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FSMA Final Rule on Preventive Controls for Human & Animal Food

September 25, 2015

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On September 17, 2015, the FDA announced two new final rules for the Food Safety Modernization Act (“FSMA”) (Pub. L. 111-353). The two new final rules are: (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food.

Covered facilities, which exclude farms, must create and implement a food safety systems that includes:

  • Hazard analysis: identification of known or reasonably foreseeable biological, chemical, and physical hazards
  • Preventive controls: measures that assure identified hazards can be minimized or prevented
  • Monitoring, verification, and corrective action plans for use of preventive controls; additionally, each animal food facility with a preventive control in place must develop a recall plan

For animal food facilities, Current Good Manufacturing Practices (“cGMP”) are being established for the first time. The animal food rule contains FDA’s baseline

FDA Extends Menu Labeling Rule Compliance Date Until December 1, 2016

This morning, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor announced that FDA is extending the compliance date for the menu labeling rules one year, making the new compliance date December 1, 2016.  Since finalizing the menu labeling rules in December of 2014, FDA states that it “has had extensive dialogue with chain restaurants, covered grocery stores and other covered businesses, and answered numerous questions on how the rule can be implemented in specific situations.”  Certainly, businesses impacted by the rule have been grappling with the substance and logistics of implementing the menu labeling rules, including working with suppliers to obtain additional information about products.  This alone can be a tricky proposition for items like alcohol and craft beers, where nutritional information required by the menu labeling rules is not always readily available.  The extension will allow all parties impacted by the menu labeling rules – a group

FDA Proposes Draft Guidance on Mandatory Recall Authority

One key element of the 2011 Food Safety Modernization Act was the Act’s grant to FDA of powers to force a product recall.  Prior to FSMA, FDA had no such authority, and was required to use other authorities to “lean” on companies to conduct a recall.  Now, FDA may force a recall where it finds that there is a reasonable probability that food is adulterated or misbranded and the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.  In addition to satisfying this fairly substantial threshold, the responsible party must refuse to voluntarily conduct a recall.  The result is that FDA has initiated its mandatory recall authority only a couple of times, notably with respect to Kasel Associates Industries, Inc.’s pet treats and dietary supplements manufactured by USPLabs.

FDA recently issued draft nonbinding guidance regarding its mandatory recall authority.  The draft

USDA Approves Genetically Modified Apples, But Will They See The Shelves?

February 22, 2015

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On  February 13, 2015, the Department of Agriculture’s Animal and Plant Health Inspection Service approved the Arctic apple, a genetically modified strain of apple developed to resist browning.  A Canadian company, Okanagan Specialty Fruits Inc., first filed its petition for deregulation nearly three years ago.  The technology works by “turning off” the production of a certain enzyme that is produced when an apple is cut or bruised.  The Arctic apple is the one of the first deregulated genetically modified products designed to promote consumer-preferred traits, as opposed to traits like herbicide tolerance that promote certain production practices.

Notwithstanding APHIS’s approval, the question still remains of whether and how widely producers and consumers will adopt the technology in today’s environment surrounding GMOs.  Because it will be at least five to seven years before Arctic apple trees can bear fruit that can be marketed, producers will be required to do some significant

It’s Time to Renew Your Food Facility Registration!

Beginning on October 1, 2014, food facilities required to be registered with the FDA must renew their food facility registrations.  The FDA currently requires registration for all domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.  This food facility registration must be renewed every two years, and the current registration period lasts until December 31, 2014.  FDA has published a number of guidance documents to assist with the food facility registration requirements, including a Q&A document and a Small Business Compliance Guide.  More information on registration procedures can be found on FDA’s website.

Food and Beverage Class Actions Are on the Rise

September 19, 2014

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The latest Bryan Cave white paper on advertising class actions indicates an increase in class action filings affecting the food and beverage industry.  The paper, which analyzes class action complaint filings in the first two quarters of 2014, reveals the following:

  • Nearly 50% of the advertising class action complaints during the relevant time period were in the food and beverage (36%) or dietary supplement (12%) industries.  This number jumps to nearly 75% if other industries regulated by the Federal Food, Drug and Cosmetic Act are included. (Cosmetics accounted for 11%, pharmaceuticals for 8%, weight loss and pet care products for 4% each.)
  • Each quarter in 2014 represents a significant increase when compared to the last quarter of 2013.
  • Most of these food and beverage advertising class actions related to food labeling and nutrition content (26%), although “natural” claims still comprise a significant number of filings (18%).

The white

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