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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mandarin Soy Sauce, Inc. 31-07-01 DETAIL

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

WARNIN G LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUEST
July 31, 2001

Michael Wu, President
Mandarin Soy Sauce, Inc.
4 Sands Station Road
Middletown, NY 10940

File No. NYK 2001-101

Dear Mr. Wu:

The U.S. Food and Drug Administration (FDA) has reviewed the labels for the Wan Ja Shari "LITE" Soy Sauce, 10 fl. oz. The labels were collected by an FDA Investigator during an inspection of your firm between August 29 and September 1, 2000.

The Lite Soy Sauce is misbranded within the meaning of section 403(r)(l)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the label bears the nutrient content claim "Lite," but the product fails to qualify for making the claim. The sodium content for the Lite Soy Sauce is reduced by 20% from the reference amount customarily consumed (RACC) when compared to the reference food. However, in order to qualify for making a "Lite" claim, the sodium content for the Lite Soy Sauce must be reduced by at least 50% from the RACC when compared to the reference food [Title 21 Code of Federal Regulations (21 CFR) 101 .56(c)(l)(i)].

The Lite Soy Sauce is misbranded within the meaning of section 403(a)(l) of the Act in that the statements "Recommended for those who should restrict their salt intake" and "Wan Ja Shari?s Lite soy sauce has approximately 30% less salt than our regular soy sauce" are misleading for a food containing 730 mg per serving. The percent difference between 730 mg and 910 mg is actually about 20%, not the declared 30% on the label. Further, we question whether the statement "Wan Ja Shari?s Lite soy sauce has approximately 30% less salt than our regular soy sauce" is a truthful statement because salt is generally composed of 39% sodium by weight.

The Lite Soy Sauce is misbranded within the meaning of section 403(r)(l)(A) of the Act in that the label bears the nutrient content claim "Less Sodium," but the product fails to qualify for making the claim. The sodium content for the Lite Soy Sauce is reduced by 20% from the RACC when compared to the reference food. However, in order to qualify for making a "Less Sodium" claim, the sodium content for the Lite Soy Sauce must be reduced by at least 25% from the RACC when compared to the reference food [21 CFR 101.61(b) (6)].

A check of supermarkets as recently as July 31,2001 indicates this product continues to be offered for sale with the objectionable label claims as described above.

The above violations concern certain new labeling requirements and are not meant to be an all-inclusive list of deficiencies concerning your labels. Other label violations can subject the food to legal action. It is your responsibility to assure that all of your products are labeled in compliance with all applicable statutes and regulations enforced by FDA.

You should take prompt measures to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.

You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations. If corrective action cannot be completed within 15 days, state the reasons for the delay and the time at which the corrections will be completed.

Your reply should be directed to Richard T. Trainor, Compliance Officer, U.S. Food and Drug Administration, 300 Hamilton Ave., White Plains, New York 10601. If you have any questions concerning the violations noted, then please contact Mr. Trainor at 914-682-6166 x 34.

Sincerely,

/s/

Edward W. Thomas

Acting District Director