Last Friday, California Governor Gavin Newsom signed the California School Food Safety Act (AB2316). The new law will prohibit California's public schools from serving school meals containing any of the following synthetic...more
On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study...more
9/26/2024
/ Class Action ,
Consumer Protection Laws ,
Final Rules ,
Food Manufacturers ,
Jurisdiction ,
Labeling ,
Medical Devices ,
Medical Research ,
Metals ,
Misleading Statements ,
Peer Review ,
Preemption ,
Premarket Approval Applications ,
Proposition 65 ,
Research Reports
We previously covered California's landmark Food Safety Act, the legislative proposals inspired by it, and the FDA's final rule revoking the authorization of brominated vegetable oil (BVO) in food products. Since then, there...more
As announced earlier this month, the longstanding Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA or Agency) and the Association of American Feed Controls Officials (AAFCO) will expire on...more
State legislatures are actively pursuing bans on food and color additives. California’s landmark Food Safety Act (Act), effective January 2027, bans the manufacture and sale of products containing brominated vegetable oil...more
Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more
7/11/2024
/ Administrative Procedure Act ,
Biologics Price Competition and Innovation Act of 2009 ,
Chevron Deference ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Jurisdiction ,
Loper Bright Enterprises v Raimondo ,
Prescription Drugs ,
Public Health Service Act ,
Rulemaking Process ,
SCOTUS ,
Statutory Interpretation
We want to inform you of a new law in Maryland, effective January 1, 2025, that mandates baby food manufacturers to test for toxic heavy metals, excluding infant formula. Known as Rudy’s Law, this legislation was inspired by...more
In a monumental opinion issued today, the U.S. Supreme Court in Loper Bright Enterprises v. Raimondo overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., holding (6-3) that deference to an agency's...more
7/1/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Constitutional Challenges ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
National Marine Fisheries Service ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Stare Decisis ,
Statutory Interpretation ,
Unconstitutional Condition
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
5/28/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape for laboratory developed tests (LDTs). This action...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
The terms vegetarian and vegan are becoming more common. Initially, how to be a practicing vegetarian or vegan was the focus. Now, these terms are used to describe not only a lifestyle, but foods, cosmetics, and clothing. ...more
As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law went into effect on...more
As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law is to go into effect on...more
As promised last month, we are happy to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the...more
On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more
Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of...more
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
On November 8, 2023, the United States Food and Drug Administration (FDA or agency) announced it does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing under...more
A new law from New York State will require companies selling certain dietary supplements in the state to pay close attention to consumers' age. Last week, Governor Kathy Hochul signed into law Assembly Bill A5610D, which...more
Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more
7/21/2023
/ Adverse Events ,
Best Practices ,
Cosmetics ,
Disclosure Requirements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Filing Deadlines ,
Food and Drug Administration (FDA) ,
Interstate Commerce ,
Manufacturers ,
Manufacturing Facilities ,
New Legislation ,
Personal Care Products ,
Product Labels ,
Recordkeeping Requirements ,
Registration Requirement
On the surface, a dispute over whether small fishing businesses should be required to pay for onboard monitors to observe their catch would not appear to be a potential game-changer for administrative law. But when the...more