Caught for not labeling Food--FDA June 2011

Your labeling violations include:

1. Your Diet to Go Tuna Meltover and New Century Foods Wahoo Burger products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products, as required by section 403(w)(1) of the Act [21 U.S.C. § 343(w)(1)].

Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as “major food allergens.” A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:

1. The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredient [section 403(w)(1)(A) of the Act, [21 U.S.C. § 343(w)(1)(A)], or
2. The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “wheat”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].

Your food labels fail to declare the following major food allergens specified by the Act:

• Diet to Go Tuna Meltover: Your product contains the allergens, fish, milk, wheat and soy; however you fail to declare them on the product label.
• New Century Foods Wahoo Fish Burger: Your product declares “fish” in the “Contains” statement; however it fails to declare the species of fish, i.e., wahoo and pollock, on its label as specified in the Act. Additionally, your product declares that it contains cod powder. If the ingredient contains cod protein, it must also be listed in the “Contains” statement.

2. Your Diet to Go Tuna Meltover and New Century Foods Wahoo Fish Burger are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that your products fail to bear a nutrition facts panel on the product label as required by 21 CFR 101.9. Your website advertises these products as being part of your “low fat” diet food plan. These products are required to bear a nutrition facts panel because the product labeling bears a nutrient content claim. A nutrient content is a claim that characterizes the level of a nutrient (i.e., fat) which is of the type required to be in the labeling of the food.

Additionally, the nutritional information listed on your website for your Tuna Meltover and Wahoo Fish Burger products is not declared in accordance with 21 CFR 101.9. For example:

• The calories from fat are not declared as required by 21 CFR 101.9(c)(1)(ii).
• The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).

• The Vitamins and Minerals are not declared as required by 21 CFR 101.9(c)(8)(iii).
• The sugar content is not declared as required by 21 CFR 101.9(c)(6)(ii).
• The % Daily Values for all of the required nutrients are not declared.
• The units for the declared fat, saturated fat, cholesterol, sodium, carbohydrate, dietary fiber and protein content are not declared.

In addition to meeting the requirements of 21 CFR 101.9, your products must also meet the requirements set forth in 21 CFR 105.66 because they are represented for special dietary use in reducing body weight. Your firm’s products are represented as being useful in reducing or maintaining body weight because the menu and nutrition information on your website present the foods as part of meal plans such as “Low-Fat Traditional 1200 Calorie” and “Low-Fat Traditional 1600 Calorie.”

3. Your Diet to Go Tuna Meltover and New Century Foods Wahoo Fish Burger products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

4. Your Diet to Go Tuna Meltover and New Century Foods Wahoo Fish Burger products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.105. Your Diet to Go Tuna Meltover fails to declare a net weight and your New Century Foods Wahoo Fish Burger fails to declare the net weight in terms of pounds and ounces as required by 21 CFR 101.105(b)(2).

5. Your Diet to Go Tuna Meltover product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more