What is a Swabathon?: Understanding the FDA Investigations

The top priority for most food manufacturers is protecting the food consumers eat. Yet, one of the major causes of product recalls in the food industry is product contamination in the processing environment by pathogens such as Salmonella and Listeria monocytogenes. These pathogens take up residence within the structure of food plants and within the processing equipment itself. Once it makes a home there, it can contaminate the food products it comes into contact with as they make their way through the production process. Continue reading What is a Swabathon?: Understanding the FDA Investigations

Technical Tuesday: The Importance of Using Valid Sampling Plans

The Food Safety Modernization Act has introduced many new food safety requirements to the food industry. In particular, FSMA places a focus on performing a hazard analysis and using preventive measures in food manufacturing. The requirement to develop and implement supplier preventive controls for raw materials and ingredients to address hazards has renewed interest in methods for sampling and testing raw materials. In order for sampling and testing to be used to address pathogen concerns identified in the hazard analysis of raw materials, a valid sampling plan must be in place. Continue reading Technical Tuesday: The Importance of Using Valid Sampling Plans

Regulatory Round-Up: The Seventh Year of FSMA – Are We There Yet?

With summer vacation season upon us, most people can relate to the angst of the question, “Are we there yet?”  In fact, I suspect many food industry professionals have recently pondered this question when reflecting on the regulations of the Food Safety Modernization Act (FSMA), and then wondered what is “coming down the pike?”

Upon enactment of the FSMA law in January 2011, the U.S. Food and Drug Administration (FDA) implemented a few requirements immediately, but the most significant rules require years to develop.  The implementation phase of the FSMA regulations officially began two years ago with the beginning of Phase II of the FDA’s operational strategy for FSMA, which included regulator training and targeted risk-based inspection, sampling, testing and data collection activities. Continue reading Regulatory Round-Up: The Seventh Year of FSMA – Are We There Yet?

How to Reduce Risk With Food Label Compliance Reviews

All natural. Gluten free. Low in fat. Organic. Peanut free. The number of claims available for use to describe a food seems endless, so how does a manufacturer or producer know which words they can and cannot use? Taking one quick trip down the grocery aisle bombards a consumer with confusing label call-outs, outrageous marketing promises and countless newly innovative products.

The food and beverage market is a multi-million dollar industry that just keeps growing, providing consumers with access to trendy or niche foods they have never heard of before. The fast-paced world of food research and new product introductions may even leave some consumers questioning how true some of these claims are on new products with their fancy marketing call-outs and implied promises of renewed health and energy. Continue reading How to Reduce Risk With Food Label Compliance Reviews

Regulatory Round-Up: An Update on FSMA Rules, Nutrition Labeling and PHOs

After a flood of food regulations during President Obama’s administration, the food regulatory environment in the United States could experience a drought in new regulations due to the deregulatory philosophy of the Trump administration and the U.S. Congress.

In April, President Trump signed an executive order with the objective of eliminating unnecessary “regulatory burdens” for the agricultural sector. Earlier this year, the U.S. House passed legislation (H.R. 5), referred to as the “filthy food act” by opponents, which would impede the development of new food regulations. The U.S. Senate is expected to vote on the bill later this month. Continue reading Regulatory Round-Up: An Update on FSMA Rules, Nutrition Labeling and PHOs

Responding to a FDA Detention Notice in the Food Industry

Has the Food and Drug Administration (FDA) detained one of your shipments? Are your fists clenched and heart racing in frustration, desperation or fear? When you receive this notification from the FDA, there’s no need to panic. Among other tasks, the FDA is responsible for keeping our food supply safe.

Why has your product been detained? When the FDA has a reason to suspect a shipment is in violation of the Federal Food, Drug and Cosmetic Act, they have the authority to detain shipments. This law gives the FDA the right to examine food, drugs, cosmetics, tobacco products, devices and radiation-emitting electronic products that are to be imported into the United States. If a product is found to be adulterated or misbranded, the FDA can refuse to admit it into the country. The FDA can detain products without physical examination on the basis of a history of violations, or on information about how a product was made. For example, if the FDA believes your fresh tomatoes were grown using a prohibited pesticide, they could detain your shipment. Continue reading Responding to a FDA Detention Notice in the Food Industry

Regulatory Round-Up: Industry Challenged by the FDA’s Sodium Reduction Targets

Did you know federal health authorities have estimated 44% of the sodium consumed by Americans comes from only 10 types of food? According to the U.S. Centers for Disease Control and Prevention, the diet of 90% of Americans exceeds the recommended dietary sodium level for optimal public health. The high sodium levels found in many processed foods have triggered calls for food companies to reduce the salt content of food products; however, eliminating this valuable additive from food products can be a complex process. Continue reading Regulatory Round-Up: Industry Challenged by the FDA’s Sodium Reduction Targets

How FDA “Swabathons” Factor Into Environmental Monitoring

Recently, 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).  Continue reading How FDA “Swabathons” Factor Into Environmental Monitoring

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

If 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. Continue reading Regulatory Round-Up: Strategies for Controlling Listeria in Ready-To-Eat Foods