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Regulatory Reform Food and Drug Administration (FDA) Food & Drug Regulations

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

Holland & Knight LLP

FDA Initiates New Post-Market Review Framework for Food Chemicals

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The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more

Morrison & Foerster LLP

FDA Seeks to Phase Out Synthetic Color Additives

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...more

Venable LLP

Food Industry Braces Itself as FDA Announces Plan to Ban Artificial Dyes

Venable LLP on

On April 21, 2025, it was reported that the U.S. Department of Health and Human Services (HHS) has released a media advisory describing the Food and Drug Administration’s (FDA) intention to remove petroleum-based synthetic...more

Troutman Pepper Locke

Opportunities for the Trump Administration to Step Up Enforcement Against Unauthorized ENDS

Troutman Pepper Locke on

Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more

Shook, Hardy & Bacon L.L.P.

FDA Revokes Rule Allowing Brominated Vegetable Oil in Foods - Food and Beverage Litigation and Regulatory Update

The U.S. Food and Drug Administration (FDA) has revoked its regulation authorizing the use of brominated vegetable oil as a food ingredient used to stabilize flavoring oils in fruit-flavored beverages after concluding it is...more

McDermott Will & Schulte

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

Troutman Pepper Locke

More States Consider Establishing Vapor Product Directories

Troutman Pepper Locke 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 Locke

Multiple States Consider Establishing Vapor Product Directories

Troutman Pepper Locke 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

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Jones Day

California Becomes the First State to Ban Four Common Food Additives

Jones Day on

With the swipe of a pen, California Governor Gavin Newsom starts the California Food Safety Act countdown to a 2027 statewide ban on four popular food additives. Starting January 1, 2027, companies manufacturing, selling,...more

Morgan Lewis - Well Done

Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods

FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - February 2023

U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more

Epstein Becker & Green

Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development

Introduction - Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - January 2023

LEGISLATION, REGULATIONS & STANDARDS - Omnibus Spending Bill Includes Congressional Notes to FDA - President Biden has signed a spending bill that includes additional funding for the U.S. Food and Drug Administration (FDA)...more

Arnall Golden Gregory LLP

In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule

Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

Knobbe Martens

FDA Proposes Changes to Medical Device Quality Regulations

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The U.S. Food and Drug Administration (FDA) published on February 23rd, 2022, a rule proposal to overhaul medical device quality control regulation. According to the FDA, the proposed rule change would “amend the device...more

Jones Day

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

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The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

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On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

Holland & Knight LLP

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

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On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

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