Regulatory Oversight, Food Safety, Supply Chain

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Hogan Lovells on 5/9/2025

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

Morgan Lewis on 4/10/2025

Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on 2/13/2025

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more

The Learned Concierge - December 2024, Vol. 15

Clark Hill PLC on 12/19/2024

The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Special Report - 2022 FDA Year in Review

McDermott Will & Schulte on 2/6/2023

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

FDA Extends Enforcement Discretion for Several Requirements in FSMA Regulations

Hogan Lovells on 3/16/2022

FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more

FSMA update: FDA announces pilot program to evaluate third-party food safety standards

Hogan Lovells on 10/30/2020

The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more

Farm-to-Table Traceability Is on Its Way: FDA Issues Proposed Rule

Wiley Rein LLP on 10/2/2020

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold certain high-risk...more

FDA Provides Update on Forthcoming New Era of Smarter Food Safety Blueprint

Hogan Lovells on 6/4/2020

The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food...more

FSMA Update: FDA Announces Continuation of Enforcement Discretion for Co-Manufacturer Supplier Verification

Hogan Lovells on 11/18/2019

On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more

FDA Releases Strategy for the Safety of Imported Food

Hogan Lovells on 3/15/2019

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more

FDA Announces Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA

Hogan Lovells on 10/1/2018

The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more

Food & Beverage Litigation Update | October 2017 #4

Shook, Hardy & Bacon L.L.P. on 10/30/2017

Furans in Baby Food May Pose Health Risk, EFSA Reports - The European Food Safety Authority (EFSA) has issued an assessment of the risks of furans and related compounds 2- and 3-methylfurans, concluding that they pose a...more

Regulatory Oversight › Food Safety › Supply Chain

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