Inspections, Compliance, Enforcement, and Criminal Investigations
Key Ingredient Market 6/17/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
June 17, 2013
RETURN RECEIPT REQUESTED
RETURN RECEIPT REQUESTED
Matthew A. Pivnick, President
Key Ingredient Market
7289 Park Drive
Bath, PA 18014
Key Ingredient Market
7289 Park Drive
Bath, PA 18014
Dear Mr. Pivnick:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 7289 Park Drive, Bath, PA, from January 24, 2013 through February 8, 2013. During that inspection, 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 Act [21 U.S.C. § 342(a)(4)]. Accordingly, your Key Ingredient Market brand “Crab & Artichoke Spread” is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
Further, during our inspection, we collected labels for your Key Ingredient Market brand “Crab & Artichoke Spread” product. We have determined, as described in more detail below, that this product is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Also, this product is adulterated within the meaning of section 402(c) of the Act [21U.S.C § 342(c)], in that it fails to adequately list color additives on the label.
You may find the Act, the Labeling regulations, the Acidified Foods regulations, the Seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance (the Guide) Fourth Edition – April 2011, through links in FDA's home page at www.fda.gov.
The significant violations of 21 CFR Part 123 are as follows:
1. You must conduct or have conducted for you 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 “Crab & Artichoke Spread” product to control the food safety hazards of pathogen growth and toxin formation, and allergenic substances inclusion. FDA recommends that controls be in place to assure that the presence of these ingredients, (i.e. wheat, soy, milk, crustaceans, and fish), are declared accurately on finished product labels.
Your firm’s February 25, 2013 response states that you intend to implement a finished HACCP plan by April 1st and you will send a copy to the District for review. At this time, we have not yet received your HACCP plan for your “Crab & Artichoke Spread”, and therefore your response to this violation is inadequate.
2. Your “Crab & Artichoke Spread” product is misbranded within the meaning of section 403(a)(1) of the Act, which provides that a food is misbranded if its labeling is false or misleading in any particular. Your product label includes the statement “All Natural.” However, one of the ingredients used in this product, (b)(4) imitation crabmeat, contains artificial flavors, sodium tripolyphosphate, tetrasodium pyrophosphate, and carmine. These are all synthetic substances. The use of a synthetic substance in the product renders your use of the term “natural” false and misleading. FDA considers use of the term “natural” on a food label to be truthful and non-misleading when “nothing artificial or synthetic . . . has been included in, or has been added to, a food that would not normally be expected to be in the food.” [58 FR 2302, 2407, January 6, 1993].
3. Your “Crab & Artichoke Spread” product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because this product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive’s listing regulation. As noted above, your “Crab & Artichoke Spread” product contains the color additive carmine. The listing regulation for carmine requires that the color additive be listed by its common or usual name, “carmine,” in the statement of ingredients [21 CFR 73.100(d)(2)]. However, the label for your “Crab & Artichoke Spread” product fails to declare the presence of carmine in the statement of ingredients.
4. Your “Crab & Artichoke Spread” product is misbranded within the meaning of section 403(x) of the Act [21 U.S.C. 343(x)] in that this product contains a coloring that bears or contains a food allergen (other than a major food allergen) that is not disclosed in accordance with 21 CFR 73.100(d). Specifically, your “Crab & Artichoke Spread” product contains, as an ingredient, (b)(4). The label for the (b)(4) declares “carmine” as an ingredient. Carmine is a color additive that is an allergen for a subset of the allergic population. See 74 Fed. Reg. 207-01 (Jan. 5, 2009). Under 21 CFR 73.100(d)(2), the label of food products intended for human use that contain carmine must specifically declare the presence of the color additive by listing its respective common or usual name, “carmine,” in the statement of ingredients in accordance with 21 CFR 101.4. However, the label for your “Crab & Artichoke Spread” product fails to declare the presence of carmine.
5. Your “Crab & Artichoke Spread” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the product bears or contains an artificial flavoring. In accordance with 21 CFR 101.22(h), the label of a food to which any flavor has been added shall declare the flavoring in the statement of ingredients. Specifically, your “Crab & Artichoke Spread” product contains, as an ingredient, (b)(4). The label for the (b)(4) declares “artificial flavors” as an ingredient. However, the label for your “Crab & Artichoke Spread” product fails to declare the presence of artificial flavors, as required by section 403(k) of the Act.
6. Your “Crab & Artichoke Spread” 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 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.
Specifically, your “Crab & Artichoke Spread” product is made using the ingredient, “(b)(4)”, which is a multi-ingredient food; however, the label for your “Crab & Artichoke Spread” does not declare the presence of many of the sub-ingredients in this multi-component food in accordance with 21 CFR 101.4(b)(2). For example, cod, wheat starch, egg whites, sorbitol, modified food starch, natural and artificial flavors, sodium tripolyphosphate, tetrasodium pyrophosphate, yeast extract, and carmine are not declared on your finished product label.
- We also point out that it appears that the “Crab and Artichoke Spread” ingredient label declares “stabilizers” as a sub-ingredient of the cream cheese ingredient and them includes a parenthetical “and/or” listing of stabilizer ingredients. Use of the term “stabilizers” and a collective “and/or” parenthetical listing of stabilizers is not provided for in 21 CFR 101.4(b). The actual stabilizer ingredients used must be declared in descending order of predominance without the term “stabilizers” in accordance with 21 CR 101.4(b)(2) and 133.133.
- In addition, the ingredient list appears to include an ingredient “Koji” which is an appropriate common or usual name.
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.
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/umc2006828.htm.
7. Your “Crab & Artichoke Spread” product is misbranded within the meaning of section 403(c) of the Act [21 U.S.C. § 343(c)] in that it is an imitation of another food and its label fails to bear, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated, as required by 21 CFR 101.3(e). Specifically, your “Crab & Artichoke Spread” product contains the ingredient “(b)(4) Imitation Crabmeat”, which is an “imitation” blend of crabmeat. However, your label fails to declare that the crab is an imitation product and must be labeled as such.
This letter may not list all the violations in your product labeling or at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, further guidance and information on food allergens can be accessed on FDA’s website at:
http://www.fda.gov/Food /GuidanceComplianceRegulatoryInformation/Guidance Documents/ Food LabelingNutrition/FoodLabelingGuide/default.htm and http://www.fda.gov/ Food/FoodSafety/FoodAllergens/default.htm.
You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
In addition, we reviewed your firm’s brochure and offer the following comments:
- You state that your product contains “No Food Coloring”; however, the imitation crab meat ingredient used in your product contains added color.
- You state that your product contains “No Additives”; however, the imitation crab meat an ingredient in your product contains additives such as natural and artificial flavors, sodium tripolyphosphate, and tetrasodium pyrophosphate.
- You state that your product contains “No sugar”; however, the imitation crab meat ingredient used in your product contains sugar.
- We also note that while you declare the specific species of fish and shellfish in your ingredients statement, you are required to declare those specific species in your “contains statement” as well.
Furthermore, our inspection determined that your facility has manufactured and distributed an acidified food, Uncle Dude’s Ridiculous brand “Marinara sauce” product, since April 22, 2011 without a registration or scheduled process on file with FDA. We acknowledge that your firm registered as an acidified foods manufacturer and filed a scheduled process for your “Marinara sauce” on March 28, 2013. Your February 25, 2013 response indicates that you will not be producing this acidified food until such time you have successfully completed a Better Process Control School. You also state that you have revised your processing records to verify adherence to the critical factors identified in your scheduled process if your firm decides to manufacture this product in the future. We will verify your corrective actions and determine your compliance with the Acidified Foods Current Good Manufacturing Practice regulations, Title 21, Code of Federal Regulations, Parts 114, (21 CFR Part 114) and Part 108, Emergency Permit Control (21 CFR Part 108) during our next inspection if this product or any other additional acidified foods are being processed at your facility at that time.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
In addition, 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.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
Anne E. Johnson
Acting District Director
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director