Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Southwest Region
Kansas City District

 

11630 W 60th St
PO Box 15905
Lenexa, KS 66285-5905
Telephone: 913-752-2100

June 7, 2001
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Craig E. Sallin, Owner
Good For You America
501 Myrtle St
Syracuse, NY 13204

Ref. No. KAN2001-025

Dear Mr Sallin:

An inspection of your firm known as Food Reserves, Inc., 110 Bismark St, Concordia, MO, on March 8-19, 2001 revealed that your firm manufactures various meal replacement food products. Our review of information for the products The Original Food Tab, Survival Tabs, and Maca Mama reveals that the products are in violation of Section 402, 403 and 505 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:

Most of the above violations concern certain new labeling requirements, and are not meant to be an all-inclusive list of deficiencies on your labels. It is your responsibility to assure that all of your products are manufactured and labeled in compliance with all applicable statutes and regulations enforced by FDA.

You should know that these serious violations of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or obtaining a court injunction against further marketing of your dietary supplements.

It is necessary for you to take action on these matters now. Please let this office know in writing within fifteen (15) working days from the date you received this letter what steps you are taking to correct the problems. We also ask that you explain how you plan to prevent these violations from happening again. If you need more time, let us know why and when you expect to complete your correction.

Your reply should be sent to Clarence R. Pendleton, Compliance Officer, at the above address.

Sincerely,
/s/
Mary Woleske for
Charles W. Sedgwick
District Director

cc:
Joyce J. Axtell, Manager
Food Reserves, Inc.
110 Bismark St
Concordia, MO 64020

This page was posted on August 20, 2006.

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