FDA and USDA Regulatory Updates
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On August 7, FDA issued a new draft guidance on the registration and listing of cosmetic product facilities and products, which is mandated by the Modernization of Cosmetic Regulations Act of 2022...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...
Ensuring Compliance with FDA Guidelines for Glycerin Identity Testing
A recent FDA warning letter concerning identity testing and contaminated glycerin highlights the significance of a recurring potential public health hazard. After several lethal poisonings...
FDA Issues Draft Guidance on Dietary Guidance Statements in Food Labeling
FDA’s latest draft guidance document on Dietary Guidance Statements in Food Labeling shares FDA’s current thinking on label, labeling and marketing statements that aims to help Americans make...
FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP)
Contrary to the expectation in the cosmetic regulatory space, the FDA has stopped accepting submissions to the voluntary cosmetic registration and listing program and will not be transferring this...
FDA Calls for Enhanced Safety Measures in Letter to Powdered Infant Formula Industry
On March 8, 2023, US FDA issued a “Call to Action” letter to all powdered infant formula manufacturers, packers, distributors, exporters, importers, and retailers in order to help protect our most...
USDA FSIS Announces Draft of New Requirements for Voluntary Use of ‘Made in the USA’ Labels
The US Department of Agriculture Food Safety Inspection Service (USDA FSIS) announced draft of a proposed change to voluntary labeling requirements for meat, poultry and eggs that use the claim...
New Dietary Supplement Ingredients Directory Launched by FDA
FDA has launched an on-line directory that lists 27 articles used in dietary supplements enabling quick references to any information FDA currently has pertaining to these articles and any actions...
USDA Announces National Organic Program (NOP) previewed the Strengthening Organic Enforcement (SOE) Final Rule
Earlier this year, USDA announced the National Organic Program (NOP) Strengthening Organic Enforcement (SOE) final rule...
FDA Seeks Maximum Allowable Civil Monetary Penalties Against Unlawful E-Liquid Manufacturers
In a first for FDA’s Center for Tobacco Products, Civil Monetary Penalty complaints have been filed against four manufacturers of e-liquids for violation of the Food Drug and Cosmetic Act...
FDA Issues 2022 Food Code
Late last year, the FDA issued the 2022 edition of the FDA Food Code providing guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail and provide a...
FDA Enforcement Discretion for Certain Qualified Health Claims and Cocoa Flavanols
FDA has indicated enforcement discretion for certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease...
FDA Proposes Restructuring Food Safety Efforts into New Human Foods Program
In a January 31, 2023 announcement, FDA proposed a vision to restructure the oversight of food safety and informed consumer choices into a new organization which will be known as the Human Foods...
FDA Issues Final Guidance on GRAS Panel Best Practices
The U.S. Food and Drug Administration (FDA) has issued a final guidance titled Best Practices for Convening a GRAS Panel. Although in most cases general recognition of safety can be supported...
Guidance for Industry: Homeopathic Drug Products
What You Need to Know The U.S. Food and Drug Administration has issued a final guidance on Homeopathic Drug Products describing the agency’s approach to prioritizing regulatory actions for...
Updates to Retail Program Standards Offers Flexibility
FDA recently released an updated 2022 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) for both food service and food retail establishments....
FDA Proposed Rule on Revising the National Drug Code Format
The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC...
Guidance for Industry: Enforcement Policy for Providing an Acceptable UFI
What You Need to Know EAS food facility registration clients will remember during the 2020 renewal period, the FDA had sent reminders of the requirement per 21 CFR 1.232(a)(2), of a unique facility...
FDA Expands Use of Remote Regulatory Assessments (RRA)
What You Need to KnowFDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on...
FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
As has long been anticipated, FDA, on April 28, 2022, announced a proposed rule that would prohibit menthol as a characterizing flavor in cigarettes, and all characterizing flavors other than...
Food Labeling Modernization Act of 2021 Introduced
‘The Food Labeling Modernization Act’ (FLMA) was introduced this month in both houses of Congress by Representative Frank Pallone (D-NJ) and Senator Richard Blumenthal (D-CT), along with...
FDA Publishes Required Records for FSVP
FDA has published a list of required records for foreign firms exporting food products for both animal and human consumption into the U.S. The Foreign Supplier Verification Program (FSVP), which is...
Final Guidance for Food Contact Notifications – Infant Formula and / or Human Milk
FDA’s Final Guidance for preparation of Food Contact Notifications for substances that come into contact with infant formula and human milk is intended to help industry understand FDA’s process...
FDA Strengthens Process of Initiating Voluntary Recalls
Voluntary recalls are a vital means to protect public health and typically are the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market. FDA’s...
Final Guidance for Abbreviated Drug Application Submissions
FDA has issued Final Guidance related to drug marketing application submissions for human drugs and recommendations for considerations of whether to submit a 501(b)(2) New Drug Application, commonly...
Farm Bill Solves “Added Sugar” Problem for Single Ingredient Products
The recently signed Farm Bill answers a number of questions, particularly for those manufacturers of single ingredient foods, jars of honey and maple syrup specifically, who objected to the...
FDA Technical Amendments for Nutrition and Supplement Facts Panels Released
FDA released a technical amendment correcting or further explaining minor errors and omissions in the May 27, 2016, Final Rules for Food Labeling: Revisions of the Nutrition and...
Food Safety Plan Builder Updates Released
FDA has released an updated version of the downloadable Food Safety Plan Builder tool designed to help owners and operators of food establishments with the development of a food safety plan that...
Updated Guidance for Declaration of Dietary Fiber in Nutrition Labels
Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber: [1] non-digestible...
USDA Announces Members of NACMCF – Two EAS Independent Consultants are Included
The names of new and returning members of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) have been announced and the committee now includes two EAS Independent...