Inspections, Compliance, Enforcement, and Criminal Investigations

Julian Bakery, Inc. 7/23/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612
 
Telephone:      949-608-2900
FAX:    949-608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
July 23, 2014                                                                                                     
WL # 27-14
Barbara L. Squier
President and Owner
Julian Bakery, Inc.
624 Garrison St.
Oceanside, CA 92054-4844
 
On February 19, 2014, the United States Food and Drug Administration (FDA) conducted an inspection of your firm located at 624 Garrison St., Oceanside, CA. During this inspection, the FDA collected samples of your Net Carb Zero Bread and the Paleo Bread products. An analysis of the collected samples and a review of your products’ labeling, including your website at http://www.julianbakery.com/ where you take orders for your products, demonstrate your Net Carb Zero Bread and Paleo Bread products are misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343].  You may find the Act and the referenced Code of Federal Regulations (CFR) through links on the FDA’s internet home page at www.fda.gov.
 
Your significant violations are as follows:
 
1.    Your Net Carb Zero Bread product is misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because the calorie content is greater than 20 percent in excess of the value for calories declared on the label [see 21 CFR 101.9(g)(5)]. Your label states the product contains 35 calories per serving size of 43 grams. However, FDA’s analysis found your product contained 54.4 calories per serving, which is 155% of the amount declared on the label. A check analysis found 53.1 and 57.7 calories per serving, which is 152% and 165% respectively, of the amount declared on the label. 
 
2.    Your Net Carb Zero Bread product is misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because the total fat content is lower than the amount declared on the label and this deficiency is not within current good manufacturing practices [see 21 CFR 101.9(g)(6)]. Your label states the total fat contained in the product is 2.5 grams per serving size of 43 grams. However, FDA’s analysis found your product contained 0.72 grams per serving, which is 28.7% of the amount declared on the label. A check analysis found 0.69 grams per serving, which is 27.6% of the amount declared on the label.
 
3.    Your Net Carb Zero Bread product is misbranded under Section 403(a)(1) of the Act in that the label is false or misleading because the label declares “0g Net Carbs,” but this statement is inconsistent with the nutrition information for carbohydrates on your product label as well as your stated definition for the term “Net Carbs” on the product label. Your label defines “Net Carbs” as follows: “Net Carbs: Subtract Fiber from Total Carbohydrates.” According to your product label, the quantity of Total Carbohydrates is 9g and the quantity of Dietary Fiber is 9g, however, the Sugars declaration on your label is 1 gram. Therefore, in accordance with your declaration for Sugars on your product label, the quantity of Total Carbohydrate for your product is actually 10 grams, which is inconsistent with your “0g Net Carbs” statement.
 
4.    Your Paleo Bread product is misbranded within the meaning of Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(l)(A)] because the labeling bears a nutrient content claim, but does not meet the requirements to make the claim. Under Section 403(r)(l)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the 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. 
 
Specifically, your website at http://www.julianbakery.com/ bears the claim “high protein,” but, according to the product labeling, does not meet the criteria to bear this claim in accordance with 21 CFR 101.54(b). The terms "high," "rich in," or "excellent source of" may be used on the label and in the labeling of foods, except meal products as defined in 21 CFR 101.13(l) and main dish products as defined in 21 CFR 101.13(m), provided that the food contains 20 percent or more of the Daily Value (DV) per reference amount customarily consumed (RACC). Your Paleo Bread product does not qualify to make a "high protein" claim because your website and the product label for your Paleo Bread, which bears the website, declare 7 g of protein per 43 gram serving, which is less than 20% of the DV for protein per 50 g RACC. 
 
The above violations outlined in this letter are not meant to be an all-inclusive list of deficiencies in your product or their labeling.  It is your responsibility to ensure all of your products comply with the Act and its implementing regulations.  You should take prompt action to correct the violations described in this letter and to establish procedures to ensure these violations do not recur. Failure to do so may result in regulatory action without further notice, including, but not limited to, seizure and/or injunction.
 
We also note the following regarding the labeling for yourNet Carb Zero and Paleo Bread products:
 
  • The required footnote for your Net Carb Zero and Paleo Bread products is incomplete [21 CFR 101.9(d)(9)]. The footnote is required on packages with space available to bear labeling greater than 40 square inches [21 CFR 101.9(j)(13)(ii)(C)].
 
  • The statement of identity for your Net Carb Zero product fails to identify the product as bread [21 CFR 101.3(a)]. The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.
 
  • The term "gluten free" is not part of the common or usual name for oat fiber in the ingredient statement for your Net Carb Zero Bread [21 CFR 101.4(a)].
 
  • At http://www.julianbakery.com/,  your Net Carb Zero Bread declares 0g of Sugars per serving and states that the product is "[S]ugar free"….  However, this is inconsistent with the actual product label, which declares 1 gram of Sugars in the Nutrition Facts panel.  
 
  • The labeling for your Net Carb Zero and Paleo Bread products have provided a meaning to the term “net carbs” that is used on your product labeling. However, FDA has not defined the term “net carbs” and we have concerns that this term may be misleading to consumers.
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you have any questions about this letter, please contact Compliance Officer Dr. Raymond W. Brullo at (949) 608-2918. Include special identifier FEI # 3009857633 in all response correspondence.
 
Your written response should be sent to Acting Director Compliance Branch, U.S. Food and Drug Administration, Los Angeles District, 19701 Fairchild, Irvine, CA 92612.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District 
 
Cc:      
Heath W. Squier, Vice President
Julian Bakery, Inc.
624 Garrison St.
Oceanside, CA 92054-4844
 
Hugo Cornejo, Acting Chief
California Food and Drug Branch
Department of Public Health
Food and Drug Branch
1500 Capital Avenue, MS-7602
Sacramento, CA 95899-7413
 

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