- Vita Food Products, Inc.
- Issuing Office:
- Chicago District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Chicago District|
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
February 18, 2015
VIA UPS NEXT DAY
Clifford K. Bolen
Vita Food Products, Inc.
2222 W. Lake Street
Chicago, IL 60612-2210
Dear Mr. Bolen:
Investigators from the United States Food and Drug Administration (FDA) conducted an inspection of your firm, Vita Food Products, Inc., located at 2222 West Lake Street, Chicago, IL, on June 16 through July 10, 2014. The investigators determined that your firm is a seafood processor and importer establishment. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).
We acknowledge receiving your FDA 483 response letter dated July 22, 2014. We found the response is inadequate. Your response did not include documentation or other evidence that your corrective actions have been implemented or a proposed timetable for the implementation of your corrective actions.
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 cold smoked Salmon products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
Your significant deviations are as follows:
- You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for Cold Smoked Salmon does not list the critical control points of (b)(4) to control the hazard of pathogen growth and toxin formation as a result of time and temperature abuse. Since these storage steps occur in different coolers, FDA recommends that each storage step be listed as a separate CCP with a critical limit that ensures that the product is maintained at 40°F or below with continuous ambient temperature monitoring.
Additionally, FDA considers cold smoked salmon to be “raw” and not fully cooked since the meat of the fish is not coagulated and retains the textural characteristics of raw fish flesh. Therefore, when (b)(4) solutions are used in water or ice that is used to rinse, wash, thaw, transport, or store salmon intended to be cold smoked, the treated salmon requires a potable water rinse and (b)(4) concentrations during treatment should not exceed (b)(4) mg/kg. The use of (b)(4) on cold smoked salmon outside of these prescribed uses would be considered that of an unapproved food additive.
For your reference, the food additive regulation 21 CFR 173.325 defines the safe use of ACS solutions on seafood (d)(1) [64 FR 44122], and finfish and crustaceans (d)(2) [69 FR 78303].
Please be advised of how the regulation 21 CFR 173.325 (d)(1) and (2) provides for the safe use of ASC solutions with regard to seafood:
- (d)(1) The additive is used as an antimicrobial agent in water and ice that are used to rinse, wash, thaw, transport, or store seafood in accordance with current industry standards of good manufacturing practice. The additive is produced by mixing an aqueous solution of sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5 to 2.9 and diluting this solution with water to achieve an actual use concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any seafood that is intended to be consumed raw shall be subjected to a potable water rinse prior to consumption.
- (2) The additive is used as a single application in processing facilities as an antimicrobial agent to reduce pathogenic bacteria due to cross-contamination during the harvesting, handling, heading, evisceration, butchering, storing, holding, packing, or packaging of finfish and crustaceans; or following the filleting of finfish; in accordance with current industry standards of good manufacturing practice. Applied as a dip or spray, the additive is used at levels that result in a sodium chlorite concentration of 1,200 ppm, in combination with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. Treated seafood shall be cooked prior to consumption.
FDA considers foods that have been exposed to food additives that have not been used in an approved manner potentially unsafe. Your firm’s HACCP plan should include critical control points for the soaking and rinsing of salmon exposed to a solution of acidified sodium chlorite. The critical control points should ensure that the approved chemical concentration that is applied to the fillets is not exceeded and a potable water rinse is implemented after soaking the fillets in acidified sodium chlorite as required in 21 CFR 173.325. Both steps are to be identified as critical control points to control for the hazard of chemical contamination.
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for Cold Smoked Salmon does not list critical limits at the following critical control points adequate to control pathogen growth and toxin formation.
- At the “2) (b)(4)” critical control point, your HACCP lists a critical limit of “(b)(4) for fresh fish”. FDA recommends a critical limit that ensures the ambient temperature of the cooler remains at 40°F or below.
- At the “4) (b)(4)” critical control point, your HACCP plan lists a critical limit of “(b)(4) Atlantic”. Your plan should not include internal temperatures as an alternative critical limit to smoking temperatures. Internal temperatures of product samples do not provide a safety assurance equivalent to controlling ambient temperatures.
- At the “1)- (b)(4)” critical control point, your HACCP plan lists a critical limit of “(b)(4)”. FDA recommends a critical limit that ensures the fresh fish fillets are held at temperatures of 40°F or below throughout transit. Internal temperatures alone cannot provide this assurance when fish are transported for a significant period of time (e.g., longer than 4 hours). FDA recommends establishing critical limits that assure that the fish are fully covered by cooling media such as ice OR that the temperature of the transport container or vehicle is maintained at or below 40°F. When fish are transported a short period of time, your firm may establish critical limits limiting the time of transportation to 4 hours AND that the fish internal temperatures are 40°F or below at time of receipt. You should sample a representative number of fish if you choose this alternative.
- At the “3) (b)(4)” critical control point, your HACCP plan lists a critical limit of “(b)(4)”.
o To prevent Clostridium botulinum toxin formation in the finished product, FDA recommends also including critical limits that establish the minimum and maximum values for the critical factors of the brining process. These should be determined through a scientific study. These critical factors may include: brine temperature, concentration of brine, brine to fish ratio, thickness of fish, fat content, etc.
o To control Staphylococcus aureus toxin formation during brining, FDA recommends establishing a critical limit to ensure that the ambient temperature of the cooler remains at 40°F or below. The temperature of cooler should be continuously monitored with a visual check of the recorded data and equipment at least once per day.
- You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan for Cold Smoked Salmon lists monitoring procedures at the following critical control points that are not adequate to control parasites as a food safety hazard and Clostridium botulinum toxin formation in the finished product.
- At the “3) (b)(4)” critical control point, your HACCP plan lists monitoring of salt and moisture content of finished product+ (b)(4) for every lot. Your plan should define how you will determine what units within the lot will be sampled). FDA recommends when testing for water phase salt (WPS) and (b)(4), a representative sample should be statistically based on the size of the lot or batch and selected to represent the worst case scenario of the brining process for every lot. For an example of worst case, a firm may select samples from the largest, thickest, highest fat content fish to ensure all of the fish are achieving the minimum WPS. This should be defined in the plan.
- Predetermined corrective action plans when included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). Corrective actions are required to address both the cause of the deficiency and to prevent potentially unsafe products from entering commerce. However, your corrective action plans for Cold Smoked Salmon at the following critical control points are not adequate to address potential pathogen growth, and the presence of undeclared allergens.
- At the “1) (b)(4)” critical control point your plans lists corrective actions that will not prevent the distribution of adulterated goods into commerce. FDA recommends the product be chilled and held for a safety evaluation based on an evaluation of the total time and temperature exposures during transportation in addition to contacting supplier. Testing samples of products does not provide an equivalent safety assurance for all affected product.
- At the “2) (b)(4)” critical control point your plan lists corrective actions that will not prevent the distribution of adulterated goods into commerce. FDA recommends the product be chilled and held for a safety evaluation based on the total time and temperature exposures in addition to making repairs or adjustments to the cooler.
- At the “5) (b)(4)” critical control point your plan lists corrective actions that will not correct the cause of the deviation. FDA recommends addressing either the procedures for labeling the products or the label review process, as appropriate, in addition to holding and repackaging the product.
Your Vita Sliced-Smoked Wild Nova Salmon, 3oz and Vita Classic Premium Slice Smoked Atlantic Nova Salmon, 4oz products are misbranded within the meaning of Section 403(r)(1)(B) of the Act [21 USC § 343(r)(1)(B)] because the label bears an unauthorized heath claim. The label claim states the following:
- “Supportive but not conclusive research shows that consumption EPA and DHA omega-3 fatty acids reduce the risk of coronary heart disease, lower blood pressure and help reduce arthritis inflammation.”
FDA has issued a letter of enforcement discretion for the following health claim regarding EPA and DHA omega-3 fatty acids "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food] provides [ ] gram of EPA and DHA omega-3 fatty acids." In the letter of enforcement discretion FDA stated that it intends to consider, the disqualifying level of sodium as a factor in the exercise of its enforcement discretion for the use of the omega-3 fatty acid qualified health claim. However, your salmon products in question exceed the disqualifying level of 480 mg sodium per 55 g reference amount customarily consumed. Additionally, there is no health claim authorized by regulation or the Act or a qualified health claim for which FDA is using enforcement discretion for EPA and DHA omega-3 fatty acids and blood pressure or arthritis.
Your Vita Sliced-Smoked Wild Nova Salmon, 3oz product is misbranded within the meaning of Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(l)(A)] because the labeling bears nutrient content claims, but does not meet the requirements to make the claims. Under Section 403(r)(l)(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. The Vita Sliced-Smoked Wild Nova Salmon, 3oz product bears the claim "Omega-3 excellent source" on the principal display panel of the product label. This statement is a nutrient content claim.
The term "excellent source" doesn't meet the criteria to bear this claim in accordance with 21 CFR 101.54(b). The terms "high," "rich in," or "excellent source” may be used on the label and in the labeling of foods, except meal products as defined in 101.13(1) and main dish products as defined in 101.13(m), provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.
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.
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 to the Food and Drug Administration, Attention: Mr. Nicholas F. Lyons, Compliance Director, 550 W. Jackson Blvd., Chicago Illinois 60661. Refer to the Unique Identification Number (CMS Case #436922) when replying. If you have questions about the content of this letter, please contact Mr. Lyons at 312-596-4220 or e-mail email@example.com.
Randy F. Pack
Acting District Director