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  5. Pamonharia do Aguinaldo Ltda. - 07/21/2015
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WARNING LETTER

Pamonharia do Aguinaldo Ltda.


Recipient:
Pamonharia do Aguinaldo Ltda.


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

July 21, 2015
 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Mr. Aguinaldo Alves Ribeiro, Director
Pamonharia do Aguinaldo Ltda.
Rodovia 354 K.m 9.5
Patos de Minas, Brazil
 
Dear Mr. Ribeiro:
 
Re: 471208
 
The United States Food and Drug Administration (FDA) inspected your facility, Pamonharia do Aguinaldo Ltda. located in Patos de Minas, Brazil on March 19-20, 2015. The inspection was conducted to determine your compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food you ship to the United States. Based on our review, we have concluded that your Brazilian Com Tamales (traditional salt mixture and sweet tamale mixture) products are in violation of the Act and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and these regulations through links in FDA's home page at www.fda.gov.
 
1.    Your Brazilian Com Tamales (traditional salt tamale mixture) and Brazilian Com Tamales (sweet tamale mixture) products are misbranded within the meaning of Section 403(w) of the Act, [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, milk, as required by section 403(w)(1) of the Act. Specifically, your products are manufactured using ''cheese,'' which contains ''milk;" however, you fail to list "milk'' on your finished product labels.
 
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines 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 as "major food allergens." A food is misbranded under section 403(w) of the Act 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 ''Contain s'' 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)(l)(A) of the Act [21 U.S.C. § 343(w)(l)(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., ''Whey (Milk)''), 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 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)(l)(B) of the Act [21 U.S.C. § 343(w)(l)(B)].
 
2.    Your Brazilian Com Tamales (traditional salt tamale mixture) and Brazilian Com Tamales (sweet tamale mixture) products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format. For example:
 
•    The product labels fail to declare a serving size in a common household measure as required by 21 CFR 101.9(b)(5).
•    The product labels fail to declare the "Servings Per Container" as required by 21 CFR 101.9(d)(3).
•    The statement of calories on the product labels are expressed in terms of kcal, which is not in accordance with 21 CFR 101.9(c)(l).
•    The product labels fail to declare percent daily values for saturated fat and cholesterol as required by 21 CFR 101.9(d)(7)(ii).
•    The product labels fail to declare sugars as required by 21 CFR 101.9(c)(6)(ii).
•    The product labels fail to declare sodium in terms of milligrams in accordance with 21 CFR 101.9(c)(4).
•    The product labels fail to declare cholesterol in terms of milligrams in accordance with 21 CFR 101.9(c)(3).
•    The product labels fail to declare calories from fat as required by 21 CFR 101.9(c)(l)(ii).
•    The amounts declared for saturated fat and trans fat are not permitted by 21 CFR 101.9(c)(2). If the amount of saturated fat and trans fat per serving is declared and is Jess than 0.5g, it must be declared as zero. ''<1 g''="" is="" not="">
 
3.    Your Brazilian Com Tamales (traditional salt tamale mixture) and Brazilian Com Tamales (sweet tamale mixture) products are misbranded within the 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 the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 10 1.4. For example, the products are manufactured using "cheese;'' however, you fail to list the sub-ingredients on your finished product labels.
 
In accordance with 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.
 
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported cheese products under Section 80l(a) of the Act (21 U.S.C. § 38l(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the allergen labeling requirements is Import Alert #99- 22. You may view this alert at: http://www.accessdata.fda.gov/cms ialialist.html.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations.
 
We also have the following comments about your labels:
 
•    Your Brazilian Com Tamales (traditional salt tamale mixture) and Brazilian Com Tamales (sweet tamale mixture) products declare "com dough'' as an ingredient; however, we question whether "com dough'' is an appropriate common or usual name of an ingredient. During the inspection, our investigator found that the com is ground and mixed with soy oil, salt (and sugar depending on the recipe) and mixed. Based on this, it would appear that either com or ground com would be an appropriate ingredient declaration or com dough with an appropriate declaration of sub-ingredients.
 
•    The product labels fail to declare the net weight in ounces. As required by 21 CFR 101.1050)(1), on packages containing less than 4 pounds or 1 gallon and labeled in terms of weight or fluid measure, the declaration shall be expressed both in ounces, with identification by weight or by liquid measure and, if applicable (1 pound or 1 pint or more) followed in parentheses by a declaration in pounds for weight units, with any remainder in terms of ounces or common or decimal fractions of the pound (see examples set forth in paragraphs (m)(l) and (2) of  21 CFR 101.105) or in the case of liquid measure, in the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see examples in paragraphs (m)(3) and (4) of 21 CFR 101.105).
 
•    The weight in pounds should be followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)].
 
•    Decimal points should be used in place of commas on the Nutrition Facts Panel.
 
We request that you respond to this office in writing, within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, your response should state the reason for the delay and the time within which corrections will be completed.
 
You should direct your written reply to: Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions regarding this letter you may contact Ms. Young via email at dehlia.young@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition