News & Analysis as of

New Regulations Federal Food Drug and Cosmetic Act (FFDCA)

DarrowEverett LLP

The DOJ’s New White-Collar Agenda: Implications for Businesses

DarrowEverett LLP on

On May 12, 2025, the Department of Justice (the “DOJ”) released its criminal—and, more specifically, white collar crime enforcement—initiatives under the current administration. This is typical each time new leadership...more

Shook, Hardy & Bacon L.L.P.

FDA, HHS Announce Measures to Phase Out Petroleum-Based Dyes in Food

The U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) have announced actions to phase out petroleum-based synthetic dyes from foods in the U.S. food supply. In a news release, FDA said...more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Regulation and Enforcement Updates

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

Foley Hoag LLP on

The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

King & Spalding

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

King & Spalding on

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

ArentFox Schiff

The Next Wave of PFAS Regulation

ArentFox Schiff on

Last fall, we wrote about the EPA’s strategic roadmap regarding its goals for investigating, regulating, and remediating Per- and Polyfluroalkyl Substances (PFAS). On November 18, 2021, the bipartisan Keep Food Containers...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Fox Rothschild LLP

California Proposes Regulations Governing Compounding In A Veterinary Premises

Fox Rothschild LLP on

The California Veterinary Medical Board has proposed amending the California Code of Regulations to clarify the process for veterinarians to compound drugs in a veterinary office for the treatment of an animal patient. As...more

Mintz - Intellectual Property Viewpoints

Navigating the Legalization of Hemp under the 2018 Farm Bill Involves Changes to the Issuance of Federal Trademarks in the...

Legalizing “hemp” under the Agricultural Improvement Act of 2018 (2018 Farm Bill) has triggered an important change for the examination of federal trademark applications concerning cannabis and cannabis-derived goods and...more

Ward and Smith, P.A.

2018 Farm Bill and Federal Trademark Protection for Hemp

Ward and Smith, P.A. on

The U.S. Patent and Trademark Office ("USPTO") generally refuses to register marks that violate federal law. Hemp and hemp-derived CBD were previously classified as Schedule I controlled substances under the Controlled...more

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

Trademark Registration Sees a New High: Registration for trademarks for goods derived from "hemp" now allowed under USPTO rules

Following the enactment of the 2018 Farm Bill [see related article1], the United States Patent and Trademark Office (USPTO) just this morning released a new Trademark Examination Guide for marks covering cannabis and...more

Mintz - Health Care Viewpoints

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more

Womble Bond Dickinson

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

Womble Bond Dickinson on

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

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