The Food and Drug Administration (FDA) published its final guidance for industry entitled “Conducting Remote Regulatory Assessments – Questions and Answers” on June 26, 2025. Initially published in draft format in July 2022...more
On January 6, 2025, FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and...more
On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more
The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more
On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more
The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more
DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more
The Office of Management and Budget (OMB) recently released the Spring 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR)...more
The U.S. Food and Drug Administration (FDA) recently published draft guidance that explains the approach the agency intends to take when evaluating the public health importance of food allergens that are not one of the nine...more
The U.S. Food and Drug Administration (FDA) has provided an update on the consumer research it plans to conduct on voluntary symbols that could potentially be used in the future to convey the nutrient content claim “healthy.”...more
For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more
The proposed rule would require that Food Safety and Inspection Service inspection decisions, such as Noncompliance Records, be appealed within 30 days....more
The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more
7/8/2021
/ APHIS ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
OMB ,
Regulatory Agencies ,
Regulatory Agenda ,
Regulatory Oversight ,
Rulemaking Process ,
USDA
The U.S. Food and Drug Administration (FDA) has released draft options for a new voluntary “healthy” symbol for packaged foods to depict the nutrient content claim. As previously noted, on 7 May 2021 the FDA issued a notice...more
California and Vermont have recently joined a growing list of states that have passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in food packaging. Relatedly, a group of environmental, consumer,...more
6/17/2021
/ Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Hazardous Substances ,
PFAS ,
Product Packaging ,
Proposed Regulation ,
Public Health ,
Regulatory Agenda ,
Toxic Chemicals ,
Toxic Exposure
The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more
5/10/2021
/ Comment Period ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Products . ,
Food Safety ,
Food Supply ,
Health Claims ,
Nutrition Facts Labels ,
Product Labels ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Standards ,
Rulemaking Process
On 22 April, the Supreme Court dealt a striking blow to the Federal Trade Commission’s (FTC) longstanding reliance on Section 13(b) of the Federal Trade Commission Act (FTC Act) as a basis for obtaining monetary relief for...more
On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more
2/25/2021
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Health Claims ,
Marijuana ,
Marketing ,
Medical Foods ,
Mental Health ,
Pharmaceutical Industry ,
Plant Based Products ,
Product Labels ,
Regulatory Oversight
On 18 December 2020 the Interagency Food Safety Analytics Collaboration (IFSAC) announced the release of its 2018 annual report on the sources of foodborne illness involving the pathogens Salmonella, Escherichia coli (E....more
12/23/2020
/ Annual Reports ,
Centers for Disease Control and Prevention (CDC) ,
E-Coli ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Listeria ,
Public Health ,
Salmonella ,
USDA
The U.S. Food and Drug Administration (FDA) released a guidance document on 1 December 2020 announcing an enforcement policy related to submission of a facility’s Unique Facility Identifier (UFI) as part of the 2020 biennial...more
On 24 November 2020, the Department of Health and Human Services (HHS) issued Notices in the Federal Register announcing two new policies related to future rulemaking procedures for all HHS agencies....more
On 10 November 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance recommending that companies voluntarily declare sesame in the ingredient list when it is used as a “flavor” or...more
11/12/2020
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) ,
Food Allergies ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Public Health ,
Retail Market ,
Voluntary Disclosure
Historically, neither food companies nor the plaintiffs’ bar have lost sleep over “recyclable” or “recycled content” claims. Over the past year, however, there has been increasing attention to and scrutiny of recyclable...more
The Office of Management and Budget (OMB) recently released the
Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
7/15/2020
/ Agribusiness ,
APHIS ,
Farms ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Food Supply ,
FSMA ,
Hemp ,
OMB ,
Regulatory Agenda ,
Regulatory Oversight ,
USDA