Maile Gradison on Draft Guidance

FDA Draft Guidance Addresses Management of Environmental Pathogen Hazards for Low-Moisture Ready-to-Eat Foods

On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more

1/13/2025 / CGMP , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Manufacturers , Public Health , Risk Management

FDA Releases Revised Appendix 1 and Introduction to Hazard Analysis and Preventive Controls Draft Guidance

The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more

3/19/2024 / Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply

FDA Issues Draft Guidance on Evaluating Public Health Impacts from Non-Major Food Allergens

The U.S. Food and Drug Administration (FDA) recently published draft guidance that explains the approach the agency intends to take when evaluating the public health importance of food allergens that are not one of the nine...more

5/9/2022 / Draft Guidance , Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) , Food Allergies , Food and Drug Administration (FDA) , Food Labeling , Food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

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

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

7/19/2021 / Dietary Supplements , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Imports , Regulatory Oversight

FDA Issues Draft Guidance on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the Draft Guidance). 1/ As FDA Associate Commissioner...more

5/3/2019 / Chain of Distribution , Draft Guidance , Food and Drug Administration (FDA) , Product Recalls , Public Comment

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

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

3/15/2019 / Agribusiness , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Health & Safety Standard , Regulatory Oversight , Regulatory Requirements , Vulnerability Assessments

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

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

10/26/2018 / Agribusiness , Draft Guidance , Farms , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Health & Safety Standard , Regulatory Oversight , Regulatory Requirements

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

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

6/26/2018 / Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Requirements , Risk Mitigation , Vulnerability Assessments

Maile Gradison

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