Tag Archives: allergens

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Highlights from the 2023 Food Safety Consortium

By Food Safety Tech Staff
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Last week, hundreds of food safety professionals, members of the FDA and USDA, and leaders in academia, food safety testing and cybersecurity met in Parsippany, New Jersey, for the 2023 Food Safety Consortium.

Keynote speaker Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS, and Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, opened the Consortium to discuss their agencies’ priorities for 2024 and took part in a town hall Q&A with attendees.

Eskin and Mettler
Sandra Eskin and Erik Mettler

In April, the USDA FSIS declared salmonella an adulterant in raw breaded chicken products. The agency is now reviewing comments and finalizing a framework for other poultry products and examining how to substantiate claims, such as “Pasture Raised,” “Grass Fed” and “Raised without Antibiotics.” Cell-cultured meat is another key focus for FSIS, and it is requiring labeling of “Cell Cultivated” on the packaging of these products.

Mettler discussed the “mass reorganization” of the FDA that is currently underway following the 2022 Reagan Udall report, noting that Jim Jones, the new Deputy Commissioner for Human Foods will have full control of policy and resources of the Human Foods program. A key focus will be risk management prioritization. Expect to see full reorganization in late summer or early fall of 2024.

Reorganization of the FDA’s Human Foods program was a hot topic that was also discussed in depth during Modernizing the U.S. Food Safety System with panelists Stephen Ostroff, former FDA commission, Barbara Kowalcyk, faculty at Georgetown University, and Bill Marler, food safety attorney with Marler Clark.

Session Highlights

This year, attendees had the opportunity to take part in full-day pre-conference workshops, including Food Safety Auditor Training with Trish Wester, president of the Association for Food Safety Auditing Professionals, and the Food Safety Culture Design Workshop with Gina Nicholson Kramer, Associate Director of Partnerships, Policy, & Learning at The Ohio State University, and Richard Fleming and Austin Welch of Sage Media.

Sessions during the two-day Consortium covered everything from data analytics to risk mitigation, grassroots food safety culture and recall trends.

Steven Gendel
Steven Gendel

Attendees were able to take part in a Panel Discussion with the Producer and Food Safety Experts Behind “Poisoned: The Dirty Truth About Your Food” Documentary with producer Kristin Lazure and featured members of the film, including Dr. Darin Detwiler, CEO of Detwiler Consulting Group, and professor at Northeastern University, attorney Bill Marler, and Brian Ronholm, director of food policy at Consumer Reports.

Steven Gendel spoke on regulatory guidance, thresholds and best practices for Allergen Advisory Labeling, followed by Tracie Sheehan of Mérieux Nutrisciences who presented Protecting Allergic Consumers through Audited and Validated Allergen Control Plans.

Cybersecurity panel FSC2023
Food Safety and Cybersecurity panel discussion

Two sessions highlighted the growing threat of cyber attacks. Attendees gained valuable insights from Mark Wittrock, Assistant Director – Health, Food, and Agriculture Resilience Office of Health Security, U.S. Department of Homeland Security, in Re-Imagining Food Protection as a National Security Issue – DHS Perspective, and Scott Algeier of the Food-Ag ISAC, who led a panel discussion on Food Safety and Cybersecurity.

“We’d like to thank all of our attendees, speakers and sponsors for helping make this year’s Food Safety Consortium a success. Through discussion, sharing of knowledge and building industry connections, the food industry will be better prepared to tackle the biggest challenges facing food safety, ensuring a safer and more resilient food supply for consumers,” said Rick Biros, founder and program director of the Consortium and publisher of Food Safety Tech. “We look forward to welcoming everyone to next year’s program in Washington, DC.”

Save the Date: The 2024 Food Safety Consortium will take place October 20-22 in Washington, DC. The call for abstracts is now open.

Reception at 2023 Consortium

About the Food Safety Consortium: ​Organized by Food Safety Tech, the Food Safety Consortium Conference, launched in 2012, is an educational and networking event that has food safety, food integrity and food defense as the foundation of its educational content. With a unique focus on science, technology, best practices and compliance, the “Consortium” features critical thinking topics that have been developed for both industry veterans and knowledgeable newcomers.

 

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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.

Food Safety Consortium 2023
From the Editor’s Desk

Tackling Today’s Greatest Food Safety Challenges:  The 2023 Food Safety Consortium

By Food Safety Tech Staff
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Food Safety Consortium 2023

Food safety and quality professionals can take advantage of three days of education, networking and panel discussions at the 11th Annual Food Safety Consortium, October 16-18 in Parsippany, New Jersey. This year’s event is co-located with the Cannabis Quality Conference and Food Defense Consortium.

In-person and virtual registration options available

Erik Mettler and Sandra Eskin

Keynote Speakers: Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Partnerships and Operational Policy, Office of Regulatory Affairs (ORA) at FDA, and Sandra Eskin, Deputy Undersecretary Food Safety, USDA, Food Safety & Inspection Service.

Following the keynote presentations, attendees can take part in a Town Hall Q&A with Mettler and Eskin, followed by a panel discussion on Modernizing the U.S. Food Safety System, featuring Stephen Ostroff. Former FDA Commissioner, Barbara Kowalcyk, Executive Director of the Center for Foodborne Illness Research and Prevention, and Bill Marler, Attorney with Food Safety Law Firm Marler Clark.

This year’s program includes four pre-conference workshops, taking place on Monday, October 16:

  • Food Safety Culture Design Workshop
  • CP-FS Credential Review Course
  • Food Safety Auditor Training
  • The Seed to Sale Safety Workshop

Days two and three feature panel discussions covering food safety culture, supply chain, recall patterns and succession planning, as well as breakout sessions on prevention, mitigation, control and regulation of key food safety hazards. Session highlights include:

Re-Imagining Food Protection as a National Security Issue – DHS Perspective, Presented by Mark Wittrock, Assistant Director – Health, Food, and Agriculture Resilience Office of Health Security, U.S. Department of Homeland Security.

The Rise of Previously Unforeseen Hazards, Presented by Tim Lombardo, EAS Consulting

Food Safety Supply Chain Management, Presented by Celso Pagutalan, ASR Group

Succession Planning for Food Safety Inspectors, Panelists: Gina Nicholson Kramer, April Bishop of TreeHouse Foods, Barbara Kowalcyk, Executive Director of the Center for Foodborne Illness Research and Prevention, Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Regulatory Affairs (ORA) at FDA, Rance Baker of NEHA, and Jorge Hernandez of Wendy’s

Food Safety Culture: Creating a “Speak Up Culture,” Presented by Austin Welch, Sage Media

Risk Mitigation through Assessment, Testing, Monitoring and Compliance, Presented by Dr. Sandra Johnson, SGS North America

Recalls Trends, Regulation and Lessons Learned, Panelists: Erik P. Mettler, MPA, MPH, Assistant Commissioner for Partnerships and Policy, Office of Regulatory Affairs (ORA) at FDA, Shawn Stevens, attorney with the Food Industry Counsel, and Stephen Ostroff, M.D. former Acting FDA Commissioner.

Food Allergen Advisory Labeling, Presented by Dr. Steven Gendel

View the full agenda.

Don’t miss out on opportunities to network with other food safety and quality professionals during the opening night reception, networking lunches and coffee breaks.

Registration options are available for in-person and hybrid team attendance.

Event Hours

  • Monday, October 16: 8:30 am – 5:00 pm (ET)
  • Tuesday, October 17: 9:00 am – 6:30 pm (ET)
  • Wednesday, October 18: 9:00 am – 4:00 pm (ET)

 

Sonia Acuña-Rubio
Allergen Alley

Reducing the Risk of Undeclared Food Allergens

By Sonia Acuña-Rubio
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Sonia Acuña-Rubio

Each year, 200,000 people in the U.S. require emergency medical care due to allergic reactions to food. Common foods that trigger allergic reactions include certain types of seafood, dairy, nuts, wheat, soy and sesame. For some, food allergy reactions can be serious and even life-threatening, requiring immediate treatment via the drug epinephrine.

Allergens are also one of the leading causes of food recalls globally. As food allergies continue to impact individuals and families across the nation, food manufacturers and distributors must be vigilant when manufacturing, packaging and selling foods to consumers.

Understanding Allergen Regulations

Many countries aim to protect individuals with food allergies by enforcing government regulations. Such regulations can require product manufacturers to disclose ingredients in packaged food and beverages.

In the U.S., the FDA recognizes nine major food allergens: crustacean shellfish, eggs, fish, milk, peanuts, tree nuts, sesame, soybeans and wheat. Sesame is the newest recognized allergen and was added in 2022 as part of the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. These allergens must be identified on labels for American food products.

Similarly, in Canada, the Canadian Food Inspection Agency (CFIA) has a list of 11 priority allergens, which includes eggs, milk, mustard, peanuts, crustaceans and mollusks, fish, sesame, soy, sulfites, tree nuts, wheat and triticale, which must be disclosed on pre-packaged foods sold in the country.

In both countries, products may be recalled due to improper labeling and announced via public notice. (A comprehensive list of recognized food allergens by country can be found on the Food Allergy Research and Resource Program (FARRP)’s website.)

Activating Your Allergen Management Program

A comprehensive and effective allergen management program protects your consumers and your company and is necessary to meet regulatory and GFSI (Global Food Safety Initiative)–benchmarked standard requirements. Creating an allergen management program involves developing processes and protocols and training employees to follow them.

Allergen cross-contact can occur when an allergenic food or ingredient is unintentionally incorporated into a food product. Food manufacturers and distributors should have a program that includes an allergen risk assessment, which helps to identify and manage any unintentional allergen contamination throughout the supply chain while tracing them throughout the facility. Good Manufacturing Protocols (GMP) should be followed for personal hygiene, handwashing, sanitation programs and more.

Managing Your Suppliers

Supplier communication is key to identifying allergens in raw materials. Use current supplier specifications and ingredient statements to identify allergens coming into the facility. Be alert for “may contain” statements and review your supplier’s allergen control policies and procedures.

In today’s food production environment, there are more supply chain disruptions than ever before. If there is a change in your raw materials or supplier, make sure that all documentation and finished product labels are updated.

Additional best practices when working with suppliers include:

  • Have a policy in place for label changes, noting that if a label from a product you purchase from a supplier changes, you must be notified of the change prior to the change being made and put into effect.
  • Ask for updated specifications/allergen information from suppliers on an annual basis. This could help to quickly identify issues if the supplier neglected to inform you of a change.

By identifying and listing sources in the facility, you can detect any ingredients and processing aids that contain or may contain allergens due to cross-contact or carry-over products. It is also important to prepare a master list of all ingredients in the facility and consider both primary and secondary ingredients, such as spices, colors and flavors.

Ask questions along the production process, identifying potential risks in recipes/formulas, traffic flow (of people, materials, and waste), potential crossovers of conveyors or pipe systems, shared equipment, storage practices, material segregation and airflow.

Avoiding Allergen Cross-Contact

Ensure that raw materials are labeled and segregated with incoming ingredient specification checks by weighing powders containing unique allergens in a separate and labeled area, covering totes or containers containing allergenic ingredients during transfer, and controlling the ventilation over lines where protein powders are dumped. Use product scheduling to maintain proper segregation.

Designate dedicated equipment, including utensils, if possible, as well as production sequencing or cleaning between allergen changeovers. Refrain from using original ingredient containers that previously held allergens. At the end of an allergen production run, conduct a complete and validated allergen clean.

Use documented visual inspection on each piece of equipment and environment between allergen changeovers and conduct regular labeling checks against the approved label/package design for each item produced. A third-party partner can be used to help develop and maintain supplier specifications, audit formulations, and review current packaging.

Protecting Consumers and Business Reputation

While ensuring products are free of any undeclared allergens may seem more challenging than ever before, establishing the right programs and practices can keep both your business and consumers healthy and safe. Implementing an allergen management plan, supplier checks, and allergen controls is key to avoiding cross-contact in the production process and throughout the supply chain, ensuing fewer disruptions in the manufacturing process, and ultimately, building trust with consumers.

Food Safety Consortium 2023
From the Editor’s Desk

Registration Open for the 2023 Food Safety Consortium

By Food Safety Tech Staff
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Food Safety Consortium 2023

Registration for the 11th Annual Food Safety Consortium, which will take place October 16-18 at the Hilton Parsippany in New Jersey, is now open.

Presented by Food Safety Tech, the Food Safety Consortium is a business-to-business conference that brings together food safety and quality assurance professionals for education, networking and discussion geared toward solving the key challenges facing the food safety industry today.

In addition to two full days of high-level panel discussions, this year’s program will include a second Food Safety Hazards track. These “Boots on the Ground” sessions provide education on the detection, mitigation, control and regulation of key food hazards.

New this year is a strategic co-location with the Cannabis Quality Conference (CQC), a business-to-business conference and expo where cannabis industry leaders and stakeholders meet to build the future of the cannabis marketplace. Registered attendees get full access to both conferences.

Registration options are available for in-person and virtual attendance.

The Consortium will kick off with presentations from Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs (ORA), and Sandra Eskin, Deputy Under Secretary for Food Safety at the USDA FSIS, followed by a Town Hall with the regulators.

Other agenda highlights include:

  • The Future of Food Safety Culture
  • The Rise of Previously Unforeseen Hazards,
  • FSMA 204: The Final Rule – Looking Ahead,
  • Anti-Food Fraud Tactics for the Entire Supply Chain
  • Bridging the gap between food safety and cybersecurity
    Protecting Allergic Consumers through Audited and Validated Allergen Control Plans
  • Succession Planning for Food Safety Inspectors
    Utilizing Food Quality Plans to Ignite Positive Food Safety Culture
  • Recalls Trends and Predictions

View the full agenda and register here.

Attendees will also have the opportunity to take part in pre-conference workshops on Monday, October 16, including:

  • Food Safety Auditor Training
  • CP-FS Credential Review Course
  • The Food Safety Culture Design Workshop
  • The Seed to Sale Safety Workshop

Event Hours

Monday, October 16: 8:30 am – 5:00 pm (Pre-conference Workshops)

Tuesday, October 17: 8 am – 6:30 pm

Wednesday, October 18: 8:30 am – 3:45 pm

Register now

Tabletop exhibits and custom sponsorship packages are available. Contact Sales Director RJ Palermo.

About Food Safety Tech

Food Safety Tech is a digital media community for food industry professionals interested in food safety and quality. We inform, educate and connect food manufacturers and processors, retail & food service, food laboratories, growers, suppliers and vendors, and regulatory agencies with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an environment that fosters safer food for consumers.

About the Food Safety Consortium

The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of its educational content. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore high-level educational tracks, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

 

Matthew Taylor

Mitigating the Risks of Food Fraud in an Inflationary Environment

By Matthew Taylor
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Matthew Taylor

Inflation can create a challenging environment for the food industry, making it more difficult to maintain product quality, safety, and transparency. In August 2022, U.S. food inflation hit a 40-year high of 11.4% and has since remained persistently high, at 10.1% in January 2023. Manufacturers and suppliers must stay vigilant and take proactive steps to mitigate the risks posed by stubbornly high food inflation and increasingly complex supply chains.

Inflation can be a catalyst for risk in food supply chains for several reasons. Rising prices could encourage bad actors or tempt manufacturers and suppliers to cut corners or compromise quality to maintain profit margins. This can lead to an increased risk of food fraud, where lower-quality or counterfeit ingredients are substituted for genuine ones or where mislabeled products are sold to unsuspecting consumers. Supply chain disruptions could increasingly affect manufacturers as suppliers struggle to manage the increased costs of raw materials, transportation, and labor, as seen this winter in Europe, with the UK experiencing shortages of tomatoes and eggs. This can result in delays, shortages, and other logistical challenges that can make it difficult to maintain product quality and safety.

Inflation can also increase food allergy and sensitivity incidents. Mislabeling or allergen contamination due to substituted alternative ingredients could put allergen or intolerance sufferers at greater risk, as well as your brand. With the threat of food fraud lurking in increasingly complex and volatile supply chains, what steps can food manufacturers take to protect themselves and their customers?

Tackling Food Fraud and Allergen Incidents

Despite legislative and industry process improvements, food fraud continues to be a significant risk in the food industry, costing businesses an estimated $30 to $40 billion annually. Food fraud refers to any act of deception, intentional or otherwise, that is intended to result in the sale of a food product that is not what it purports to be. This can take many forms, from adulterating ingredients to misbranding and counterfeiting.

The consequences of food fraud can be severe and include economic losses, harm to human health, damage to the reputation of food companies and loss of consumer confidence in the food supply. Food fraud can also cause environmental consequences, including the illegal use of pesticides, or overfishing, which can have long-term effects on the environment, wildlife, and ecosystems.

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In recent years, several high-profile cases of food fraud have occurred, including the widespread contamination of infant formula with melamine in China and the horse meat scandal in Europe. These incidents have highlighted the need for better measures to prevent food fraud and to ensure the safety of the food supply.

To protect the integrity and bolster consumer and producer confidence in organic food, which has long been a target of food fraud, the USDA published one of the largest-ever reforms to their organic program in January 2023. However, many risks remain as legislation tries to catch and close loopholes.

One of the challenges of preventing food fraud is that the supply chain is often complex and global, making it difficult to track the origin of ingredients and monitor their quality. In addition, many food frauds are not detected until they reach the end-consumer, making it difficult to recall contaminated products. In order to mitigate the risk of food fraud, it is essential to plan ahead and implement strong supply chain management practices, including the use of technology such as traceability systems and predictive analytics.

A good starting point to mitigate your risk of food fraud is to conduct a deep dive into your highest-risk raw materials and suppliers instead of trying to tackle everything at once, particularly if you have a large number of raw materials to assess. For instance, you may want to prioritize raw materials that have been linked to recent fraud incidents, such as infant formula, honey, and olive oil.

Four Steps to Protecting Your Business

Know your supply chain. Controlling and understanding your supply chain is essential for minimizing risk. It is important to audit your supply chain back to the field, if possible, or at least to the production and processing facility. For smaller businesses, forensic auditing may not be feasible. However, there are still steps they can take to protect themselves, such as seeking third-party certification programs that verify the sustainability, quality, and ethical sourcing of ingredients. Going back by more than one step in your supply chain is crucial, and conducting a vulnerability assessment of your raw materials and suppliers is an excellent starting point.

Shop around safely. Review the market for potential alternate suppliers or less ‘at risk’ ingredients, subject to the required quality checks and labeling requirements. It is crucial to thoroughly assess current and potential new suppliers and ensure they meet the minimum Global Food Safety Initiative (GFSI) certification standards, wherever possible. Scrutinize all raw material specifications, including the country of origin, as countries with less established food safety regulations may pose a higher risk. Establishing solid relationships with your suppliers and engaging in regular communication with them is also essential to maintain a high standard of quality, safety, and sustainability.

Be vigilant about ingredients. Markets are constantly evolving, and economic, social, and environmental changes can impact the substitution risk profile of any ingredient that you purchase. To manage this risk, it is essential to have an up-to-date awareness of the various market forces that affect ingredients and their availability.

It is important to note that product adulteration may not always be motivated by economic factors. As ingredients become in short supply, manufacturers may make local substitution decisions to keep the supply available. Remember, there is no substitute for a thorough risk-assessed approach to managing this challenge with a complete and detailed understanding of your supply chains.

Utilize training to build awareness and readiness. Training employees on how to identify, prevent and respond to incidents of potential food fraud or allergens is essential but often challenging for food manufacturers. Regular training should include the types of fraud, how to recognize suspicious behavior, and the importance of accurate record-keeping. Ensuring your teams are trained on what to do is there is a food fraud issue is also key, as is testing the teams through mock exercises to see how they would manage a food fraud event in the business.

Persistently high food inflation rates have created a challenging environment for the food industry, making it harder for manufacturers and suppliers to maintain product quality, safety, and transparency. Food businesses must exercise extra vigilance to face an increased risk of food fraud, supply chain disruptions, and an increase in food allergy and sensitivity incidents. Now is the time to proactively mitigate these risks by prioritizing transparency, gaining control and understanding of supply chains, and acting to prevent food fraud.

It is important to note that no system is foolproof. Food manufacturers should regularly assess and improve their supply chain management practices to ensure they are up to date with industry best practices and changing threats. Increasing your transparency in the ingredient supply chain requires a commitment to responsible sourcing and a willingness to invest in traceability, certification, and supplier relationships. While the risks to food quality and safety are well known, businesses need to ask themselves the right questions and take the necessary steps to protect themselves and their customers. By doing so, they can protect their brand reputation and consumer confidence in the food supply and the environment.

 

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FDA Releases List of 2023 Priority Guidance Topics for Foods Program

By Food Safety Tech Staff
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The FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.

The guidance documents do not impose legally enforceable requirements, but they can help stakeholders plan for potential changes that may impact their businesses and organizations. The agency anticipates it will publish many of the listed documents by January 2024.

The priority list of draft and final guidance topics include (by category):

Allergens

  • Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
  • Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
  • Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders

Food Additives

  • Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
  • Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry

Food Safety

  • Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
  • Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
  • Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
  • Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff

FSMA

  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
  • Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry

Labeling

  • Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
  • Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
  • Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry

Public comments on the list of 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.

 

2022 FDA Food Code

FDA Issues 2022 Food Code

2022 FDA Food Code

The FDA has issued the 2022 edition of the FDA Food Code, which contains some significant changes, including:

  • Adding sesame as a major food allergen to reflect that the Food Allergy Safety, Treatment, Education, and Research Act of 2021 established sesame as the 9th major food allergen
  • Informing consumers, in writing, of major food allergens as ingredients in unpackaged food
  • Adding labeling of major food allergens in bulk food that is available for consumer self-dispensing
  • Creating new requirements for the allowance of pet dogs in outdoor dining spaces
  • Revising the definition of intact meat, including enhancements to clarify time/temperature cooking requirements

For the first time, the FDA Food Code specifically addresses food donations, included as part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. The National Strategy, which was rolled out in September at the White House Conference on Hunger, Nutrition, and Health, provides a roadmap of actions the federal government is taking to end hunger and reduce diet-related diseases by 2030.

The FDA noted that the 2022 edition reflects the input of regulatory officials, industry, academia, and consumers that participated in the 2020 biennial meeting of the Conference for Food Protection (CFP).

The Food Code is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Alternatives that offer an equivalent level of public health protection to ensure that food at retail and food service is safe are recognized in the Food Code.

View a full list of the Summary of Changes.

 

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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.

Karen Constable
Food Fraud Quick Bites

Where’s the Coconut?

By Karen Constable
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Karen Constable

Coconut water and coconut milk are vulnerable to food fraud because they can easily be diluted with other liquids and adulterated with undeclared ingredients, such as added sweeteners and dairy products, that are difficult for consumers to detect. The FoodChainID Food Fraud Database[i] (formerly the Decernis and United States Pharmacopeia [USP] database) contains 20 records related to coconut water, coconut milk and coconut milk powder. These include one story of a “coconut water” manufacturer that was found to be using water, sugar and flavoring to make the beverage, which contained no coconut at all.[ii]

Because the potential diluents and adulterants are cheap and easily available, the fraud is both profitable and easy to perpetrate. Organic coconut products are also at risk of having their organic status faked. Six of the Food Chain ID records are for products that were falsely labelled “organic.”

The addition of undeclared sweeteners is a commonly perpetrated fraud in coconut water. In the U.S., it has been estimated that 15% of all imported coconut waters are adulterated with added sugars that are not declared on the label.[iii] In 2021, Brazilian authorities confiscated 173,000 litres of coconut water with added sugars.[iv] Authorities in the United Kingdom reported that the presence of undeclared sugars in coconut water was “widespread” in 2017.[v]

Coconut milk and coconut milk powder have been adulterated with undeclared cow’s milk powder[vi] and with cornflour.[vii] Adulteration with dairy products poses a serious food safety risk to allergic consumers. To protect such consumers, food fraud risk mitigation activities for coconut milks, creams and yogurts should include regular monitoring for the presence of dairy allergens.

References:

[i] https://www.foodchainid.com/food-fraud-database/

[ii] Trinidad Express Newspapers (2016) “Health Ministry Removes Local Coconut Water Off the Market.” Available at: https://trinidadexpress.com/news/local/health-ministry-removes-local-coconut-water-off-the-market/article_0f37536d-0968-5a73-a6f2-cba56a4e6beb.html [Accessed 6 Oct. 2022]

[iii] Foodnavigator-usa.com (2014). “Fifteen percent of coconut waters mislabeled; let’s level the playing field.” Available at: http://www.foodnavigator-usa.com/Suppliers2/iTi-15-of-coconut-water-mislabeled  [Accessed 6 Oct. 2022].

[iv] Ministério da Agricultura, Pecuária e Abastecimento (2021) “Ação de fiscalização do Mapa apreende 173 mil litros de bebidas com indícios de fraude.” Available at: https://www.gov.br/agricultura/pt-br/assuntos/noticias/mapa-apreende-173-mil-litros-de-bebidas-com-indicios-de-fraude [Accessed 6 Oct. 2022]

[v] The Grocer (2017) “FSA probe finds widespread addition of undeclared sugar in coconut water.” Available at: https://www.thegrocer.co.uk/soft-drinks/fsa-probe-finds-widespread-addition-of-undeclared-sugar-in-coconut-water/558787.article

[vi] Centre for Food Safety The Government of Hong Kong Special Administrative Region, Food Alerts / Allergy Alerts – “Undeclared allergen (milk) found in prepackaged coconut milk powder.” Available at: https://www.cfs.gov.hk/english/whatsnew/whatsnew_fa/2017_177.html  [Accessed 6 Oct. 2022]

[vii] Azlin-Hasim, S., Siang, Q., Yusof, F., Khairi Zainol, M. and Mohd, H. (2019). “Chemical Composition and Potential Adulterants In Coconut Milk Sold In Kuala Lumpur.” Malays. Appl. Biol, [online] 48(3), pp.27–34. Available at: http://journalarticle.ukm.my/14685/1/48_03_04.pdf  [Accessed 6 Oct. 2022]