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U.S. Department of Health and Human Services

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Enforcement Actions

Stew Leonard's Holdings LLC 10/28/09

   

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

Public Health Service
Food and Drug Administration
 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

 

WARNING LETTER
NWE-06-10W


October 28, 2009

VIA FEDERAL EXPRESS

Stew Leonard Jr.
Stew Leonard's Holdings, LLC
100 Westport Avenue
Norwalk, Connecticut 06851-3915

Dear Mr. Leonard:

On February 24, 2009, the Food and Drug Administration (FDA) collected a sample of your Stew Leonard's Oriental Mix, manufacturer code 0493, to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's food labeling requirements (21 CFR Part 101-Food Labeling). On July 2 and 13, 2009, FDA collected additional evidence from your firm. You can find the Act and the food labeling regulations through links on FDA's web page at www.fda.gov.

FDA analyzed the sample of your Stew Leonard's Oriental Mix to determine whether the Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states that one serving (1 oz) of this product contains 1 gram of saturated fat. However, the analysis performed by FDA on the sample that it collected found 1.68 grams of saturated fat per serving (original analysis) and 1.57 grams of saturated fat per serving (check analysis). Therefore, your product is misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading because the amount of saturated fat present is more than the amount declared [see CFR 101.9(g)(5)].

The letter is not intended to be an all-inclusive review of your firm's products and their labeling. It is your responsibility to ensure that all your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violation. Failure to promptly correct this violation may result in regulatory action without further notice. For instance, we may take further action to seize your product and/or enjoin your firm from operating.

As some general information, in compliance with the allergen labeling requirements under section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)], if a label declares the word "Contains," the word "Contains" must be followed by the name of the food source from which the major food allergen is derived. In the case of a tree nut, "the name of the food source from which the major food allergen is derived" means the name of the specific type of nut (e.g., almonds, cashews, walnuts, etc.). For additional information about food allergen labeling,please see:
http://www.fda.gov/Food/GuidanceComplianceRegulatorvlnformation/
GuidanceDocuments/FoodLabelingNutrition/ucm059116.htm.

Furthermore, we note that your Stew Leonard's Oriental Mix fails to meet the nutrition facts requirements in 21 CFR 101.9 because the serving size declaration ("Serving Size: 1 oz (30g)") is not expressed in common household measure [see 21 CFR 101.9(b)(5)]. In addition, we note that the combined declared amounts of dietary fiber (1g) and sugars (13g) is 14 grams, which is greater than the declared amount of 12 grams of total carbohydrate.

Finally, the net quantity of contents statement on this product ("Net Wt. 16 oz. (454g)") does not meet the requirement in 21 CFR 101.105(j) because the label fails to declare both ounces and pounds, i.e., "Net Wt. 16 oz (1 lb) (454g)."

You should notify this office in writing, within 15 working days of receipt of this letter, of any corrective actions, including an explanation of each step being taken to prevent the recurrence of similar conditions. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within 15 working days, state when the corrections will be completed and the reason for your delay.

Please send your reply to Maren C. Forsyth, Compliance Officer, Food and Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions please contact Ms. Forsyth at 781-596-7769.

Sincerely,
/s/

John Marzilli

District Director
New England District


(b) (4)