diabetes, according to a constituent update. FDA reportedly found...more

K&L Gates LLP

Litigation Minute: Beauty From Within and the Confusing Claims Landscape

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What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more

Venable LLP

Mitigating Class Action Exposure: An Excerpt from the Advertising Law Tool Kit

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When it comes to mitigating the risk of class action lawsuits, the best offense is a good defense. Companies can take many steps to reduce their exposure to class action litigation before it happens, including the tactics...more

Morgan Lewis - Well Done

Yogurt and Type Two Diabetes: FDA Serves Up New Qualified Health Claim

The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two...more

Foley & Lardner LLP

Understanding the Risks Associated with Social Media Marketing

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Healthy food and beverage (“F&B”) companies frequently use social media to advertise. When used appropriately, social media campaigns can be incredibly effective tools to help emerging F&B companies reach target consumers,...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation and Regulatory Update

LEGISLATION, REGULATIONS & STANDARDS - 20 State AGs Ask FDA to Act on Lead, Metals in Baby Food - Citing a wave of childhood lead poisoning connected to recalled applesauce pouches, a group of 20 state attorneys...more

Venable LLP

[Event] 10th Advertising Law Symposium - March 21st, Washington, DC

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It’s that time of year again—Ad Law Symposium is back! Please join us in DC for this highly anticipated event focused on providing you with the information you need to promote your brand with confidence. Combining the...more

Venable LLP

Marketing FDA-Regulated Products: An Excerpt from the Advertising Law Tool Kit

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The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more

Troutman Pepper

More States Consider Establishing Vapor Product Directories

Troutman Pepper on

We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more

Troutman Pepper

En Banc Fifth Circuit Solidifies Circuit Split on Flavored ENDS Product MDOs

Troutman Pepper on

In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...more

Arnall Golden Gregory LLP

This Time of Year: OPDP Issues First Letter in 2024 for Unlawful Promotion

Better Than Ezra’s early 1990s single, “This Time of Year,” came to mind when we saw the Food and Drug Administration’s Office of Prescription Drug Promotion issue its first Untitled Letter (also known as a Notice of...more

Troutman Pepper

Multiple States Consider Establishing Vapor Product Directories

Troutman Pepper on

This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Arnall Golden Gregory LLP

(Maybe) I Can See More Clearly Now: FDA Issues Q&A Guidance on DTC Rx Ads

On December 26, 2023, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Questions and Answers Guidance for industry titled “Direct-to-Consumer Prescription Drug Advertisements:...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

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