Inspections, Compliance, Enforcement, and Criminal Investigations
The Gourmet Padre 16-Jul-04
Department of Health and Human Services
Public Health Service
Atlanta District Office
July 16, 2004
VIA FEDERAL EXPRESS
Ralph O. Marsh, President
The Gourmet Padre
405 W. Cloverhurst Avenue
Athens, GA 30606
Dear Mr. Marsh:
As a follow-up to our inspection of your firm on January 15, 2004, the Food and Drug Administration (FDA) purchased one of your products, The Gourmet Padre's Divine Cheesecake, Raspberry. Based on our review of the label for this product (copy enclosed), we have concluded that the product is misbranded under 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. You can find the Act and regulations on our web site at www.fda.gov
Your product is misbranded within the meaning of section 403(i)(2) of the Act in that it is fabricated from two or more ingredients, but the label fails to bear the common or usual name of each ingredient as required by 21 CFR 101.4. The label of your product does not include an ingredient list.
Furthermore, your product is misbranded within the meaning of section 403(e)(1) of the Act because its label fails to specify the place of business of the manufacturer, packer or distributor as required by 21 CFR 101.5.
The above mentioned violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to assure that all of your products are in compliance with all applicable statuses enforced by FDA.
We may take further action if you do not promptly correct these violations. For instance, we may recommend that the United States bring a legal action to seize your product(s) and/or enjoin your firm from operating.
Please 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 violations described above, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
During our inspection of your facility on January 15, 2004, we also noted that your firm uses a Red Raspberry Concentrate flavoring ingredient that contains Red 40 and Blue 1 as well as natural and artificial flavors. Based on our investigator's report of the inspection, we believe you are using the Red Raspberry Concentrate in your "Divine Cheesecake, Raspberry" product. If this is the case, your product label must list the artificial flavoring in the ingredient statement (see 21 CFR 101.4(b)(2) and 101.22(h)), and the statement of identity on the product label must comply with 21 CFR 101.22(i)(2) by including the word(s) "artificial" or "artificially flavored" as part of the name of the characterizing flavor (e.g. "Divine Cheesecake, Artificially Flavored Raspberry"). Additionally, the certified color additives Red 40 and Blue 1 must be individually declared in the ingredient statement on the product label by their common or usual names, as specified in 21 CFR 101.22(k)(l).
Please send your reply to Carlos A. Bonnin, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mr. Bonnin at 404-253-1277.
Mary H. Woleske, Director
Enclosure (copy of product label)