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What do FDA’s Preventive Controls Rules Actually Mean?

St. Louis Partner Brandon Neuschafer authored an article Nov. 10 in Refrigerated & Frozen Foods magazine concerning the FDA’s Preventive Controls Rules. Released on Sept. 10, the rules aim to shift the focus of U.S. food safety away from incident response and toward prevention. “FDA expects that many large facilities are already doing a vast majority of what is now being required,” Neuschafer wrote. “Those facilities may still need to develop additional documentation or tweak procedures. Interesting and complicated issues swirl around companies who are not themselves food facilities, but are technology and equipment providers to such facilities.” Click here to read his full article.

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FDA Proposes Draft Guidance on Mandatory Recall Authority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

PROPOSITION 65 CLAIMS AND 4-MEI: PROVING THAT DEFERENCE TO THE FDA IS NECESSARY.

March 26, 2015

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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

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.

New FDA Guidance on “Gluten Free” Claims

Following up on last year’s “gluten-free” labeling rule, the FDA has now published guidance to help industry interpret and apply the rule.  All food products claiming to be “gluten-free” must comply with the rule by August 5, 2014.  At its essence, according to the FDA, “gluten-free” means that the food does not contain an ingredient made from a gluten-containing grain unless that grain has been processed to remove the gluten and the remaining gluten in he ingredient does not exceed 20 parts per million.  Food containing unavoidable amounts of gluten, such as from cross-contact, must still be below the 20 ppm threshold to use the “gluten-free” claim.  The rule does not require testing of gluten levels, but a company using the claim is responsible for ensuring that its product meets the established threshold to avoid product being adulterated and/or misbranded.

Interestingly, FDA has specifically stated that the “gluten-free” claim can

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