|Company:||Ole' Mexican Foods, Inc.|
|Subject:||Promotional Claims False & Misleading/Misbranded|
|Issuer:||Atlanta District Office|
|Issued:||Nov. 6, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Atlanta District Office
November 6, 2007
VIA FEDERAL EXPRESS
Eduardo Moreno, President
Ole’ Mexican Foods, Inc.
6585 Crescent Drive
Norcross, GA 30071
Dear Mr. Moreno:
On May 21, 2007, an investigator of the Food and Drug Administration (FDA) collected a sample of your product La Banderita brand Soft Taco, lot number “EXP 7/14/07”, sold at [redacted] located at [redacted] . Based on FDA's analysis of this product and review of its labeling, FDA concludes that the product is misbranded under sections 403(a)(1) and 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 343(a)(1), 21 U.S.C. 343(r)(1)(A)] and Title 21 of the Code of Federal Regulations (21 CFR). You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov .
The violations are as follows:
1. Your product is misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading because the amount of total fat present in the food is over 20 percent more than the amount declared on the label [see 21 CFR 101.9(g)(5)]. Based on an FDA analysis of your product, the amount of total fat per 45 gram serving was determined to be 5.31 grams (check analysis 5.49 grams). The per serving amount of total fat present in the product is 266% (check analysis 275%) of the label declaration of 2 grams of total fat per serving.
2. Your product is also misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the label bears the nutrient content claim “low fat,” but the product does not comply with the regulation which would allow it to bear such claim [21 CFR 101.62(b)(2)]. The regulation defines “low fat” to mean that the product contains 3 grams or less of fat per reference amount customarily consumed [21 CFR 101.62(b)(2)(i)(A)]. FDA analysis revealed that your soft taco product contains 5.31 grams of fat per serving (check analysis 5.49 grams); therefore, your product does not meet the definition of “low fat.”
Your product is further misbranded under section 403(r)(1)(A) of the Act because the label bears the nutrient content claim “High Source of fiber,” but the product does not meet the definition for “low fat” and the label does not bear a disclosure statement about fat content, as required by section 403(r)(2)(A)(v) of the Act (21 U.S.C. 343(r)(2)(A)(v)). Product labels that bear nutrient content claims for fiber and do not meet the definition for “low fat” in 21 CFR 101.62(b)(2)(i)(A) must bear a disclosure statement about total fat content in immediate proximity to the fiber claim, e.g., “Contains [x amount] of total fat per serving. See nutrition information for fat content.” (See 21 CFR 101.54(d)).
A copy of the analytical worksheets has been enclosed for your information.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the laws and regulations enforced by FDA. You should take prompt action to correct the violations and prevent their future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.
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 noted violations. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within 15 working days, state the reasons for the delay and the time at which the corrections will be completed.
In addition to these violations listed above, we have the following additional comments:
1. The increments for calories, calcium and iron declared on the Nutrition Facts panel are not declared in accordance with the requirements specified in 21 CFR 101.9(c). Under this regulation, the caloric content per serving shall be expressed to the nearest 10-calorie increment above 50 calories [21 CFR 101.9(c)(1)]. The percentages of the Daily Value for vitamins and minerals shall be expressed to the nearest 2-percent increment up to the 10-percent level [21 CFR 101.9(c)(8)(iii)].
2. Your labeling is inconsistent in that the Nutrition Facts panel lists dietary fiber content per serving as 6 grams, but the claim “Dietary Fiber (4g)” appears next to the Nutrition Facts panel. Also, the Nutrition Facts panel lists Total Carb. (carbohydrates) per serving as 11 grams, but the claim “Total Carb. (9g)” also appears on the label.
Please send your reply to Karen Y. Dodson, 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 Mrs. Dodson at (404) 253-1299.
Mary H. Woleske, Director