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  5. St. Moritz Bakery Inc - 476843 - 03/11/2016
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CLOSEOUT LETTER

St. Moritz Bakery Inc MARCS-CMS 476843 —


Recipient:
Recipient Name
Mr. Manfred H. Maehler,
St. Moritz Bakery Inc

1943 Avenida Plaza Real

Oceanside, CA 92056
United States

Issuing Office:
Los Angeles District Office

United States


  

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
 
March 11, 2016                                                                                                 
WL# 23-16
Manfred H. Maehler
President and CEO
St. Moritz Bakery Inc. dba Mahler’s Bakery
1943 Avenida Plaza Real
Oceanside, CA 92056
 
On July 7 through July 9, 2015, the United States Food and Drug Administration (FDA) conducted an inspection of your firm located at 1943 Avenida Plaza Real, Oceanside, CA. During this inspection, the FDA collected labels of your “California Lifestyle Flax + Soy Bread”, “California Lifestyle Vegetable Protein Bread” and “California Lifestyle Cinnamon Walnut with Flax & Soy” products. The Food and Drug Administration (FDA or we) reviewed the labels for these products and determined that your “California Lifestyle Flax + Soy Bread”, “California Lifestyle Vegetable Protein Bread” and “California Lifestyle Cinnamon Walnut with Flax & Soy” products are misbranded in violation of the Federal Food, Drug, and Cosmetic Act (the Act) [Title 21, United States Code (U.S.C.), sections 301 et seq.] and the applicable regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
1.    Your “California Lifestyle Flax + Soy Bread,” “Vegetable Protein Bread” and “Cinnamon Walnut with Flax & Soy” products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. §343(q)], in that the nutrition facts information is not presented in the appropriate format in accordance with 21 CFR 101.9. For example:
  • The labels contain the claim “High Protein” and fail to declare a %DV for protein, which is required when a nutrient content claim is made [21 CFR 101.9(c)(7)(i)]. 
2.    Your “California Lifestyle Flax + Soy Bread,” “Vegetable Protein Bread” and “Cinnamon Walnut with Flax & Soy” products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labels bear nutrient content claims, but the products do not meet the requirements to bear the 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 labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirement pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. For example:
  • The “California Lifestyle Flax + Soy Bread” and “Cinnamon Walnut with Flax & Soy” products bear the claim “extra protein” on the back panel. “Extra protein” is a claim that is authorized under 21 CFR 101.54(e) and requires identification of the reference food, among other information. However, the products do not meet the requirements for the claim, in part, because the label claims do not identify the reference food and the percentage that the protein is greater relative to the DRV (21 CFR 101.54(e)(1)(iii)(A)), or the quantitative information comparing the level of the nutrient in the product per labeled serving with that of the reference food that it replaces (21 CFR 101.54(e)(1)(iii)(B)).
  • The “California Lifestyle Flax + Soy Bread” and “Vegetable Protein Bread” products bear the claim “A Good Source of Fiber.” However, the products are not “low” in total fat as defined in 21 CFR 101.62(b)(2) and the claims do not disclose the level of total fat per labeled serving in accordance with 21 CFR 101.54(d)(1). Under 21 CFR 101.62(b)(2), a bread product is “low fat” if it contains 3g or less of fat per RACC. These products declare 3 grams of fat per 34 grams of bread, which equates to 4 grams of fat per 50 gram RACC.
  • The California Lifestyle Flax + Soy Bread, Vegetable Protein Bread and Cinnamon Walnut with Flax & Soy products bear the claim “Low Carb.” FDA has not defined nutrient content claims for carbohydrates; therefore, the use of this claim misbrands your product under section 403(r)(1)(A) of the Act.
3.    Your “California Lifestyle Flax + Soy Bread,” “Vegetable Protein Bread” and “Cinnamon Walnut with Flax & Soy” products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. §343(f)] because the labels fail to list the address of the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
We also offer the following comments:
  • We note that your “California Lifestyle Flax + Soy Bread, Vegetable Protein Bread” and “Cinnamon Walnut with Flax & Soy” products bear the claim “Low Carb Bread Diabetes.”   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), FDA revoked 21 CFR 105.67, concluding that its provisions for diabetic labeling were outdated and misleading. FDA further concluded that the use of label statements identifying specific foods as particularly useful for diabetics was misleading. Therefore, we recommend you remove the claim “Low Carb Diabetes” from your product labeling.
  • Your “California Lifestyle Cinnamon Walnut with Flax & Soy” product fails to declare the statement of identity of the food, bread, on the principal display panel as required by 21 CFR 101.3.
  • Your “California Lifestyle Flax + Soy Bread” and “Cinnamon Walnut with Flax & Soy” products have the statement “Allergy Information: Made in a facility that uses tree nuts and soy.” This language implies that these products do not intentionally contain tree nuts or soy, but that they might be exposed to cross-contact with those ingredients as a result of other activities within your facility. But in fact, “Soy Flour,” “Almond Meal,” and “Sliced Almonds” are ingredients in both of these products, and “Walnuts” are an ingredient in your “Cinnamon Walnut with Flax & Soy” product.
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. It is your responsibility to ensure the products you manufacture and distribute are in compliance with all requirements of the Act and applicable FDA regulations.
 
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice. 
 
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 Marco Esteves at (949) 608-4439. Include special identifier FEI # (b)(4) in all response correspondence.
 
Your written response should be sent to Daniel Cline, Acting Director Compliance Branch, U.S. Food and Drug Administration, Los Angeles District, 19701 Fairchild, Irvine, CA 92612.
 
Sincerely,
/S/ 
LCDR Steven Porter, Acting Director
Los Angeles District
 
 
CC:     
David M. Mazzera, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435                  
Sacramento, CA 95899-7435

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