Inspections, Compliance, Enforcement, and Criminal Investigations

Smoked Seafood, Inc. dba Little Mermaid Smokehouse 6/27/17

 

  

Black HHS-Blue FDA Logo

 

Division of Human and Animal Food Operations West 5
19701 Fairchild, Irvine CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417 

 
 

 

UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
WARNING LETTER
 
 
June 27, 2017                                                                                                           WL #515739-17                                                                                        
 
Manik Mona Saakyan, President & Co-Owner
Saak (Sam) Saakyan, Secretary & Co-Owner
Smoked Seafood, Inc. d/b/a Little Mermaid Smokehouse
7409 Bellaire Avenue
North Hollywood, CA 91605-4304 US
 
Dear Ms. and Mr. Saakyan:
 
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 7409 Bellaire Avenue, North Hollywood, California, from November 29 through December 19, 2016. During our inspection,our investigators collected labels of your products. Based on our review, we have determined that your Little Mermaid Smoke House Salmon/Kapitan, Little Mermaid Smoke House Seafood Croissant, Little Mermaid Smoke House Smoked Salmon Trout, Little Mermaid Smoke House Smoked Gorbusha, and Little Mermaid Smoke House Balik/Kapitan products (henceforth referred to as Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan, respectively) are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and the applicable food labeling regulations in Title 21, CFR, Part 101. You may find the Act and FDA regulations on the internet through links on the FDA webpage at www.fda.gov.
 
Misbranding Violations:
 
1.    Your Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan 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 “fish” by the specific species names as required by Section 403(w)(1) of the Act.
 
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines a major food allergen as 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, which certain exceptions, e.g. highly refined oils derived from a major food allergen. 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 is 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, 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 Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan products are manufactured with “fish,” a major food allergen; however, you do not properly declare the food source from which the major food allergen is derived. The food source from which the major food allergen is derived for your products means the species of fish or Crustacean shellfish.
 
Our investigator noted that your products refer to steelhead trout as gorbush, escolar as kapitan, and sturgeon as balik. However, these are not appropriate names for the respective species of fish and, therefore, your product labels do not properly declare the following major food allergens specified by the Act, in that the specific species of fish is not declared:
  • Steelhead/rainbow trout: Your Smoked Gorbusha product label declares “Gorbusha” and your Smoked Salmon Trout product label declares “Salmon Trout” which are not acceptable names for the species of fish, steelhead/rainbow trout.
  • Escolar: Your Salmon/Kapitan product label declares “Kapitan” which is not an acceptable name for the species of fish, escolar.
  • Sturgeon: Your Balik/Kapitan product label declares “Balik” which is not an acceptable name for the species of fish, sturgeon.
  • Salmon: Your Seafood Croissant and Salmon Kapitan product labels fail to declare the specific salmon species in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA); “Salmon” is not appropriately specific. 
Furthermore, we note your Seafood Croissant product contains “crab imitation” as an ingredient. This ingredient is understood to be a multicomponent ingredient which typically contains allergenic sub-ingredients, such as fish, wheat, soy, or eggs. All allergenic ingredients and sub-ingredients must be declared in accordance with FALCPA.
 
2.    Your Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan products are misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product labels fail to declare an appropriate common or usual name of the food. For example:
  • Your Salmon/Kapitan and Balik/Kapitan products are labeled with statements of identity that includes “Kapitan” which is not an appropriate common or usual name for escolar.
  • Your Balik/Kapitan product is labeled with a statement of identity that includes “Balik” which is not an appropriate common or usual name for sturgeon.
  • Your Smoked Gorbusha product is labeled with a statement of identity that includes “Gorbusha” which is not an appropriate common or usual name for steelhead/rainbow trout.
  • Your Smoked Salmon Trout product is labeled with a statement of identity that includes “Salmon Trout” which is not an appropriate common or usual name for steelhead/rainbow trout.
  • Your Little Mermaid Seafood Croissant product does not appear to bear an appropriate common or usual name for the product. In accordance with 21 CFR 101.3(b) and 21 CFR 102.5, the product name must be an appropriately descriptive term for the food. A “croissant” is commonly understood to be a buttery, flaky pastry; however, according to the ingredient statement for this product, the product is solely seafood with salt and flavor. 
FDA provides guidance on acceptable market names through The Seafood List, which provides information to assist manufacturers in properly labeling seafood and to reflect the acceptable market names of new species introduced into the U.S. marketplace.
 
An acceptable name is a name that FDA recognizes as a suitable "statement of identity" (21 CFR 101.3) in the labeling of a species. An acceptable name fairly represents the identity of the species to U.S. consumers because it is not confusingly similar to the name of another species and because it is not otherwise misleading. Acceptable names for seafood species are listed in the “Acceptable Market Name(s)” and “Common Name” columns of The Seafood List, except when The Seafood List indicates that the Common Name is prohibited by the Federal Food, Drug, and Cosmetic Act (FD&C Act) or regulation. FDA recognizes these names as suitable for the label statement of identity and ingredient list, as required under the FD&C Act.
 
3.    Your Salmon/Kapitan, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan products are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4. For example:
  • Your Salmon/Kapitan product label declares “Kapitan” as an ingredient. “Kapitan” is not a common or usual name for escolar.
  • Your Smoked Salmon Trout and Smoked Gorbusha product labels declare “Salmon Trout” and “Gorbusha” in the respective ingredient statements. These terms are not common or usual names for steelhead/rainbow trout.
  • Your Balik/Kapitan product label implies that the product contains sturgeon; however, your product label fails to declare sturgeon in the ingredient list.
  • Your Salmon/Kapitan and Seafood Croissant products declare the ingredient “salmon;” however, “salmon” by itself is not the common or usual name for a specific salmon species.
Furthermore, your Seafood Croissant product is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients, but the label fails to declare all sub-ingredients (ingredients of an ingredient in a finished product), as required by 21 CFR 101.4(b)(2). Specifically, the product label does not list the component ingredients for the “crab imitation” ingredient, which is understood to be a multicomponent ingredient.
 
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or 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 [21 CFR 101.4(b)(2)].
 
4.    Your Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that nutrition information (e.g. Nutrition Facts Label) required by 21 CFR 101.9 is not provided. No evidence has been provided to indicate that your firm or products meet any nutrition facts labeling exemption criteria set forth in 21 CFR 101.9(j).

This letter may not list all of the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and the Seafood HACCP regulation (21 CFR Part 123), Current Good Manufacturing Practice regulation (21 CFR Part 110) and Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.  
 
We also have the following comments:
  • We note that your products appear to use foreign names on the product labels. If the name of the food is intended to bring the article to the attention of a person who does not speak English, all required information must be presented in the foreign language [21 CFR 101.5(c)].
  • Your Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, and Smoked Gorbusha products declare “Natural Smoke” in the ingredient declaration while your Balik/Kapitan product declares “Natural Smoke flavor” in the ingredient declaration. If these smoke ingredients are added flavors, they should be declared in accordance with 21 CFR 101.22; however, if these ingredients describe the smoking process, then they must not be listed as ingredients in the ingredient statement.
  • Your Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan products do not provide the place of business street address on your product labels. In accordance with 21 CFR 101.5(d), the statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
  • Your Seafood Croissant and Balik/Kapitan products declare kosher salt as an ingredient with the word “KOSHER” appearing in larger font than other ingredients. The intent of this formatting is not clear. Declarations made on your label must not be misleading.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations and to prevent these violations or other similar violations from occurring again. Include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the date by which you will have completed the corrections. 
 
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 means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-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. 
 
Please send your reply:
 
CDR Matthew Walburger, Acting Director, Compliance Branch
U.S. Food and Drug Administration
Human and Animal Food West 5 Compliance Branch
19701 Fairchild
Irvine, CA 92612
 
If you have questions regarding any issue in this letter, please contact Mr. Robert McNab at (949) 608-4409 or robert.mcnab@fda.hhs.gov. Please reference CMS number 515739 in your response.
 
Sincerely,
/S/ 
Darlene Almogela, Acting Division Director
Office of Human and Animal Food Operations
Division West 5
U.S. Food & Drug Administration
 
 
cc:      
David M. Mazzera, PhD, Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence


 

Page Last Updated: 10/23/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English