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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Middle East Bakery, Inc. 08-Jan-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

New England District

One Montvale Avenue

Stoneham, Massachusetts 02180

TEL 781-596-7700

FAX 781-596-7896

January 8, 2002

WARNING LETTER

NWE-10-02W

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. John Boghos

President

Middle East Bakery, Inc.

1111 Riverside Drive

Methuen, MA 01844

Dear Mr. Boghos:

The Food & Drug Administration (FDA) has reviewed your label for Joseph? s Middle

East 100% Stone Ground Whole Wheat Bread, which was collected by FDA

Investigator Christopher M. Elliott on June 29, 2001. Our review reveals that this label

causes the above product to be in violation of section 403 of the Federal Food, Drug,

and Cosmetic Act (the Act), and Title 21, Code of federal Regulations (21 CFR), Part

101 - Food Labeling as follows:

The product is misbranded within the meaning of Section 403 (a)(l) of the Act in that its actual iron content is significantly less than the amount declared on the nutrition labeling. FDA? s analysis of your product concluded it contained an actual iron content of 7.2% (percent daily value per serving) as compared to the 10% stated on the nutrition labeling.

The product is also misbranded within the meaning of Section 403(r)(l)(A) of

the Act in that the label bears the nutrient claim "No Fat Added", which has

not been authorized by FDA at this time.

In addition, the following labeling deficiency was also noted upon reviewing the

product?s nutrition information label:

An asterisk as required under 21 CFR 101.9(d)(9) does not precede the Percent Daily Values footnote.

The above violations concern certain new and current labeling requirements and are not meant to be an all-inclusive list of deficiencies. Labeling violations such as these may

cause the product to be adulterated or misbranded within the meaning of the Act and,

as such, subject to legal action without further notice, such as seizure and/or injunction.

It is your responsibility to assure that a of your products are labeled in compliance with

all applicable regulations enforced by FDA. Information regarding the food labeling

regulations may be obtained through the Internet at http://www.fda.gov.

You should notify this office in writing within fifteen (15) working days of receipt of this

letter of the specific steps you have taken to correct the note d violations along with a

copy of the revised label. If corrective action cannot b e complete d within 15 working

days, state the reason for the delay a n d the time period within which the corrections will

be completed.

Your reply should be directed to James A. DiNovo, Compliance Officer, U.S. Food &

Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, MA 02180. If you

have any questions concerning th e violations noted, please contact Mr. DiNovo by

calling 787-596-7720.

Sincerely,

Gail T. Costello, Director

England District