Regulatory Update

Regulatory Round-Up: Food Allergies – A Growing Health Issue Challenging Food Manufacturers

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Food allergies are known to affect millions of Americans annually, and a new study has confirmed the growing prevalence of serious reactions to food allergens. Between the years 2007 and 2016, the number of serious allergic reactions to food spiked nearly 400 percent in the United States, according to a report by FAIR Health.

As insurance claims surged within the past decade, product recalls and consumer lawsuits against food companies due to allergen labeling errors have also increased. The complexity of the global food supply chain is creating new headaches for food manufacturers trying to control allergen hazards. As demonstrated in recent years, the undisclosed presence of an allergen in one ingredient (e.g. ground cumin or cumin powder) can trigger recalls of a wide variety of finished products. Continue Reading

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Regulatory Update

Regulatory Round-Up: Food Regulations in Limbo Due to Trump’s “One in, Two Out” Policy

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The Trump Administration’s Executive Orders requiring federal agencies to eliminate two regulations for every new regulation is adversely impacting the agencies responsible for food safety and nutrition. On July 20th, the federal government released the latest Unified Agenda of federal regulatory activities, which contained a new category for regulations requiring further review or consideration.

Within the Spring 2017 agenda, more than 100 regulatory measures were identified under this new category “inactive,” including significant regulations related to food labeling, organic agriculture and the Food Safety Modernization Act (FSMA). The impactful regulatory measures considered “inactive” in the food industry are detailed below: Continue Reading

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Regulatory Update

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

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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

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Regulatory Update

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

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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

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Regulatory Update

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

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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

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Nutrition Regulatory Update

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

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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

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Regulatory Update

Regulatory Round-Up: Keys to Preventing Undeclared Allergens and Reducing Recalls

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A decade ago, allergens were an uncommon cause of meat and poultry product recalls in the United States. The proportion of meat and poultry products recalled annually due to allergens steadily increased from 8% in 2008 to 35% in 2012 due to increased awareness of the issue by inspection personnel and establishments. Moreover, the total number of recall events involving meat and poultry products due to undeclared allergens increased 103% between the calendar years 2012 and 2015. Undeclared allergens have now become the leading reason for recalls of meat and poultry products from the U.S. marketplace. Continue Reading

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Regulatory Update

Regulatory Round-Up: Third-Party Audits, GFSI and FSMA – FDA Seeks Strategic Partnerships for Imported Foods

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Questions about the role of industry standards for complying with the Food Safety Modernization Act (FSMA) have existed since the law was enacted more than six years ago. Due to the upcoming requirements for foreign supplier verification, industry stakeholders are urging the FDA to extend the compliance date, and to clarify the role of private entities for supporting compliance with the new FSMA requirements for imported food.

The role of strategic partnerships for improving the safety of imported food was the focus of a two-day FDA public hearing held last week (February 14-15, 2017). The hearing followed public meetings held last year on imported food safety, which raised questions about the role of private certification schemes and third-party audits for supporting compliance with FSMA by foreign suppliers. Continue Reading

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