WARNING LETTER
National Food Industries LLC
MARCS-CMS 633740 —
August 18, 2022
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Piyush Mahesh
Recipient Title
Owner
National Food Industries LLC
Al Quoz – 1, Interchange No. 3, Road No. 8, Behind Time Squares
Centre P.O. Box 222
Dubai
United Arab Emirates
piyush@nfidubai.com
qc@nfidubai.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
August 18, 2022
RE: 633740, 634411, 638165
Dear Mr. Mahesh,
This letter is to advise you that the U.S. Food and Drug Administration (FDA) is taking steps to subject your food products to detention without physical examination (DWPE) when offered for entry into the United States. More information about DWPE is provided in this letter below. This letter describes the reason for the action and the next steps you can take.
A representative of the FDA conducted an inspection of your ready-to-eat (RTE) snack food manufacturing facility, National Food Industries LLC, located at National Industries Park, Plot No. Tpo 10422, Dubai, United Arab Emirates on March 14 to 18, 2022. 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.
During the inspection, our investigator collected three products labels of your Mr. Krisps brand RTE snack foods. Based on our inspection, we found serious violations of the FDA’s Food Labeling regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101), causing your 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 may find the Act and FDA regulations through links on FDA’s homepage at www.fda.gov.
Misbranding
Your Mr. Krisps brand Salad Chips, Pizza Flavor, and Cheez Balls products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 343].
Based on our inspectional findings, we are placing your Mr. Krisps Salad Chips and Mr. Krisps Pizza Flavor products on Import Alert #99-22, “Detention Without Physical Examination of Foods Containing Undeclared Major Food Allergens or Foods That Fail to Properly Label Major Food Allergens.” We are also placing your Mr. Krisps brand Salad Chips, Pizza Flavor, and Cheez Balls products on Import Alert #99-39, “Detention Without Physical Examination of Imported Food Products That Appear to be Misbranded.”
As a result, when your firm’s products are offered for import into the United States, FDA may take steps to refuse their admission, called Detention Without Physical Examination (DWPE). You may view Import Alert #99-22 at https://www.accessdata.fda.gov/CMS_IA/importalert_561.html and Import Alert #99-39 at https://www.accessdata.fda.gov/CMS_IA/importalert_1144.html.
FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. This procedure is generally based on past history or other information, such as an establishment inspection report, indicating that the manufacturing facility or the product may not be in compliance with FDA’s laws and regulations.
Your labeling violations related to Import Alert #99-22:
1. Your Mr. Krisps Salad Chips and Mr. Krisps Pizza Flavor 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, the Salad Chips product is manufactured using a
(b)(4)
which contains the major food allergen milk, and the Pizza Flavor product is manufactured using “
(b)(4)
” which also contains the major food allergen milk.
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 “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 ingredients, 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 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)].
We have reviewed the label proofs provided in your June 7, 2022, email to our CSO, and acknowledge you have revised the ingredient lists on both product label proofs to read “Contains Milk and Milk Products.” However, these appear to be proposed label revisions (label proofs) and are not actual labels, and no evidence was provided that the proposed revisions have been implemented. Additionally, your response did not include information on what steps your firm has taken to address the product that was already distributed without the allergen declaration.
Your labeling violations related to Import Alert #99-39:
1. Your Mr. Krisps Salad Chips and Mr. Krisps Cheez Balls 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 on the principal display panel, as required by 21 CFR 101.7.
Additionally, your Mr. Krisps Pizza Flavor product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] and section 4(a)(2) and (a)(3) of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. 1453(a)(2) and (a)(3)] because the label fails to declare the net quantity of contents in avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1).
2. Your Mr. Krisps Salad Chips and Mr. Krisps Pizza Flavor 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 each ingredient is not declared on the label, as required by 21 CFR 101.4. Specifically:
a. The ingredient “
(b)(4)
” in your Salad Chips product is not declared by its common or usual name in the ingredient statement. The label declares the ingredient as “
(b)(4)
” but “
(b)(4)
” is not an appropriate ingredient name in the U.S. Additionally, based on the “
(b)(4)
” ingredient list, this ingredient does not meet the definition of either an artificial or natural flavor, per 21 CFR 101.22(a). Therefore, it cannot be declared as a flavor.
b. The sub-ingredients in the “
(b)(4)
” in your Salad Chips product must be declared, as required by 21 CFR 101.4(b)(2). 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.
c. The ingredient “
(b)(4)
” in your Pizza Flavor product is not declared by its common or usual name in the ingredient statement, as required by 21 CFR 101.4(a)(1). The product label declares “
(b)(4)
,” which is not an appropriate ingredient name in the U.S. Additionally, based on the “
(b)(4)
” ingredient list, this ingredient does not meet the definition of an artificial or natural flavor, per 21 CFR 101.22(a). Therefore, it cannot be declared as a flavor.
d. The sub-ingredients in the “
(b)(4)
” in the Pizza Flavor product must be declared, as required by 21 CFR 101.4(b)(2). 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.
3. Your Mr. Krisps Salad Chips and Mr. Krisps Pizza Flavor products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading.
a. Your Salad Chips ingredient list includes “
(b)(4)
”; however, the “
(b)(4)
” ingredient contains “
(b)(4)
” and “
(b)(4)
,” which are artificial colors and an added preservative.
b. Your Pizza Flavor ingredient list includes “
(b)(4)
”; however, the “
(b)(4)
” ingredient contains “
(b)(4)
” and “
(b)(4)
,” which are artificial colors and an added preservative.
4. Your Mr. Krisps Salad Chips and Mr. Krisps Pizza Flavor products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the products contain artificial colorings, but the product labels fail to declare the colors. Specifically, your Salad Chips contain “
(b)(4)
,” and your Pizza Flavor product contains “
(b)(4)
.”
5. Your Mr. Krisps Pizza Flavor product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the label fails to bear the common or usual name of the food, as required by 21 CFR 101.3(b). Specifically, “
(b)(4)
” is not an appropriate common or usual name, nor does it appropriately describe a food that has potatoes as the most predominant ingredient [21 CFR 101.3(b)].
6. Your Mr. Krisps Salad Chips, Mr. Krisps Pizza Flavor, and Mr. Krisps Cheez Balls products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutritional Facts Labels) does not comply with the requirements in 21 CFR 101.9. For example:
a. Your Salad Chips, Pizza Flavor, and Cheez Balls product labels do not declare the serving size in a common household measure, as required by 21 CFR 101.9(b)(1). The term serving or serving size means an amount of food customarily consumed per eating occasion by persons 4 years of age or older which is expressed in a common household measure that is appropriate to the food.
b. Your Salad Chips, Pizza Flavor, and Cheez Balls product labels list the calories per serving incorrectly; calories must be expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increments above 50 calories, as required by 21 CFR 101.9(c)(1).
c. Your Salad Chips, Pizza Flavor, and Cheez Balls product labels fail to declare polyunsaturated fat and monounsaturated fat, as required by 21 CFR 101.9(c)(2)(iii) and (iv). The product labels bear the claims “
(b)(4)
” and “
(b)(4)
.” In accordance with 21 CFR 101.9(c)(2)(iii) and (iv), when a claim about fatty acids or cholesterol is made on the label or in labeling of a food, other than one that meets the criteria in 21 CFR 101.62(b)(1) for a claim for “fat free,” a label declaration of polyunsaturated fat and monounsaturated fat is required.
d. Your Salad Chips, Pizza Flavor, and Cheez Balls product labels do not list information on calories and servings per container in accordance with 21 CFR 101.9(d).
e. Your Pizza Flavor and Cheez Balls product labels are not in accordance with 21 CFR 101.9(b)(12)(i). Specifically, products that are packaged and sold individually and that contain at least
(b)(4)
percent and up to and including
(b)(4)
percent of the applicable reference amount must provide an additional column within the Nutrition Facts Label (NFL) that lists the quantitative amounts and percent Daily Values for the entire package, as well as a column listing the quantitative amounts and percent Daily Values for a serving that is less than the entire package (i.e., the serving size derived from the reference amount). The first column would be based on the serving size for the product and the second column would be based on the entire contents of the package. The Pizza Flavor package contains approximately
(b)(4)
% of the reference amount customarily consumed (RACC) for this product, and the Cheez Balls appear to contain between
(b)(4)
percent of the RACC for this product. However, the NFLs fail to include an additional column with nutrition information for the entire package.
f. Your Salad Chips product label lists the amount of sodium per serving incorrectly; sodium must be expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams, and to the nearest 10-milligram increment when the serving contains more than 140 milligrams, as required by 21 CFR 101.9(c)(4).
7. Your Mr. Krisps Salad Chips, Mr. Krisps Pizza Flavor, and Mr. Krisps Cheez Balls products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the labels bear nutrient content claims, but the products do not meet the requirements to bear the claim. Your Mr. Krisps Salad Chips and Mr. Krisps Cheez Balls product labels declare “
(b)(4)
” and “
(b)(4)
” and your Mr. Krisps Pizza Flavor product declares “
(b)(4)
” and “
(b)(4)
.” 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 promulgated by the Secretary (or, by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient causes the product to be misbranded under section 403(r)(1)(A) of the Act.
Specifically, the product labels fail to bear the disclosure statement required by 21 CFR 101.13(h)(1) for total fat, saturated fat, and/or sodium. If a food contains more than 13 grams of fat, 4 grams of saturated fat, 60 milligrams of cholesterol, or 480 milligrams of sodium per RACC or per labeled serving, or, for a food with a RACC of 30 grams or less or 2 tablespoons or less, per 50 grams, then that food must bear a statement disclosing that the nutrient exceeding the specified level is present in the food as follows: “See nutrition information for __ content” with the blank filled in with the identity of the nutrient exceeding the specified level (e.g., “See nutrition information for sodium content”).
a. Your Salad Chips product contains saturated fat and sodium in excess of the disclosure amount per
(b)(4)
grams, but the label fails to bear the required disclosure statement.
b. Your Pizza Flavor product contains total fat and saturated fat in excess of the disclosure amount per
(b)(4)
grams, but the label fails to bear the required disclosure statement.
c. Your Cheez Balls product contains total fat and sodium in excess of the disclosure amount per
(b)(4)
grams, but the label fails to bear the required disclosure statement.
Your June 7, 2022, email included proposed label revisions (label proofs) for your Mr. Krisps Salad Chips and Mr. Krisps Pizza Flavor products. However, these appear to be proposed revisions for the product labels and not actual product labels and are also not in compliance with the Act. For example, they do not comply with the requirements in 21 CFR 101, Food Labeling regulations. Additionally, you did not indicate whether your firm has reviewed the other product labels for compliance with food labeling regulations, as discussed with you during the inspection. Therefore, the adequacy of your firm’s response cannot be fully determined at this time as you have not provided objective evidence of corrective actions.
If you wish to request removal from Import Alerts #99-22 and #99-39, you should address the labeling violations described above. Please provide all necessary documentation to verify that violative conditions no longer exist, e.g., full, and complete copies of your revised product labels and the ingredient statements from the product ingredients. Information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, it may be sent via email to: Importalerts2@fda.hhs.gov.
Adulteration
In addition, during the inspection the FDA investigator also found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing these deviations found at your firm.
We have determined that these ready-to-eat (RTE) foods are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's website at http://www.fda.gov.
To date, we have not received a response to the inspectional observations listed on the Form FDA 483, Inspectional Observations, dated March 18, 2022.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. Your hazard analysis for RTE corn-based cheese puffs and your hazard analysis for RTE potato chips did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a). Specifically:
a. Your hazard analysis did not identify and evaluate the hazard of allergens in your ingredients to determine whether allergens are a hazard requiring a preventive control. Further, your hazard evaluation did not consider the effect of allergens in ingredients on the safety of your food, as required by 21 CFR 117.130(c)(2)(iii). Your facility manufactures and labels products which include milk-containing ingredients. Mr. Krisps Cheez Balls (corn-based cheese puffs) contain cheddar cheese, and Mr. Krisps Salad Chips and Mr. Krisps Pizza Flavor (potato chips) contain cheese powder with cheese solids and whey solids. These ingredients contain milk, a major food allergen. Therefore, the presence of allergens in your ingredients is a known or reasonably foreseeable hazard requiring a preventive control (i.e., labeling the finished foods to ensure that that the finished food is not misbranded under section 403(w) of the Act).
b. You did not appropriately evaluate contamination with environmental pathogens, such as
Salmonella
and
Listeria monocytogenes
, to determine whether it is a hazard requiring a preventive control. Your hazard analysis for RTE corn-based cheese puffs considered post-roasting microorganism contamination at the steps of
(b)(4)
. Your hazard analysis for RTE potato chips considered post-frying microorganism contamination at the steps of
(b)(4)
addition, buffer storage/inspection, metal detection, and filling/sealing. You determined in both hazard analyses that a preventive control was not necessary because the hazard was controlled by “
(b)(4)
.” However, your RTE corn-based cheese puffs and RTE potato chips are exposed to the environment at the above steps (after being cooked and until they are packaged). The RTE packaged foods do not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. A knowledgeable person manufacturing/processing food in your circumstances would identify environmental pathogens as a hazard requiring preventive controls (i.e., sanitation controls). In addition, when asked during the inspection for a copy of your “
(b)(4)
,” you were unable to provide them. Preventive controls for sanitation include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens (see 21 CFR 117.135(c)(3)).
Note that if contamination with environmental pathogens is a hazard requiring a preventive control, the controls must be verified by environmental monitoring (i.e., for an environmental pathogen or an appropriate indicator organism as required by 21 CFR 117.165(a)(3)). Your environmental monitoring tests (Aerobic Plate Count, Total Coliforms,
E. coli, Staphylococcus aureus
, and Enterobacteriaceae), while reasonable tests for general sanitation, are not appropriate as indicator microorganisms for the presence of environmental pathogens such as
Salmonella
and
Listeria monocytogenes
. In addition, your environmental sampling schedule for the year 2022 calls for the collection of
(b)(4)
on your corn production line and
(b)(4)
on your pellet (potato chip) production line, as well as
(b)(4)
, every 6 months. You should consider whether your number of sampling sites is adequate to determine whether preventive controls are effective (see 21 CFR 117.165(b)(3)(iii)) and whether your frequency for collecting and testing samples is adequate to determine whether preventive controls are effective (see 21 CFR 117.165(b)(3)(iv)).
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
2. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 117.35(c). Specifically, the following conditions were observed:
a. On March 14 and 16, 2022, more than ten flies were observed on the lid of the
(b)(4)
Blending Machine located in the blending/mixing room. The
(b)(4)
Blender is used to blend RTE ingredients such as cheese powder and seasoning, for flavoring food products.
b. On March 14 and 16, 2022, more than six flies were observed on the
(b)(4)
Blender used to blend corn curds prior to baking corn-based cheese puffs.
Failure to adequately address these serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117) may lead to regulatory action. For instance, we may take further action to refuse admission of your imported snack food products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). For your information, an example of an Import Alert that conveys information specific to foreign firms where FDA has evidence that a firm's lack of or inadequate preventive controls or inadequate CGMPs has led to adulteration of food products within the meaning of section 402(a)(4) of the Act is Import Alert #99-43. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter.
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 or have taken to correct these Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
You should direct your written reply regarding the adulteration violations to Rosemary Sexton, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-607), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Sexton via email at Rosemary.Sexton@fda.hhs.gov. Please reference #CMS 633740 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Thomas Kuntz
Acting Director
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
08/30/2022
Regulated Product(s)
Food & Beverages