Tag Archives: draft guidance

Seafood

FDA Issues Draft Guidance on Sampling for Seafood Subject to DWPE

By Food Safety Tech Staff
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Seafood

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.” The draft guidance provides recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import Alert because of the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition.

The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to have their products removed from DWPE. It also addresses the concern that industry may experience challenges in supporting their arguments about the safety of seafood products subject to DWPE.

Per the draft guidance, foreign manufacturers or other interested parties requesting removal of product from DWPE should provide information to FDA to adequately demonstrate that the conditions that gave rise to the appearance of the violation have been resolved. This may include evidence of a root cause analysis, relevant corrections to the manufacturing process, and/or other controls that have been implemented to address the violation, and hazard analysis critical control point (HACCP) documents, in addition to testing results for consecutive non-violative shipments.

The number of consecutive non-violative shipments required is guided by the FDA’s Regulatory Procedures Manual (RPM), Chapter 9, Sections 9-8-15 and 9-8-16. Typically, five to 12 shipments help demonstrate that the conditions that gave rise to the appearance of the violation have been resolved, per the FDA.

The testing submitted should be from a statistically robust number of samples based on the size of the article and representative of the affected article. The draft guidance includes recommended analytical methods for testing, as well as sampling schedule recommendations with the amount (by weight) of product recommended for collection to represent each sample unit.

Download the draft guidance here.

Stakeholders can submit comments on the draft guidance by April 12, 2024, using docket number FDA-2023-D-5303.

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FDA Releases New Draft Guidance Chapters on Food Allergens and Acidified Foods

By Food Safety Tech Staff
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The FDA has released two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.

Chapter 11—Food Allergen Program—explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and how to ensure that food products are properly labeled with respect to the major food allergens. It provides examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices (CGMPs) and preventive controls. The chapter also discusses circumstances in which, despite adherence to appropriate CGMPs and preventive controls, allergen presence due to cross-contact cannot be completely avoided and provides options to consider in these scenarios, including the voluntary use of allergen advisory statements when appropriate.

Chapter 16—Acidified Foods—applies to manufacturers of acidified foods (such as some processed sauces, beans, cucumbers or cabbage that have an overall pH of 4.6 or below). It provides procedures, practices and processes to meet requirements in the acidified foods regulations and to meet requirements under the preventive controls for human foods rule.

Stakeholders can submit comments on the new chapters at Regulations.gov (Docket No. FDA-2016-D-2343). Comments should be submitted within 180 days of September 26, 2023, to ensure the FDA receives comments before it begins work on the final versions of the guidance documents.

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FDA CFSAN Announces Priority Guidances for Remainder of 2023

By Food Safety Tech Staff
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Infant food safety, including new arsenic and cadmium action levels, are among the new priorities the FDA plans to address before the end of 2023. On July 6, the FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023.

The following guidance topics have been added to the 2023 agenda:

  • Draft Guidance on Dietary Supplement Master Files
  • Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
  • Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
  • Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
  • Amendment to the Menu Labeling Supplemental Guidance
  • Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.

Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA – 2021-N-0553.

The FDA’s list of guidance topics is just one of several resources that the Foods Program routinely shares with stakeholders and partners to inform them of agency priorities. Most proposed and final rules are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government wide. A list of those FDA regulations and guidance documents under Administration review is available on the Office of Management and Budget website.

 

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FDA Reopens Comment Period for Draft Guidance on Labeling of Plant-Based Milk Alternatives

By Food Safety Tech Staff
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On April 20, The FDA announced that it will reopen the comment period for the draft guidance “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry” in response to requests from stakeholders to allow additional time for interested persons to develop and submit comments.

The draft guidance, originally published in the Federal Register on February 22, 2023, was developed to help ensure appropriate labeling of plant-based products that are marketed and sold as alternatives to milk (aka plant-based milk alternatives, or PBMA). It provides industry with recommendations for clear labeling to help consumers make more informed purchasing decisions. It also clarifies that the common or usual names of some PBMA have been established by common usage, and these names include “soy milk” and “almond milk.”

The FDA recommends that PBMA products that are labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition that is different than milk, include a voluntary nutrient statement that conveys how the product compares with milk based on USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria. The goal is to help consumers make informed dietary choices when it comes to understanding certain nutritional differences between plant-based products that are labeled with “milk” in their names and milk.

If a PBMA is not labeled with “milk” as part of its name, but instead is labeled with another term like “beverage” or “drink” and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations in the draft guidance would not apply.

In 2018, the FDA issued notice soliciting comments from the public to gain insight into how consumers use PBMA products and how they understand the term “milk” when included in the names of products made, for example, from soy, peas and nuts. The agency received more than 13,000 comments.

In its statement announcing the draft guidance, the FDA noted that, after reviewing these comments and conducting focus group studies with consumers, it determined that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk. However, many consumers may not be aware of the nutritional differences between milk and PBMA products. For example, almond or oat-based PBMA products may contain some calcium and be consumed as a source of calcium, but their overall nutritional content is not similar to milk.

Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-0451.

 

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FDA Issues Two New Guidances on Food Allergen Labeling Requirements

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The FDA has issued two new guidance documents on food allergen labeling requirements.

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry updates the previous edition (Edition 4) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

The FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act adds sesame to the list of major food allergens effective January 1, 2023.

The draft guidance includes:

  • New questions and answers about food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of major food allergens in the labeling of dietary supplement products; and other technical labeling issues.
  • Revised questions and answers to update and clarify information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish.
  • Images that show examples of labeling requirements.

The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

Stakeholders can submit comments about the draft guidance within 60 days of the November 30 publication of the notice in the Federal Register. Submit comments electronically on www.regulations.gov or by mail:

Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s Docket ID: FDA-2022-D-0099.

Allergens

FDA Issues Draft Guidance Emphasizing Increased Importance on Food Allergens

By Food Safety Tech Staff
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Allergens

Today the FDA issued a draft guidance that shines a spotlight on the importance of assessing food allergens that are not one of the nine major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, sesame and soybeans). “The nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities,” said CFSAN Director Susan Mayne, Ph.D., in an agency release. “This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and transparent manner, which can inform potential future actions to better help protect the health of consumers.”

The draft, “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act”, targets immunoglobulin E antibody (IgE)-mediated food allergies, which can cause severe and life-threatening reactions such as anaphylaxis. The document reviews the evidence that establishes a food as a cause of IgE-mediated food allergy and scientific factors, such as prevalence, severity and allergenic potency, that the FDA would consider in evaluations. It also reviews the agency’s recommendations for identifying and evidence to determine the public health importance of a non-listed food allergen.

Comments on the draft guidance can be submitted by August 17, 2022.

FDA

FDA Releases Supplemental Draft Guidance for Intentional Adulteration Rule

By Food Safety Tech Staff
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Read the series: Lessons Learned from Intentional Adulteration Vulnerability AssessmentsThis week FDA issued a supplemental draft guidance to aid in compliance with the FSMA Intentional Adulteration Rule. The draft, “Mitigation Strategies to Protect Food Against Intentional Adulteration”, includes chapters that address food defense corrective actions and verification, reanalysis and recordkeeping. It also includes appendices on FDA’s Mitigation Strategies Database, along with how business can assess their status as a small or very small business.

This is the third and final installment of the draft guidance for the IA rule.

The FDA is still on schedule to begin routine intentional adulteration inspections next month.

FSMA

FDA Issues Draft Guidance on Supply Chain Program for PC Animal Food

By Food Safety Tech Staff
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FSMA

Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.

According to an agency news release, the draft guidance will help facilities in the following areas:

  • “Determine whether they need a supply-chain program;
  • Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
  • Establish frequency of supplier verification activities;
  • Meet documentation and recordkeeping requirements; and
  • Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”

In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.

The FDA is accepting public comments on the draft for the next 180 days.

FSMA

FDA Releases Chapter 6 of Draft Guidance for PC Rule

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FSMA

Last week FDA released the sixth chapter of the draft guidance, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”. The document aims to assist food facilities in establishing and implementing a heat treatment (i.e., baking or cooking) to prevent bacterial contamination.

Learn more about FSMA compliance at the 2017 Food Safety Consortium | November 28– December 1 | The 60-page draft guidance addresses the use of heat treatments as a process control, providing information on understanding potential hazards, design and validation of the heat treatment, establishing and implementing monitoring procedures (and how often), verification, and record keeping.

FDA states that it intends to publish at least 14 chapters of the guidance. In just two weeks, the compliance date for the preventive controls for human food rule falls for small businesses (fewer than 500 full-time employees).

Sprouts

FDA’s Draft Guidance Aims to Help Keep Sprouts Contamination Free

By Food Safety Tech Staff
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Sprouts

Between 1996 and 2016, sprouts have been responsible to 46 outbreaks in the United States, which has led to nearly 2500 illnesses and three deaths, according to FDA. They have presented a consistent challenge to operators, because sprouts are most often produced in conditions that are ideal for bacteria growth.

Today FDA issued a draft guidance to assist sprout operators in complying with the FSMA Produce Rule, which requires “covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens, test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes, and take corrective actions when needed.”

Large sprout operators must comply with the Produce Rule (applicable provisions) by January 26. Small business must comply by January 26, 2018 and very small businesses by January 28, 2019.

The draft guidance, Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations, is open for comment for the next 180 days.