FDA WARNING_LETTER - Julian Bakery, Inc.

On February 19, 2014, the FDA inspected Julian Bakery, Inc. in Oceanside, CA, collecting samples of Net Carb Zero Bread and Paleo Bread. Analysis and label review, including the firm's website, revealed that both products are misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act. Key violations for Net Carb Zero Bread include misrepresentation of calorie content (found 54.4 calories vs. 35 declared, exceeding 20% tolerance per 21 CFR 101.9(g)(5)) and total fat content (found 0.72g vs. 2.5g declared, below tolerance per 21 CFR 101.9(g)(6)). The "0g Net Carbs" claim was found false or misleading due to inconsistency with declared carbohydrates and sugars. For Paleo Bread, a "high protein" claim on the website was unauthorized as the product did not meet 21 CFR 101.54(b) criteria. Additional labeling deficiencies for both products included an incomplete required footnote (21 CFR 101.9(d)(9)), the Net Carb Zero product lacking a proper statement of identity as bread (21 CFR 101.3(a)), and the term "gluten free" incorrectly used for oat fiber (21 CFR 101.4(a)). Furthermore, the Net Carb Zero Bread's website declared "0g Sugars" and "sugar free," contradicting the product label's 1 gram of sugars. Julian Bakery, Inc. is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines must be submitted within fifteen working days, with failure to comply potentially leading to regulatory actions such as seizure or injunction.