| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Baltimore District Office|
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
MAY 18, 2015
Mr. Young H. Han, CEO
6965 Gateway Ct.
Manassas, VA 20109
Dear Mr. Han:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility Seamus LLC, located at 6965 Gateway Ct., Manassas, VA 20109, on October 29, 2014, through November 5, 2014. During the inspection, FDA found that your facility had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented unsanitary conditions and seafood HACCP deviations present in your facility at the time of the inspection.
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 342(a)(4)]. Accordingly, your frozen vacuum packaged cooked ready to eat eel kabayaki products are adulterated, in that they have been prepared, packed, or held under unsanitary conditions whereby they may have been rendered injurious to health.
Furthermore, during the inspection our investigator obtained the labels that your firm uses for three different 100% Natural Fresh Water Eel products: Fillet, Kabayaki, and Hot and Spicy. We have reviewed the labels and found them in violation of the food labeling regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101), which causes 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, FDA's regulations, seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
Seafood HACCP Violation:
1. You must conduct or have conducted a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for your frozen vacuum packaged cooked ready to eat eel kabayaki products to control the food safety hazards of pathogen growth and toxin formation, including Clostridium botulinum growth and toxin formation, and undeclared allergens.
a. With regard to pathogen growth and toxin formation, your broiled eel kabayaki and hot and spicy eel products (cooked eel in soy sauce and mirin), are ready to eat. Your firm's HACCP plan should have controls in place to assure that the fish are cooked sufficiently to result in a blog reduction of Listeria monocytogenes.
b. With regard to the hazard of Clostridium botulinum growth and toxin formation, our investigator noted during the inspection that your firm vacuum packages your finished product and places it inside a freezer for storage. Your firm's HACCP plan should ensure that each individual package of finished product is labeled with instructions to keep frozen and thaw under refrigeration immediately before use (e.g., "Important, Keep Frozen, Thaw Under Refrigeration Immediately Before Use.").
c. With regard to undeclared allergens, your firm's HACCP plan should ensure that allergens, including the market name of the fish (e.g., eel, soy, and sulfites) in the product formulation are accurately declared on your product labels. We recommend you include a critical control point in your HACCP plan to visually check the finished product packages for labels to ensure allergens are properly declared on the label.
2. Your 100% Natural Fresh Water Eel (Kabayaki and fillet) 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 product, 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:
i. 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
ii. 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. "'(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)(l)(B)].
Your food label fails to declare the following major food allergens specified by the Act:
• Wheat: Your 100% Natural Fresh Water Eel (Kabayaki and fillet) products are manufactured using (b)(4) Soy Sauce, which contains wheat.
• Fish: All three product labels fail to declare the major food allergen, eel, in the list of ingredients or in a separate "Contains" statement.
3. Your 100% Natural Fresh Water Eel (Kabayaki and fillet) 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 labeling bears a nutrient content claim, but does not meet the requirements to make 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 food, must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product 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.
For example, your label bears the claim "high in Omega 3," but doesn't meet the criteria to bear this claim in accordance with 21 CFR 101.54(b). Claims that state a product is "high" in a nutrient may be made on the label of foods provided the food contains twenty percent (20%) or more of the RDI or DRV per RACC [21 CFR 101.54(b)]. Further, the claim "high in Omega 3" is an unauthorized nutrient content claim because there are no established RDI's or DRY's for this substance. Although various nutrient content claims for ALA, DHA, and EPA Omega-3 fatty acids have been statutorily authorized through the notification procedure in section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)], the claim for omega 3 on your labels does not meet the requirements for any of these claims. Specifically, among other requirements, the claims authorized under the notification procedure must specify whether the claim is referring to ALA, DHA, or EPA omega-3 fatty acids.
Whereas there is only one nutrient content claim for high source of ALA Omega 3 fatty acids that is authorized under section 403(r)(2)(G) of the Act, the claim on your package "high in omega 3" is not consistent with the authorized claim in that it does not include the additional information on the amount of ALA in a serving and the daily value for ALA. The only claim for excellent source of ALA that will be authorized under section 403(r)(2)(G) of the Act is:
• "Excellent source of ALA.' ('High in ALA,' 'Rich in ALA') Contains __ mg of ALA per serving, which is % of the 1.6 g Daily Value for ALA."
Additionally, your 100% Natural Fresh Water Eel (Kabayaki, fillet and Hot and Spicy) product labels bear the relative claim "[C]ontains higher amounts of protein and lower levels of fat," but do not meet the criteria to bear these claims in accordance with 21 CFR 101.54(e)(1)(iii). The "higher amounts of protein" claim is an implied "more" claim [21 CFR 101.54(e)] and the "lower levels of fat" claim is a "lower in fat" claim [21 CFR 101.62(b)(4)]. A food may bear a statement that compares the level of a nutrient in the food with the level of a nutrient in a reference food, however it is difficult to assess whether "farm-raised eel" products are an appropriate reference food, as required by 21 CFR 101.130)(1). Furthermore, the label for your 100% Natural Fresh Water Eel (Kabayaki, fillet and Hot and Spicy) product does not state the percentage (or fraction) of the amount of the nutrient in the reference food by which the nutrient in the labeled food differs per labeled serving, as required by 21 CFR 101.130)(2) and 21 CFR 101.54(e)(1)(iii)(A).
4. Your 100% Natural Fresh Water Eel (Kabayaki and Hot and Spicy) product is 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 and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). Specifically, the finished product labeling for this product lists "soy sauce" as an ingredient, which, according to the label of the "soy sauce" contains the following subingredients: water, wheat, soybeans, salt, and sodium benzoate. In addition, the finished product labeling revealed that "mirin (Japanese sweet wine)" is an ingredient in the 100% Natural Fresh Water Eel, which contains the following sub-ingredients: com syrup, high fructose com syrup, water, fermented rice seasoning, vinegar, and sodium benzoate.
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 [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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.
5. Your 100% Natural Fresh Water Eel (Kabayaki, fillet and Hot and Spicy) product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts panel is lacking required information and is not in an appropriate format as defined in 21 CFR 101.9. For example, your 100% Natural Fresh Water Eel (Kabayaki, fillet and Hot and Spicy) product makes a protein claim ("[C]ontains higher amounts of protein); however, the nutrition facts panel does not declare a % DV for protein, which is required when a claim is made for protein [21 CFR 101.9(c)(7)(i)]. Similarly, your product is making a claim about fatty acids ("high in Omega 3"); therefore the nutrition information must declare the amount of polyunsaturated and monounsaturated fats [21 CFR 101.9(c)(2)(iii) and 101.9(c)(2)(iv)].
6. Your 100% Natural Fresh Water Eel (Kabayaki, fillet and Hot and Spicy) product is misbranded with the meaning of section 403(f) because your product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
7. Your 100% Natural Fresh Water Eel (Kabayaki, fillet and Hot and Spicy) product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] because the product fails to declare the zip code. The label in use at the time of the inspection lists the location of the business as Manassas, Virginia USA. The statement of the place of business shall include the ZIP code, as required by 21 CFR 101.5(d).
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulation and the Good Manufacturing Practice regulation (21 CFR 110). 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.
In addition to the above violations, we have the following comments:.
• Your 100% Natural Fresh Water Eel (Unagi Kabayaki) product declares the terms "100% Natural" and "all natural" on the front and back of the packaging, respectively. The FDA considers use of the term “natural” on a food label to be truthful and non-misleading only when nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be there [58 FR 2302, 2407, January 6, 1993; 21 CFR 101.22(a)]. We recommend that you review all of your product labels to be consistent with our policy to avoid additional misbranding of your food products
• Your 100% Natural Fresh Water Eel (fillet) product is labeled with the label designed for the Kabayaki product. Therefore, the label is false based on the statement on the principle display panel (PDP) which declares "unagi kobayaki," the vignette of the cooked, seasoned product on the PDP, the incorrect ingredient statement, and the incorrect nutrition label.
• The net quantity of contents statement does not appear to be on the bottom 30% of the principal display panel [21 CFR 101.105(f)]. Moreover, the regulations within section 21 CFR 101.105 do not provide for the use of the terms "+/- 10%."
• We encourage you to also declare the Net Weight in metric measure for your 100% Natural Fresh Water Eel (Kabayaki and fillet) product [15 U.S.C. § 1453(a)(2) (Fair Packaging and Labeling Act)].
• The word "Registeration ... " is misspelled.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response, documentation such as HACCP and verification records, revised labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Additionally, 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. Are-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 there-inspection and assessing and collecting there-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 to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice via telephone at (410) 779-5463 or email at firstname.lastname@example.org.
Baltimore District Office