News & Analysis as of

Advertising Federal Food Drug and Cosmetic Act (FFDCA)

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

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...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

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

Goodwin

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

Goodwin on

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

Foley Hoag LLP

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

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On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

Husch Blackwell LLP

The Future of Functional Foods

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Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more

Foley & Lardner LLP

Who Regulates My Product?

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In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding the regulatory authorities that oversee your product. This is not...more

Mintz - Health Care Viewpoints

FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

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Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more

Fox Rothschild LLP

Pumpkin or Squash?

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As Fall comes to an end and we’ve consumed enough pumpkin pie to last us until next year, we remind you of the pumpkin vs. squash advertising debate that is more mind-boggling than what Grandma brought to your Thanksgiving...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - July 2021: Budding Legislation – The Cannabis Administration and Opportunity Act

On July 14, 2021, Senate Majority Leader Chuck Schumer, together with Senate Finance Committee Chair Ron Wyden and Senator Cory Booker, released a discussion draft of the Cannabis Administration and Opportunity Act (the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - July 2021

[co-author: Richa Patel, Summer Associate] The July 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fluid trademarks and the Cannabis Administration and Opportunity Act. Plus, check out the answer key...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

Kelley Drye & Warren LLP

Up & Up & Out. Structure/Function Claims Preempted by the FDCA

Last week, in a substantial win for the dietary supplement industry, the Ninth Circuit Court of Appeals upheld the Northern District of California’s grant of summary judgment to Target, ruling that state law false advertising...more

Patterson Belknap Webb & Tyler LLP

Courts Say CBD-Product False Ad Actions Should Mellow During FDA Rulemaking Process

Over the past few months, federal courts throughout the country have stayed litigation challenging the labeling of products infused or made with cannabidiol, better known as CBD. These courts, acknowledging that labeling and...more

Patterson Belknap Webb & Tyler LLP

In Butter-Flavored Spray Case, Federal Labeling Preemption Sticks In the End

Federal food-labeling laws preempt state laws that impose requirements different from or in addition to those established by federal law. In some cases, the FDA has spoken directly to a labeling issue by regulation, and if...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

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Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

Seyfarth Shaw LLP

Some Things Never Change: COVID-19’s Impact on CBD (or Lack Thereof)

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Hemp production, unlike much of the farming industry, has not declined due to COVID-19.  Meanwhile, certain CBD companies have wasted no time in making unsubstantiated claims related to COVID-19.  In turn, FDA and FTC...more

Foley Hoag LLP

FDA Issues Guidance on Supply Interruptions and Discontinuance Notification Requirements for Emergency and Life Supporting Drugs

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On April 1, 2020, FDA issued a guidance document instructing companies on how to notify the agency of a permanent discontinuance or interruption of manufacturing of certain products pursuant to Section 506C of the FDCA (21...more

Seyfarth Shaw LLP

False Advertising: Changing Your Business To Meet Market Needs During The COVID-19 Pandemic

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From severe shortages in medical masks and ventilation equipment worldwide to the curious “toilet paper desert” in America,  COVID-19 is creating temporary and long-term disruptions in the availability of both highly...more

Manatt, Phelps & Phillips, LLP

FDA Will Study Impact of Influencers on Drug Market

The Food and Drug Administration (FDA) has announced plans to consider the impact of influencers and payment disclosures on the prescription drug market with a pair of new studies....more

Stinson LLP

CBD Industry Experiences Wave of New Consumer Lawsuits

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The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....more

Perkins Coie

Multiple CBD Class Actions Filed With More Expected

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On the heels of the U.S. Food and Drug Administration’s (FDA) recent declarations regarding the safety of products containing cannabidiol (CBD), several companies have been hit with class action lawsuits alleging that that...more

BCLP

What Rules Will Govern Claims Relating to CBD in Food, Beverages and Supplements?

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Within the last two months, three class action lawsuits have been filed in federal courts against companies that sell ingestible products containing cannabidiol (CBD), a chemical compound found in the cannabis plant, alleging...more

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