News & Analysis as of

Dietary Supplements Federal Food Drug and Cosmetic Act (FFDCA)

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

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

Rivkin Radler LLP on

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

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

Polsinelli

FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

Polsinelli on

Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more

K&L Gates LLP

Litigation Minute: Beauty From Within and the Confusing Claims Landscape

K&L Gates LLP on

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

Perkins Coie

Dietary Supplements: FDA Issues Final Guidance for NDIN Procedures and Timeframes

Perkins Coie on

On March 5, FDA published its long-awaited Final Guidance on New Dietary Ingredient Notification (NDIN) Procedures and Timeframes (Final Guidance). This new guidance updates and finalizes Section V of FDA’s revised 2016 Draft...more

Epstein Becker & Green

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

Epstein Becker & Green on

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more

Foley Hoag LLP

Product Liability Update - January 2024

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MASSACHUSETTS - First Circuit Holds Putative Class Action Claims Alleging Deceptive Practices In Labeling of Lactase Product As Dietary Supplement Instead Of Drug When Product Claimed To Treat Lactose Intolerance...more

Venable LLP

Natural Products Association Challenges New York Law Prohibiting the Sale of Over-the-Counter Diet Pills and Certain Dietary...

Venable LLP on

This week, the Natural Products Association (NPA) filed a lawsuit against New York State challenging the constitutionality of a new state law prohibiting the sale of over-the-counter diet pills and dietary supplements for...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 Hoag LLP

Product Liability Update - September 2023

Foley Hoag LLP on

Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more

Holland & Knight LLP

Congressional Leaders Seek Stakeholder Input Regarding CBD Regulation

Holland & Knight LLP on

The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more

Rivkin Radler LLP

Modernization of Cosmetics Regulation Act of 2022

Rivkin Radler LLP on

FDA WILL HAVE EXTENSIVE AUTHORITY TO REGULATE COSMETICS- Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321(i), “cosmetics” are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on,...more

Vicente LLP

Functional Mushrooms: The Difference Between Regulation as a Food, Food Additive, or Dietary Supplement

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Consumers are increasingly interested in incorporating functional or adaptogenic mushrooms into their diets due to their potential health benefits, such as boosting immunity, reducing inflammation, and promoting overall...more

MoFo Life Sciences

Fluoride Supplement Manufacturer Forced To Address Misleading Labeling Allegations

MoFo Life Sciences on

Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2021

Harris Beach PLLC on

From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more

Alston & Bird

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

Alston & Bird on

Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more

Vicente LLP

Federal Hemp Legislation Outlook: What’s on the Horizon for 2022?

Vicente LLP on

Hemp was federally legalized nearly four years ago. Since then, the industry has dealt with constantly changing rules, despite being in regulatory purgatory due to snail-paced progress from the U.S. Food & Drug Administration...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

King & Spalding

FDA Rejects Bids To Market CBD-Based Dietary Supplements

King & Spalding on

On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...more

King & Spalding

Selling CBD-Infused Products Might Be Riskier Than You Think

King & Spalding on

The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more

Vicente LLP

What Is The FDA Saying About Full Spectrum Hemp? Key Takeaways From Rejections Of NDINs

Vicente LLP on

Almost three years since the legalization of hemp production in the United States, the U.S. Food and Drug Administration (FDA) is still in the process of determining the regulatory framework for CBD and other hemp...more

Foley Hoag LLP

The Not So Weaved Web: The Fate of CBD Products is in FDA’s Hands

Foley Hoag LLP on

More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more

Partridge Snow & Hahn LLP

FDA Refuses to Approve CBD As a Food Ingredient or Supplement

The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. Instead of clarifying the...more

Vicente LLP

Cannabis Administration And Opportunity Act: What The Proposed Federal Cannabis Laws Would Mean For Hemp

Vicente LLP on

On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more

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