FDA WARNING_LETTER - Today's Temptations, Inc. - October 26, 2009

On October 14-26, 2009, the FDA inspected Today's Temptations, Inc., a bakery product manufacturer and distributor. The inspection revealed multiple misbranding violations under the Federal Food, Drug, and Cosmetic Act.

The "Whole Wheat bread" product was misbranded due to unauthorized nutrient content claims ("Fat Free," "Hi-Fibre," "Sugar Free," "Only 2g Digestible Carbs") that did not meet regulatory requirements (21 CFR 101.62(b), 21 CFR 101.60(c)(1)). Specifically, the "fat free" claim was made despite containing canola oil without proper disclosure, and the "sugar free" claim failed to meet calorie labeling requirements. The "Only 2g Digestible Carbs" claim was unauthorized. Additionally, the "Whole Wheat bread" was misbranded for failing to declare eggs, a major food allergen, as required by Section 403(w) of the Act. Its nutrition facts panel was also deficient, lacking serving size in common household measures, vitamin/mineral amounts, the required footnote, and grams of sugar alcohol (21 CFR 101.9).

"Kolaczki Cookies" were misbranded for failing to declare sub-ingredients of multi-component ingredients like margarine and assorted fillings (21 CFR 101.4(b)(2)). Both "Kolaczki