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?

Regulatory Round-Up: How to Avoid “A Pound of Cure” With Evolving Nutrition and Food Labeling Rules

A well-known idiom attributed to Benjamin Franklin states, “An ounce of prevention is worth a pound of cure.” This provides an apt analogy for the importance of proper nutrition for disease prevention in modern times. Consumers are often advised to modify their diets to prevent the progression of serious diseases. Moreover, the importance of understanding the evolving food labeling regulations cannot be underestimated for food companies seeking to prevent food product recalls and other enforcement activities related to labeling errors. Continue reading Regulatory Round-Up: How to Avoid “A Pound of Cure” With Evolving Nutrition and Food Labeling Rules

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

Regulatory Round-Up: What is a ‘Healthy’ Food? – FDA Reconsidering the Definition of ‘Healthy’

What is a “healthy” food? Should a “healthy” food contain specific levels of vitamins and minerals? Conversely, should a “healthy” food limit potentially harmful components such as saturated fat, cholesterol, sugar or sodium? Questions surrounding the definition of a “healthy” labeling claim have surged in recent years due to the rising consumer demand for nutritious foods. Continue reading Regulatory Round-Up: What is a ‘Healthy’ Food? – FDA Reconsidering the Definition of ‘Healthy’

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

Regulatory Round-Up: FSIS Unveils Strategic Food Safety Goals

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 Regulatory Round-Up: FSIS Unveils Strategic Food Safety Goals

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

Implementation 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).  Continue reading Regulatory Round-Up: New FSMA Guidance Tackles Hazard Disclosure, VQIP

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

Industry Seeks Harmonization of FDA Nutrition Mandates 

Responding 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. Continue reading Regulatory Round-Up: Industry Seeks Harmonization of Nutrition Compliance Dates

Regulatory Round-Up: New Criteria for “Healthy” Foods

FDA Revising Criteria for “Healthy” Food

Reflecting 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. Continue reading Regulatory Round-Up: New Criteria for “Healthy” Foods