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WARNING LETTER

Elmec Industries, Inc. Aug 31, 2015

Elmec Industries, Inc. - 08/31/2015


Recipient:
Elmec Industries, Inc.


United States

Issuing Office:
San Juan District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
San Juan District
Compliance Branch
466 Fernández Juncos
San Juan, Puerto Rico 00901
 
Telephone: (787) 729-8500
FAX: (787) 729-8765

 

WARNING LETTER
CMS Case No. 461345
 
August 31, 2015
 
15-SJN-WL-04
 
UPS Next Day Delivery Service
 
 
Mr. Andrés Llama
Owner
Elmec Industries, Inc. (FEI: 2618913)
229 Avenue González Clemente
Mayaguez, Puerto Rico 00680
 
Dear Mr. Llama:
 
An inspection of your food manufacturing facility located at 229 José González Clemente Avenue, Comercio Street, Mayaguez, Puerto Rico, was conducted on March 2, 4, 9 and 12, 2015, by an Investigator of the United States Food and Drug Administration (FDA). The inspection found that your “Cedó Pudin” and “Cedó Lite Baked Caramel Custard,” products are not labeled in accordance with FDA’s food labeling regulations, Title 21 Code of Federal Regulations Part 101 [21 CFR Part 101]. These violations cause your products to be misbranded in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You can find the Act and the CFR through links on FDA’s home page at http://www.fda.gov
 
The labeling violations are as follows:
 
1.    Your “Cedó Pudin” product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare all major food allergens present in the products, as required by section 403(w)(1) of the Act. 
 
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 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. “Whey (Milk))”, 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 “Cedó Pudin” 3oz and 20oz labels fail to declare wheat and soy as major food allergens.
 
2.    Your “Cedó Lite Baked Caramel Custard” product continues to be misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the label bears the nutrient content claim “lite,” but the product does not meet the requirements to bear the claim. 
 
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 regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
 
Specifically, your “Cedó Lite Baked Caramel Custard” product bears on its label the nutrient content claim “Lite,” however, the product does not meet the requirements to bear such a claim under 21 CFR 101.56(b).  As required under 21 CFR 101.56(b)(2), a food that derives less than 50% of its calories from fat may use the nutrient content claim “lite” if the number of calories in the food is reduced by at least one-third per reference amount customarily consumed (RACC)  compared to an appropriate reference food or its fat content is reduced by 50% or more per RACC compared to the reference food that it resembles or for which it substitutes. Both conditions are not required. 
 
Additionally, the claim must bear the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.56(b)(3). The label of your “Cedó Lite Baked Caramel Custard” product does not declare the identity of the reference food, and the percent (or fraction) that the calories and fat were reduced are not declared as required under 21 CFR 101.56(b)(3)(i). In addition, quantitative information comparing the level of calories and fat content with that of the reference food is not declared as required under of 21 CFR 101.56(b)(3)(ii). Therefore, the “lite” claim on the label of this product does not meet the requirements of 21 CFR 101.56(b).
 
3.    Your “Cedó Pudin” (3oz and 20oz) and “Cedó Lite Baked Caramel Custard” 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, but the labels fail to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. For example:
  • Your “Cedó Pudin” (20oz) label does not declare “Maltodextrin”, “evaporated milk” or “Potassium Sorbate” that is declared on your “Cedo Pudin” (3oz) label. Evaporated milk is not one of the ingredients listed in 21 CFR 101.4(b)(4) under the class name “milk.” The sub-ingredients for the multi-component ingredients, e.g., bread and margarine are not listed. The declaration of the flavor on your “Cedó Pudin” (20oz) label is simply declared as vanilla rather than imitation vanilla. In addition, “Sorbistat” is a trade name and ingredients should be declared by common or usual name, not a trade name.
  • The label for the Cedó Lite Baked Caramel Custard” lists “artificial sweetener.” “Artificial sweetener” is not the common or usual name of an ingredient. The term “benzoate” is not a common or usual name for an ingredient.
According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or “sub-ingredients”) may be met by either (i) parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or (ii) by listing the component ingredients without listing the multi-component 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.  
 
4.    Your “Cedó Pudin” and “Cedó Lite Baked Caramel Custard” are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Specifically, the nutrition label information does not meet the format requirements in 21 CFR 101.9(c) and (d).
 
5.    Your products “Cedó Pudin” (3oz and 20oz) and “Cedó Lite Baked Caramel Custard” products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the ingredient statement for your products declares the presence of potassium sorbate and sodium benzoate, but fails to provide a separate description of the function of these ingredient as required by 21 CFR 101.22(j).
 
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies in your products or their labeling. You are reminded that it is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these and similar violations. Failure to promptly correct the violation may result in regulatory action without further notice, including seizure and/or injunction.
 
We also offer the following comment:
  • Your “Cedó Lite Baked Caramel Custard” product bears the nutrient content claim “Lo Cal.” “Low calorie” is defined in 21 CFR 101.60(b)(2). Under 21 CFR 101.60(b)(2), a “low calorie” nutrient content claim may be used on the label of a food that has a RACC greater than 30 grams or greater than two tablespoons and that does not provide more than 40 calories per RACC.  Although we were not provided with enough information to determine the caloric content of a ½ cup (which is the RACC) of “Cedó Lite Baked Caramel Custard,” we question whether the claim “Lo Cal” on the product label meets the requirements of 21 CFR 101.60(b)(2).  This product declares 140 calories per 3 ounce serving.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within 15 working days from receipt of this letter. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
Your reply should be directed to Ms. Maridalia Torres, District Director, Food and Drug Administration, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223.  If you have any questions regarding this letter, please contact Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or marilyn.santiago@fda.hhs.gov
 
Sincerely,
/S/
Maridalia Torres
District Director
San Juan District