Inspections, Compliance, Enforcement, and Criminal Investigations
Food For Life Baking Company, Inc. 27-May-08
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
May 27, 2008
Robert James Torres, President
Food For Life Baking Company, Inc.
2991 Doherty Street
Corona, CA 92879-5811
Dear Mr. Torres:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2991 Doherty Street, Corona, CA 92879-5811 from November 27, 2007 to December 4, 2007. During the inspection, we collected samples of labels and labeling for several of your products. Based on our review of your product labels and labeling, your Food For Life® Spelt Bread product is misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 343]. Regulations implementing requirements of the Act are found in Title 21 of the Code of Federal Regulations (21 CFR). You may find the Act and FDA regulations through links in FDA's homepage at www.fda.gov.
The labeling violations we noted are as follows:
1. Your Food For Life® Spelt Bread is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] because the label fails to list the food allergen wheat. 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 the exception of highly refined oils. 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 (e.g., "spelt (wheat)"), 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 Food For Life® Spelt Bread product is manufactured with spelt, which is Triticum spelta L. The term "wheat" in section 201(qq) means any species in the genus Triticum. Thus, for the purposes of section 201(qq), wheat includes grains such as spelt. See Guidance for Industry, Questions and Answers Regarding Food Allergens, Section II, #27, http://www.cfsan.fda.gov/~dms/alrguid4.html.
During the inspection, the investigator collected labels for your Food For Life® Spelt Bread. There were two different labels for this product in use on bags of this product at your facility, one bearing the statement of identity "Food For Life Wheat Alternative Fruit Juice Sweetened Spelt Bread," and the other bearing the statement of identity "Food For Life® Fruit Juice Sweetened Spelt Bread." The ingredient statement on both labels lists spelt as an ingredient; however, the labels do not declare the allergen "wheat". If you continue to use either of these labels on your Food For Life Spelt Bread, you must affix a self-adhesive sticker that cannot be easily removed to declare the allergen wheat. During the inspection, our investigator determined that only a small number of your Food For Life Spelt Bread labels present at your facility bore a sticker declaring the presence of wheat.
2. Your Food For Life® Spelt Bread product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because its labeling is false or misleading. The outer cartons for this product contain a sticker with the statement, "Wheat-Alternative Spelt Bread". Additionally, the label bearing the statement of identity "Food For Life® Wheat Alternative Fruit Juice Sweetened Spelt Bread" contains the statements "Wheat Alternative" and "This unique bread is designed for those looking for an alternative to wheat". These labeling statements falsely suggest that this product does not contain wheat; however, as explained above, this product contains spelt, which is a species of wheat.
3. Your Food For Life" Spelt Bread product labeled as "Food For Life® Wheat Alternative Fruit Juice Sweetened Spelt Bread" is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] because the label fails to declare trans fat as required in 21 CFR 101.9(c)(2)(ii).
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
In addition to the labeling violations mentioned above, we have the following labeling comment regarding your product: the ingredient statement on the Food For Life® Spelt Bread product lists soy lecithin as an ingredient. If a label uses a "Contains" statement to comply with section 403(w), the "Contains" statement must include all of the major food allergens in the product, including soy. Regarding the labeling of soy lecithin as an allergen under section 403(w), we note that FDA has issued guidance stating its intent to exercise enforcement discretion for a limited time for certain foods in which soy lecithin has been used as a component of a release agent; however, the guidance also states that FDA expects manufacturers of foods that use soy lecithin as a component of a release agent to revise the labels of their products to comply with FALCPA by the end of the enforcement discretion period. See "Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act" at http://www.cfsan.fda.gov/~dms/soyguld.html.
In addition, our investigator issued a Form FDA-483, Inspectional Observations, at the end of this inspection, and discussed these observations with you at that time. The observations listed on the FDA 483 pertained to current good manufacturing practice (CGMP) for foods. During the discussion with our investigator, you promised corrective action to address the GMP observations within 30 days. We will verify the implementation of these corrections during a future inspection.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include each step that has been or will be taken to completely correct the current violations and to prevent the recurrence of similar violations, the time within which correction will be completed, and any documentation necessary to show that the correction has been achieved. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
If you have any questions about this letter, please contact Compliance Officer Mariza Jafary at (949) 608-2977.
Your written reply should be addressed to:
Pamela B. Schweikert
Direct of Compliance
U.S. Food and Drug Administration
Irvine, CA 92612-2506
Alonza E. Cruse
Cc: Jeff Farrar, DVM, PhD, MPH
Department of Health Services
Food and Drug Branch
1500 Capitol Avenue
P.O.Box 997413, MS-7602
Sacramento, CA 95899-7413