Food Safety & Quality Blog
Mérieux NutriSciences is dedicated to helping companies worldwide find practical solutions to today's food safety and quality challenges throughout the supply chain.

How FDA “Swabathons” Factor Into Environmental Monitoring

Posted by Tim Freier, Ph.D.

February 7, 2017 at 10:00 AM

swabathon_blog copy.jpgRecently, significant changes have been made to how the US Food and Drug Administration (FDA) conducts investigations of food manufacturing facilities. For starters, note that I did not say FDA inspections; they are now investigations. This change in semantics indicates a shift from a superficial “look around” a facility to diving into records and sometimes taking hundreds of environmental pathogen samples. The Food Safety Modernization Act (FSMA) has prompted many of these changes, and has given the FDA increased power and access to records. The FDA is also now much more likely than in the past to involve the Department of Justice if there is any possibility of criminal intent. Along with this significant new regulatory authority, the industry has seen major leaps forward in microbial strain tracking technology, the most important being Next Generation Sequencing and its use for Whole Genome Sequencing (WGS). 

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Topics: Environmental Monitoring, FDA, Preventive Environmental Monitoring, Whole Genome Sequencing, Swabathons

Regulatory Round-Up: Strategies for Controlling Listeria in Ready-To-Eat Foods

Posted by Patrick Kennedy

January 26, 2017 at 10:00 AM

rte regulatory blog.jpgIf you are subject to the final rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule), then you should be aware of FDA’s new recommendations for controlling Listeria monocytogenes in ready-to-eat (RTE) foods. Manufacturers, processors, packers and holders of RTE foods will benefit from an understanding of the strategies and recommendations described within the new draft guidance. 

Released this month, the draft guidance sheds light on the agency’s thinking regarding effective strategies for controlling L. monocytogenes in RTE foods, including identifying the risks associated with raw materials and ingredients, listericidal process control, environmental monitoring, product testing, and the analysis of verification data trends.

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Topics: FDA Regulation Updates, FDA, Pathogens, Preventive Controls, Listeria, Ready-to-Eat Foods, CGMPs, Hazard Analysis

The Hidden Cost of Product Recalls

Posted by Seth Keller

January 19, 2017 at 10:00 AM

hidden_cost_recalls_blog.jpegIn 2016, various high profile recalls and minor scale recalls threatened the public safety of consumers across North America. Although it’s impossible to eliminate human error, and thus recalls entirely, it is paramount to understand the direct economic impact of recalls and related risks. Likewise, there are extensive efforts made by regulatory agencies to support food manufacturers as a supplement to the efforts your company should be making to ensure you remain off the recall lists in 2017.

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Topics: Food Safety, Environmental Monitoring, Recalls, FDA, Preventive Controls, Product Recalls

Technical Tuesdays: Analyzing Government Reports on Illness Outbreaks and Recalls

Posted by Dave Evanson

January 17, 2017 at 10:00 AM

government_report_blog.jpgGovernmental agencies overseeing the food industry have traditionally had a love/hate relationship with the sector. With the advent of new regulations, this relationship is sure to face its share of future challenges as well. However, government agencies ultimately take responsibility for the public’s health, and they provide support to the industry to keep consumers safe. Some of the tools made available to the public, as well as food safety professionals, identify public health issues related to various etiologic agents. 

Both the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) provide daily updates on food recall events, as well as recalls of dietary supplements. Additionally, a compilation of both FDA and USDA events is available to the public. In keeping up with the Joneses, apps and widgets also offer a way the food industry or consumers in general to stay informed. The information available from these sources includes the etiologic agent involved, product type and other important data.  

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Topics: USDA, Recalls, FDA, Government Agencies, Foodborne Illness, Product Recalls

Regulatory Round-Up: Food Labeling Changes From 2016 and Beyond

Posted by Patrick Kennedy

January 9, 2017 at 10:00 AM

regulatory_blog_1.9.jpegOn the regulatory front, 2016 presented many challenges for the North American food industry. While the year featured the initial implementation of FSMA regulations and passage of the GMO labeling law, the North American food industry was also confronted by a slew of regulatory changes related to food labeling. 

Last year, the food industry monitored the development of several potentially significant regulatory initiatives with upcoming compliance dates, including the revision of the FDA Nutrition Facts Panel (July 26, 2018), menu labeling for restaurants (May 5, 2017) and the withdrawal of the GRAS status of PHOs (June 18, 2018).

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Topics: FSIS, USDA, Nutritional Labeling, FDA, Nutrition, Nutrition Facts Label, Canada, CFIA, Nutrition Facts

Regulatory Round-Up: FSIS Unveils Strategic Food Safety Goals

Posted by Patrick Kennedy

December 12, 2016 at 10:00 AM

regulatory_blog2.jpegThe USDA Food Safety and Inspection Service (FSIS) recently unveiled its five-year strategic plan for ensuring the safety of meat, poultry and processed egg products. Covering the fiscal years 2017-2021, the objectives of the Strategic Plan are classified within the core goals of preventing foodborne illness, modernizing inspection systems and scientific techniques, and improving operational excellence. 

To prevent product contamination and related illness from FSIS-regulated products, the agency intends to strengthen sampling programs, promote food defense practices, and ensure domestic establishments are meeting pathogen reduction performance standards. The alignment of domestic and international program sampling objectives and the strengthening of existing testing activities for imported products were identified as additional priorities. 

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Topics: FSIS, Food Safety, Food Safety Modernization Act (FSMA), FDA Regulation Updates, FDA, FSMA, Voluntary Qualified Importer Program, Whole Genome Sequencing

New to the Nutrition Label: What Are Added Sugars?

Posted by Katie Schott

November 30, 2016 at 10:00 AM

added_sugar_blog.jpgHow sweet is it? Beginning July 26, 2018, the true nature of your products’ sugar content will be on display with the new mandatory Added Sugars line on the Nutrition Facts Label. But how do you know what is considered an added sugar? To answer that question, we need to delve into the new Food and Drug Administration (FDA) nutrition labeling requirements.

On July 26, 2016, the FDA released new nutrition labeling regulations, which includes an overhaul of the required Nutrition Facts Label. The new regulations go into effect in July 2018 for large food manufacturers, and July 2019 for food manufacturers with less that $10 million in annual food sales. One of the most notable differences on the new label is the Added Sugars line. This new addition will be located directly beneath the Total Sugars line, which will replace the Sugars line on the old label.

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Topics: Nutritional Labeling, FDA, Nutrition Facts Label, Added Sugars

Regulatory Round-Up: New FSMA Guidance Tackles Hazard Disclosure, VQIP

Posted by Patrick Kennedy

November 28, 2016 at 10:00 AM

regulatory_blog.jpegImplementation of the Food Safety Modernization Act (FSMA) regulations will continue despite the outcome of the recent presidential election and suggestions to reduce federal oversight of the food industry. The U.S. Food and Drug Administration (FDA) recently published two guidance documents to support industry compliance with upcoming FSMA regulations, including the controversial FSMA requirement for disclosing hazards, and the Voluntary Qualified Importer Program (VQIP). 

Written disclosure statements for identifying hazards are mandated by four of the seven foundational FSMA rules, including the rules for preventive controls for human food, preventive controls for animal food, produce safety, and foreign supplier verification program (FSVP). 

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Topics: Food Safety, Food Safety Modernization Act (FSMA), FDA Regulation Updates, FDA, FSMA, Foreign Suppliers, Foreign Suppliers Verification Program, Voluntary Qualified Importer Program

Regulatory Round-Up: Industry Seeks Harmonization of Nutrition Compliance Dates

Posted by Patrick Kennedy

November 11, 2016 at 10:00 AM

Industry Seeks Harmonization of FDA Nutrition Mandates 

regulatory_roundup_2.jpegResponding to food industry requests to harmonize the compliance dates of upcoming food labeling and nutrition initiatives, the Food and Drug Administration (FDA) recently clarified that the compliance dates are already coordinated to take effect in summer 2018. 

Industry groups contend, however, that it will be difficult for manufacturers to comply with the revised nutrition labeling rules since the agency has not yet provided key pieces of the regulatory puzzle. 

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Topics: Food Safety, Nutritional Labeling, FDA Regulation Updates, FDA, Nutrition

Regulatory Round-Up: New Criteria for "Healthy" Foods

Posted by Patrick Kennedy

October 31, 2016 at 10:00 AM

FDA Revising Criteria for “Healthy” Food

regulatory_round_up_blog.jpegReflecting the latest scientific information, including the link between diet and chronic diseases, the Food and Drug Administration (FDA) issued a final guidance in late September to stipulate the approved use of the labeling claim “healthy” on packaged foods and to request industry comments regarding the use of the term. Industry comments should inform FDA’s efforts to redefine the term “healthy” in order to align with the new final rules for updating the Nutrition Facts Panel and serving size information for packaged foods.

The final guidance advised food manufacturers of the agency’s intent to exercise enforcement discretion regarding use of the implied nutrient content claim “healthy” relative to the latest recommendations. The guidance highlights acceptable uses for the labeling term relative to low fat, and beneficial nutrients such as potassium and vitamin D.

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Topics: Food Safety, Nutritional Labeling, FDA Regulation Updates, FDA, Nutrition, Health Claims

Regulatory Round-Up: Implementation of FSMA Produce Safety and Foreign Suppliers Verification Programs

Posted by Patrick Kennedy

October 17, 2016 at 10:00 AM

States Preparing to Implement Produce Safety Rule

fruit_and_vegetable.jpgA partnership between federal and state regulators is vital for the successful implementation of the produce safety programs mandated by the Food Safety Modernization Act (FSMA). On September 9, the Food and Drug Administration (FDA) announced that 42 states will receive $21.8 million over a five-year period to facilitate the implementation of the produce safety rules. The participation of state regulators in the implementation of state produce safety programs is dependent upon federal funds, according to the National Association of State Departments of Agriculture (NASDA). State and federal agencies will begin to coordinate efforts soon as certain produce safety requirements will take effect in January 2018 for large farms.

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Topics: Food Safety, FDA Regulation Updates, FDA, Produce, Foreign Suppliers, Foreign Suppliers Verification Program, Produce Safety

Digesting the New FDA Dietary Fiber Definition

Posted by Nick Price

October 12, 2016 at 10:00 AM

fiber_blog_photo.jpgDietary fiber has received a significant amount of attention recently as part of a series of updates made to nutrition facts labels rolled out by FDA earlier this spring. The agency’s new definition of dietary fiber is “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants,” and “isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.” The key here being ‘beneficial fiber’ as defined by FDA.

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Topics: Nutritional Labeling, FDA Regulation Updates, Dietary Fiber, FDA

Regulatory Round-Up: Proposition 65 and Infant Formula Health Claims

Posted by Patrick Kennedy

October 3, 2016 at 10:00 AM

Proposition 65 Update – Aspartame, Vinyl Acetate, Nitrite 

regulatory_compliance-3.jpgAn upcoming meeting of California’s Office of Environmental Health Hazard Assessment (OEHHA) will consider the carcinogenic risks of several food, pesticide and packaging chemicals, including aspartame. OEHHA, the agency responsible for maintaining the state’s Proposition 65 list of chemicals known to cause cancer, recently released hazard identification materials for several chemicals to facilitate public consultation. Under Proposition 65, products containing a listed chemical in excess of the regulatory threshold must display a warning label indicating the presence of a known carcinogen or toxin.

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Topics: Food Safety, FDA Regulation Updates, FDA, Infant Formula, Proposition 65, Health Claims

Final FSMA rule targets intentional adulteration – Eight things to know about the new regulation

Posted by Patrick Kennedy

June 10, 2016 at 10:00 AM

fsma_blog_size_image.jpegThe seventh and final major rule mandated by the Food Safety Modernization Act (FSMA) was recently published paving the way for the full implementation of the law. The final rule for mitigation strategies to prevent the intentional adulteration of food, also known as ‘food defense’, imposes new requirements for foreign and domestic food facilities. Following are eight points to know about the ‘food defense’ final rule and a few notes regarding the related issue of economically motivated adulteration.

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Topics: Food Safety, Food Safety Modernization Act (FSMA), FDA Regulation Updates, FDA, FSMA, Food Defense

FDA's New Views On What We Call Fiber

Posted by John Szpylka, Ph.D.

May 6, 2016 at 10:00 AM

Nutrition-Label.pngChanging Definitions
FDA is proposing significant changes to nutritional labels including redefining which carbohydrates can be declared as dietary fiber. This new definition would require proof the proposed carbohydrate demonstrates physiological benefits associated with dietary fiber. Until the carbohydrate is proven to have these benefits and is accepted by the agency, it would only be listed as a carbohydrate on the nutrition label. Once recognized by FDA as a dietary fiber, the label could then be adjusted to include this carbohydrate in the declared amount of dietary fiber.

Historically, the amount of dietary fiber declared on nutritional panels was the amount that was measured via approved AOAC analytical methods (notably 985.29, 991.43, and more recently 2009.01 and 2011.25). These methods measure the amount of carbohydrates that are not digested by enzymes found in the body.

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Topics: FDA, Fiber

How Will the FDA Nutrition Labeling Rules Impact Your Business?

Posted by Xochitl Javier

January 29, 2016 at 3:00 PM

Food SafetyMany of us are closely following with anticipation how the final rules for the FDA Nutrition Facts Panels will shape up. Speaking of final rules, FDA recently posted its annual regulatory agenda in which the agency provided insights on the status of various regulatory initiatives. As expected, the agenda affirms the agency's committment to completing rules related to food labeling. Without delays, FDA announced March 2016 as the date for final ruling. With the implementation of the ruling, over 700,000 food and beverage nutrition facts labels will need to meet new compliance standards. While many have debated the true economic impact -- with FDA estimating nearly $2.3 billion cost to industry -- there is no doubt that for many companies the process will be complex and time-consuming. In addition to relabeling, new package designs and packaging costs, there are additional considerations, such as new recordkeeping processes and very likely reformulations, for many companies. From greater label clarity for consumers to dire chronic health conditions in the American population, FDA has cited numerous reasons for the labeling changes.

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Topics: Nutritional Labeling, FDA Regulation Updates, FDA

Keys to Understanding the Preventive Controls Rule for Human Food

Posted by Patrick Kennedy

September 25, 2015 at 11:00 AM

FSMAFor more than four years, food industry stakeholders have been eagerly awaiting publication of the final versions of the “seven foundational rules” mandated by FDA Food Safety Modernization Act (FSMA). This month, the Food and Drug Administration (FDA) issued the two final rules requiring facilities to identify potential hazards and implement controls for human food and animal food.

In the simplest terms, the final rule for human food requires firms to identify significant food safety risks, implement controls to mitigate the risks, monitor and verify the effectiveness of the processes, manage supply chain risks, and document activities.

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Topics: Food Safety Modernization Act (FSMA), FDA

FDA Releases FSMA Preventive Controls for Animal Food

Posted by John Williams

September 11, 2015 at 10:30 AM

Pet Food FSMAThe FDA Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food rule is now final, and compliance dates for some businesses begin in September 2016.

This final rule is the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia and other stakeholders. This outreach began before the rule was proposed in October 2013.

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Topics: Food Safety Modernization Act (FSMA), Pet Food, FDA

Will FSMA rules impact FDA food recall trends?

Posted by Patrick Kennedy

August 21, 2015 at 10:00 AM

Mérieux NutriSciences ConestogaAn upward trend in U.S food recalls during the past decade and a recent spike in recalls due to hidden allergens underscore the importance of global food supply chain management and Good Manufacturing Practices (GMPs).

The complex global food supply chain, involving the sourcing of multiple ingredients from numerous suppliers, is often linked to a higher risk of recalls due to microbial or chemical hazards. To combat the upward trend in recalls and improve the safety of imports, the Food and Drug Administration (FDA) is expected to implement several key regulations of the Food Safety Modernization Act (FSMA) this year to bolster preventive controls and supplier verification.

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Topics: Food Safety Modernization Act (FSMA), FDA


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