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

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

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

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

In 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. Continue Reading

Governmental 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. Continue Reading

On 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). Continue Reading

The 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. Continue Reading