Royce DuBiner on Food and Drug Administration (FDA)

Retailers at Risk: FDA Issues Advisory on Recreational Nitrous Oxide Products

On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more

6/17/2025 / Class Action , Consumer Protection Laws , Enforcement Actions , Food and Drug Administration (FDA) , Hazardous Substances , Manufacturers , Product Labels , Regulatory Oversight , Retailers , Risk Management

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

5/6/2025 / Appeals , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Regulatory Requirements

West Virginia Joins Growing List of States to Ban Food Dyes

On March 24, 2025, West Virginia Gov. Patrick Morrisey signed House Bill 2354 into law, prohibiting the sale and distribution of food products with certain artificial food dyes and chemicals. The signing of HB 2354 means West...more

4/1/2025 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Manufacturers , New Legislation , Proposed Legislation , Public Health , State and Local Government

Behind the Counter: Nitrous Oxide Requires Responsible Regulation, Continues to Show Risk

Across the United States, nitrous oxide (N2O), also known as laughing gas or nitrous, continues to be sold in convenience stores, gas stations and other easy-to-access locations with limited national enforcement. N2O serves a...more

2/25/2025 / Consumer Protection Laws , Controlled Substances , Food and Drug Administration (FDA) , Manufacturers , Retailers , Strict Product Liability , Unfair or Deceptive Trade Practices

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more

1/30/2025 / Centers for Medicare & Medicaid Services (CMS) , CMMI , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , MedPAC , New Guidance , Pharmaceutical Industry

FDA Bans Red Dye No. 3 in Food and Drugs, Sets Deadlines for Manufacturers to Reformulate

On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more

1/21/2025 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Manufacturers , Public Health , Regulatory Requirements

Interest in Psilocybin Continues to “Mushroom” for Potential Mental Health Treatment

Interest in the potential for psilocybin to be developed as a mental health treatment has continued to grow in recent months, due in part to recent activity by the U.S. Food and Drug Administration (FDA) and Drug Enforcement...more

4/2/2024 / Clinical Trials , Controlled Substances Act , Food and Drug Administration (FDA) , Life Sciences , Mental Health

FDA Releases Final Quality Management System Regulation Amendments

The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 CFR 820....more

2/9/2024 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

FDA Publishes Two Key Guidance Documents on Cosmetics Facility Registration and Product Listing

The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more

1/29/2024 / Cosmetics , Food and Drug Administration (FDA) , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Product Labels , Product Packaging

FDA Releases Its Scientific Support for Rescheduling Marijuana to Schedule III

On Jan. 12, 2024, the U.S. Department of Health and Human Services (HHS) officially released unredacted documents detailing the U.S. Food and Drug Administration’s (FDA) reasons for recommending that the Drug Enforcement...more

1/19/2024 / Controlled Substances , Controlled Substances Act , Food and Drug Administration (FDA) , Marijuana , Schedule I Drugs

Off-Label “Free Speech” Theory Does Not Fly for Convicted Former Medical Device Executives in 1st Circuit

A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by...more

1/19/2024 / 510(k) RTA , First Amendment , Food and Drug Administration (FDA) , Life Sciences , Medical Devices

FDA Provides New Resource on Redundancy Risk Management Plans for Critical Food Manufacturers

On Nov. 22, 2023, the U.S. Food and Drug Administration (FDA) published a new resource for manufacturers of critical foods — defined as any infant formula or medical food — reminding manufacturers of their obligation to...more

12/22/2023 / Food and Drug Administration (FDA) , Food Manufacturers , Food Supply , Risk Management , Supply Chain

FDA Issues Draft Guidance on Providing Health Care Providers With Scientific Information on Unapproved Uses of Approved/Cleared...

On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more

12/22/2023 / Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA Warning Letter Declares Delta-8 and CBD Gummies ‘Adulterated Foods’

On Dec. 6, 2023, the U.S. Food and Drug Administration (FDA) sent a warning letter to the owners of online hemp, tetrahydrocannabinol (THC) and cannabidiol (CBD) retailer Hemp-xr.com for introducing adulterated foods into...more

12/13/2023 / Cannabidiol (CBD) oil , Food and Drug Administration (FDA) , Hemp , Marijuana , Marijuana-Infused Edibles , Warning Letters

HHS Rescheduling, SAFER Banking Act May Change the Marijuana Landscape

In late August 2023, the Department of Health and Human Services (HHS) recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substances Act (CSA), signaling the...more

11/15/2023 / Banking Sector , Controlled Substances Act , DEA , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Marijuana , Marijuana Related Businesses , Popular

FDA Proposes Brominated Vegetable Oil Ban

On Nov. 2, 2023, the Food and Drug Administration proposed revoking the regulation that authorizes the use of brominated vegetable oil (BVO) in food. BVO is a vegetable oil with added bromine that prevents the separation of...more

11/7/2023 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Proposed Rules

FDA Publishes New Guidance on Cybersecurity in Medical Devices

In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more

10/3/2023 / Cyber Attacks , Cybersecurity , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Popular

FDA Issues Draft Guidance for Cosmetic Product Listing and Facility Registration

On Aug. 7, 2023, the U.S. Food and Drug Administration (FDA) released draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” which would require facilities that...more

8/25/2023 / Cosmetics , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Registration Requirement

Contract Research Organization Acquisitions: Critical Due Diligence Pathways

Bidding for attractive businesses in the pharma services space continues to accelerate, with new interest emerging daily from investors who traditionally have not focused on the sector. With this influx comes an urgent need...more

8/8/2023 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Due Diligence , Food and Drug Administration (FDA)

In the Weeds: Cannabis Clinical Trial Expands, Topicals Often Mislabeled, High Potency May Mean High Addiction

Newsworthy Highlights - Company to Expand Clinical Trial of Cannabis Therapy for Tourette Syndrome. A pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system...more

7/28/2022 / Cannabis Products , Dispensaries , Food and Drug Administration (FDA) , Marijuana , Marijuana Related Businesses , Recreational Use , USDA

In the Weeds: FDA Warns Against CBD for Food-Producing Animals, Okla. Suspends Lab License, Calif. Launches Cannabis Access Map

Newsworthy Highlights - FDA Continues CBD Warnings; Sends Letters to Companies Selling CBD Products for Food-Producing Animals. On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to four...more

6/2/2022 / Cannabidiol (CBD) oil , Cannabis Products , Food and Drug Administration (FDA) , Marijuana , Marijuana Related Businesses , Medical Marijuana , Recreational Use

Royce DuBiner

McGuireWoods LLP

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)