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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cemac Foods Corporation 21-Dec-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4990


WARNING LETTER
08-PHI-05

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 21, 2007

Mr. Thomas May, Vice President
Trugman-Nash, Inc.
19 West 44th Street
Suite 1402
New York, NY 10036

Dear Mr. May:

Inspections of your manufacturing plant, Cemac Foods Corporation, located at 1821 E. Sedgley Avenue, Philadelphia, PA, conducted by the Food and Drug Administration (FDA) from June 21, 2007 through June 29, 2007 and from August 9, 2007 through August 14, 2007, revealed that some of your cheesecake products are misbranded within the meaning of sections 403(w)(1) [21 U.S.C. 343(w)(1)] and 403(i)(2) [21 U.S.C. 343(i)(2)] of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (CFR) Part 101. You may find the Act and the FDA regulations through links in FDA's home page at http:www.fda.gov.

The violations we noted are as follows:

1. Your Linda's Plain Cheesecake (28 oz.) and Unbelievable brand Premium Cheesecakes(64 oz.) in Plain NY Style, Strawberry Swirl, Chocolate Swirl, and Raspberry Swirl varieties are misbranded under section 403(w) [21 U.S.C. 343(w)] of the Act in that the labels fail to declare all major food allergens present in these products, as required by section 403(w)(1). Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as major food allergens 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. 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 43(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 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)].

According to the formulation information we obtained during the inspections, your Linda's Plain Cheesecake (28 oz.) and Unbelievable brand Premium Cheesecakes(64oz.) in Plain New York Style and Strawberry Swirl flavors are manufactured with [redacted] your Unbelievable brand Premium Cheesecake (64 oz.) in Raspberry Swirl and Chocolate Swirl flavors are manufactured with [redacted] and all varieties of your Unbelievable brand Premium Cheesecakes (64 oz.) referred to in this letter are manufactured with [redacted] The [redacted] brand [redacted], and [redacted] are all multi-component ingredients which contain the major allergen "wheat," which is not declared on the finished labels of these products.

We note that at the end of the inspection, Yoseph Zahal, Director of Operations, promised to put an add-on sticker with a "contains" statement on all product labels distributed to include all allergens in each of the products to temporarily address the lack of allergens identified on the existing labels.

2. Your Linda's Plain Cheesecake (28 oz.), Unbelievable brand Premium Cheesecake in Plain NY Style (28 oz.), and Unbelievable brand Premium. Cheesecake (64 oz.) in Plain New York Style, Strawberry Swirl, Chocolate Swirl, and Raspberry Swirl flavors are misbranded under section 403(i)(2) [21 U.S.C. 343(i)(2)] of the Act in that they are fabricated from two or more ingredients, but the labels, fail to bear a complete list of all of the ingredients by common or usual name of each ingredient as required by 21 CFR 101.4. Because the [redacted] and [redacted] ingredients that themselves contain two or more ingredients, each ingredient used to make the [redacted] and [redacted] must be declared on the finished product label as specified under 21 CFR 101.4(b)(2). This requirement may be met by either parenthetically listing the components after the common or usual name of each ingredient or by listing the components without listing the ingredient itself. Under the first alternative, the components must be listed in descending order of predominance in the ingredient; under the second alternative, the components must be listed in descending order of predominance in the finished food. Deviations from this requirement include:

The labels on your Linda's Plain Cheesecake (28 oz.) and Unbelievable brand Premium Cheesecake in Plain NY Style (28 oz.) fail to declare all of the components in the [redacted] ingredient, i.e., high fructose corn syrup, graham flour, salt, and the components of the enriched flour. The label on your Unbelievable brand Premium Cheesecake (64 oz.) in Plain New York Style and Strawberry Swirl varieties also fails to declare all of the components in the [redacted] ingredient, i.e., high fructose corn syrup and the components of the enriched flour. The label on your Unbelievable brand Premium Cheesecake (64 oz.) in Raspberry Swirl and Chocolate Swirl varieties fails to declare all of the components of the [redacted] ingredient, i.e., chocolate, wheat flour, and the components of the enriched flour.

Furthermore, the labels on your Linda's Plain Cheesecake (28 oz.), Unbelievable brand Premium Cheesecake in Plain NY Style (28 oz.), and Unbelievable brand Premium Cheesecakes in Plain New York Style, Strawberry Swirl, Raspberry Swirl, and Chocolate Swirl varieties (64 oz.) do not specify the common or usual names of the individual fat and/or oil ingredients in the vegetable shortening ingredient, as required by 21 CFR 101.4(b)(14).

We also note that the label for the Unbelievable brand Premium Cheesecakes (64 oz.) referred to in this letter incorrectly declares that the Strawberry Swirl variety contains "strawberries," rather than [redacted] and that the Raspberry Swirl variety contains "raspberries," rather than [redacted].

You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure or injunction.

This letter may not list all the deviations 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 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:

In addition to the above violations, we have the following comments regarding your product labeling:

  • The "Nutrition Facts" panel on your Linda's Plain Cheesecake (28 oz.) is not set off in a box as required by 21 CFR 101.9(d)(1)(i). Furthermore, the declaration of "Calories," "Total Fat," "Cholesterol," "Sodium," "Total Carbohydrates," and "Protein" and the "%DV" must be highlighted by bold or extra bold type or highlighting so that they are prominently distinguished from the other information, as required by 21 CFR 101.9(d)(1)(iv). There is currently no distinction on this label between the print type of the noted information and the indented nutrients.

  • The"Nutrition Facts" panel on your Linda's Plain Cheesecake (28 oz.) also fails to contain hairlines or bars separating the nutrients and required statements as required by 21 CFR 101.9(d)(1)(v) and 21 CFR 101.9(d)(4).

  • The "Nutrition Facts," panels on your Linda's Plain Cheesecake (28 oz.), Unbelievable brand Premium Cheesecake in Plain NY Style (28 oz.), and Unbelievable brand Premium Cheesecakes (64 oz.) referred to in this letter fail to round the percentages for vitamin A as specified by 21 CFR 101.9(c)(8)(iii). Specifically, percentages must be expressed to the nearest 2-percent increment up to and including the 10-percent level, and the nearest 5-percent increment above 10 percent and up to and including the 50-percent level.

  • The serving size information on the "Nutrition Facts" panels of your Unbelievable brand Premium Cheesecakes (64 oz.) referred to in this letter fails to indicate a description of the visual unit of measure(e.g., "Serving Size 4oz (114g/1 slice)" as, required by 21 CFR 101.9(b)(5)(iii)).

Furthermore, we note that the cheesecake products referenced in this letter are all manufactured with either the [redacted] ingredients. Both of these ingredients are manufactured with a vegetable shortening (partially hydrogenated soybean and/or cottonseed oil). With the exception of your Unbelievable brand Premium Cheesecake in Plain NY Style (28oz:), these cheesecakes' labels do not declare that the products may contain soy. Under section 201(qq) of the Act, highly refined oils are exempt from the definition of a major food allergen. If the soybean oil in the vegetable shortening is a highly refined oil, it would not be considered a major food allergen and thus would not have to be represented as required by section 403(w). However, if the soybean oil is not highly refined, it would not be exempt from the definition of a major food allergen and would have to be identified as required by section 403(w). In either case, the ingredient would have to be properly included in the ingredient list of your products:

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 these deviations. You may wish to include in your response documentation that would be useful in assisting us in evaluating your corrections, including copies of the add-on stickers with allergen information that Mr. Yoseph Zahal committed to provide during the inspection. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations. Copies of the revised labels should also be submitted.

Please send your reply to the Food and Drug Administration, Attention: Lynn S. Bonner, Compliance Officer. If you have questions regarding any issue in this letter, please contact Ms. Bonrner at 215-717-3074.

Sincerely,

/S/

Thomas D. Gardine
District Director
Philadelphia District

Isb

cc: Cemac Foods Corporation
1821 E. Sedgley Avenue
Philadelphia, PA 19124-5619
Attn: Yoseph Zahal, Director of Operations

Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Sherri Morris, Acting Chief, Food Safety Division