News & Analysis as of

Food Supply Draft Guidance Food and Drug Administration (FDA)

Hogan Lovells

FDA Releases Revised Appendix 1 and Introduction to Hazard Analysis and Preventive Controls Draft Guidance

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The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more

Perkins Coie

Food Allergen Programs and Acidified Foods: FDA Adds Two New Chapters to its Draft Guidance on Preventive Controls for Human Food

Perkins Coie on

On September 26, 2023, the U.S. Food & Drug Administration (FDA) added two new chapters to the agency’s draft guidance (the Draft Guidance): Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods. These additions...more

Ervin Cohen & Jessup LLP

FDA Announces Updated Foods Program Priorities

On July 6, 2023, the U.S. Food and Drug Administration (“FDA”) released an updated list of draft and final topics that the agency anticipates publishing guidance documents for by the end of December 2023....more

Hogan Lovells

FDA seeks comment on food labeling information in e-commerce

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The U.S. Food and Drug Administration (FDA) is requesting comment on the availability of nutrition, ingredient, and allergen information online for packaged foods sold through online grocery shopping platforms.  FDA explains...more

MoFo Life Sciences

FDA Releases Draft Guidance For Labeling Of Plant-Based Milk Alternatives

MoFo Life Sciences on

In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration...more

Womble Bond Dickinson

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

Womble Bond Dickinson on

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

Hogan Lovells

Two recent developments regarding FDA inspection-related activities

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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

Hogan Lovells

FDA Issues Draft Guidance on Evaluating Public Health Impacts from Non-Major Food Allergens

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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

Morgan Lewis - Well Done

FDA Outlines Evaluation Approach to Non-Major Food Allergens in Draft Guidance

Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk,...more

Hogan Lovells

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

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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

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

FDA Releases Draft Guidance regarding the Low Calorie Sweetener – Allulose

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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

Hogan Lovells

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

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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

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

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

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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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | October 2018 #4

Silverman Publishes “In Search of the Reasonable Consumer: When Courts Find Food Class Action Litigation Goes Too Far” - Shook Partner Cary Silverman has authored an article for the University of Cincinnati Law Review...more

Hogan Lovells

FDA Issues Draft Guidance on Publishing Retail Consignees Lists to Effectuate Certain Human and Animal Food Recalls

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On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety....more

Hogan Lovells

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on

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

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