News & Analysis as of

Food Safety Draft Guidance

Hogan Lovells

FDA Issues “Phase II” Draft Guidance on Voluntary Sodium Reduction Targets

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On August 15, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance with new, voluntary sodium reduction targets for foods, with the goal of reducing sodium intake to 2,750 milligrams (mg) per day from the...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update | Issue 825

LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Draft Guidance for Sodium Reduction Efforts - The U.S. Food and Drug Administration (FDA) has issued draft guidance that would support reducing the average...more

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FDA Releases Revised Appendix 1 and Introduction to Hazard Analysis and Preventive Controls Draft Guidance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The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more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 Safety Focus: FDA Updates Draft HARPC Guidance for Human Food

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published revisions to its multichapter draft guidance for industry on Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food (the Draft Guidance). 89...more

Hogan Lovells

FDA Releases New Draft Guidance Chapter on Acidified Foods

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In September 2023, FDA released two new chapters to its Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) Draft Guidance (Draft Guidance). New draft Chapter 11 is focused on food allergen programs, and...more

Hogan Lovells

FDA releases draft guidance on food allergen programs under the Preventive Controls rule

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The U.S. Food and Drug Administration (FDA) recently issued a new food allergen-focused chapter of its Hazard Analysis and Risk-Based Preventive Controls for Human Food draft guidance. The new chapter addresses allergen...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Food Allergen Programs and Acidified Foods: FDA Adds Two New Chapters to its Draft Guidance on Preventive Controls for Human Food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On September 26, 2023, the U.S. Food & Drug Administration (FDA) added two new chapters to the agency’s draft guidance (the Draft Guidance): Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods.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

Davis Wright Tremaine LLP

Making Sense of FDA's Draft Guidance on Plant-Based Milk Alternatives

In February, the U.S. Food and Drug Administration (FDA) issued draft guidance describing its "current view" of how companies should name plant-based foods marketed and sold as alternatives to milk. In this hotly contested...more

Cozen O'Connor

FDA Draft Guidance on Lead in Baby Food Earns AG Support

Cozen O'Connor on

A group of 21 Democratic AGs wrote a comment letter to the FDA in connection with the agency’s Draft Guidance to Industry on Action Levels for Lead in Food Intended for Babies and Young Children (“Lead Guidance”). The letter...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

FDA issues draft guidance setting action levels for lead in food intended for babies and young children

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The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry on Action Levels for Lead in Food Intended for Babies and Young Children (Draft Guidance). The proposed action levels would apply to processed...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 oversight of food products covered by Systems Recognition Arrangements

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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

Kelley Drye & Warren LLP

Greater than the Sum of Its Parts: FDA Releases Supplemental Draft Completing its Draft Guidance Regarding Protecting Food Against...

FDA’s recently released Supplemental Draft Guidance entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry” serves as a substantial supplement to the lengthy Revised Draft...more

Hogan Lovells

AMS Releases Draft Instructions on Validating a Refining Process for National Bioengineered Food Disclosure Standard

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The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking public comment on draft instructions to validate a refining process under the National Bioengineered Food Disclosure Standard...more

BakerHostetler

FDA and Pharmacy Weekly Digest - August 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Calls for Improved Practices in the Papaya Industry – The FDA reported trends in outbreaks of Salmonella in fresh papaya. ...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

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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

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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

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