News & Analysis as of

Health and Safety Federal Food Drug and Cosmetic Act (FFDCA)

McDermott Will & Emery

Bye-bye, bright dyes: Strategies for responding to FDA’s synthetic food dye phase-out

McDermott Will & Emery on

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase out petroleum-based synthetic dyes from the US food supply by the end of 2026,...more

Paul Hastings LLP

Recent Investigations by the Texas Attorney General Piggyback on Federal ‘Make America Healthy Again’ Initiatives

Paul Hastings LLP on

Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more

Holland & Knight LLP

Ninth Circuit Holds That California Food-Labeling Law Is Not Preempted by Federal Law

Holland & Knight LLP on

In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more

Wiley Rein LLP

Time’s Up! Cosmetic Facilities Must Comply With FDA’s New Registration Requirements by July 1

Wiley Rein LLP on

The July 1, 2024 deadline is fast approaching for cosmetic product manufacturers to comply with new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Passage of the...more

Arnall Golden Gregory LLP

Magic’s in the Makeup: FDA Modernizes Cosmetic Product Labeling Requirements

“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more

Wilson Sonsini Goodrich & Rosati

A Much-Needed Makeover: Congress Signs Updates to Cosmetic Regulations

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022, as part of the year-end Consolidated Appropriations Act, 2023, added significant new requirements for manufacturers,...more

Akin Gump Strauss Hauer & Feld LLP

Preparedness Policy Takes Shape: PREVENT Pandemics Act Enacted Ahead of PAHPA Reauthorization

On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ and FDA Target Companies That Undermine FDA Oversight

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Seyfarth Shaw LLP

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

Seyfarth Shaw LLP on

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

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

Seyfarth Shaw LLP on

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

Hogan Lovells on

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

King & Spalding

FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)

King & Spalding on

Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

Brownstein Hyatt Farber Schreck

FDA Cracks Down on Companies Selling CBD Products

The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease,...more

McDermott Will & Emery

What to Know About FDA’s Recent Statements on CBD

McDermott Will & Emery on

Last week FDA issued a public release on CBD titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis derived Compounds, Including CBD.” The FDA document does not...more

Mintz - Health Care Viewpoints

First Indicators of FDA’s Policy Decision on CBD and Cannabis-Derived Ingredients: “Only Limited Data” and “Real Risks”

We have previously blogged about the Food and Drug Administration’s year of listening and information gathering related to products containing cannabis or cannabis-derived compounds since the 2018 Farm Bill removed “hemp”...more

Perkins Coie

FDA Declines to Conclude CBD is Safe and Sends Flurry of Warning Letters

Perkins Coie on

On November 25, 2019, the U.S. Federal Drug Administration (FDA) took several significant actions regarding sellers of products containing cannabidiol (CBD). The FDA announced that it cannot conclude that CBD is “generally...more

Wilson Sonsini Goodrich & Rosati

FDA Declares CBD Is Not GRAS and Signals That It Will Maintain Its Deliberate Approach

With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an...more

McDermott Will & Emery

FDA Regulatory Check-Up: CBD and Dietary Supplements

McDermott Will & Emery on

The Food and Drug Administration (FDA) has communicated a commitment to ensuring that firms marketing dietary supplements are not misleading particularly vulnerable consumers (e.g., elderly, cancer patients, or children) with...more

Foley Hoag LLP - Cannabis and the Law

Steps FDA Can Take to Expedite Marketing CBD in Food and Dietary Supplements

The U.S. Food and Drug Administration (“FDA”) currently takes the position that cannabidiol (CBD) and other cannibinoids cannot be used in dietary supplements and food because of statutory provisions under the Federal Food,...more

McDermott Will & Emery

Learnings from the FDA Hearing on Cannabis and Cannabis-Derived Compounds

On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health...more

Steptoe & Johnson PLLC

FDA Holds First Public Hearing on CBD Regulation

As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more

McDermott Will & Emery

FDA Announces Public Hearing on Products Containing Cannabis or Cannabis-Derived Compounds

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional...more

Holland & Knight LLP

FDA Issues Draft Guidance on Bulk Substances for Compounding by Outsourcing Facilities

Holland & Knight LLP on

On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more

Bergeson & Campbell, P.C.

EPA Requests Comments on Revocation of Chlorpyrifos Tolerances

On October 30, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on a proposal to revoke all tolerances for the insecticide chlorpyrifos in response to a U.S. Court of Appeals for...more

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