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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Natural Ovens of Manitowoc Inc Respone Letter #2

September 18, 2003

 

Tyra S. Wisecup 
Compliance Officer 
212 Third Avenue South
Minneapolis, MN 55401

Via Fax (612) 334-4134
Hard copy will follow with labels

 

RE: MIN 03-15

 

Dear Ms. Wisecup:

Because our new labels will not arrive until September 29, 2003, I wanted to get you the label information before the absolute deadline. We will still send in samples of the actual printed labels as soon as they arrive.

7 Grain Herb Bread has been discontinued effective 9/27/03.

As determined earlier, the omega-3 is correctly shown on our labels per laboratory analyses forwarded to you on April 23, 2003.

The difficulty we faced was in attempting to obtain a correct analysis of the amount of fiber contained in our natural breads. We submitted samples to two different labs that came back with an amount much lower than the amount of fiber we knew were added to the whole grain breads. We doubled the added fiber and one lab reported an even lower fiber content, and the other reported the same amount as in the first samples. When questioned, both laboratories stated that they lose fiber during the process of analysis.

While attending a Food Policy Conference in Washington, DC, with speakers from the FDA, I talked with a person from the Labeling office. She said that she was aware that some of the fiber is lost during the process of analysis, and that the FDA has no legal definition of fiber. She stated that the FDA had appointed a committee to look into a more accurate method of analyzing the fiber in natural grain products. She also said that George Fahey, University of Illinois, Urbana had been appointed to head up the committee on fiber analysis.

We immediately contacted Mr. Fahey and submitted samples of our breads for fiber analysis. Copies of his lab reports are enclosed, which include the fructans and oligosaccharides fibers. Also included are copies of Critical Reviews of Dietary Fiber published in Food Science and Nutrition, 41(5):353-362 (2001).

To sum up, the nutrition information on the new labels will read –

Multi Grain Bread – Calories – 70; Total Fat – 1g; Carbohydrates – 14g; Fiber – 3g; Protein – 3g; (9+44+12=65) Deleted from label, “Antioxidants help prevent….”.

Right Wheat Bread – Calories – 70g; Total Fat – 2g; Carbohydrates – 13g; Fiber – 3g; Protein – 4g (18+40+16=74)

100% Whole Grain Bread – Calories – 70; Total Fat – 1g; Carbohydrates – 14g; Fiber – 4g; Protein – 4g; (9+40+16=65)

Sunny Millet Bread – Deleted: “Antioxidants help prevent….”

Health Max Bread – Deleted: “Antioxidants help prevent….”

All references to “high” or “rich” have been removed.

We trust we are now in full compliance with your labeling requirements. Samples of the printed labels will follow as soon as received.

 

Sincerely,

 

Paul A. Stitt, MS, Biochemistry

PS: Enclosed are copies of scientific studies performed by the FDA using our own ground flaxseed.