FDA Enforcement and Recall Report Week of June 6

Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.

FDA Recalls – Allergen Recalls

Recall postings picked up steam again this past week. After only three new recall postings preceding the Memorial Day holiday a full 23 recall postings this past week. It appears Listeria is continuing to drive the number of recalls – a full 16 of the 23 notices involved Listeria. This is likely still tied to the CRF recall.  As the CRF recall continues to cool – this week will provide evidence of how many recalls remain – expect to see allergen recalls swing back to the top. Undeclared allergens are traditionally the top reason for recalls. That will change as FSMA goes into effect – the FDA is requiring all allergens be declared or properly controlled under the HARPC rule.

Also note the recall for insufficient pasteurization. As FSMA goes into effect it will not be enough to simply note a supplier pasteurizes a product, but to ensure that process is validated and adequately controlling the risk. This type of recall will soon have FSMA implications!

FDA Warning Letters

FDA Warning Letters post weekly but generally are issued earlier than posted. There were no new Warning Letters. This post will be amended when the latest Warning Letters are added.

Please contact our Washington D.C. or Charlotte NC office with any FDA recall, Warning Letter or other enforcement questions.

06/04/2016 MaraNatha Sunflower Seed Butter Listeria monocytogenes MaraNatha
06/04/2016 PediaSmart Dairy Vanilla complete nutrition beverage powder packaged in 12.7 ounce cans Possible under-delivery of nutrition using included scoop Nature’s One
06/03/2016 Mountain Thins Trail Mix Listeria monocytogenes Brown & Haley
06/03/2016 Hostess Snack cakes, donuts Undeclared peanut Hostess Brands LLC
06/03/2016 Kashi, Bear Naked Snack bars, granola, granola bars Listeria monocytogenes Kashi Company
06/03/2016 Jarlsberg Cheese spread, cookies and cream dessert Undeclared eggs Chelsea Food Services
06/03/2016 Hickory Harvest, IM Good, Sheetz, and others Sunflower Kernels Listeria monocytogenes Hickory Harvest Foods
06/03/2016 Bayou Brothers Creole sauce Undeclared fish Bayou Brothers
06/03/2016 Hy-Vee Salad topping, trail mix, trail mix bars, protein bars Listeria monocytogenes Hy-Vee, Inc.
06/03/2016 Alpine Valley, Wegmans, Flave Fitness, Gonzo, more Products containing sunflower kernels Listeria monocytogenes First Source
06/02/2016 Clif and Clif Bar Energy bars, trail mix bars Listeria monocytogenes Clif Bar & Company
06/02/2016 Jungle Jim, Windy Acres Sunflower seeds, trail mix Listeria monocytogenes Windy Acres Candy & Nut Company
06/02/2016 Quaker Quinoa granola bars Listeria monocytogenes The Quaker Oats Company
06/02/2016 Sun Life Sunflower spreads Listeria monocytogenes Nu Life Market
06/02/2016 Durkee, Food Club, Hy-Vee Salad toppings Listeria monocytogenes ACH Food Companies, Inc.
06/02/2016 Bybee’s,Columbia River Organics, Northwest Growers Select and others Frozen Organic and Traditional Fruits and Vegetables Listeria monocytogenes, CRF2016 CRF Frozen Foods
06/01/2016 Various: Sunrich, Spitz, Navitas Natural, Planters, Kar’s Sunflower kernels Listeria monocytogenes SunOpta Inc.
06/01/2016 Frontera Frontera Undeclared Soy Frontera Foods
06/01/2016 Publix Nut, Seed and Raisin mix Listeria monocytogenes Publix Super Markets
06/01/2016 Meadow Gold Whipping cream and Half & Half Insufficient pasteurization Meadow Gold Dairy
05/31/2016 Kashi and Bear Naked Granola Bars, Granola Listeria monocytogenes Kashi Company
05/31/2016 Backroad Country Cranberry Nut Delight Mix, Honey Island Crunch Mix, Peanut Butter Pretzels, Walnuts Halves & Pieces, Sun Flower seeds Listeria monocytogenes Troyer® Cheese Inc.
05/31/2016 Gold Medal, Gold Medal Wondra, Signature Kitchens Flour E.coli General Mills
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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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