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June 17, 2024

WARNING LETTER

Ref: CMS Case #672140

Dear Mr. Gavin:

This is to advise you that the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 738 W. Van Buren Street, Phoenix, AZ 85007 from October 3, 2023 through October 27, 2023 and the FDA-commissioned Kansas Department of Agriculture employees conducted a contracted inspection of your facility located at 5005 SW Wenger Street, Topeka, KS 66609 from November 13, 2023 through November 27, 2023. Based on the inspectional findings and review of your product labels we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

1. Your Sara Lee brand Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain ready-to-eat (RTE) bread loaf products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations. The Brownberry brand Whole Grains 12 Grains and Seeds RTE bread loaf product is misbranded for a similar reason; the product label includes walnuts, almonds, and hazelnuts in the ingredient and “Contains” statements; however, these nuts are not ingredients in the formulation of the product. FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls (see 21 CFR Part 117). Instead, firms must comply with applicable requirements to address allergen cross-contact.

2. Your Brownberry brand Whole Grains 12 Grains and Seeds product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that:
    a. You use (b)(4) for (b)(4), (b)(4) as (b)(4), and (b)(4) for (b)(4), but do not list these ingredients on the product label.
    b. The ingredient list declares “Kamut®” which is not part of the common or usual name of Khorasan wheat because it is a brand name. Furthermore, Khorasan is misspelled as “Khorsan.”

We understand that the (b)(4), (b)(4), and (b)(4) ingredients are not declared on the finished product label because you consider them to be present at insignificant levels and not to have a functional or technical effect on the product. However, you were previously informed that the (b)(4), and (b)(4) all provide technical functions in the finished product and therefore these ingredients do not meet the definition of processing aids described in 21 CFR § 101.100(a)(3)(ii) and must be declared on the label, as required by 21 CFR § 101.4.

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also offer the following comments:

• Separate from the food allergen labeling requirements of the Act, firms may voluntarily place other information or statements on the labels of food products to disclose information about allergens to consumers. For example, firms may choose to voluntarily place allergen advisory statements on products to alert consumers to the possible presence of major food allergens due to cross-contact. Any allergen advisory statement must be truthful and not misleading.
• During the state inspection, the inspector questioned why the Brown Sugar Powder and (b)(4) - Flavor were not declared on the label, and you stated that the Brown Sugar Powder and the (b)(4) ingredients meet the definition of “Natural Flavors” and are considered to be included as that on the label. According to 21 CFR § 101.22(a)(3), the term “natural flavor” means “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.” Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR §§ 182.10, 182.20, 182.40, and 182.50 and Part 184, and the substances listed in 21 CFR § 172.510. If these ingredients do not meet the definition of natural flavor contained in 21 CFR § 101.22(a)(3), they may not be declared as such on the label.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to Kathy Tormey, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at Kathleen.tormey@fda.hhs.gov. You may reach Ms. Tormey at (303) 236-3137 if you have any questions about this matter.

Sincerely,
/S/

E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4

Cc: Zeeshan NMI Hafiz, Director of Operations
Bimbo Bakeries USA, Inc.
738 W. Van Buren Street
Phoenix, AZ 85007-2546
Zeeshan.Hafiz@grupobimbo.com

Melissa D. Brossard, Plant Manager
Bimbo Bakeries USA, Inc.
5005 SW Wenger Street
Topeka, KS 66609
Melissa.brossard@grupobimbo.com