Jansen's Sweet Sinsations, Inc. 10/13/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700         FAX: (513) 679-2761

October 13, 2011

Warning Letter CIN-12-207773-02

VIA UPS

Mr. Norbert H. Jansen, Owner/President
Jansen’s Sweet Sinsations, Inc.
6221 Snider Road
Mason, OH 45040

Dear Mr. Jansen:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 6221 Snider Road, Mason, OH, from June 20 through June 22, 2011. The inspection revealed that your packaged bread product does not bear a label and is therefore misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343].  Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). The inspection also revealed a significant violation of the Current Good Manufacturing Practice (CGMP) regulation for foods at 21 CFR Part 110. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders the products manufactured in your facility adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. The Act and FDA regulations can be found through links on FDA's webpage at http://www.fda.gov.

Misbranded Food
FDA’s inspection revealed that your firm sells wholesale bread product packaged in individual, clear plastic bags.  Because your packaged bread product does not bear a label containing all of the information required in 21 CFR Part 101, this product is misbranded within the meaning of section 403 of the Act. Specifically:

1. Your packaged bread product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the product fails to bear a label declaring the major food allergen, wheat, as required by section 403(w)(1).

Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines “major food allergens” as 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 adjacent to the list of ingredients (section 403(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 (e.g., “flour (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)]).

Specifically, your packaged bread product is manufactured with flour, which contains wheat.  However, your finished product fails to bear a label declaring the presence of wheat, a major food allergen.

2. Your packaged bread product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the product label fails to bear its common or usual name.  Specifically, 21 CFR 101.3 requires that the principal display panel of a food in package form bear a statement of identity, in terms of the name specified in or required by any applicable Federal law or regulation, or in the absence thereof, the common or usual name of the food, or in the absence thereof, an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food.

3. Your packaged bread 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 label fails to list the  required ingredients by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4. 

4. Your packaged bread product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product fails to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

5. Your packaged bread product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105.

Adulterated Food
Your significant CGMP violation is as follows:

Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator observed flying insects and ants in your production area.  However, during the close-out meeting, you told our investigator that you would not be taking any additional steps to control the insects living in your production area.

This letter is not intended to be an all-inclusive list of violations that may exist at your facility or with respect to your products. You are responsible for ensuring that your facility and your products are in compliance with the Act and all applicable regulations.

You should take prompt action to correct these violations and to implement procedures to prevent such violations from recurring. Failure to do so may result in regulatory action by FDA without further notice. Such action includes seizure and/or injunction.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the noted violations. 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 also include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Please send your written reply to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer, 6751 Steger Drive, Cincinnati, OH 45237-3097. If you have any questions regarding any issue in this letter, please contact Mr. Rabe at (513) 679-2700 ext. 2163 or Stephen.Rabe@fda.hhs.gov.

Sincerely,
/s/
Jane M. Kreis
Acting District Director
Cincinnati District









      

-