Inspections, Compliance, Enforcement, and Criminal Investigations
J-Tel, Inc dba Buxton Foods 6/30/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Ste 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142
June 30, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 19
J-Tel, Inc. dba Buxton Foods
415 A North 42nd Street
Grand Forks, North Dakota 58203
Dear Mr. Tellman:
An inspection of your facility located at 401 Broadway, Buxton, North Dakota, was conducted by an investigator from the Food and Drug Administration (FDA) on February 25 and 26, 2009. This inspection verified that your firm manufactures and distributes a variety of food products. At the inspection, you also provided our inspector with copies of new labels for your Red Pepper Chip Sauce that you expected to be in use on or about March 2, 2009. Our review of your product labels reveals violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's labeling regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). As a result of these violations, several of your products are misbranded within the meaning of sections 403(e), 403(i) and 403(q) of the Act [21 U.S.C. §§ 343(e), 343(i) and 343(q)]. You may find the Act and the CFR through links in FDA's home page at www.fda.gov.
1. Your products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they are fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. For example, the revised label that you provided the FDA inspector for your Red Pepper Chip Sauce label lists "Tomatoes" and "Brown Sugar" in the ingredient statement, but does not list all of the sub-ingredients for these ingredients. The label for your Grainery brand Famous Beer Cheese Soup fails to declare yellow #6 and erroneously declares red #40 under "Food Coloring."
The requirement to list these sub-ingredients may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient (21 CFR 101.4(b)(2)(i)) (e.g., "Brown Sugar (sugar, molasses)"); and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food (21 CFR 101.4(b)(2)(ii)) (e.g., listing "sugar" and "molasses" in the list of ingredients in descending order of predominance in the finished food).
2. Your Grainery brand Famous Beer Cheese Soup product is misbranded with the meaning of section 403(q)(2)(A) of the Act [21 U.S.C. § 343(q)(2)(A)] because the amount of trans fat is not declared in the Nutrition Fact Panel, as required by 21 CFR 101.9(c)(2)(ii).
3. Your Red Pepper Chip Sauce is misbranded within the meaning of section 403(e) of the Act [21 U.S.C. § 343(e)] because the product fails to completely or accurately declare the place of business, street address, city, state and zip code. The label in use at the time of the inspection and the new label list the location of the business as Grand Forks, North Dakota 58201. Your corporate office is located in Grand Forks but the firm is not listed in a current telephone directory and thus the label must include the street address, as required by 21 CFR 101.5(d).
The above violations concern certain labeling requirements and are not meant to be an all-inclusive list of deficiencies that may exist in any of your product labeling. It is your responsibility to ensure that your establishment is in compliance with all requirements of Federal regulations.
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include seizure and injunction.Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
W. Charles Becoat