| Public Health Service Food and Drug Administration |
San Juan District |
Department of Health and Human Services
September 8, 2011
WARNING LETTER
11-SJN-WL-14
VIA OVERNIGHT MAIL
Return Receipt Requested
Mr. Andrés A. Barbeito Vidaillet
President and Owner
Postres de Aquí, Inc.
P. O. Box 194867
San Juan, Puerto Rico 00919 – 4867
Dear Mr. Barbeito:
The United States Food and Drug Administration (FDA) conducted an inspection of your food product manufacturing facility located at Calle B M-1066-07-04 Barrio Palmas, Cataño, Puerto Rico 00962 on March 9 – 10 and April 4 – 5, 2011. During the inspection, samples and copies of your labeling were collected. Our review of your labeling revealed that your firm’s products are not labeled in accordance with Title 21 CFR Part 101, Food Labeling regulation, (21 CFR Part 101). These violations cause your Avena Sin Azúcar Anadida (Oatmeal without sugar added) and Muffin de Guineo (Banana Muffin) products to be adulterated within the meaning of section 402 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342], and your Muffin de Guineo (Banana Muffin), Flan de Vainilla (Vanilla Custard), Flan de Coco (Coconut Custard), Tres Leches (Three Milks), and Avena Sin Azúcar Anadida (Oatmeal without sugar added) products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
Your significant violations are as follows:
Adulterated Products
- Your Avena Sin Azúcar Anadida (Oatmeal without sugar added) product is adulterated within the meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains a food additive, aspartame, which is unsafe within the meaning of section 409(a)(2) of the Act [21 U.S.C. § 348(a)(2)].
Under section 409(a)(2), a food additive is deemed unsafe unless it is used in conformity with a food additive regulation prescribing the conditions under which such additive may be safely used. Specifically, 21 CFR 172.804(d)(2) states that a condition of the safe use for the food additive aspartame is that aspartame containing product labels must bear the statement “PHENYLKETONURICS: CONTAINS PHENYLALANINE.” Your Avena Sin Azúcar Anadida (Oatmeal without sugar added) contains the additive aspartame as a sweetening agent or flavor enhancer; however, your label fails to bear the statement “PHENYLKETONURICS: CONTAINS PHENYLALANINE” on either the principal display panel or information panel.
- Your Muffin de Guineo (Banana Muffin) 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 U.S.C. § 379e(a)].
Under section 721(a), a color additive is deemed unsafe unless it is used in conformity with the color additive’s listing regulation. Specifically, 21 CFR 74.705(d)(2), 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. Your Muffin de Guineo (Banana Muffin) is manufactured with (b)(4), which contains FD&C Yellow No. 5; however, the label for your Muffin de Guineo (Banana Muffin) product fails to declare the presence of FD&C Yellow No. 5 in the ingredient statement.
Misbranded Products
- Your Muffin de Guineo (Banana Muffin) 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 artificial coloring but fails to bear labeling stating that fact.
In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added must declare the coloring in the statement of ingredients. Your Muffin de Guineo (Banana Muffin) is manufactured with (b)(4), an ingredient containing FD&C Yellow No. 5; however, the product fails to declare this artificial coloring on the finished product label.
- Your products, listed below, are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products bear or contain a chemical preservative but fail to bear labeling declaring its presence.
In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative has been added must bear a declaration of both the common or usual name of the ingredient and a separate description of its function, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.” Specifically:
- The ingredient statements for your Flan de Vainilla (Vanilla Custard), Flan de Coco (Coconut Custard), and Avena Sin Azúcar Anadida (Oatmeal without sugar added) products declare the presence of sodium benzoate and potassium sorbate, but fail to provide a separate description of the function of the ingredient as required;
- The ingredient statement for your Tres Leches (Three Milks) product declares the presence of potassium sorbate, but fails to provide a separate description of the function of the ingredient as required;
- The ingredient statement for your Muffin de Guineo (Banana Muffin) product declares the presence of a chemical preservative by listing its function (“Preservative”), but fails to include the common or usual name of this ingredient.
- Your Muffin de Guineo (Banana Muffin) product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that its labeling is false and misleading because you fail to identify on this product’s labeling that the characterizing flavor is provided by an artificial flavor. Specifically, your product is made with (b)(4) which contains an “artificial flavor.”
The manufacturer of the Banana Icing Fruit has identified the name of this food with the characterizing flavor designation “artificially flavored.” Because the name of your product is “Banana Muffin,” banana is considered the characterizing flavor of the product, and this flavor must be declared in accordance with 21 CFR 101.22(i). For example, if the food contains any artificial flavor that simulates, resembles, or reinforces the characterizing flavor, the name of the food must be accompanied by the common or usual name of the characterizing flavor, and the name of the characterizing flavor must be accompanied by the word(s) “artificial” or “artificially flavored” (e.g., “artificially flavored banana”) (21 CFR 101.22(i)(2)).
- Your Tres Leches (Three Milks) and Muffin de Guineo (Banana Muffin) products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels for these products fail to declare the known major food allergens, soy, wheat, and milk, as specified by 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)].
Specifically, your Tres Leches (Three Milks) product formulation reveals that (b)(4) and Filling are used in the manufacturing process, which contains soy protein concentrate and soy lecithin as sub-ingredients; however, your finished product label fails to declare the presence of the major food allergen, soy. In addition, your Muffin de Guineo (Banana Muffin) product formulation reveals that Enriched Flour and (b)(4) ingredients are used in the manufacturing process which contain wheat and milk, respectively; however, your finished product label fails to declare the presence of the major food allergens, wheat and milk.
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
- Your Avena Sin Azúcar Anadida (Oatmeal without sugar added) product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the label bears the claim “Sin Azucar Anadida” (without sugar added) on the principal display panel, but fails to comply with the requirements for the use of the term.
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a FDA regulation authorizing the use of such a claim. Specifically, your label bears the nutrient content claim “Sin Azucar Añadida” (without sugar added). However, because this product does not meet the definition of a “low calorie” or “calorie reduced” food, it must include a disclaimer statement that the food is not “low calorie” or “calorie reduced” and a statement that directs the consumers’ attention to the nutrition panel for further information on sugar and calorie content, as required in 21 CFR 101.60(c)(2)(v). Your Avena Sin Azúcar Anadida product does not bear the disclaimer or direct the consumer’s attention to the nutrition panel.
- Your Muffin de Guineo (Banana Muffin) and Tres Leches (Three Milks) 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 they fail to bear a label that lists the common or usual name of each ingredient. Specifically, your Muffin de Guineo (Banana Muffin) and Tres Leches (Three Milks) products contain “enriched flour,” which is a multi-component standardized food; however, the labels of these products fail to include the ingredients that comprise “enriched flour.” In addition, your Muffin de Guineo (Banana Muffin) is manufactured with (b)(4), which are, multi-component foods; however, the label of this product fails to declare the ingredients that comprise these multi-component foods on the label.
According to 21 CFR 101.4(b)(2), 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.
7. Your Muffin de Guineo (Banana Muffin) product is further misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients, but it fails to bear a label that lists the common or usual name of each ingredient. Specifically, your Muffin de Guineo (Banana Muffin) product is manufactured with “aceite vegetal” (vegetable oil) but fails to identify the specific fat and/or oil ingredient by its common or usual name (e.g., soybean oil), as required by 21 CFR 101.4(b)(14).
8. Your products, listed below, are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because your firm is not currently exempt from the nutrition labeling requirements under section 403(q)(5)(D) of the Act [21 U.S.C. § 343(q)(5)(D)] and your products fail to bear nutrition information on the package label as specified in 21 CFR 101.9. Specifically:
- Your Flan de Vainilla (Vanilla Custard) and Flan de Coco (Coconut Custard) product labels fail to bear any nutrition labeling information in accordance with 21 CFR 101.9;
- The nutrition information for your Muffin de Guineo (Banana Muffin) fails to bear a statement of the number of grams of “Trans Fat” in accordance with 21 CFR 101.9(c)(2)(ii);
- The declaration of trans fat is not properly declared on your Tres Leches (Three Milks) product label because it is on the same line as Grasa Total (Total Fat) [21 CFR 101.9(c)(2)(ii)];
- Your Avena sin Azúcar Anadida (Oatmeal without sugar added) and Tres Leches (Three Milks) do not include a value for the declared “Serving per container” in accordance with 21 CFR 101.9(d)(3)(ii).
Section 403(q) of the Act [21 U.S.C. § 343(q)] requires that packaged foods bear nutrition labeling information unless they qualify for an exemption, including the “small business exemption” set forth in sections 403(q)(5)(D) and (E) of the Act. However, in accordance with 21 CFR 101.9(j)(1) and (18), if any nutrient content claim (e.g., 0 grams Trans Fat), health claim, or other nutrition information is provided on the label, or in labeling or advertising, the small business exemption is not applicable for a product.
9. Your Flan de Vainilla (Vanilla Custard), Flan de Coco (Coconut Custard), and Muffin de Guineo (Banana Muffin) products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the products fail to completely declare the place of business, street address, city, state and zip code as required by 21 CFR 101.5. In addition, based on your street address of M-1066-07- Res Barrio Palmas Calle B, the location of your firm is in Catano, PR and not San Juan, PR.
We acknowledge receipt of your letter dated April 15, 2011 responding to the list of inspectional observations, FDA-483 issued to you on April 5, 2011 at the conclusion of the inspection. We found that the proposed corrective actions will adequately address the deficiencies reported in the FDA-483. These measures will be verified during the next inspection of your firm. However, your response letter did not address the labeling observations discussed with you during the course of the inspection and at the conclusion of the inspection.
This letter is not meant to be an all-inclusive list of the violations at your establishment. You are reminded that it is your responsibility for ensuring that your firm operates in compliance with the Act and all applicable implementing regulations. You should take prompt action to correct these violations and to implement procedures to prevent such violations from recurring. Failure to do so may result in regulatory action without further notice. Such action includes seizure and/or injunction.
In addition we have the following comments:
- Your Muffin de Guineo (Banana Muffin) does not use the term “net weight” when stating the net quantity of contents on the principal display panel, in accordance with 21 CFR 101.105(j)(3).
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You may include in your response copies of the revised labels for the products that your firm manufactures and distributes, or other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Rafael Nevárez, Compliance Officer, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Nevárez at (787) 474-9545.
Sincerely,
/S/
Maridalia Torres
District Director
San Juan District
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