Manufacturers and processors of U.S.-distributed cosmetic products must renew their facility registration for the first time by July 1, 2026. To assist with the biennial registration requirement, the Food and Drug...more
2/18/2026
/ Compliance ,
Cosmetics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Manufacturers ,
Manufacturing Facilities ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
New Guidance ,
Registration Requirement ,
Regulatory Oversight ,
Regulatory Requirements ,
Reporting Requirements
The U.S. Food and Drug Administration (FDA) announced several coordinated updates on February 5, 2026, that collectively signal a major shift in the agency’s oversight of “no artificial colors” claims on foods intended for...more
2/13/2026
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Manufacturers ,
New Guidance ,
Product Labels ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) has issued a draft guidance reminding the cosmetics industry that the agency can access a variety of business records during an inspection of a product’s responsible person and...more
2/3/2026
/ Cosmetics ,
Draft Guidance ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Manufacturing Facilities ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Popular ,
Recordkeeping Requirements ,
Regulatory Authority ,
Regulatory Oversight ,
Regulatory Requirements ,
Reporting Requirements
The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) recently released the highly anticipated 2025-2030 Dietary Guidelines for Americans, which the Trump Administration...more
1/23/2026
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
Dietary Guidelines ,
Federal Funding ,
Food Labeling ,
Food Manufacturers ,
New Guidance ,
Public Health ,
Public Schools ,
Regulatory Oversight ,
Regulatory Requirements ,
Request For Information ,
School Lunch Programs ,
SNAP Program ,
Trump Administration ,
USDA
The U.S. Food and Drug Administration (FDA, or the Agency) published a draft guidance explaining its mandatory recall authority for cosmetic products on December 18, 2025 (90 FR 59129). Entitled “Questions and Answers...more
1/6/2026
/ Administrative Hearings ,
Cosmetics ,
Draft Guidance ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
New Guidance ,
Popular ,
Product Recalls ,
Regulatory Authority ,
Regulatory Requirements ,
Statutory Authority
On November 28, 2025, the U.S. Food and Drug Administration (FDA) withdrew its 2024 proposed rule entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.” 90 FR 54603. The...more
12/8/2025
/ Administrative Procedure Act ,
Asbestos ,
Cosmetics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Popular ,
Proposed Rules ,
Public Health ,
Regulatory Requirements ,
Rulemaking Process ,
Testing Requirements ,
Toxic Chemicals
Senator Roger Marshall (R-KS) introduced much-anticipated legislation this month that seeks to reform the process by which “generally recognized as safe” (GRAS) substances are assessed by the U.S. Food and Drug Administration...more
11/24/2025
/ Disclosure Requirements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
GRAS ,
New Legislation ,
Notification Requirements ,
Proposed Legislation ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements
In Natural Grocers v. Rollins, the U.S. Court of Appeals for the Ninth Circuit significantly upended certain parts of the U.S. Department of Agriculture’s (USDA) National Bioengineered Food Disclosure Standard (BE Rule). ...more
11/12/2025
/ Administrative Procedure Act ,
Agribusiness ,
Agricultural Marketing Act ,
Appeals ,
Appellate Courts ,
Bioengineering ,
Disclosure Requirements ,
Food Labeling ,
GMO ,
Judicial Review ,
Regulatory Authority ,
Regulatory Requirements ,
Remand ,
Rulemaking Process ,
Statutory Interpretation ,
Threshold Requirements ,
USDA ,
Vacated ,
Vacatur
On Thursday September 25, the U.S. Department of Justice (DOJ) announced the creation of a new Enforcement & Affirmative Litigation Branch within the Civil Division. According to the DOJ press release, DOJ’s affirmative...more
10/8/2025
/ Constitutional Challenges ,
Consumer Product Safety Commission (CPSC) ,
Consumer Protection Laws ,
COPPA ,
Department of Justice (DOJ) ,
Deregulation ,
Enforcement Actions ,
Enforcement Priorities ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Immigration Enforcement ,
Regulatory Authority ,
Regulatory Reform ,
State and Local Government ,
Unfair or Deceptive Trade Practices
On September 9, 2025, the Make America Healthy Again (MAHA) Commission released its Strategy Report for combating “the childhood chronic disease crisis.” The MAHA Commission determined this crisis existed in its May 2025 MAHA...more
9/23/2025
/ Agricultural Sector ,
Centers for Disease Control and Prevention (CDC) ,
Chemicals ,
Department of Health and Human Services (HHS) ,
Dietary Guidelines ,
Environmental Policies ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Supply ,
GRAS ,
NEPA ,
PFAS ,
Popular ,
Public Health ,
Research and Development ,
State Legislatures ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA) ,
USDA
With food policy remaining a top priority for the Trump Administration, the U.S. Food and Drug Administration (FDA), acting under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has swiftly advanced a number...more
8/12/2025
/ Comment Period ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Popular ,
Proposed Rules ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Trump Administration
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA):
•Standardized test methods to detect...more
1/20/2025
/ Asbestos ,
Consumer Product Companies ,
Cosmetics ,
Enforcement ,
Final Rules ,
Food and Drug Administration (FDA) ,
Labeling ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
OMB ,
Proposed Rules ,
Regulatory Agenda
The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more
1/9/2025
/ Compliance ,
Cosmetics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
New Guidance ,
Public Comment ,
Registration Requirement ,
Regulatory Agenda ,
Regulatory Requirements ,
Small Business
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
The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of critical drugs, medical devices, and biologic...more
In what could be a game-changer to the dietary supplement and food industry, the U.S. Food and Drug Administration (FDA or Agency) is proposing to amend the investigational new drug (IND) regulations to exempt clinical...more
On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more
On this episode of “Food for Thought and Thoughts on Food,” Ann Begley and Amaru Sanchez join to discuss regulatory and commercialization challenges facing novel foods today. The pair interview Ahmed Khan, Founder and Editor...more
The U.S. Food and Drug Administration (FDA or Agency) recently announced the availability of a new draft guidance titled “Conducting Remote Regulatory Assessments: Questions and Answers” (RRA Draft Guidance). Remote...more
Recently, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance titled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act” (Draft Guidance)....more
On September 3, 2021, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) published an Advance Notice of Proposed Rulemaking (ANPR) on the Labeling of Meat or Poultry Products...more
On June 8, 2021, the White House released its 250-page “Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth” report (the Report) and an accompanying fact sheet entitled:...more
On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more
The U.S. Food and Drug Administration (FDA) published a request for information in the Federal Register in connection with labeling of foods made with cultured seafood cells. FDA will use the information received to decide...more
On September 22, 2020, the U.S. Food and Drug Administration (FDA) announced the establishment of the Digital Health Center of Excellence (DHCE) within FDA’s Center for Devices and Radiological Health (CDRH). Bakul Patel will...more