| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human ServicesMay 31, 2011
WARNING LETTER
11-NWJ-19
VIA UNITED PARCEL SERVICE
Brenda Issac, CEO
Butterfly Bakery Inc.
200 Clifton Blvd
Clifton, NJ 07011
Dear Ms. Issac:
On December 08, 2010, an investigator from the New Jersey District Office of the United States Food and Drug Administration (FDA) collected samples of your No Sugar Added Blueberry Muffins (14.5 oz) product and your Sugar Free Double Chocolate Chip Muffins (14.5 oz) product. Based on our analysis of these products and review of the product labels, we have concluded that these products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and the food labeling regulations through links on FDA’s web page at www.fda.gov.
Your No Sugar Added Blueberry Muffins (14.5 oz) product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because the amount of total fat and saturated fat are greater than 20% in excess of the value declared on the label [21 CFR 101.9(g)(5)]. The product label states that one serving (1/2 muffin-51g) contains an amount of 3.5 g total fat per serving (5% daily value) and 0.5 g saturated fat per serving (3% daily value). However, FDA analysis found that the total fat in this product was 9.44g per serving, or 170% in excess of the total fat declared on your product’s label. FDA’s check analysis found that the total fat in this product was 10.5g per serving, or 200% in excess of the total fat declared on your product's label. Additionally, FDA analysis found that saturated fat was 2.3g per serving (original and check analysis), or 360% in excess of the saturated fat declared on your product's label.
Your Sugar Free Double Chocolate Chip Muffins (14.5oz) product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because the amount of total fat and saturated fat is greater than 20% in excess of the value declared on the label [21 CFR 101.9(g)(5)]. The product label states that one serving (1/2 muffin-51g) contains an amount of 3.5g total fat per serving (5% daily value) and an amount of 0.5g saturated fat per serving (3% daily value). However, FDA analysis found the total fat in this product was 9.64g per serving, or 175% in excess of the total fat declared on your product’s label. FDA’s check analysis found the total fat in this product was 9.95g per serving, or 184% in excess of the total fat declared on your product's label. Additionally, FDA analysis found the saturated fat was 2.72g per serving, or 444% in excess of the saturated fat declared on your product’s label. FDA’s check analysis found the saturated fat was 1.84g per serving, or 268% in excess of the saturated fat declared on your product's label.
Your No Sugar Added Blueberry Muffins (14.5oz) product and Sugar Free Double Chocolate Chip Muffins (14.5oz) product are misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)] in that the products fail to declare all major food allergens present in the product, in particular milk, 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 major food allergens as: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as, any food ingredient containing proteins derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient bearing or containing, a major food allergen, unless either:
(A) 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 ingredients [Section 403(w)(1)(A) of the Act; 21 U.S.C. § 343(w)(1)(A)]; or
(B) 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, except 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 appearing 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)].
Specifically, your No Sugar Added Blueberry Muffins (14.5oz) product and Sugar Free Double Chocolate Chip Muffins (14.5oz) product are labeled to contain “sodium caseinate,” but they fail to declare the presence of the major food allergen “milk” on their labels.
Your No Sugar Added Blueberry Muffins (14.5oz) product and Sugar Free Double Chocolate Chip Muffins (14.5oz) product are misbranded within the meaning of Section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] in that the serving size and nutrition information are not based on the established reference amount customarily consumed (RACC). The RACC established by regulation for muffins is 55 grams [21 CFR 101.12(b), Table 2, Coffee cakes, crumb cakes, … muffins...]. According to the information presented on the labels, each muffin weighs 102 grams (185% of the RACC). Under the current regulations, the serving size for a muffin that weighs 67% to less than 200% of the RACC is one muffin [21 CFR 101.9(b)(2)(i)(C)].
This 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 products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. Such action may include, but is not limited to, seizure or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to assure similar violations do not occur. You should include in your response documentation such as revised labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen working days, state the reason for the delay and the time frame within which any remaining violations will be completed.
Your reply should be sent to the following address: U.S. Food & Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attn: Stephanie Durso, Compliance Officer.
Sincerely,
/s/
Diana Amador-Toro
District Director, New Jersey District
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