Inspections, Compliance, Enforcement, and Criminal Investigations
Los Genuinos, Inc. 6/2/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
- Your Los Genuinos Mantecaditos 6 oz. product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive’s listing regulation. Your Los Genuinos Mantecaditos 6 oz. product contains FD&C Yellow No. 5. The listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. However, the label for the product fails to declare the presence of FD&C Yellow No. 5 in the ingredient statement.
- Your Los Genuinos Mantecaditos 4 oz. and 6 oz. 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 the major food allergen, wheat, as required by section 403(w)(1) of the Act. Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as “major food allergens” 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. 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:
- 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
- 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., “flour (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 Los Genuinos Mantecaditos 4 oz, and 6 oz. products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient, as required by 21 CFR 101.4. Specifically:
- During the inspection, you certified that your Los Genuinos Mantecaditos 4 oz. product contains “shortening;” however the label for your product does not accurately declare shortening as an ingredient. Under 21 CFR 101.4(b)(14), each individual fat and or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g., “beef fat,” “cottonseed oil”) in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as “____ shortening” or “blend of ____ oils,” the blank to be filled in with the word “vegetable,” “animal,” “marine,” or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., “vegetable oil shortening (soybean and cottonseed oil).”
- Your Los Genuinos Mantecaditos 4 oz. and 6 oz. products, contain enriched flour, which is a standardized, multi-component ingredient; however, your finished product label fails to declare the sub-ingredients. The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
- Your Los Genuinos Mantecaditos 4 oz. and 6 oz. products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the labels for these products fail to provide nutrition information in accordance with 21 CFR 101.9. Specifically, the declaration of the number of servings per container is not in accordance with 21 CFR 101.9(b)(8). The number of servings per container must be rounded to the nearest whole number, except for the number of servings between 2 and 5, which should be rounded to the nearest 0.5 serving. However, the number of servings per container declared on the labels for your products is 5.25
- In accordance with 21 CFR 101.15(c)(2), if a food product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Because your product is distributed solely in Puerto Rico, it is acceptable for it to be labeled solely in Spanish [21 CFR 101.15(c)(1)]; however, if it contains any information in another language, such as English, all of the required label information must appear in both languages.
- We note that your Mantecaditos products are manufactured with “shortening” which contains partially hydrated soybean oil and cottonseed oils. Soy is a major food allergen and is therefore subject to the allergen source labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA). Section 201(qq)(2)(A) of the Act provides an exemption for highly refined oils; therefore, highly refined soybean oil would not be subject to the allergen source labeling requirements of Section 403(w). If the soybean oil is not highly refined, however, the product label must declare the presence of soy consistent with section 403(w) of the Act. Additional information about allergen source labeling is available on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
- Your declaration of the number of servings per container on the label for your Los Genuinos 4 oz. product is 5.25 servings. Based on the declared serving size of 2 cookies (32 grams), the servings per container should be 3.5.