Inspections, Compliance, Enforcement, and Criminal Investigations
Almi Inc 10/28/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
October 28, 2009
Mr. Alexander Lev, President
5419 N. Mascher Street
Philadelphia, PA 19120-2907
Dear Mr. Lev:
During an inspection of your filled pasta and pastry manufacturing plant at 5419 N. Mascher Street, Philadelphia, PA, on March 12, 16 and 18, 2009, and an investigation of your raw material source manufacturer, (b)(4) on July 8, 2009, the Food and Drug Administration (FDA) documented serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). First, filled pasta and pastry-products, such as pierogies and blintzes, are misbranded under sections 403(w), 403(i)(2), 403(e)(2) and 403(q) of the Act [21 U.S.C. §§ 343(w), 343(i)(2), and 343(q)] and FDA's implementing regulations in Title 21, Code of Federal Regulations (CFR), Part 101. In addition, (b)(3)(A) You may find the Act and regulations through lin1es in FDA's home page at www.fda.gov.
1. Your Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products, 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 ingredients, [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)(1)(B)].
Your food labels fail to declare the following major food allergens specified by the Act:
• (b)(4): Your Pierogi with Potatoes and Home Style Dough contain (b)(4) which are components of the flour and margarine.
• (b)(4): Your Pierogi with Farmer Cheese contains (b)(4), which are components of flour and cheese.
2. Your Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough are also misbranded with 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, but the label fails to declare the common or usual name of each ingredient in the products as required by 21 CFR 101.4. For example:
• Your Pierogi with Potatoes product uses (b)(4):the onion filling but you fail to list it in your ingredient statement on your product label as required by 21 CFR 101.4(a). In addition, the label for this product fails to list the sub-ingredients in the potato flakes, flour and margarine as required by 21 CFR 101.4(b)(2).
• The label of your Home Style Dough product declares the presence of flour and margarine. The label of your Pierogi with Potatoes declares the presence of potato flakes, flour and margarine. Flour, potato flakes and margarine are multi-ingredient foods, and the sub-ingredients are not declared in accordance with 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 Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough products are further misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
• The term "BLINTZES" used in conjunction with the serving size declaration on the labeling for your Pierogi with Farmer Cheese and Pierogi with Potatoes products is inconsistent with the statement of identity for the products. In accordance with 21 CFR 101.9(b)(5)(iv), a description of the individual unit shall be used when expressing the serving size for pieces in discrete units.
• The reference amount customarily consumed (RACC), in accordance with 21 CFR 101.12 for pierogies is 140 grams (g). Based on the serving size on the product label, "5 BLINTZES (60g)," it appears that each pieorgi weighs 12g. Based on the 140g RACC, it appears that a more appropriate serving size statement would be "12 PIEROGIES (144g)". Because the appropriate RACC for this product is 140g, all of the nutrient information on your Nutrition Facts panel must be based on the number of pieces closest to the RACC.
• Your product label fails to list the amount of trans fat in accordance with 101.9(c)(2)(ii)
4. Your Pierogi with Farmer Cheese, Pierogi with Potatoes and Home Style Dough products are additionally misbranded within the meaning of section 403(e)(2) [21 U.S.C. § 343(e)(2)] in that your products' labeling does not declare the net quantity of contents in accordance with 21 CFR 101.105(j)(1).
You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
During our label review we also noted these additional observations:
• The statement of identity is provided in both English and another language on your Pierogi with Potatoes, Pierogi with Farmer Cheese and Home Style Dough products, however none of the other required information is provided in the other language in accordance with 21 CFR 101.15(c)(2).
• Regarding your use of the word, "Usually" in your serving per container declaration for your Pierogi products, the number of servings should be declared in accordance with 21
• There is no requirement to repeat the statement of identity for a food in the Nutrition Facts Panel [21 CFR 101.9(d)(12)]. Therefore, your use of the term "BLINTZES" with
the serving size declaration on the label for your Pierogi with Farmer Cheese and Pierogi with Potatoes is not required.
This letter may not list all the violations at your facility and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations, including the Good Manufacturing Practice regulations (21 CFR Part 110). You are also responsible for ensuring that all of your products are labeled in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, you may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your labels.
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.
Your response should be sent to Rhonda J. Walley, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Walley can be reached at 215-717-3079 or via e-mail: email@example.com.
Kirk D. Sooter
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, Assistant Director