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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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New Century Foods Corp.

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
Fax: (410) 779-5703 

 

                                                                                                                                                                               
FEI: 3004640323
WARNING LETTER
CMS # 171212
 
June 15, 2011
 
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
 
Mr. Hilton L. Davis, President/Owner
New Century Foods Corporation t/a Diet To Go
8533- F Terminal Road
Lorton, VA 22079  
 
Dear Mr. Davis:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 8533- F Terminal Road, Lorton, VA, from January 20-21 and February 2 and 4, 2011, and determined that your firm is a manufacturer, labeler and distributor of ready-to-eat (RTE) diet meal food products and distributes these RTE products via mail order and through local distribution. During the inspection, our investigators collected samples of a number of products bearing the “Diet to Go” name and the “NCF” (New Century Foods) name. FDA also reviewed your website at www.diettogo.com in May 2011. Based on our review of your product labels and website, we have determined that your Diet to Go Tuna Meltovers and New Century Foods Wahoo Fish Burger RTE products are in violation of the Federal Food, Drug and Cosmetic Act (the Act) and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.
 
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 ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). Specifically, your Diet to Go Tuna Meltover fails to list any of the ingredients in your product.
 
During our label review we also noted these additional observations:
  • Your firm’s website includes several meal plan options which include nutrient content claims, such as “low fat,” “low in calories,” “low cholesterol,” “low sodium” and the implied nutrient content claim, “healthy.” As mentioned previously in the letter, you fail to declare the units for the nutrient values of your products. Once corrected, it is your responsibility to ensure that your products meet the requirements to make such nutrient content claims.   
  • Your product labels fail to declare serving size [21 CFR 101.9(b)]. The serving size must be determined based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b)]. If your products are intended for weight control and available only through your weight control program, you may determine the serving size that is consistent with the meal plan or program.   However, the products must bear a statement, “for sale only through ____ program”, e.g. Diet to Go program on the principal display panel.
  • Your product labels fail to declare the number of servings per container [21 CFR 101.9(b)(8)]; however, if your products are packaged as single serving containers as defined in 21 CFR 101.9(b)(6), the number of servings per container is not required if the information is stated in the net quantity of content declaration.
  • Your New Century Foods Wahoo Fish Burger groups the preservatives within the ingredient statement. 21 CFR 101.4 does not provide for collective labeling; therefore, each preservative ingredient must be declared by its common or usual name in descending order of predominance by weight.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products marked by your firm comply with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as copies of the new labels for the products that your firm manufactures and distributes, or other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.
 
                                                                                   
Sincerely,
/S/ 
Evelyn Bonnin
District Director
Baltimore District