Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-05062016
Timestamp: 2020-01-20 19:24:03
Document Index: 30555276

Matched Legal Cases: ['art 101', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343']

Sweet Production Inc. - 05/06/2016 | FDA
Sweet Production Inc. - 05/06/2016
Sweet Production Inc. May 06, 2016
Ms. Doreen Chin
915 Terminal Way Ste B
FEI: 3010873774
During an inspection of your firm located in San Carlos, CA on January 13 through January 27, 2016, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures muffins, cakes, and other bakery products. During this inspection, our Investigators found that the “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are not labeled in accordance with FDA’s food labeling regulations, Title 21 Code of Federal Regulations Part 101 [21 CFR 101]. These violations cause the products to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You can find the Act and its implementing regulations at www.fda.gov.
1. Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergens; milk, soy, eggs, and wheat as required by section 403(w)(1) of the Act.
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients as stated in section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
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 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) as stated in section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
Specifically, according to your recipes, your “Banana Walnut Muffin,” “Red Velvet Cake,” and “Pumpkin Cream Cheese Muffin” products are manufactured using (b)(4) which contains eggs, wheat, soy, and milk; however, you fail to declare wheat, soy, eggs, and milk on your finished product labels.
2. Your “Red Velvet Cake” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Specifically, FD&C Red No. 3 and FD&C Red No. 40 are not declared by their listed names or appropriate abbreviations as required under 21 CFR 101.22(k)(1).
3. Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the labels, as required by 21 CFR 101.4. Specifically, your product labels fail to include an ingredient statement on the packaged labels as required by 21 CFR 101.4(a). Ingredient information must be provided on the label of packaged food regardless of whether the customer requests it.
4. Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the product labels fail to include a statement of identity as required by 21 CFR 101.3.
5. Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” and “Red Velvet Cake” products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents as required by 21 CFR 101.105.
6. Your “Banana Walnut Muffin,” “Pumpkin Cream Cheese Muffin,” “Red Velvet Cake” product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) does not meet the requirements under 21 CFR 101.9. For example,
The “Red Velvet” product label fails to declare the appropriate reference amount customarily consumed (RACC) as required by 21 CFR 101.9(b)(2) and 21 CFR 101.12(b)(Table 2). Therefore, all of the nutrient values are incorrect.
The “Red Velvet” product label fails to declare a serving size in a household measure as required by 21 CFR 101.9(b)(1), (b)(5), and (b)(7).
The number of servings per container for the “Banana Walnut Muffin” and “Pumpkin Cream Cheese Muffin” are not declared in accordance with 21 CFR 101.9(b)(8)(iii). These products are not sold in single serving containers.
If any nutrient content claims are made for your products i.e. “low fat” and “sugar free,” the product labels must include nutrition labeling if they are served or sold to the consumer in the package in which they are received in accordance with 21 CFR 101.9(j)(2).
Refer to the Unique Identification Number CMS case 492716 when replying.
If you have any questions about the content of this letter please contact Ms. Lydia S. Chan, Compliance Officer at (510) 337-6776.