FDA and USDA Regulatory Updates
FDA Announces Proposed Rule to Require Submission of Tracking Numbers for Imports of E-Cigarette Products
Recently, FDA and the Department of the Treasury are announcing a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of Electronic Nicotine...
Durbin Introduces Legislation To Improve Safety And Ensure Transparency Of Dietary Supplements
9 Out Of 10 American Adults Support Listing Requirements For Dietary SupplementsWASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today introduced the Dietary Supplement Listing Act of 2024,...
FDA Announces Registration and Listing Updates: The Release of New Discontinuation/Relisting Features in Cosmetics Direct
Cosmetics Constituent Update Today the U.S. Food and Drug Administration (FDA) announced the release of the following enhancements to help industry keep their registration and listing submissions up...
FDA Enhances Tobacco Retailer Inspection Database
This week, FDA’s Center for Tobacco Products updated the presentation of information about tobacco compliance check outcomes on the FDA website and expanded the information available. The...
FDA Releases Update of Priority Guidance Topics for Foods Program
Earlier this year, the FDA released the draft and final guidance topics that are a priority for the agency’s Foods Program to complete during 2024. Since January, the FDA has issued the following...
FY2024 OMUFA User Fees Announced by FDA
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023...
FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”...
FDA Issues Import Alert for Food Products with Chemical Contaminants Including PFAS
On March 20, 2024, the US FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert...
FDA Launches Searchable Tobacco Products Database
Database Lists Tobacco Products—Including E-Cigarettes—That May Be Legally MarketedToday, FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco...
FDA Proposed Rule on “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs”
FDA proposes to revise the existing regulations regarding the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of...
USDA Finalizes Voluntary “Product of USA” Label Claim to Enhance Consumer Protection
USDA today published its “Product of USA” final rule, which will allow voluntary “Product of USA” or “Made in the USA” label claims to be used on meat, poultry, and egg products only when they are...
FDA Announces Release of First Final Guidance Section for NDIN – NDI Notification Procedures and Timeframes
The FDA recently announced final guidance for industry on “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes.” This guidance is intended to help manufacturers and...
FDA Issued a Final Guidance Document on CARES Act Reporting Requirements
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological...
FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance
The FDA has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft...
FDA Issues Final QMSR Regulation and FAQ
The Food and Drug Administration (FDA) issued a final rule on January 31, 2024, to amend the medical device current good manufacturing practice (CGMP) requirements of the Quality System (QS)...
FDA Issues Revised Draft Guidance for Topical Ophthalmic Drug Products
The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft...
Upcoming FDA Food Guidance Materials for 2024
On January 25, 2024, the U.S. Food and Drug Administration’s Foods Program posted a list of new / updated food regulations it plans to publish in 2024 and beyond. These include:Amendments to...
FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products
The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.”...
FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products
Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are...
FDA Announces Availability of Draft Supplemental Guidance on Menu Labeling
The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled Menu Labeling: Supplemental Guidance for Industry (Edition 2). To respond to...
FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
Today, the U.S. Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements...
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
FDA has issued a Draft Guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”. Comments may be made to Docket number FDA-2023-D-4416 by 26 December...
MoCRA Preparations Should be in Progress
As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering...
The FDA Has Updated the Food Traceability Frequently Asked Questions on the Website
On September 28, 2023, the U.S. Food and Drug Administration (FDA) has updated its Food Traceability Frequently Asked Questions (FAQ) to provide additional information about this rule. The Food...
FDA Issues New Guidance for Allergen Management and Control
On September 26, 2023, US FDA issued an updated Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This new guidance material includes a new chapter...
FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
On Friday 15 September 2023, the FDA issued a draft guidance shedding light on the much-anticipated MoCRA registration and listing requirements. The guidance, titled “Registration and Listing of...
FDA Extends Comment Period for TPMP Proposed Rule
On March 10, the U.S. Food and Drug Administration published a proposed rule titled, Requirements for Tobacco Product Manufacturing Practice. FDA is extending the proposed rule’s comment period by...
Federal Judge Strikes Down FDA Regulation of Premium Cigars
In a major win for the premium cigar industry, Judge Amit Mehta of the U.S. District Court for Washington D.C. has vacated FDA’s deeming regulations for premium, hand-rolled cigars. As a result, the...
FDA Releases New Guidance on Cosmetic Facility and Product Registration
On August 7, FDA issued a new draft guidance on the registration and listing of cosmetic product facilities and products, which is mandated by the Modernization of Cosmetic Regulations Act of 2022...
Congress Seeks Input on CBD Regulation by August 18
On July 27, 2023, the U.S. Congress requested information to guide the assessment of the potential for a regulatory pathway for hemp-derived Cannabidiol (CBD) products with the goal to prioritize...