| Public Health Service Food and Drug Administration |
| Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863 |
Department of Health and Human ServicesMarch 25, 2010
WARNING LETTER
CHI-05-10
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Al B. Filin, President
Today's Temptations, Inc.
1900 North Austin Avenue
Chicago, Illinois 60639
Dear Mr. Filin:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 1900 North Austin Avenue in Chicago, IL, October 14 -26, 2009 and verified that your firm manufactures and distributes bakery products. Our review of your product labels and other evidence collected during the inspection has determined that your products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Parts 101. You can find the Act and labeling regulations on FDA's website at www.fda.gov.
Your Whole Wheat bread product is misbranded within the meaning of Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product makes nutrient content claims but does not meet the requirements to make those claims. Under Section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the label or labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under Section 403(r)(1)(A) of the Act.
Your Whole Wheat bread product makes the following claims:
o Fat Free
o Hi-Fibre
o Sugar Free
o Only 2g Digestible Carbs
Under 21 CFR 101.62(b), to use the term "fat free," a food must contain less than 0.5 grams of fat per reference amount customarily consumed (RACC) and per labeled serving. It must not contain an added ingredient that is a fat or that is generally understood to contain fat unless the ingredient statement lists the ingredient followed by an asterisk that refers to a statement indicating that the amount of fat added is insignificant. And, must either be specially processed to remove fat from the food or is labeled to disclose that fat is not usually present in the food. Your Whole Wheat bread product, however, contains canola oil which is an added ingredient generally understood to contain fat. Therefore, to use the term "fat free" in association with this product, you must indicate that the amount of fat added by canola oil is insignificant by placing an appropriate statement on the product label, in accordance with 21 CFR 101.62(b)(ii).
Under 21 CFR 101.60(c)(1), to use the term "sugar free," a food must contain less than 0.5 grams of sugars per RACC and per labeled serving. It must contain no ingredient that is a sugar or that is generally understood by consumers to contain sugars unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states "add a trivial amount of sugar," "adds a negligible amount of sugar," or "adds a dietarily insignificant amount of sugar." It also must be labeled "low calorie" or "reduced calorie" or bear a relative claim of special dietary usefulness labeled in compliance with 21 CFR 101.60(b). Your product fails to meet the requirements of 21 CFR 101.60(c)(1)(iii) for the sugar free claim.
The statement "Only 2g Digestible Carbs" is an unauthorized nutrient content claim. FDA has not defined this claim for use on food products.
In addition, your Whole Wheat bread product is misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)] because the label fails to declare the presence of a major food allergen. Specifically, your product fails to declare eggs. Section 201 (qq) of the Act [21 U.S.C. § 321 (qq)] defines as "major food allergens" milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain limited exceptions. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
The word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)]; or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Your Kolaczki Cookies 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 each ingredient is not declared on the label as described in 21 CFR 101.4(b)(2). For example:
• Your Kolaczki Cookies ingredient statement lists margarine but fails to list the multi-ingredient components of margarine. The standard of identity for margarine listed in 21 CFR 166.110(d) requires that each ingredient used in margarine be declared on the label, as required in 21 CFR Part 101.
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
Your Whole Wheat bread, Almond Coffee Cake, Kolaczki Cookies, and Plain Pound Cake products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the product labels do not contain nutrition facts information in an appropriate format as defined in 21 CFR 101.9. For example:
• Kolaczki Cookies and Plain Pound Cake
o These products do not have nutrition information, and they are not exempt from the requirement to bear a Nutrition Facts panel under 21 CFR 101.9. Your firm may be eligible to file for a small business nutrition labeling exemption for products which do not provide nutrition information, nutrient information, nutrient content or health claims on the labels, labeling or advertising. In accordance with 21 CFR 101.9(j)(18), a firm may qualify for this exemption if the firm has fewer than 100 full time employees and fewer than 100,000 units of a product are being sold in the United States, provided that the product labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim. A firm is required to file an exemption notice each year with FDA unless the firm has fewer than 10 full time equivalent employees. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
• Whole Wheat bread
o The product label fails to declare the serving size in common household measures as required by 21 CFR 101.9(b)(7).
o The product label fails to declare a statement of the amount per serving of the vitamins and minerals as described as required by 21 CFR 101.9(c)(8).
o The product label fails to include a footnote that states, "Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs ... " as required by 21 CFR 101.9(d)(9).
o The product label fails to include the grams of the sugar alcohol, malitol syrup, in accordance with 21 CFR 101.9(c)(6)(iii). A statement of the number of grams of sugar alcohol per serving must be declared in the nutrient label when a claim is made in reference to sugar or sugar alcohols.
• Almond Coffee Cake
o The product label fails to declare the serving size in common household measures as required by 21 CFR 101.9(b)(7).
o The nutrients are not listed in the required order in accordance with 21 CFR 101.9(c).
o The product label fails to declare a statement of the amount per serving of the vitamins and minerals as described as required by 21 CFR 101.9(c)(8).
o The product label fails to include a footnote that states, "Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs... " as required by 21 CFR 101.9(d)(9).
The above observations are not intended to provide an all-inclusive list of the violations at your facility. lt is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm's current good manufacturing practices. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.
In addition to the deviations noted above, we have the following additional comments regarding the labeling for your products:
The fiber content of your Whole Wheat bread product, as declared on its label, meets the 20 percent of the daily reference value (DRV) for fiber based on the 50 gram RACC, which is required to make a high fiber nutrient content claim under 21 CFR 101.54(b); however, because the product does not meet the criteria per labeled serving, your high fiber claim must be followed by the criteria for the claim as required by 21 CFR 101.12(g). You must state, e.g., "high fiber, 5 grams or more per serving of bread (__ piece(s)(50 grams)." See 21 CFR 101.13(p)(1).
Your Almond Coffee Cake contains an almond filling. If the almond filling is a multi-component food, you must list all sub-ingredients in accordance with 21 CFR 101.4(b)(2)(i) or 21 CFR 101.4(b)(2)(ii). In addition, your Kolaczki Cookies list assorted fillings in the ingredient statement; each filling used to manufacture your Kolaczki Cookies must be specified and all ingredients used in those fillings must be declared in the ingredient statement.
The statement of identity for your Whole Wheat bread product does not include the word "bread" as required by 21 CFR 101.3.
The net quantities of contents on your Whole Wheat bread product, Almond Coffee Cake, Kolaczki Cookies, and the Plain Pound Cake labels are not declared in accordance with the requirements in 21 CFR 101.105(j)(1) and the examples in 101.105(m)(1).
The product labels for your Almond Coffee Cake and Whole Wheat bread product fail to include hairlines to separate the text of each Nutrient and Percent Daily Value from the Nutrient and Percent Daily Value above and below it as required by 21 CFR 101.9(d)(1)(v).
Your Whole Wheat bread product label includes the statement, "Good for diabetics." FDA has not stated that a specific food is more useful than another food in the diet of a diabetic. Prior to June 1996, there was a special dietary regulation (21 CFR 105.67) that provided for the special dietary claim "may be useful in the diet of diabetics" on food product labels. In the Federal Register (FR) of June 3,1996 (61 FR 27771), the FDA revoked 21 CFR 105.67. The FDA concluded, consistent with current dietary advice, that the provisions for diabetic labeling in 21 CFR 105.67 are outdated and misleading. The agency also stated that the health claim provisions in Section 403(r) of the Act provide an adequate regulatory framework to prevent any use of the term "diabetic" that is not scientifically valid or that is misleading. Since publication of the June 3, 1996 FR announcement, we have been discouraging the marketing of foods specifically for diabetics. Therefore, we recommend you remove the language from the label of your Whole Wheat bread product.
The FDA has also determined that your facility is subject to the registration requirement in Section 415 of the Act [21 U.S.C. § 350d] and FDA's implementing regulation at 21 CFR Part 1, Subpart H. During our inspection at your facility, you were advised of this requirement. Our records indicate that, to date, your facility has not registered with FDA. The failure to register a facility as required is a prohibited act under Section 301 (dd) of the Act [21 U.S.C. § 331(dd)]. Please register your facility immediately. Registration may be accomplished online at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, you may contact the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156 to inquiry about mail or fax registration and related forms.
On June 11, 2009, FDA issued your firm an Untitled Letter as a result of a label review for your Whole Wheat bread product. The FDA's review of the product label found that the product was misbranded within the meaning of the Act. As of March 23, 2010, the Chicago District Office has not received any written correspondence from your firm indicating corrective actions have been implemented since the issuance of the FDA483, Inspectional Observations, on October 26, 2009.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Ms. Rosemary Sexton, Compliance Officer, Food and Drug Administration located at 550 W. Jackson Blvd., 16th Floor, Chicago, IL 60661. If you have questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225 or rosemary.sexton@fda.hhs.gov.
Sincerely,
/S/
Scott J. MacIntire
District Director
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