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FSMA Final Rule on Preventive Controls for Human & Animal Food

September 25, 2015


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

The Demise of Country of Origin Labeling (COOL)

The Demise of Country of Origin Labeling (COOL)

May 26, 2015

Authored by: Sara Ahmed

Digest has been tracking the U.S. Country of Origin Labeling (“COOL”) rules that the WTO decided last year violate international fair trade rules.  It was the third time the WTO found COOL to be unfairly discriminatory.

In response to the threat of retaliation by Canada and Mexico, last week, the House Agricultural Committee voted to repeal a portion of COOL.  Under the bill, beef, pork, and chicken products will likely no longer state where the animals were born, slaughtered, and packaged.  The USDA had previously tried to no avail to revamp the rules upon the WTO’s prior rulings.

The U.S. National Farmers Union’s President, Roger Johnson, has been vocal in his feelings against the move to repeal portions of COOL and stated: “The House Agriculture Committee has succumbed to lobbying and scare tactics from foreign governments and multinational meatpackers and inserted itself prematurely into the WTO process by voting for a bill

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


March 26, 2015


Plaintiffs have made food labeling class actions a rapidly-growing field in recent years, particularly in the Northern District of California. They typically rely on California’s regimen of consumer fraud statutes when bringing those claims. California also has Proposition 65, which requires labeling of substances that a state agency concludes may cause cancer or birth defects. The threshold for labeling is quite low, meaning that even the most mundane items often include—or should include—warnings. Indeed, plaintiffs recently have used the “lack” of a Proposition 65 label on food products as a basis for consumer fraud and other claims even though the Food and Drug Administration finds no health risk from the relevant ingredient and already dictates labeling requirements regarding the ingredient. Such lawsuits are irreconcilable with the purpose of federal food labeling requirements.

Proposition 65 And Its Relationship To 4-MeI In Beverages.

In the past

A new circuit split regarding food labeling consumer fraud claims

March 18, 2015


A recent opinion from the Ninth Circuit may cause considerable confusion regarding what food manufacturers may put on their labels outside of the familiar Nutrition Facts Label. In fact, the opinion filed March 13, 2015, is at odds with earlier unpublished decisions from the Ninth and Third Circuits.

Reid v. Johnson & Johnson, No. 12-56726 (9th Cir. Mar. 13, 2015), is part of the wave of food labeling class actions making its way through the Ninth Circuit. That plaintiff alleged a host of consumer fraud claims based on the defendants’ Benecol vegetable oil-based spread. Benecol’s label prominently states that the product contains “No Trans Fat.” In truth, the product contains small amounts of trans fat, which the plaintiff contends is quite harmful to human health.

The difficulty that Reid presents is that FDA regulations require that the Nutrition Facts Label on Benecol state that

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