Regulatory Oversight, Food Safety, Draft Guidance

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

Morgan Lewis - As Prescribed on 6/6/2025

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

Ramifications of FDA’s Proposed Action Levels for Heavy Metals in Baby Food

Womble Bond Dickinson on 3/13/2023

On March 4, 2021, we wrote about lawsuits concerning alleged high levels of heavy metals in baby foods (“Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers”). A precipitating factor was a staff report...more

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

Hogan Lovells on 7/19/2021

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

FDA Issues Draft Guidance on Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting

Hogan Lovells on 7/3/2019

FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Hogan Lovells on 5/20/2019

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

FDA Releases Draft Guidance regarding the Low Calorie Sweetener – Allulose

Hogan Lovells on 4/26/2019

Last week, the FDA released a draft guidance regarding the low calorie sweetener, allulose, and stated the agency will not treat this ingredient as contributing to total or added sugars content in the nutrition information....more

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

Hogan Lovells on 4/26/2019

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on 3/15/2019

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more

FSIS Releases Draft Guideline on Complaint Handling and Foreign Materials

Hogan Lovells on 3/13/2019

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products...more

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

Hogan Lovells on 10/26/2018

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on 6/26/2018

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more

Regulatory Oversight › Food Safety › Draft Guidance

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