Stew Leonard’s Holdings LLC - 681214 - 11/18/2024 (2024)

November 18, 2024

WARNING LETTER

Ref: CMS Case #681214

Dear Mr. Leonard:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 99 Federal Rd., Danbury, CT from January 26, 2024 to February 12, 2024. Based on inspectional findings and review of the product labels collected during the inspection, we have identified significant 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 FDA’s homepage at www.fda.gov.

On January 23, 2024, after being notified of a consumer complaint received by the FDA regarding an anaphylactic death associated with Stew Leonard’s brand Florentine Cookies, your firm recalled the cookies. The products contained peanuts and eggs but your printed label on the package did not contain an allergen statement or ingredient declaration for peanuts or eggs.

1. Your Florentine Cookies products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergens, peanuts and egg, as required by section 403(w)(1) of the Act. Specifically, your Florentine Cookies products are manufactured for you using peanuts and eggs as ingredients, but these ingredients are not listed on the finished product label.

Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as “major food allergens.” A food is misbranded under section 403(w) of the Act 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., “Whey (Milk)”), except 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)].

2. Your Florentine Cookies and Rainbow Cookies products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients, and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically,

• The Florentine Cookies product is manufactured with the following ingredients that are not declared on your finished product label: peanuts, eggs, margarine (and its sub-ingredients), citric acid, mixed tocopherols, and palm kernel oil.
• The Rainbow Cookies product is manufactured with the following ingredients that are not declared on your finished product label: Rice Flour, Apricot Kernels, Raspberries, Baking Powder (Sodium Acid Pyrophosphate, Baking Soda, Corn Starch, Monocalcium Phosphate), Wheat Gluten, Potassium Sorbate Preservative, Calcium Citrate, Fruit Juice Color, Vegetable Juice Color, Sodium Lauryl Sulfate, Calcium Chloride, Carnauba Wax, and Xanthan Gum. Further, we note that your finished product label does not appear to have been updated after changing cookie suppliers.

According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

3. Your Rainbow Cookies product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the Nutrition Facts label (NFL) is not in accordance with 21 CFR 101.9. Specifically, the NFL is not in the correct format. For example:
a. The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii).
b. It lacks the declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii)
c. It lacks the declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii)
d. The footnote is not as required by 21 CFR 101.9(d)(9).

This letter is not intended to be an all-inclusive list of the violations that may exist 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 your facility 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, or injunction.

We also have the following comment:

• Your Florentine Cookies product lists “Sodium Benzoate” and “Soy Nuts” as ingredients which are not present on the ingredient list of the bulk cookies you receive. We note that your product label must accurately reflect the ingredients used to make this cookie. If the sodium benzoate ingredient performs a preservative function in this product, the function of the preservative must be declared to be in compliance with 21 CFR 101.22(j).

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 providing copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time frame 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.

Please send your reply to the Food and Drug Administration via email to HFP-OCE-Labeling@fda.hhs.gov. If sending a response by mail, address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Critical Foods and Dietary Supplement Enforcement HFS-608, 5001 Campus Drive, College Park, MD 20740.If you have any questions regarding any issues in this letter, please contact HFP-OCE-Labeling@fda.hhs.gov and include reference #681214 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program