FDA Calls on Food Companies to Correct Labeling Violations
This posting was written by William Zale, Editor of CCH Advertising Law Guide.
The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.
The action follows an October 2009 statement by Commissioner of Food and Drugs Margaret Hamburg, M.D., encouraging companies to review their labeling to ensure that they were in compliance with FDA regulations, and were truthful and not misleading.
Letter to Industry
In an open letter to Industry dated March 3, 2010, Dr. Hamburg underscored the importance of providing nutrition information that consumers could rely on.
“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,” Dr. Hamburg said in the letter.
She also expressed her hope that the warning letters would clarify the FDA’s expectations for food manufacturers as they review their current labeling.
Front-of-Package Labeling Initiative
Dr. Hamburg has made nutrition labeling a priority for the FDA. The warning letters are the agency’s 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.
Warning Letters
The violations cited in the warning letters 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, according to the FDA’s press release.
-------------------------
Firm: Dreyers Grand Ice Cream, Inc.
Product: Nestle Drumstick Classic Vanilla Fudge
Type of Claim of Major Topic Area: The front panel shows that the product has no trans fat, but it doesn't have a disclosure statement to alert consumers that the product has significant levels of saturated fat and total fat.
Action: Warning Letter
-------------------------
Firm: Dreyers Grand Ice Cream, Inc.
Product: Dreyers Dibs Bite Sized Ice Cream Snacks Vanilla Ice Cream with Nestle Crunch Coating
Type of Claim of Major Topic Area: The front panel shows that the product has no trans fat, but it doesn't have a disclosure statement to alert consumers that the product has significant levels of saturated fat and total fat.
Action: Warning Letter
-------------------------
Firm: Gorton's, Inc.
Product: Gorton's Fish Fillets
Type of Claim of Major Topic Area: The front panel shows that the product has no trans fat, but it doesn't have a disclosure statement to alert consumers that the product has significant levels of sodium, saturated fat and total fat.
Action: Warning Letter
-------------------------
Firm: Schwan's Consumer Brands
Product:Mrs. Smith's Coconut Custard Pie
Type of Claim of Major Topic Area: The front panel shows that the product has no trans fat, but it doesn't have a disclosure statement to alert consumers that the product has significant levels of saturated fat and total fat.
Action: Warning Letter
-------------------------
Firm: Spectrum Organic Products, Inc.
Product: Organic All Vegetable Shortening
Type of Claim of Major Topic Area: The front panel shows that the product has no trans fat, but it doesn't have a disclosure statement to alert consumers that the product has significant levels of saturated fat and total fat.
Action: Warning Letter
-------------------------
Firm: Spectrum Organic Products, Inc.
Product: Organic All Vegetable Shortening
Type of Claim of Major Topic Area: The product makes nutrient content claims such as "cholesterol free," "less saturated fat than butter," and "good source of … monounsaturated fat," but does not meet the legal requirements to make these claims.
Action: Warning Letter
-------------------------
Firm: Beech-nut
Product: Beechnut DHA Plus line of products
Type of Claim of Major Topic Area: The product makes claims on its website such as "no added refined sugar" and "plus vitamins and minerals," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm:Beech-nut
Product: Beechnut Whole Grain Oatmeal with mixed fruit
Type of Claim of Major Topic Area: The product makes claims such as "low sodium," "plus fiber," and "plus vitamins & minerals," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm:PBM Products
Product:Parent's Choice Little Puffs Plus Calcium Blueberry Naturally Flavored
Type of Claim of Major Topic Area: The product makes claims such as "plus calcium," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm:PBM Products
Product: Parent's Choice Little Puffs Made with Whole Grains Peach-Mango Naturally Flavored
Type of Claim of Major Topic Area: The product makes claims such as "a good source of calcium," "a good source of Vitamin D," and "a good source of iron," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm: Nestle
Product: Juicy Juice Brain Development Fruit Juice Beverage
Type of Claim of Major Topic Area: The product makes claims such as "no sugar added," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter (issued 12/2009)
-------------------------
Firm: Nestle
Product: Juicy Juice All-Natural 100% Juice Orange Tangerine and Juicy Juice All-Natural 100% Juice Grape
Type of Claim of Major Topic Area: The product labels imply that the products are 100% juice when they are actually
juice blends with added flavors.
Action: Warning Letter (issued 12/2009)
-------------------------
Firm: Nestle Nutrition
Product: Gerber's 2nd Foods Carrots
Type of Claim of Major Topic Area: The product makes claims such as "healthy," "excellent source of … Vitamin A," and "no added sugar," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm: Nestle Nutrition
Product: Gerber Graduates Puffs
Type of Claim of Major Topic Area: The product makes claims such as "good source of iron, zinc, and Vitamin E," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm: Redco Foods
Product: Salada Naturally Decaffeinated Green Tea
Type of Claim of Major Topic Area: The product makes claims that it will treat, prevent, or cure diseases such as Alzheimer's disease, rheumatism, and cancer. These types of claims are not allowed on food products.
Action: Warning letter
-------------------------
Firm: Redco Foods
Product: Salada Naturally Decaffeinated Green Tea
Type of Claim of Major Topic Area: The product makes claims on the product website that it is effective in the prevention of cardiovascular disease, but this claim has been not authorized for this product.
Action: Warning letter
-------------------------
Firm: Redco Foods
Product: Salada Naturally Decaffeinated Green Tea
Type of Claim of Major Topic Area: The product makes claims such as "fortified with antioxidants," but the claim does not meet the requirements of the antioxidant regulation.
Action: Warning letter
-------------------------
Firm: Sunsweet Growers
Product: Antioxidant Blend Dried Fruit Mix
Type of Claim of Major Topic Area: The product makes claims such as “full of nutritious antioxidants,” but the claim does not meet the requirements of the antioxidant regulation.
Action: Warning letter
-------------------------
Firm: Fleminger Inc.
Product: TeaForHealth Green Tea products Dr. Lee's TeaForHealth 710EGCG inabottle Green TeaTea For Health 710EGCG Ready-To-Drink Natural Brewed Green Tea
Type of Claim of Major Topic Area: The product makes claims that it will treat, prevent, or cure diseases such as Alzheimer's disease, diabetes, and cancer. These types of claims are not allowed on food products.
Action: Warning Letter
-------------------------
Firm: Fleminger Inc.
Product: TeaForHealth Green Tea products Dr. Lee's TeaForHealth 710EGCG inabottle Green TeaTea For Health 710EGCG Ready-To-Drink Natural Brewed Green Tea
Type of Claim of Major Topic Area: FDA has authorized a qualified health claim for green tea, but the claims for these products do not meet the criteria established by FDA.
Action: Warning Letter
-------------------------
Firm: Fleminger Inc.
Product: TeaForHealth Green Tea products Dr. Lee's TeaForHealth 710EGCG inabottle Green TeaTea For Health 710EGCG Ready-To-Drink Natural Brewed Green Tea
Type of Claim of Major Topic Area: The product makes claims such as "drink high antioxidant green tea," but the claim does not meet the requirements of the antioxidant regulation.
Action: Warning Letter
-------------------------
Firm: POM Wonderful
Product: POM Wonderful 100% Pomegranate Juice
Type of Claim of Major Topic Area: The product makes claims that it will treat, prevent, or cure diseases such as hypertension, diabetes, and cancer. These types of claims are not allowed on food products.
Action: Warning Letter
-------------------------
Firm: Ken's Foods, Inc.
Product: Ken's Healthy Options Salad Dressings
Type of Claim of Major Topic Area: The product makes claims such as, "Healthy Options," but has more fat than is allowed in products labeled as "healthy."
Action: Warning Letter
-------------------------
Firm: Pompeian, Inc.
Product: Pompeian Imported Extra Light Olive Oil
Type of Claim of Major Topic Area: The product makes nutrient content claims such as "light," and "high in good monounsaturated fat," but doesn't meet the requirement to make these claims.
Action: Warning Letter
-------------------------
Firm: Pompeian, Inc.
Product: Pompeian Imported Extra Light Olive Oil
Type of Claim of Major Topic Area: The product makes claims that it will treat, prevent, or cure diseases such as heart disease and cancer. These types of claims are not allowed on food products.
Action: Warning Letter
-------------------------
Firm: Diamond Food,Inc.
Product: Diamond of California Shelled Walnuts
Type of Claim of Major Topic Area: The product label makes claims that the product can help prevent heart disease. FDA has authorized a claim relating walnuts and heart disease, but the claim on this product doesn't meet the requirements to make the claim.
Action: Warning Letter
-------------------------
Firm: Diamond Food,Inc.
Product: Diamond of California Shelled Walnuts
Type of Claim of Major Topic Area: The product makes claims that it will treat, prevent, or cure diseases such as heart disease, arthritis and cancer. These types of claims are not allowed on food products.
Action: Warning Letter
-------------------------
Firm: First Juice, Inc.
Product: Organic Fruit and Veggie Juice Beverage products
Type of Claim of Major Topic Area: The product make claims such as "plus calcium," and "50% less sugar," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm: First Juice, Inc.
Product: Purple carrot products
Type of Claim of Major Topic Area: The products make claims that the products will "reduce the risk of cancer and stroke," This claim has not been authorized by FDA for use on food products.
Action: Warning Letter
-------------------------
Firm: Want Want Foods
Product: Baby Mum-Mum Original Selected Superior Rice Rusks
Type of Claim of Major Topic Area: The product make claims such as "low in fat," and "no added fats for oils," which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.
Action: Warning Letter
-------------------------
Firm: Nature's Path Foods, Inc.
Product: Organic Flax Plus Multibran Cereal
Type of Claim of Major Topic Area: The product label includes the nutrient claim, "excellent source of Omega-3+," which has not been approved for use on food products.
Action: Untitled Letter
No comments:
Post a Comment