March 4, 2010
WASHINGTONThe U.S. Food and Drug Administration (FDA) notified 18 food manufacturers regarding the labeling of food products that violate the federal Food, Drug, and Cosmetic Act. The violations cited include unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as healthy, and others that have strict, regulatory definitions.
Companies that received warning letters have 15 business days to inform the FDA of the steps they will take to correct their labeling or be subject to legal proceedings that would remove misbranded products from the marketplace.
The action follows an October 2009 statement by FDA Commissioner Margaret Hamburg, MD, encouraging companies to review their labeling to ensure that they were in compliance with FDA regulations, and were truthful and not misleading.
In an open letter to industry dated March 3, Hamburg underscored the importance of providing nutrition information that consumers could rely on. She also expressed her hope that the warning letters would clarify the FDAs expectations for food manufacturers as they review their current labeling.
"Today, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States," she said.
Hamburg has made nutrition labeling a priority for the FDA. The warning letters are the agencys most recent action to help improve consumers ability to make nutritious choices. The FDA soon will propose guidance regarding calorie and nutrient labeling on the front of food packages and plans to work collaboratively with the food industry to design and implement innovative approaches to front-of-package labeling that can help consumers choose healthy diets.
The 17 food manufacturers and the products with "misleading" labels are (click on the hyperlink to see the individual warning letters):
Dreyers Grand Ice Cream,Inc.: Nestle Drumstick Classic Vanilla Fudge and Dreyer's Dibs Bite Sized Ice Cream Snacks Vanilla Ice Cream (unsupported nutrient claim; trans-fat-free claim on high saturated-fat product);
Gorton's, Inc.: Gorton's Fish Fillets (trans-fat free claim on high-saturated-fat product);
Schwan's Consumer Brands: Mrs. Smith's Classic Coconut Custard Pie (trans-fat-free claim on product high in saturated fat);
Spectrum Organic Products, Inc.: Organic All Vegetable Shortening (cholesterol-free claim on product high in fats);
Beech-nut: DHA Plus line of products and Beechnut Whole Grain Oatmeal with mixed fruit (nutrient claims on products for small children);
PBM Products: Parent's Choice Little Puffs Plus Calcium Blueberry Naturally Flavored Parent's Choice Little Puffs Made with Whole Grains Peach-Mango Naturally Flavored (nutrient claims on products for small children);
Nestlé USA: Juicy Juice All-Natural 100% Juice Orange Tangerine and Juicy Juice All-Natural 100% Juice Grape (misleading claims of juice content; nutrient claims on products for small children);
Nestlé Nutrition: Gerber's 2nd Foods Carrots and Gerber Graduates Puffs (nutrient claims on products for small children);
Redco Foods: Salada Naturally Decaffeinated Green Tea (promoted for conditions that cause the product to be a drug; unapproved nutrient claim; unapproved health claim);
Sunsweet Growers: Sunsweet Antioxidant Blend dried fruit mix (unapproved nutrient claim);
Fleminger, Inc.: TeaForHealth green tea products and Dr. Lee's TeaForHealth RTE green tea product (promoted for conditions that cause the products to be drugs; unapproved nutrient claim; unauthorized health claims);
POM Wonderful: POM Wonderful 100% Pomegranate Juice (promoted for conditions that cause the products to be drugs; unauthorized health claims);
Ken's Foods, Inc.: Healthy Options Salad Dressings (unauthorized health claims; low-fat claims on product high in fats);
Pompeian: Pompeian Imported Extra Light Olive Oil ("light" claim for product high in fat; unsupported nutrient claim; unauthorized health claims);
Diamond Food, Inc.: Diamond Shelled Walnuts (unauthorized health claims);
First Juice, Inc.: Organic Fruit and Veggie Juice Beverage products and Purple carrot products (unauthorized nutrient and health claims);
Want Want Foods: Baby Mum-Mum Original Selected Superior Rice Rusks (nutrient claim on product for small children);
Nature's Path Foods, Inc.: Organic Flax Plus Multigrain Cereal (unapproved nutrient claim).
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