Food Safety

News & Analysis as of

Food for Thought: FDA Approves Genetically Engineered Salmon

On November 19, the U.S. Food and Drug Administration approved genetically engineered (GE) salmon for consumption as food. AquaBounty Technologies, Inc. filed an application with the FDA for the approval of AquAdvantage...more

Top takeaways from the 2015 Las Vegas Marijuana Business Convention

Joan Lebow, Carl Rowley, and Fred Roth of Thompson Coburn's cannabis practice attended Marijuana Business Media’s 2015 Marijuana Business Conference at the Rio Hotel, Las Vegas, where more than 5,500 attendees attended...more

FDA Issues New Food Safety Rules

The U.S. Food and Drug Administration (“FDA”) issued three new rules on November 13 implementing the 2011 Food Safety Modernization Act. The Final Rule on Produce Safety establishes microbial water quality standards for water...more

FSMA Comes Down on the Farm: FDA Finalizes Produce Safety Standards

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released the prepublication version of its final rule regarding Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human...more

It Will Only Cost You an Audit: FDA Releases FSMA Third-Party Certification Rule

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications...more

Food from Faraway Lands: FDA Releases FSMA Foreign Supplier Food Safety Rule

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Foreign Supplier Verification Programs for Food Importers (FSVP Rule). The new rule requires importers to ensure that...more

EP and Council of the EU Reach Agreement on Proposed Novel Food Regulation

On November 11, 2015, the Council of the European Union (EU) announced that its Permanent Representatives Committee approved the proposed novel food regulation. On November 16, 2015, the European Parliament (EP) and the...more

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

Update on Health Canada's Modernization Makeover: Proposed Changes to Labelling Standards for Products Containing Acetaminophen

Health Canada is in the midst of a “modernization makeover.” The Agency is undertaking a multi-year, comprehensive review of its regulatory frameworks for health products and food. Among other things, modernization efforts...more

New sentencing guidelines for health and safety, corporate manslaughter, food safety & hygiene offences

On 3 November 2015 the Sentencing Council published the long awaited Definitive Guideline for the Sentencing of Health and Safety, Corporate Manslaughter and Food Safety and Hygiene offences. For the first time, courts in...more

Will the FDA’s Proposed Rule on the Sanitary Transportation of Food Apply to International Shipments?

Yes, the FDA’s Proposed Rule, required to be published by March 31, 2016, will apply to food shipments being transported into the U.S., directly, by motor or rail vehicle, or transferred onto a motor or rail vehicle for...more

Food Recall Events: The Importance of Evaluating Your Insurance Coverage Before a Voluntary and Mandatory Food Recall

Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

The U.S. Food and Drug Administration (FDA) continues to publish new Rules as part of its implementation of the Food Safety and Modernization Act (FSMA). In addition to new animal feed and food safety rules, the FDA recently...more

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

The new FDA Rule revamping cGMPs and implementing new rules referred to as HARPC will impact the food industry greatly. In this second in a three-part series, we will discuss the FDA’s changes to cGMPs, noting the changes...more

Long-awaited overhaul of FDA food safety rules arrives – Part III: Hazard Analysis and Risk-Based Preventive Controls

In the first two articles in this series, Life Sciences Decoded explored the FDA’s new Rule revamping the food Good Manufacturing Practices (cGMPs) and creating the new Hazard Analysis and Risk-Based Preventive Controls...more

Food and Beverage Alert (US) - October 2015

FSMA will have major impact on dietary ingredient suppliers, expert says. The biggest change in food regulation in the US in the past 75 years will have a major effect on the suppliers of dietary ingredients, a food-quality...more

Food Safety Does Not Exist In A Vacuum, and Neither Do the FSMA’s Rules: What the New Rules on Preventive Controls for Human and...

On September 17, 2015 the FDA published the first two of its seven rules in conjunction with the Food Safety Modernization Act’s (the “FSMA”) regulatory scheme. The rules, which focus on Current Good Manufacturing Practices...more

CEO Conviction Aligns With Trend of Aggressive Foodborne Illness Prosecutions

The former CEO of Peanut Corporation of America (PCA), has been sentenced to an unprecedented 28 years for his role in the 2008-09 Salmonella outbreak linked to the deaths of nine people and more than 700 illnesses. While it...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

FDA Releases Two Final Food Safety Rules: What You Need to Know

Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more

Finally Coming to Fruition: FDA’s Rule on the Sanitary Transportation of Food

Twenty-five years after Congress first tried to ensure that garbage trucks aren’t also used to haul fresh produce, a federal regulation establishing sanitation standards for the transportation of human and animal food by...more

FDA Warns Companies About Powdered Caffeine

We Americans love our energy-boosting drinks, never mind that so many have been shown to pose threats of heart disease, high blood pressure and other problems for some people. The newest form of caffeine-infusion is a powder...more

FDA Finalizes First Two Rules Under FSMA

On September 10, 2015, the U.S. Food and Drug Administration (FDA) finalized its long-anticipated preventive control rules for human and animal food under the Food Safety Modernization Act (FSMA). The Current Good...more

Long-Awaited FSMA Final Rules Published

On September 10, 2015, the U.S. Food and Drug Administration (FDA) made public two final Food Safety Modernization Act (FSMA) rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls...more

FSMA Rules for Preventive Controls for Human and Animal Food Manufacturing Finalized

On September 10, 2015, FDA issued a prepublication notice of its long-anticipated preventive control rules for human and animal food under the Food Safety Modernization Act (FSMA). The Current Good Manufacturing Practice,...more

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